Braz J Cardiovasc Surg 2019;34(2):239-60

GUIDELINE

The Brazilian Society for Cardiovascular Surgery

(SBCCV) and Brazilian Society for Extracorporeal
Circulation (SBCEC) Standards and Guidelines
for Perfusion Practice
Luiz Fernando Caneo1, MD, PhD; Gregory Matte2, CCP, LP, FPP; Robert Groom3, PhD; Rodolfo A. Neirotti4, MD,
PhD, FEACTS; Paulo Manuel Pêgo-Fernandes5, MD, PhD; Juan Alberto C. Mejia6, MD, PhD; Fernando Augusto
Marinho dos Santos Figueira7, MD; Élio Barreto de Carvalho Filho8, MSc; Fábio Murilo da Costa8, Sintya Tertuliano
Chalegre9,10, MSc; Renato Abdala Karam Kalil11, MD, MSc, PhD; Rui M. S. Almeida12, MD, MSc, PhD; on behalf of
DECAM/SBCCV13 and SBCEC14

DOI: 10.21470/1678-9741-2018-0347

A primary role for clinical medicine societies is to develop the published American Society for Extracorporeal Technology
standards and guidelines for practice as an instrument to (AmSECT) with a phased adoption recommendation set as an
promote safe and effective patient care. The Brazilian Society for achievable goal. Further, we recommend that cardiac surgery
Cardiovascular Surgery (SBCCV) represented by its Department programs develop institution-specific protocols to support the
for Mechanical Circulatory Assistance (DECAM) and the the clinical use of these guidelines.
Brazilian Society for Extracorporeal Circulation (SBCEC) conducted
a careful critical review of current clinical perfusion practices in The Pioneering Era of Cardiac Surgery
Brazil. In addition, a literature review focused on patient safety
and surgical outcomes in cardiac surgery was performed. This Open heart surgery has developed considerably over the
is the first joint initiative of these two societies (SBCCV/SBCEC) past several decades including numerous pioneering efforts
to provide a framework for safe and effective clinical perfusion in Brazil regarding biomedical engineering and circulatory
practice for our cardiac surgery patients. The purpose of this support[1]. Pioneer surgeons, such as John Kirklin, Francis Fontan,
pioneering work was to develop guidelines for the perfusion Euryclides Zerbini, Adib Jatene, and Denton Cooley were part of
profession and for those involved in cardiopulmonary bypass our lives and we were able to study their papers, witness their
(CPB) technology in our country. Both the SBCCV and the SBCEC presentations and participate in professional discussions. They
recommend that institutions and clinical teams adopt the are passing away one after another but their work, techniques,
standards and guidelines outlined in this text. The standards experience and wisdom stays with us as their legacy. The
and guidelines we recommend are based on those published by impact of their methods profoundly changed the lives of our

1 12
Cardiovascular Surgery Division, Instituto do Coração, Hospital das Clínicas da Universidade Estadual do Oeste do Paraná (UNIOESTE), Cascavel, PR, Brazil.
13
Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São Departamento de Assistência Circulatória Mecânica (DECAM) da Sociedade
Paulo, SP, Brazil. Brasileira de Cirurgia Cardiovascular (SBCCV), São Paulo, SP, Brazil.
2 14
Department of Cardiac Surgery, Boston Children’s Hospital, Boston, MA, USA. Sociedade Brasileira de Circulação Extracorpórea (SBCEC), São Paulo, SP, Brazil.
3
Maine Medical Partners - Cardiothoracic Surgery, Portland, USA.
4
Clinical Professor of Surgery and Pediatrics, Emeritus Michigan State University,
Correspondence Address:
MI, USA.
5 Luiz Fernando Caneo
Thoracic Surgery Division of the Instituto do Coração, Hospital das Clínicas da
https://orcid.org/0000-0001-5545-8172
Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da
Paulo, SP, Brazil.
6 Universidade de São Paulo (InCor-HCFMUSP) – Pediatric Cardiac Surgery Unit
Unidade de Transplante e Insuficiência Cardíaca do Hospital de Messejana Dr.
Av. Dr. Eneas de Carvalho Aguiar, 44 – Bloco II, 2° andar, sala 5 – São Paulo, SP, Brazil
Carlos Alberto Studart Gomes, Fortaleza, CE, Brazil.
7 Zip code: 05403-900
Instituto de Medicina Integral Professor Fernando Figueira (IMIP), Recife, PE, Brazil.
8 E-mail: [email protected]
Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil.
9
Pronto-Socorro Cardiológico de Pernambuco, (PROCAPE), Recife, PE, Brazil.
10
Universidade de Pernambuco (UPE), Recife, PE, Brazil. Article received on October 30th, 2018.
11
Instituto de Cardiologia do Rio Grande do Sul – Fundação Universitária de Article accepted on October 30th, 2018.
Cardiologia, Porto Alegre, RS, Brazil. Fast Track

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for Extracorporeal Circulation (SBCEC) Standards and Guidelines for Perfusion Practice

patients with congenital heart defects, giving them the chance are in discussion with the Federal Councils regarding ways for
of enjoying a better quality of life. Now, the pioneering era of this activity to be uniformly recognized by the Professions and
cardiac surgery has essentially ended in Brazil. subsequently legalized with a federal law regulating perfusion
Congenital cardiac surgery is markedly changing and activities. Brazilian perfusionists must have the education, tools
surgeon-centered outcomes are being replaced by team- and authority to perform their job and to become active and
based efforts with new paradigms requiring an adaptive work respected members of the multidisciplinary cardiac surgery team.
environment in institutions where cardiac surgery is performed. Several limitations currently exist which impair the advancement
As William Norwood aptly put in his paper, Our Roots, of perfusion practice, including educational gaps, a lack of case
Our Future[1,2], "Institutions are not what they are by historical ownership, and a lack of tools to assess the adequacy of perfusion
prerogative: the people walking the halls are responsible for in real time during surgery. This is a vicious cycle which impacts
maintaining the legacy and creating new vistas." That being said, outcomes and patient safety.
we need to continue the initial work of our pioneers and press On a positive note, it is important to highlight the progress
on upgrading their achievements to ever higher standards. The made by the Brazilian Society of Extracorporeal Circulation.
era we have now entered is no longer about quantity, it is about Supported and stimulated by their society, a significant
achieving excellent whole-patient quality outcomes including number of Brazilian perfusionists have had the opportunity to
optimized neurologic outcomes. We must dig deep into issues attend symposium-based perfusion related courses, exchange
that impact the quality of outcomes, teamwork and overall experiences with more advanced international programs and
transparency in our respective professions. to discuss current techniques of extracorporeal circulation with
local perfusionists and those from abroad.
Reviewing Perfusion Practice: Time to Stop Living in the Past In more developed countries, perfusionists have the freedom
to choose perfusion products according their performance, their
Brazil has a strong history of innovation that extends back to
patient population's needs, and the information available in the
the earliest days of cardiac surgery when our centers pioneered
literature. Each component is selected via an independent decision
advances in heart-lung machines (HLMs), cardiac valves, conduit
with the ideal components used to build the circuit. Alternatively,
implants, and surgical techniques. Brazil started to produce
in Brazilian perfusion practice, it is difficult to be objective since
their own HLMs in 1959 and indeed used one of them to
product decisions are almost exclusively based on price and
perform the first heart transplantation in South America. These
subjective preferences due to the lack of scientific publications
innovations highlighted the teamwork primarily of surgeons and
comparing Brazilian perfusion products with those available in
biomedical engineers. This was natural since surgeons and other
other markets. In our country, oxygenator manufacturers typically
physicians were the first ‘perfusionists'. Additionally, perfusion
provide complimentary HLMs with an agreement that their
products, including a series of oxygenators, were developed
oxygenator can only be guaranteed on their HLM. There is an
and manufactured domestically. While we fondly remember
obvious conflict of interest with such an agreement. This implied
these great achievements, we also need to focus on the future.
agreement has no scientific basis and, to our knowledge, is not
Unfortunately, there are still people living in the past and not
practiced elsewhere which speaks to the need for change in
adapting to evolving cardiac surgery and perfusion practices. We
Brazilian cardiac surgery. Again, our culture needs to adapt to end
continue to blame our economic burden for the stagnation of
such practices for the benefit of our patients. This is even more
our practice while paying little to no attention to the need for
of a concern when one notes that the majority of HLMs made
cultural change in the operating room.
and used in Brazil do not have servoregulating safety devices
Furthermore, clinical perfusion has not been recognized by
incorporated for arterial flow, cardioplegia delivery, level sensing,
the government as a distinctive profession until quite recently.
and bubble detectors. Servoregulation for HLM functions is not
Currently, only five professional councils recognize Perfusion
enough. Perfusionists must also be trained to operate the devices.
as a specialty for their undergraduates: Biology, Biomedicine,
Standards for perfusion practice, including the use of safety
Nursing, Pharmacy, and Physiotherapy. These professions do not
devices, must be established and adhered to.
have a standardized perfusion-specific curriculum. Consequently,
perfusionist education and training is heterogenous. Furthermore,
Why are Clinical Perfusion Standards so Important?
it is still the case in Brazil that perfusionists must follow the
instructions of surgeons and anesthesiologists. In fact, the conduct The Gritten Report[3] published by the University Hospitals
of perfusion is only considered a medical act once the perfusion of Bristol National Health Service (NHS) Foundation Trust of
record is signed by the surgeon. This practice risks perfusionists Great Britain described the death of a five-month-old infant
not taking full ownership for the conduct of CPB and that raises undergoing complex cardiac surgery and was released May
serious safety concerns since the surgeon and anesthesiologist 25, 2005. The Root Cause Analysis (RCA) report was led by Mark
have much to attend to during cardiac surgery and the Gritten, an independent and nationally known NHS senior
perfusionist is the individual who can best manage extracorporeal professional. A police investigation and coroner's inquest
support with all of its nuances. These facts support the outdated labeled the case 'unlawful killing‘. In English law, unlawful killing
paradigm whereby perfusionists are essentially asked to follow the means that the killing was made without lawful excuse and in
instructions of surgeons and anesthesiologists during CPB instead violation of criminal law including murder, manslaughter, and
of working collaboratively within a famework of well-developed infanticide. The finding of unlawful killing must be beyond
perfusion practice guidelines. Currently, the SBCEC and the SBCCV reasonable doubt; that is, the evidence must be overwhelmingly

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Extracorporeal Circulation (SBCEC) Standards and Guidelines for Perfusion Practice

obvious that death would result from the act when all factors are Considering our context, the effort of publishing this
taken into account. Otherwise, a verdict of accidental death or document by the societies SBCCV and SBCEC should be
death by misadventure would apply. The death was the result considered as one of most important steps for the future of
of a calcium overdose by a perfusionist that caused irreversible cardiopulmonary bypass practice in Brazil.
brain damage and subsequent death the day after surgery. The The “holy trinity” for the cardiac surgey patient— perfusionist,
hospital put safeguards into place immediately to minimize any surgeon and anesthesist— is a critical issue for optimal
similar incidents happening again. Also, the National Society of outcomes in cardiac surgery. Therefore, publication in Brazil of
Perfusionists perhaps carried some responsibility for this incident the Standards and Guidelines for Perfusion Practice aims not only
because it does not appear to have disseminated other perfusion to improve CPB but also to improve overall surgical outcomes as
incidents between its members. an important quality improvment initiative.
The report concluded that this was a unique but avoidable
incident that resulted in an indictment not just to the perfusionist Perfusion and the Pediatric Cardiac Surgery:
involved in the accident, but to all perfusionists and the perfusion
profession as a whole in Great Britain. Had a similar incident In the early 1950s, the pioneers of congenital cardiac
happened in São Paulo or Rio or elsewhere in Brazil, would the surgery, among them— Bigelow, Lewis, Kirklin, Gibbon and
SBCEC or SBCCV also be held responsible? others— realized that the time available with hypothermia
Perfusion practice during cardiovascular surgery is recognized and inflow occlusion would not be sufficient to safely perform
in the international literature as a critical component to successful lenghty intracardiac operations and that an extracorporeal
patient outcomes. Therefore, as medical societies, we have the support system would be needed. In 1954, Lillehei introduced
responsibility to change our culture, our commercial practices, the technique of controlled cross-circulation, in which a
legislation, regulations and whatever else which involves our patient’s parent functioned as the extracorporeal pump and
specialty which can improve patient outcomes[4,5]. The intent of oxygenator— a system that put both the parent and the child at
our proposed standards and guidelines document is to provide risk. Therefore, the development of mechanical cardiopulmonary
a modern framework for the practice of cardiopulmonary bypass bypass circuits in the late 1950s was an important step for the
in Brazil that can maximize patient safety and outcomes. progress of congenital cardiac surgery. Since then, extracorporeal
The standards and guidelines document we developed perfusion circuits have come a long way to the current low prime
for perfusion practice in Brazil is based on publications from membrane oxygenators, the use of centrifugal pumps, vacuum-
AmSECT[6,7]. It focuses on the role of written institutional protocols assisted venous drainage, electronic gas blenders, in-line oxygen
to dictate clinical practice. We worked on four main subjects: analyzers and other important devices.
a. empowerment of perfusion as profession with a focus on The array and complexity of the equipment, the perfusion
professional qualification and education standards techniques to manage a wide variety of patient’s age and size
b. standardization of perfusion practices along with the broad spectrum of surgical procedures are real
c. mandatory safety devices challenges that require properly trained and knowledgeable
d. importance of non-technical skills and patient centered perfusionists.
team work Because one size does not fit all, the need for a standalone
Standards and Guidelines document to perform perfusion for
Professional Constraints: congenital heart surgery is unquestionable and it will in many
ways be unique as compared to the one used for the correction
Although perfusion is considered a medical act, Perfusion of acquired heart disease in adults.
as a profession is still not fully regulated in Brazil. Consequently, Providing cardiopulmonary support for repair of congenital
the legal responsibility for what happens at the pump is unclear. heart lesions has become a specialty standing on its own. This
The surgeon’s knowledge of what is actually happening on context should determine the strategies and processes to address
the pump at all times during an operation depends upon their
these issues; the professionals, administrators, and professional
communications with the perfusionist. The surgeon’s signature on
societies should be engaged in planning, setting and articulating
the perfusion record is a formality which does not ensure proper
the goals of robust pediatric perfusion standards and guidelines
care during CPB. This practice jeopardizes the development of a
to improve the outcomes in pediatric cardiac surgery.
new generation of perfusionists who should be taking ownership
The Brazilian Society for Cardiovascular Surgery (SBCCV)
for their individual perfusion cases and, of course, introducing
and the Brazilian Society for Extracorporeal Circulation (SBCEC)
the necessary changes to modernize existing clinical practices.
Standards and Guidelines for Perfusion Practice address
The Perfusionist must be responsible for the whole procedure of
perfusion in general. We believe that developing a specific
extracorporeal circulation and be an active member of the cardiac
Brazilian Pediatric Perfusion Standards and Guidelines document
surgery team, as is the case with most enters abroad.
is essential and that it should be published in the near future to
According to the SBCEC, perfusionists are expected to have:
complement this document.
a. Dedication to the patient
b. Full integration with the team in which they work
Development of this Document
c. Professional competence
d. Personal ethical and professional conduct, as well as The Standards and Guidelines for Perfusion Practice will serve
being zealous, affable, aware and observant. as a useful guide for Brazilian cardiac surgical teams to develop

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for Extracorporeal Circulation (SBCEC) Standards and Guidelines for Perfusion Practice

institution-specific protocols aimed at improving the reliability, accept this document as an official position for the Standards
safety, and effectiveness of cardiopulmonary bypass. We are and Guidelines for Perfusion Practice in Brazil. Both documents
aware that the development of a Standards and Guidelines are included in this manuscript. The SBCCV and SBCEC
for Perfusion document alone will not change patient care or endorse this comprehensive report and strongly recommend
outcomes. Safe, reliable, and effective care will be best served implementation.
through the implementation of institutional protocols based on
these standards. SBCCV/SBCEC’s Standards and Guidelines for Minimum Standards for Perfusion Practice in Brazil:
Perfusion Practice reflect the changing landscape for perfusion
Seven standards were identified as the minimum
leading to the safe and optimal provision of cardiopulmonary
recomendation for perfusion practice. The SBCCV and SBCEC
bypass for our patients as well as a working team-based
considers these seven standards as mandatory for all cardiac
environment that is supportive of these policies.
surgical centers (Appendix 1).
We preferred to name this document “Standards and
Guidelines for Perfusion Practice” because this terminology is
SBCCV/SBCEC Comprehensive Standards and Guidelines for
contemporary and coincides with the language used by other
Perfusion Practice in Brazil:
professional medical societies, including AmSECT [8].
The SBCCV/SBCEC Standards and Guidelines for Perfusion The Perfusion Standards listed in Appendix 2 have been
Practice: 2018 is primarily based on a previous document modified and adapted to the Brazilian regulatoy agencies’
developed by AmSECT, through its Perfusion Quality Committee. policies and recommendations, by taking The American
Initially, AmSECT developed a draft standard for perfusion Society of ExtraCorporeal Technology (AmSECT) Standards and
entitled the “Essentials for Perfusion Practice, Clinical Function: Guidelines as a model[7] and translated to Portuguese. The final
Conduct of Extracorporeal Circulation,” which was originally document consists of 15 areas of practice including 50 Standards
endorsed by the membership in 1993[9], and then reviewed and and 38 Guidelines (Appendix 1) with the first standard focusing
revised on a number of occasions[10-12]. In 2011, the AmSECT on the development of institutional protocols to support
Board of Directors (BOD) asked the International Consortium their implementation and use. Each institution must commit
for Evidence-Based Perfusion (ICEBP) subcommittee to review to working towards implementing all standards for patients
and update the “Essentials and Guidelines” document. The ICEBP undergoing cardiovascular surgery.
conducted a careful review and critique of the document as well
as its relevance and purpose, given the focus on patient safety Terminology
and surgical outcomes. This initiative resulted in a revised joint
The SBCCV and SBCEC would like to point out that cardiac
document entitled, the Report from AmSECT’s, International
surgery clinicians must understand the terminology used in this
Consortium for Evidence-Based Perfusion American Society
report. The meanings of these words, as described in the AmSECT
of ExtraCorporeal Technology Standards and Guidelines for
publications, are listed below in order to facilitate understanding
Perfusion Practice: 2013[13]. It was developed as an outgrowth of
and adoption of the Standards and Guidelines[7]:
marrying evidence-based practices from the literature with an
understanding of the context in which care is currently provided. Standards: practices, technology, and/or conduct of
Quite notably at the same time, the Minimum Standards for care that institutions shall meet to fulfill the minimum
Perfusion Practice in Brazil document was developed as an requirements for cardiopulmonary bypass
outgrowth of ongoing collaboration with the International Guidelines: recommendation that should be considered
Quality Improvement Collaborative for Congenital Heart Surgery and may assist in the development and implementation of
(IQIC) which is managed from Boston Children’s Hospital and protocols
overseen by an international steering committee. Adoption Protocols: an institution-specific written document, derived
of the Minimum Standards for Perfusion Practice in Brazil from professional standards and guidelines, which contains
document will empower perfusionists to effect change at their decision and treatment algorithms
institution by working towards practice standards endorsed by
their national organizations including minimum safety devices In this document, the word shall is used to indicate a
for all cardiopulmonary bypass cases, monitoring devices to help mandatory requirement
assess the adequacy of perfusion, and promotion of a team- In this document, the word should is used to indicate a
based appoach for the care of cardiac surgical patients. Our recommendation
vision to improve perfusion practice, and thus patient outcomes, In this document, the term surgical care team is used
is for the minimum standards to be adopted as soon as possible to indicate the components of the system: surgeon,
by Brazilian cardiac surgery teams with the comprehensive list anesthesiologist, perfusionist, nurse, and technicians
of AmSECT standards phased in as soon as practial given the
constraints discussed previously.
CONCLUSION
Following translation to Portuguese and critical review by
colleagues, this final document was presented to the SBCCV and The SBCCV and SBCEC both recognize the vital need for
SBCEC for their steering commitiee aproval. A majority of the cultural and clinical changes in the application of cardiopulmonary
members of the steering commities of both societies voted to bypass in Brazil. Cardiac surgery centers must adopt the Minimum

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Standards For Perfusion Practice in Brazil as soon as possible 13. Baker RA, Bronson SL, Dickinson TA, Fitzgerald DC, Likosky DS, Mellas
and work towards adopting the Comprehensive Standards NB, et al. Consortium for Evidence-Based Perfusion: American Society
and Guidelines for Perfusion Practice in Brazil moving forward. of Extracorporeal Technology Standards and Guidelines for Perfusion
Ultimately, a team-based approach utilizing nationally endorsed Practice: 2013. J Extra Corpor Technol. 2013 Sep;45(3):156-66.
standards will help ensure safe and optimal cardiopulmonary
bypass for all our patients and improve outcomes for the complex
population we serve.
RELEVANT PUBLICATIONS
ACKNOWLEGDEMENTS • American Society of ExtraCorporeal Technology [Internet].
The DECAM/SBCCV and SBCEC would like to thank AmSECT American Society of ExtraCorporeal Technology Standards
for graciously allowing us to use their pioneering efforts as and Guidelines for Perfusion Practice 5/23/2017) [Internet].
we work to improve perfusion practice in Brazil. Furthermore, Chicago (IL): American Society of ExtraCorporeal Technology;
the authors would like to thank Robert Baker, Chair of the c2019 [cited 2019 Feb 08]. Available from: http://www.
International Consortium for Evidence Based Perfusion (ICEBP) amsect.org/p/cm/ld/fid=1617
Executive Committee for his review of this document and expert • SBCEC: Sociedade Brasileira de Circulação Extracorpórea.
opinion as we developed this manuscript. Normas Brasileiras para o Exercício da Especialidade de
Perfusionista em Circulação Extracorpórea [Internet].
Campinas (SP): SBCEC; 2017 [cited 2018 Feb 08]. 54 p.
Available from: http://www.sbcec.com.br/br/images/pdf/
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7. SBCEC: Sociedade Brasileira de Circulação Extracorpórea. Normas
• National Library of Medicine (US), National Institutes of
Brasileiras para o Exercício da Especialidade de Perfusionista em
Circulação Extracorpórea [Internet]. Campinas (SP): SBCEC; 2017 [cited
Health (US). Collection Development Manual: standards
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pdf/normas_brasileiras_cec.pdf Medicine (US), National Institutes of Health (US); 2004 [cited
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Appendix 1
essentials; approve revised code of ethics. Perfusion Life. 1993;10:14.
10. Kurusz M. Standards of practice in perfusion. Perfusion. 1994 Minimum Standards for Perfusion Practice in Brazil
May;9(3):211-5.
11. Hill AG, Kurusz M. Perfusion standards and guidelines. Perfusion. 1997 Minimum Standard 1: Perfusion practice must be guided by
Jul;12(4):251-5. a written set of policies developed within the institution and
12. Kurusz M. Standards update on perfusion equipment and practice. approved by physician leadership. (See also Comprehensive
Perfusion. 2005 Jul;20(4):205-8. Standard 1).

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for Extracorporeal Circulation (SBCEC) Standards and Guidelines for Perfusion Practice

Minimum Standard 2: Each perfusionist must be adequately equipe de perfusionistas deve participar das atividades anuais
trained through a defined education process. Staff must de educação continuada e dos programas de melhoria de
participate in annual continuing education activities and qualidade da instituição (para mais detalhes, veja Comprehensive
institutional based quality improvement programs. (See also Standards 2 e 13).
Comprehensive Standards 2 and 13).
Minimum Standard 3: A equipe cirúrgica deve discutir o plano
Minimum Standard 3: The care team must discuss the bypass de perfusão antes da incisão na pele, assim como anticoagulação
plan before incision; anticoagulation plan and target ACT values, e valores de TCA alvo, fluxos de perfusão, hematócrito alvo e
pump flows, hematocrit management, target temperature, política transfusional, temperatura alvo, estratégia de proteção
myocardial protection plan, blood gas management, blood miocárdica e manuseio da pressão arterial. A comunicação
pressure goals, etc. Closed-loop communication must be em alça fechada (closed loop) deve ser usada durante todo
used during the procedure. The care team must have real- o procedimento. A equipe deve promover uma discussão
time multidisciplinary discussion regarding all concerns during multidisciplinar em tempo real sobre todas as preocupações
bypass (i.e., blood pressure too low, poor venous drainage, durante a circulação extracorpórea (ou seja, pressão arterial muito
falling NIRS, need for blood product transfusion, etc.). (See also baixa, dificuldade com a drenagem venosa, queda dos valores da
Comprehensive Standards 1, 3, 5, 8 and 12). oximetria cerebral não invasiva – near-infrared spectroscopy –
NIRS, necessidade de hemoderivados, dentre outras) (para mais
Minimum Standard 4: Perfusion equipment must be maintained
detalhes, veja Comprehensive Standards 1, 3, 5, 8 e 12).
by qualified personnel. An appropriately sized selection of
equipment and standardized disposables must be used for each Minimum Standard 4: A manutenção do equipamento de
patient with back-up equipment available. Back-up supplies of perfusão deve ser realizada por pessoal qualificado. A escolha
cannulae and connectors, etc., must be located next to the primary adequada dos equipamentos necessários e dos descartáveis
perfusionist in the OR. The bypass circuit must be set-up on the padronizados em protocolo institucional deve ser realizada para
heart-lung machine before the patient arrives in the operating cada paciente, assim como um equipamento de reserva deve
room. (See also Comprehensive Standards 6 and 14). estar disponível para a perfusão. Os suprimentos e componentes
descartáveis do circuito (cânulas e conectores etc.) em
Minimum Standard 5: The perfusion record must include
duplicidade devem estar localizados o mais próximo possível do
sufficient timed data to reconstruct a bypass run, include the
perfusionista responsável pelo caso, preferencialmente na sala
prebypass checklist and list the products used for the case. The
de cirurgia. O circuito de circulação extracorpórea (CEC) deve ser
perfusion record must be part of part of the patient’s medical
montado na máquina de CEC antes que o paciente chegue à sala
record. (See also Comprehensive Standards 3,4, 5, 7, 8, 9 and 12).
de operação (para mais detalhes, veja Comprehensive Standards
Minimum Standard 6: The follow monitoring and safety 6 e 14).
devices must be used for all patients; patient and circuit
Minimum Standard 5: A ficha (registro) de perfusão deve
temperature probes, reservoir level sensor, bypass system and
incluir dados suficientes para reconstruir a perfusão por inteiro,
cardioplegia temperature and pressure, an arterial line filter, flow
incluindo um checklist pré-CEC e contendo todas as drogas e
probe, one-way valve on the vent line, back-up oxygen supply,
descartáveis utilizados para a condução do caso. A ficha de
SvO2 monitoring and a hand crank. The following items should
perfusão deve ser parte do prontuário médico do paciente
be considered for every case: NIRS monitoring and bubble
e deve ser anexada a ele. Uma cópia deve ser mantida com a
detection. Servoregulation must be utilized where available.
equipe de perfusão (para mais detalhes, veja Comprehensive
Blood gases must be verified on a defined schedule. (See also
Standards 3, 4, 5, 7, 8, 9 e 12).
Comprehensive Standards 6, 7, 10 and 11).
Minimum Standard 6: Os seguintes dispositivos de monitoração
Minimum Standard 7: The perfusion team must have adequate
e segurança devem ser utilizados para todos os pacientes:
storage space near the operating theater for back-up and
sensores de temperatura no paciente, no circuito venoso e
emergency supplies. A comfortable chair which allows for close
arterial e na cardioplegia; sensor de nível de reservatório; sensor
monitoring of the perfusion circuit should be available to the
de bolhas; sistema de pressão na linha arterial e na linha de
perfusoinist during bypass. (See also Comprehensive Standard 14).
infusão da cardioplegia; filtro de linha arterial; fluxômetro na
linha arterial; válvula unidirecional na linha aspiração da aorta/
Appendix 1 átrio esquerdo; cilindro de oxigênio de reserva; equipamento de
Padrões Mínimos para a Prática de Perfusão no Brasil monitoração da SvO2; monitor de oximetria cerebral contínua
(NIRS); detector de bolhas e “hand cranck” para manuseio manual
Minimum Standard 1: As práticas de perfusão devem ser da bomba arterial. A servorregulação deve ser utilizada sempre
orientadas por um conjunto de políticas desenvolvidas dentro da que disponível. Os gases no sangue devem ser verificados em
instituição, disponíveis na forma escrita e aprovadas pelo)a) chefe uma rotina predefinida em protocolo (para mais detalhes, veja
da equipe cirúrgica (para mais detalhes, veja Comprehensive Comprehensive Standards 6, 7, 10 e 11).
Standard 1).
Minimum Standard 7: A equipe de perfusão deve ter espaço
Minimum Standard 2: Cada perfusionista deve ser treinado de armazenamento adequado perto da sala de cirurgia para
adequadamente em um processo de formação definido. Toda a suprimentos de emergência. Uma cadeira confortável que

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permita um monitoramento próximo do circuito de perfusão performed by the perfusionist, flow of the operation, and
deve estar disponível durante a perfusão (para mais detalhes, location of primary and ancillary items required during CPB.
veja Comprehensive Standard 14). Support staff may include a perfusionist, nursing, technical,
or nontechnical staff.
Appendix 2 Guideline 2.3: A standardized process to educate, train, and
SBCCV/SBCEC Comprehensive Standards and Guidelines for to evaluate annually perfusion staff should be developed
Perfusion Practice in Brazil* and followed.

Standard 1: Development of Institutionally based Protocols Guideline 2.4: It is recommended any perfusion procedure
be conducted by two perfusionists, ensuring a better
Standard 1.1: As a mechanism for applying each standard procedural safety.
to clinical practice, an institution or service provider shall
develop and implement an operating procedure (protocol) Guideline 2.5: Use of Personal Protective Equipment: The
for each of the standards. perfusionist should use Personal Protective Equipment
(PPE), such as masks, goggles and procedure gloves while
Standard 1.2: The protocol shall be: conducting CPB. Gloves should be changed after drawing a
• Approved by the Chairman of Cardiac Surgery, or his or her blood sample, blood products administrtion and manipulation
designee, Director of Perfusion or equivalent, and other (blood bag) or whenever exposed to a blood splash[3].
relevant clinical governance committees if available.
• Reviewed and revised annually or more frequently when Standard 3: Perfusion Record
deemed necessary.
Standard 3.1: The perfusion record (written and/or
Guideline 1.1: Deviation from protocol may be at the electronic) for each CPB procedure shall be included as part
discretion of the Surgical Care Team and should be of the patient’s permanent medical record. The perfusion
documented in the perfusion record. record shall be maintained and stored according to institution
Standard 2: Qualification, Competency, and Support Staff policy for retaining patient medical records.

Standard 2.1: Extracorporeal circulation should only be Standard 3.2: The record shall include:
performed by a professional trained among the professions • Patient information including demographics and
recognized by SBCEC and SBCCV as competent to carry out preoperative risk factors (Appendix A)
the procedure; have a post-graduate degree recognized by • Information sufficient to accurately describe the
the Brazilian Ministry of Education (MEC) with minimum procedure, personnel, and equipment (Appendix B).
workload described in article 12 of the Brazilian Standards for • Patient physiological parameters documented at
the Exercise of the Specialty of Perfusionist in Extracorporeal a frequency determined by institutional protocol
Circulation or SBCEC Specialist Degree[1], validated by this (Appendix C).
society; or professionals who fall within the sole paragraph of • Blood gas and anticoagulation monitoring results
Article 2 of the aforementioned Standard. (Appendix D).
Standard 2.2: Perfusionist competency shall be assessed • Signature of the perfusionist (and all relief perfusionists)
annually to evaluate compliance with departmental performing the procedure.
protocols.
Guideline 3.1: There should be perfusion (writing and/or
Standard 2.3: The perfusionist shall attend, participate, and electronic) record for each performed CPB procedure. The
engage in perfusion-related continuing education courses perfusion record must include a free text space for recording
on an annual basis. comments, including verbal orders given by the medical staff,
Standard 2.4: Support staff shall be available on-site to assist including verbal orders given by the supervising physician.
the primary perfusionist during CPB procedures. Guideline 3.2: The perfusion record should include the
Guideline 2.1: An individual graduating from an accredited signatures of the physician(s) providing oversight for the CPB
perfusion education program should complete all procedure.
requirements for the Sociedade Brasileira de Circulação Guideline 3.3: Raw data (e.g., blood flow, pressure, and
Extracorpórea (SBCEC) certification.
temperature values) contained in electronic perfusion
Guideline 2.2: A standardized process should be developed databases should be stored for a time period in accordance
and followed to identify, orient, and educate support with your institution’s policy for retaining electronic patient
staff to ensure they have general knowledge of the duties medical records.

*Note: “The SBCCV/SBCEC Comprehensive Standards and Guidelines for Perfusion Practice in Brazil have been modified and adapted,
following Brazilian regulatory agencies’ policies and recommendation, from The American Society of Extracorporeal Technology
(AmSECT) Standards and Guidelines[2] and translated to Portuguese”

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Standard 4: Checklist Standard 6.2: A bubble detector shall be used during CPB
procedures.
Standard 4.1: The perfusionist shall use a checklist for each
• The gross/macrobubble detector shall be used to control
CPB procedure[4].
the arterial pump or to allow interruption of the arterial
Standard 4.2: Checklists shall be included as part of the blood flow.
patient’s permanent medical record. • The detector system shall include an audible and visual alarm
and be positioned according to manufacturer instructions
Guideline 4.1: The perfusionist should use checklists in a
for use to enable timely identification and action.
read-verify manner where critical steps that should have
been performed are confirmed[4]. Completion of the check- Standard 6.3: A level sensor shall be used during CPB
list should be performed by two people, one person being procedures using a (hard-shell) reservoir.
the primary perfusionist responsible for operation of the • The level sensor shall be either servo-regulated to control
heart lung machine during the intraoperative period. In the arterial pump or to allow interruption of the arterial
services where there is no availability of another professional blood flow.
perfusionist, a systematic routine of checking the items • The level sensor shall include an audible and visual alarm
contained in the checklist should be adopted, in order to and be positioned according to the manufacturer’s
minimize the occurrence of adverse events. instructions to allow an appropriate reaction time and a
safe operational volume.
Guideline 4.2: The perfusionist should use a checklist
throughout the entire perioperative period (e.g., setup, pre-
Standard 6.4: Temperature monitoring of the arterial outflow
bypass, initial onset of bypass, before cessation of bypass,
from the oxygenator shall be used during CPB procedures.
postbypass, and/or any return to bypass). • The temperature sensor shall include an audible and
Guideline 4.3: The perfusionist should use a checklist for visual alarm to prevent high arterial outlet temperatures.
other ancillary perfusion services (e.g., cell salvage, intra-aortic Standard 6.5: An arterial-line filter shall be used during CPB
balloon pump, extracorporeal membrane oxygenation). procedures.
Standard 5: Communication Standard 6.6: A one-way valve in the vent line shall be used
Standard 5.1: A patient-specific management plan for the during CPB procedures.
CPB procedure shall be prepared and communicated to Standard 6.7: A method for retrograde flow avoid- ance
the surgical team either during the preoperative briefing or when using a centrifugal pump shall be used during CPB
before beginning the procedure[5]. procedures.
Guideline 5.1: The use of cellular telephone technology in • At least one method to prevent retrograde flow shall be
the operating room should be avoided, since it is a distracting used for systems using centrifugal pumps for systemic
factor and predispose the patient to the risk of contamination circulation. Examples of retrograde avoidance systems
by potentially infectious bacteria, compromising the quality may include the following:
and safety of the health assistance. When their use is • One-way flow valves;
unavoidable, the devices must be pre-sanitized according to • Hard-stop detent controls to prevent accidental
the institution protocol for infection control[6-8]. reduction in pump speed;
• Electronically activated arterial line clamps; or
Guideline 5.2: Protocol-driven communication (e.g., closed- • A low-speed visual and audible alarm.
loop) should be used to acknowledge verbal commands,
verify the content, and reduce ambiguity[9-11]. Standard 6.8: An anesthetic gas scavenge line shall be used
whenever inhalation agents are introduced into the circuit
Guideline 5.3: The primary perfusionist should participate in during CPB procedures.
the postprocedure debrief with the surgical team.
Standard 6.9: Hand cranks shall be readily available during
Standard 6: Safety Devices CPB procedures.

Standard 6.1: Pressure monitoring of the arterial line, Standard 6.10: A back-up gas supply shall be available
cardioplegia delivery systems, and venous reservoir (when during CPB procedures.
vacuum assisted venous drainage is used) shall be used Standard 6.11: A back-up battery supply for the CPB
during CPB procedures. machine shall be available during CPB procedures.
• The pressure monitor shall be either servoregulated
Guideline 6.1: A ventilating gas oxygen analyzer should be
to control the arterial/cardioplegia pump or to allow
used during CPB procedures.
interruption to the arterial/cardioplegia flow.
• The pressure monitor shall include an audible and visual Guideline 6.2: A level sensor should be used during CPB
alarm. procedures using a soft-shell reservoir.

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• The level sensor should be either servo-regulated to • Pulmonary artery blood pressure.
control the arterial pump or to allow interruption of the
Guideline 7.4: Continuous in-line blood gas monitoring
arterial blood flow.
should be used during CPB.
• The level sensor should include an audible and visual
Guideline 7.5: Cerebral oximetry should be used during
alarm and be positioned according to manufacturer’s
CPB.
instructions to allow an appropriate reaction time and a
safe operational volume. Guideline 7.6: Arterial blood flow should be monitored
continually at a point in the CPB circuit where it accurately
• The use of an air bubble detector distal to the outlet can
reflects the flow delivered to the patient during CPB (e.g.,
be used as a surrogate level detector.
distal to intracircuit shunts).
Guideline 6.3: The tubing pack should be provided by
the manufacturer "pre-assembled", pre-connected and in Standard 8: Anticoagulation
a sterile tray separating the circuit that will be used in the
Standard 8.1: The perfusionist, in collaboration with the
surgical field of the one that will be mounted in the heart-
physician-in-charge, shall define the intended treatment
lung machine (HLM), offering more safety to the perfusion
algorithm for anticoagulation management (heparin) and
itsef and granting faster circuit assembly.
an alternative algorithm for when heparin is not suitable,
including acceptable ranges for activated clotting time (ACT).
Standard 7: Monitoring (obs: to be performed in conjunction
with Standard 3) Standard 8.2: The perfusionist shall work closely with the
surgical care team to monitor and treat the patient’s anti-
Standard 7.1: Patient arterial blood pressure shall be coagulation status before, during, and after the CPB period.
monitored continually during CPB.
Guideline 8.1: The surgical care team should determine
Standard 7.2: Arterial line pressure shall be monitored the target ACT by considering relevant factors, including
continually during CPB. variability in the measurement of ACT attributed to the
Standard 7.3: Arterial blood flow shall be monitored device’s performance characteristics.
continually during CPB. Guideline 8.2: Patient-specific initial heparin dose should be
Standard 7.4: Cardioplegia dose, delivery method, line determined by one of the following methods:
pressure (antegrade), coronary sinus pressure (retrograde), and • Weight;
ischemic intervals shall be monitored continually during CPB. • Dose–response curve (automated or manual);
• Blood volume; or
Standard 7.5: Patient and device temperatures shall be • Body surface area.
monitored continually during CPB.
• Patient (e.g., nasopharyngeal, rectal, bladder, esophageal). Guideline 8.3: Anticoagulation monitoring should include
• Heart–lung machine (arterial, venous and cardioplegia). the testing of ACT. Additional monitoring tests may include:
• Heater cooler (H2O temperature). • Heparin level measurement, e.g., heparin/protamine
titration or unfractionated heparin level;
Standard 7.6: Blood gas analyses shall be monitored con- • Partial thromboplastin time;
tinually or at regular intervals during CPB (Appendix D). • Thromboelastograph;
Standard 7.7: Hematocrit (or hemoglobin) shall be • Thrombin time; and/or
monitored continually during CPB. • Anti-Xa.
Any point-of-care (POC) device should be used under the
Standard 7.8: Oxygen fraction and gas flow rates shall be
hospital clinical laboratory policies. The Clinical Laboratory
monitored continually during CPB (Appendix D).
Director is responsible for all POCs tests performed within
Standard 7.9: The percentage of venous line occlusion of the the institution. The clinical laboratory should provide
venous occluder shall be monitored continually during CPB. documented standard procedures to all sites using POC
devices for guidance on its pre-analytical, analytical and
Standard 7.10: Venous oxygen saturation shall be monitored
post-analytical phases, including:
continually during CPB.
a. systematic recording and release of interim results;
Guideline 7.1: Carbon dioxide removal should be monitored b. procedure for potentially critical lab test results;
continually during CPB. c. systematic review of results and release of reports by
qualified professional.
Guideline 7.2: Arterial oxygen saturation should be
monitored continually during CPB. The clinical laboratory should keep records for the quality
control program as well as the standards procedures to
Guideline 7.3: The following patient pressures should be perform them. The clinical laboratory should promote and
monitored during CPB: maintain records of its ongoing users’ education process for
• Central venous pressure; and/or POC equipments[12].

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Guideline 8.4: Additional doses of heparin during CPB Standard 10.2: Devices used to measure gas exchange shall
should be determined by using an ACT and/or heparin/ be calibrated according to the manufacturer’s instructions
protamine titration. Note: in patients requiring longer for use.
CPB times (>2 to 3 hours), maintenance of higher and/or
Standard 10.3: Blood gas analysis shall be performed and
patient-specific heparin concentrations during CPB may be
recorded according to protocol.
considered to reduce hemostatic system activation, reduce
consumption of platelets and coagulation proteins, and to Guideline 10.1: Point-of-care testing should be considered
reduce blood transfusion (Class IIb, Level of evidence B)[13]. to provide accurate and timely information for blood gas
analysis[14].
Guideline 8.5: Heparin reversal should be confirmed by ACT
and/or heparin/protamine titration. Guideline 10.2: Oxygen delivery and consumption
calculations should be used to evaluate and optimize gas
Standard 9: Blood Management exchange[15]:

Standard 9.1: The perfusionist shall participate in efforts Oxygen delivery: DO2 = 10 CI CaO2
to minimize hemodilution and avoid unnecessary blood Oxygen consumption: VO2 = 10 CI (CaO2 – CvO2)
transfusions[13]. Where:
Standard 9.2: The perfusionist shall minimize the CPB circuit CaO2 (arterial oxygen content) = (Hb x 1.36 x SaO2) + (0.0031
size to reduce prime volume[13]. x PaO2)
and
Standard 9.3: The perfusionist shall calculate and CvO2 (mixed venous oxygen content) = (Hb x 1.36 x SvO2) +
communicate to the surgical team before initiating CPB a (0.0031 x PvO2)
patient’s predicted postdilutional hemoglobin or hematocrit.
CI = cardiac index
Guideline 9.1: Blood management efforts should include HB = hemoglobin
the following[13]: PaO2 = partial pressure of oxygen in arterial blood
• Participate in preoperative briefings (discussions) with the PvO2 = partial pressure of oxygen in venous blood
surgical care team (Standard 5.1) regarding transfusion SaO2 = arterial oxygen saturation
strategies and target hematocrit values. SvO2 = venous oxygen saturation
• Participation in a multidisciplinary blood management team.
• Minimize hemodilution by: Guideline 11.1: Variance from intended and targeted blood
• Matching the size of the CPB circuit to the size of the patient; flow should be communicated to the physician-in-charge.
• Autologous priming of CPB circuit, including retrograde Guideline 11.2: Appropriate blood flow rate should be
arterial and venous antegrade priming; determined by evaluation of:
• Biocompatible coating on the surface of all CPB • Acid base balance
components; • Base excess;
• Perioperative blood cell recovery and reinfusion after • Anesthetic level;
being appropriately processed; and CPB circuit blood • Arterial blood pressure;
salvage at the end of the procedure. • Cerebral oximetry;
Guideline 9.2: Point-of-care hemostasis monitoring should • Lactate burden; and
be used to minimize blood loss. • Oxygen delivery and consumption (refer to Guideline
10.2 for formulae).
Monitoring may include:
• Venous pO2
• International normalized ratio;
• Arterial pO2
• Partial thromboplastin time;
• Hemoglobin concentration
• Prothrombin time;
• Arterial oxygen saturation
• Thrombin time;
• Systemic vascular resistance (SVR);
• Thromboelastography/thromboelastometry;
• Temperature; and
• Platelet count; and/or
• Venous oxygen saturation.
• Platelet function analysis.
Standard 12: Blood Pressure
Standard 10: Gas Exchange
Standard 12.1: The perfusionist, in collaboration with
Standard 10.1: Gas exchange shall be maintained during the physician-in-charge, shall define and communicate
CPB according to protocol accounting for: the intended treatment algorithm for blood pressure
• The individual patient characteristics/risk profile; management before CPB, including acceptable ranges for
• Oxygenator type, design, and instructions for use; and blood pressure. Obs: in many circumstances, the physician-
• Blood flow, temperature, and metabolic demand. in-charge may direct the perfusionist to modify the intended

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blood pressure management to address circumstances Standard 14.2: Preventive maintenance on perfusion
occurring during the CPB procedure. equipment shall be performed and documented on a
regularly scheduled basis by the perfusion team and/or
Standard 12.2: The perfusionist shall work closely with the
appropriately trained and qualified biomedical engineering
surgical care team to maintain blood pressure according to
staff. Any or all of the following may determine the interval of
protocol during CPB.
such maintenance:
Guideline 12.1: Variance from intended and targeted blood • Manufacturer recommendations;
pressure should be documented and communicated to • External accrediting agency guidelines; and/or
the physician-in-charge to allow for changes in the blood • Institutional requirements.
pressure management plan.
Note: In the case of consigned equipment, the owner of the
Standard 13: Quality Assurance and Improvement CPB machine is responsible for maintaining the perfusion
set, and all liabilities and legal issues will be assigned to it. In
Standard 13.1: The perfusionist shall actively participate in
the case of an adverse event resulting from the use of this
both institutional and departmental quality assurance and
equipment, even if the equipment is proven to be defective,
improvement programs.
even with adequate maintenance and not related to improper
Guideline 13.1: The perfusionist should collect data use by the perfusionist, the owner of the equipment and not
regarding conduction of the perfusion through a clinical the institution shall be held liable.
registry or database.
Therefore, there should be an updated document for each
Guideline 13.2: The perfusionist should use this data for of the equipment used, with dates and details of preventive
quality control and improvement projects[16,17]. and corrective maintenance and that should be filed in the
perfusion service/department or clinical engineering unit of
Guideline13.3: The perfusionist should evaluate the
the institution[20].
postoperative period of the patient in a standard form
(Appendix E), storing data for periodic evaluation of perfusion Standard 14.3: The organization shall have a written
in his service[18]. procedure for perfusion equipment failures[21].
Guideline 13.4: Specific and periodic meetings should be Standard 14.4: Appropriate back-up perfusion supplies
held in his service for the review of avoidable errors occurring shall be readily available. Obs: when CPB machine is not
in his daily practice. property of the institution, the equipement’s owner will be
responsible for the replacement, and has legal responsibility
Guideline 13.5: Any adverse events shall be notified in
for this action.
writing to the responsible sector, which shall forward them
to the regulatory agencies and other competent areas after
Standard 15: Duty Hours
their verification. The service should encourage notifications
to be always carried out, establishing a direct line of Standard 15.1: The perfusionist can be hired by the hospital
communication between the team and the risk management or through a medical services company, respecting the labor
department, guaranteeing their confidentiality[19]. laws according to the signed agreement.
Standard 15.2: It is briefly forbidden for the perfusionist
Standard 14: Maintenance
to be engaged to perform perfusion and perform another
Standard 14.1: The perfusionist shall assure that properly function in the service with the same labor contract.
maintained and functioning equipment is used in the
Guideline 15.1 The perfusionist should receive a minimum
conduct of CPB, including (but not limited to):
of 8 hours of rest period for each consecutive 16-hour work
• Heart–lung machine Pumps
period[22-24].
• Timers
• Pressure monitors
• Temperature monitors
• Low-level alarm
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Surgeons; Out 2016. Available from: https://www.facs.org/about-acs/ GVIMS/GGTES/ANVISA N.1/2005. Orientações gerais para a
statements/89-distractions notificação de eventos adversos relacionados à assistência à
8. Cunha C, Moraes F, Monteiro V, Feitosa F, Silva I. Avaliação microbiológica assistência à saúde. Revisada 28 de Agosto de 2018. [Internet].
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reci.v6i3.6717 a31c-42d6-91d7-464889cc6e50&method=download
9. Conselho Regional de Enfermagem de Santa Catarina (COREN). Parecer 21. Ministerio da Saúde (MS), Agência Nacional de Vigilância Sanitária
Coren/SC n. 005/CT/2015. Assunto: Uso de aparelho celular no ambiente (ANVISA). Resolução de Direotria Colegiada – RDC n. 2, de 24 de janeiro
hospitalar [Internet]. Florianopolis (SC): Coren; 2016 [cited 2019 Feb de 2010. Dispõe sobre o gerenciamento de tecnologias em saúde em
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no-ambiente-hospitalar.pdf portal.anvisa.gov.br/documents/10181/2718376/RDC_02_2010_COMP.
10. Wadhera RK, Parker SH, Burkhart HM, Greason KL, Neal JR, Levenick pdf/0a8661c8-9323-4747-b103-6e83c4ff41cd
KM, et al. Is the "sterile cockpit" concept applicable to cardiovascular 22. Lipschultz A. Environment of Care Essentials for Health Care. Biomed
surgery critical intervals or critical events? The impact of protocol-driven Instruct Technol. 2012;46(5):384.
communication during cardiopulmonary bypass. J Thorac Cardiovasc 23. The Society of Clinical Perfusion Scientists of Great Britain and
Surg. 2010 Feb;139(2):312-9. doi: 10.1016/j.jtcvs.2009.10.048. Ireland, The College of Clinical Perfusion Scientists of Great
11. Whyte S, Cartmill C, Gardezi F, Reznick R, Orser BA, Doran D, Lingard Britain and Ireland. Standards of Practice Document. Standards
L. Uptake of a team briefing in the operating theatre: a Burkean of practice document [Internet]. London: The Society of Clinical
dramatistic analysis. Soc Sci Med. 2009 Dec;69(12):1757-66. Doi: Perfusion Scientists of Great Britain & Ireland; c 2018. Available
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12. de Vries EN, Prins HA, Crolla RM, den Outer AJ, van Andel G, van Helden content&task=view&id=25&Itemid=40"www.scps.org.uk/index.
SH, et al. Effect of a comprehensive surgical safety system on patient php?option=com_content&task=view&id=25&Itemid=40.
outcomes. N Engl J Med. 2010 Nov 11;363(20):1928-37. doi: 10.1056/ 24. Accreditation Council for Graduate Medical Education (ACGME). Policies
NEJMsa0911535. and procedures [Internet]. Chicago (IL): ACGME; Sep 29, 2018 [cited
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(ANVISA). Resoluçao RDC n. 302, de 13 de outubro de 2005. Dispõe ab_ACGMEPoliciesProcedures.pdf
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br/documents/10181/2718376/RDC_302_2005_COMP.pdf/7038e853-
afae-4729-948b-ef6eb3931b19 Appendix A
14. Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Patient Information
Ferraris VA, Brown JR, Despotis GJ, Hammon JW, Reece TB, Saha SP, Song
HK, Clough ER; Society of Cardiovascular Anesthesiologists Special Task 1. Medical record number
Force on Blood Transfusion, Shore-Lesserson LJ, Goodnough LT, Mazer
2. Patient surname, first name
CD, Shander A, Stafford-Smith M, Waters J; International Consortium for
Evidence Based Perfusion, Baker RA, Dickinson TA, FitzGerald DJ, Likosky 3. Demographics
DS, Shann KG. 2011 update to the Society of Thoracic Surgeons and a. Age (date of birth)
the Society of Cardiovascular Anesthesiologists blood conservation b. Gender

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c. Height g. Ultrafiltration device

d. Weight h. Arterial cannula
e. Body surface area (BSA) i. Venous cannula
4. Blood type j. Cardioplegia cannulae
5. Laboratory data k. Sump/vent(s)
a. Hemoglobin/hematocrit
b. Predicted hematocrit on bypass Note: Manufacturer, model, serial, and/or lot numbers should be
c. White blood cell count documented with items a–k.
d. Platelet count
e. Activated partial prothrombin time Appendix C
f. Sodium Patient Physiological and Perfusionist Practice Parameters
g. K+
Documented at a Frequency Determined by Institutional
h. Blood urea nitrogen/creatine
Protocol
i. Glucose
j. Other relevant laboratory values
1.Blood flow rates (RPM)
6. Patient allergies
2.Arterial blood pressure
7. Planned procedure
8. Medical history/risk factors (recommended) 3.Arterial line pressure
a. Cardiovascular 4.Central venous/pulmonary artery pressure
b. Pulmonary
c. Renal 5.Vacuum assist venous return (VAVR)
d. Neurologic a. VAVR pressure
e. Gastrointestinal/endocrine b. Venous inlet pressure (VIP)
6.Arterial/venous blood gases
Appendix B 7.Venous oxygen saturation
Information Sufficient to Accurately Describe the Procedure,
8.Patient temperatures, including:
Personnel, and Equipment
a.Patient core (at least one)
1. Date of procedure I. Nasopharyngeal
II. Bladder
2. Type of procedure
III. Esophageal
3. Perfusionist(s) names IV. Rectal
4. Surgeon(s) name V. Tympanic
5. Anesthesiologist(s) name VI. Myocardium (optional)
6. Nurse(s) name 9.Cardiopulmonary bypass temperatures:
7. Operating room number I. Venous return blood
8. Comments/events (recommended) II. Arterial blood inflow
9. Equipment III. Water bath(s) (optional)
a. Heart–lung machine 10. Oxygenator gases including gas flow rate and concentration(s)
b. Cell salvage (autotransfusion) device 11. Input fluid volumes including:
c. Heater/cooler a. Prime
Note: Items A–C are often uniquely identified (e.g., Pump 1, 2, 3, b. Blood products
etc.) The related serial numbers for each component (e.g., roller c. Asanguineous fluids
pumps, vaporizer, blender, etc.) are documented and stored d. Cardioplegic solution
locally. e. Autologous components
10. Disposables 12. Cardioplegia
a. Oxygenator I. Solution (ratio)
b. Cardiotomy reservoir II. Route
c. Tubing pack/arterial line filter III. Flow
IV. Pressure
d. Centrifugal pump head
V. Temperature
e. Cardioplegia delivery system VI. Volume
f. Cell salvage (autotransfusion) 13. Output fluid volumes, including:

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a.Urine output • Composition and preparation of cardioplegia.

b.Ultrafiltrate • Cannulas that will be used.
• All circuit connections.
14. Medications and/or inhalational anesthetic agents
• Calibration and direction of the rollers.
administered through extracorporeal circuit
• Calibration of pressure, flow and bubble sensors and alarms.
• Calibration of cardioplegia pressure sensors.
Appendix D
• Calibration and connection of the gas monitor.
Blood Gas, Electrolyte, and Anticoagulation Monitoring Results • Availability of disposable materials and emergency
equipment (hand crank, emergency light, etc.)
1. Blood gases • Dose and administration of heparin.
a. pO2 • Outcome of ACT before starting ECC.
b. pCO2 • Availability of drugs, needles, syringes, and serum and
c. pH blood infusion kits for use during CPB.  
d. Base excess
e. Bicarbonate concentration Appendix 2
f. Saturation
g. Potassium concentration SBCCV/SBCEC Padrões e Diretrizes Abrangentes para a
h. Ionized calcium concentration i. Sodium concentration Prática de Perfusão no Brasil*
j. Lactate
k. Glucose Standard 1: Desenvolvimento de um protocolo institucional
l. Hemoglobin/hematocrit próprio
2. Activated clotting times (ACTs) and/or heparin/ protamine Standard 1.1: A instituição ou o provedor de serviços de
assay results and/or thromboelastography results. perfusão deve desenvolver e implementar os procedimentos
operacionais padrão (protocolo, POP) para cada um dos
Appendix E procedimentos realizados como um mecanismo de aplicação
das recomendações desse documento para a prática clínica.
Postoperative Evaluation of Patients Submitted to
Extracorporeal Circulation Standard 1.2: O protocolo deverá ser:
• Aprovado pelo(a) chefe da cirurgia cardíaca ou seu/
1. Name sua designado(a), diretor(a) da perfusão ou equivalente
2. Patient's hospital identification number ou outra pessoa ou comitê de relevância hierárquica de
3. Date of surgery decisão das práticas clínicas institucionais.
4. Date/Time of ICU admission • Revisto e reavaliado, ao menos anualmente ou com maior
5. Values of CK, CKMB and Troponin at 6hs, 12hs and 24hs frequência quando necessário.
6. Ejection fraction in the postoperative period.
7. Vasoactive drugs dose used at 6hs, 12hs and 24hs Guideline 1.1: Mudanças no protocolo podem ser feitas a
8. Water balance every 6 hours until completing 48 hours of ICU critério da Equipe Cirúrgica e devem ser documentadas na
9. Central venous pressure every 6 hours, until completing 48 ficha de perfusão.
hours of ICU
10. Use of blood products Standard 2: Qualificação, Competência e Pessoal de Apoio
11. Extubation Time Standard 2.1: A circulação extracorpórea só deve ser ralizada
12. Date of ICU discharge por profissional formado nas profissões reconhecidas pela
Sociedade Brasileira de Circulação Extracorpórea (SBCEC)
Appendix F e pela Sociedade Brasileira de Cirurgia Cardiovasccular
Checklist (SBCCV) como competentes para realizar o procedimento;
ter pós-graduação reconhecida pelo MEC com carga horária
The checklist should check, at least: mínima descrita no artigo 12 das Normas Brasileiras para o
Exercício da Especialidade de Perfusionista em Circulação
• Integrity and operation of the CEC machine and heat
Extracorpórea ou Título de Especialista da SBCEC[1], validado
exchanger.
por esta Sociedade; ou profissionais que se enquadram no
• Operation of gas systems and connections to the
parágrafo único do artigo 2º da Norma acima citada.
oxygenator.
• Correct identification of the patient. Standard 2.2: As competências do perfusionista devem ser
• Availability of blood products. avaliadas anualmente com o intuito de averiguar se estão em
• Composition of the perfusate. conformidade com os protocolos departamentais.

*Nota: “SBCCV/SBCEC Padrões e Diretrizes Abrangentes para a Prática de Perfusão no Brasil” foram baseados e adaptados da publi-
cação “The American Society of ExtraCorporeal Technology (AmSECT) Standards and Guidelines[2] e traduzidos para o português.

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Standard 2.3: O perfusionista deve assistir, participar e se Guideline 3.1: Deverá haver uma ficha (registro) de perfusão
envolver em cursos de educação continuada relacionados à (escrita e/ou eletrônica) para cada procedimento de CEC. A
perfusão ao menos uma vez ao ano. ficha de perfusão deve incluir um espaço de texto livre para
registro de comentários, incluindo ordens verbais dadas pela
Standard 2.4: O pessoal de apoio deve estar disponível no
equipe médica pertinentes à perfusão realizada.
local para auxiliar o perfusionista durante os procedimentos
necessários na condução da CEC. Guideline 3.2: O registro de perfusão deve incluir as
assinaturas do(s) médico(s) responsável(is) pela supervisão
Guideline 2.1: Um indivíduo que se formar em um programa da CEC.
credenciado de educação em perfusão deve preencher
todos os requisitos para a certificação da SBCEC. Guideline 3.3: Os dados brutos (por exemplo, fluxo
sanguíneo, pressão e valores de temperatura) contidos
Guideline 2.2: Um processo padronizado deve ser em bancos de dados de perfusão eletrônica devem ser
desenvolvido e seguido para identificar, orientar e educar armazenados por um período de tempo definido pela
a equipe de suporte de forma a garantir que todos tenham política institucional referente à retenção de registros
conhecimento geral das funções desempenhadas pelo médicos eletrônicos de pacientes.
perfusionista, fluxo cirúrgico e localização dos itens essenciais
e auxiliares necessários durante a CEC. A equipe de apoio Standard 4: Checklist
inclui equipes de perfusionistas, enfermagem, técnicos e Standard 4.1: O perfusionista deve utilizar um checklist para
pessoal administrativo. cada perfusão realizada[4].
Guideline 2.3: Um programa estruturado para educar, Standard 4.2: O checklist deve ser preenchido, incluído e
treinar e avaliar a equipe de perfusão, ao menos anualmente, anexado ao prontuário do paciente.
deve ser desenvolvido e seguido.
Guideline 4.1: O perfusionista deve fazer o checklist lendo-o
Guideline 2.4: É recomendada a existência de dois em voz alta a outro perfusionista e marcando cada um
perfusionistas por procedimento, garantindo maior dos itens após a confirmação de que aquela ação, definida
segurança ao procedimento. item a item, foi realizada[4]. O preenchimento do cheklist
deve ser realizado por duas pessoas, sendo uma delas o
Guideline 2.5: Utilização de equipamentos de proteção
perfusionista principal responsável pela condução da CEC
individual. Durante a condução da CEC o perfusionista deve
durante o período intraoperatório. Nos serviços em que
utilizar equipamentos de proteção individual (EPI), como
não há a disponibilidade de outro profissional perfusionista,
máscaras, óculos e luvas de procedimento. As luvas devem
deve ser adotada uma rotina sistemática de verificação dos
ser trocadas após a coleta de amostra, após a troca de
itens contidos no checklist, com o objetivo de minimizar a
solução (bolsa de sangue) do equipo ou sempre que estiver
ocorrência de eventos adversos.
com respingo de sangue[2].
Guideline 4.2: O perfusionista deve utilizar o checklist ao
Standard 3: Ficha (Registro) de Perfusão longo de todo o período perioperatório (p. ex., montagem
da máquina de CEC, pré-CEC, fase inicial da perfusão, antes
Standard 3.1: A ficha (registro) de perfusão (escrita e/ou
da saída da perfusão, após a perfusão e/ou qualquer retorno
eletrônica) para cada procedimento de CEC deve ser incluída
à CEC).
como parte do prontuário médico do paciente. O registro de
perfusão deve ser mantido e armazenado de acordo com a Guideline 4.3: O perfusionista deve utilizar o checklist para
política da instituição para a retenção de registros médicos os demais serviços auxiliares à perfusão (isto é, recuperação
(prontuário) do paciente. sanguínea através de “cell salvage”, balão intra-aórtico,
oxigenação por membrana extracorpórea – extracorporeal
Standard 3.2: A ficha (registro) deve incluir: membrane oxygenation – ECMO, entre outros).
• Informações do paciente, incluindo dados demográficos e
fatores de risco pré-operatório (Appendix A). Standard 5: Comunicação
• Informações necessárias para descrever com precisão
Standard 5.1: Um plano de perfusão individualizado e
o procedimento, pessoal e equipamento utilizado
especifíco ao paciente deve ser preparado e comunicado à
(Appendix B).
equipe cirúrgica tanto no “briefing” quanto antes do início do
• Parâmetros fisiológicos do paciente documentados de
procedimento[5].
acordo com a frequência determinada pelo protocolo
institucional (Appendix C). Guideline 5.1: O uso de aparelhos de telefone celular em
• Gases sanguíneos e resultados da monitoração da sala cirúrgica deve ser evitado e em CEC deve ser proibido,
anticoagulação (Appendix D). visto que é um fator de distração e predisponente para riscos
• o Assinatura e carimbo do perfusionista (e de todos os ao paciente. Além disso, a grande maioria está contaminada
demais perfusionistas de apoio) que participaram do por bactérias potencialmente infectantes, comprometendo
procedimento. a qualidade e segurança da assistência. Quando seu uso for

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inevitável, os aparelhos devem ser higienizados previamente, permita ao perfusionista anular o filtro em caso de obstrução
conforme protocolo de antissepsia da instituição[6-8]. ou rupture.
Guideline 5.2: A comunicação padronizada por meio de Standard 6.6: Uma válvula “one-way” deve ser utilizada na
protocolos específicos (p. ex., closed loop communication) deve linha de aspiração da aorta/átrio esquerdo durante a perfusão.
ser utilizada para o reconhecimento dos comandos verbais,
Standard 6.7: Deve ser utilizado pelo menos um método
verificação de conteúdo e redução de ambiguidade[9-11].
para evitar o fluxo retrógrado para a circulação sistêmica em
Guideline 5.3: O perfusionista principal deverá participar do circuitos com bombas centrífugas. Exemplos de sistemas de
“debrief” pós-operatório com toda a equipe cirúrgica. evasão retrógrada podem incluir:
• Válvulas de fluxo unidirecional (one-way flow valves);
Standard 6: Dispositivos de Segurança
• Controles de redução de velocidade da bomba com
Standard 6.1: O monitoramento de pressão da linha mecanismos de prevenção de acionamento acidental
arterial, do sistema de administração de cardioplegia e do (hard-stop detent controls);
reservatório venoso (quando a drenagem venosa assistida • Pinças de acionamento eletrônico na linha arterial; ou
por vácuo for utilizada) deve ser realizado e documentado • Alarme audiovisual em caso de baixa velocidade da bomba.
durante a CEC.
Standard 6.8: Uma linha de eliminação de gases deve ser
• O monitor de pressão deve ser servorregulado para o utilizada sempre que anestésicos inalatórios forem utilizados
controle do rolete arterial e de cardioplegia de acordo diretamente no circuito durante a perfusão.
com a pressão da linha arterial e da linha de cardioplegia,
Standard 6.9: Manivelas manuais (hand cranks) devem estar
permitindo a interrupção do fluxo de ambas.
prontamente disponíveis durante a perfusão.
• O monitor de pressão deve incluir um alarme audiovisual.
Standard 6.10: Backups (alternativas de segurança) de fonte
Standard 6.2: Detector de bolhas deve ser utilizado durante
de gás (p. ex., cilindro de oxigênio/ar comprimido) devem
a CEC.
estar prontamente disponíveis durante a CEC.
• O detector de macrobolhas deve ser usado para controlar
Standard 6.11: A máquina de CEC deve possuir bateria
a bomba arterial ou para permitir a interrupção do fluxo
incorporada ou outra fonte de energia suplementar
sanguíneo arterial.
disponível durante toda a perfusão.
• O sistema detector deve incluir um alarme audível e
visual e ser posicionado de acordo com as instruções do Guideline 6.1: Um analisador de oxigênio da mistura de gás
fabricante para uso do oxigenador, ligado e testado antes (sweep flow) antes da entrada de gás da membrana deve ser
de cada procedimento, de forma a permitir a identificação utilizado durante a perfusão.
e ação a tempo de evitar sua passagem para o paciente.
Guideline 6.2: Um sensor de nível deve ser usado durante
Standard 6.3: Um sensor de nível deve ser utilizado durante os procedimentos de CPB com um reservatório fechado
a CEC quando utilizado um reservatório rígido (hard-shell (soft-shell reservoir).
venous reservoir) no circuito. • O sensor de nível deve ser servorregulado para controlar
a bomba arterial ou para permitir a interrupção do fluxo
• O sensor de nível deve ser servorregulado para controlar
sanguíneo arterial.
a bomba arterial ou para permitir a interrupção do fluxo
• O sensor de nível deve incluir um alarme sonoro e visual e
sanguíneo arterial.
ser posicionado de acordo com as instruções do fabricante
• O sensor de nível deve incluir um alarme audível e visual e
para permitir um tempo de reação apropriado e um
ser posicionado de acordo com as instruções do fabricante
volume operacional seguro.
para permitir um tempo de reação apropriado e um
• O uso de um detector de bolhas de ar distal à saída do
volume operacional seguro.
reservatório pode ser utilizado em substituição ao detector
Standard 6.4: O monitoramento da temperatura da de nível.
saída arterial do oxigenador deve ser utilizado durante os
Guideline 6.3: A bandeja de tubos disponibilizados para
procedimentos de CEC.
montagem do circuito deve ser disponibilizada “pré-
• O sensor de temperatura deve incluir um alarme audível e montada”, pré-conectada e em bandeja estéril separando o
visual para a prevenção de temperaturas elevada na saída circuito que ficará no campo cirúrgico daquele que ficará na
arterial do oxigenador. máquina de CEC, ofertando mais segurança ao procedimento
e gerando mais rapidez na montagem do circuito.
Standard 6.5: Um filtro arterial isolado ou acoplado ao
oxigenador deve ser utilizado em todo o circuito de CEC.
Standard 7: Monitoração (obs.: para ser realizado em
Quando usado de forma isolada do oxigenador, deve ser
conjunto com Standard 3)
utilizado no circuito depois do oxigenador e deve contar
com uma linha de recirculação conectada ao reservatório Standard 7.1: A pressão arterial do paciente deve ser
de cardiotomia ou venoso. Deve dispor de um “bypass” que monitorada de forma contínua durante toda a CEC.

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Standard 7.2: A pressão da linha arterial do circuito de CEC da anticoagulação (heparina) e um algoritmo alternativo para
deve ser monitorada durante toda a perfusão. a heparinização não adequada, incluindo intervalos aceitáveis
para o tempo de coagulação ativada (TCA).
Standard 7.3: O fluxo arterial deve ser monitorado
continuamente durante toda a perfusão. Standard 8.2: O perfusionista deve trabalhar em estreita
colaboração com a equipe de cuidados cirúrgicos na
Standard 7.4: A dose de cardioplegia, o método de infusão,
monitoração e no tratamento do estado de coagulação do
a pressão de linha (cardioplegia anterógrada), a pressão do
paciente antes, durante e após a CEC.
seio coronário (cardioplegia retrógrada) e os intervalos de
isquemia devem ser continuamente monitorados durante a Guideline 8.1: A equipe cirúrgica deve determinar o alvo do
CEC. TCA considerando fatores relevantes, incluindo variabilidade
em sua medida atribuída às características de desempenho
Standard 7.5: A temperatura do paciente e dos dispositivos
do dispositivo.
deve ser continuamente monitorada durante a CEC.
Guideline 8.2: A dose inicial de heparina específica para
• Paciente: nasofaríngea, retal, vesical, esofágica. o paciente deve ser determinada por um dos seguintes
• Máquina de CEC: arterial, venosa e cardioplegia. métodos:
• Trocador de calor (heater-cooler): temperatura da água. • Peso;
Standard 7.6: A análise de gases sanguíneos (gasometria) • Curva de dose-resposta (automatizada ou manual);
deve ser monitorada continuamente ou em intervalos • Volume sanguíneo; ou
regulares durante a CEC (Appendix D). • Superfície corpórea.

Standard 7.7: O hematócrito (ou hemoglobina) deve ser Guideline 8.3: O monitoramento da anticoagulação deve
monitorado continuamente durante a CEC. incluir o TCA, devendo-se realizar um TCA inicial, outro após
a protamina e, durante a CEC, pelo menos um a cada 30
Standard 7.8: A fração de oxigênio (FiO2) e o fluxo de gás minutos. Testes de monitoramento adicionais podem incluir:
(sweep flow) devem ser monitorados continuamente durante • Nível de heparina (p. ex., titulação de heparina/protamina
a CEC (Appendix D). ou nível de heparina não fracionado);
• Tempo de tromboplastina parcial ativada (TTPa);
Standard 7.9: A porcentagem de oclusão da linha venosa
• Tromboelastograma;
do oclusor venoso (clamp venoso automatizado), quando
• Tempo de trombina (TP); e/ou
disponível, deve ser monitorada continuamente durante a
• Anti-Xa.
CEC.
A execução dos testes laboratoriais remotos – TLR (point-
Standard 7.10: Saturação venosa de oxigênio deve ser of-care) deve estar vinculada a um laboratório clínico do
monitorada continuamente ou em intervalos regulares hospital. O responsável técnico pelo laboratório clínico é
durante a CEC. responsável por todos os TLR realizados dentro da instituição.
O laboratório clínico deve disponibilizar, nos locais de
Guideline 7.1: A remoção de CO2 (etCO2 ou pCO2) deve ser
realização de TLR, procedimentos documentados com
continuamente monitorada durante a CEC.
orientações sobre suas fases pré-analítica, analítica e pós-
Guideline 7.2: A saturação arterial de oxigênio (SaO2) deve analítica, incluindo:
ser continuamente monitorada durante a CEC. a. Sistemática de registro e liberação de resultados provisórios.
b. Procedimento para resultados potencialmente críticos.
Guideline 7.3: As seguintes pressões do paciente devem ser
c. Sistemática de revisão de resultados e liberação de laudos
monitoradas durante a CEC:
por profissional habilitado.
• Pressão venosa central (PVC); e/ou
O laboratório clínico deve manter registros dos controles da
• Pressão da artéria pulmonar.
qualidade, bem como procedimentos para sua realização.O
Guideline 7.4: Os gases sanguíneos devem ser laboratório clínico deve promover e manter registros de seu
continuamente monitorados (in-line) durante a CEC. processo de educação permanente para os usuários dos
equipamentos de TLR[12].
Guideline 7.5: A oximetria cerebral (NIRS) deve ser utilizada
durante a CEC sempre que dísponível. Guideline 8.4: As doses adicionais de heparina durante a
CEC devem ser determinadas usando a titulação pelo TCA e/
Guideline 7.6: O fluxo sanguíneo arterial deve ser
ou heparina/protamina. Nota: em pacientes que requerem
monitorado continuamente em um ponto no circuito no
tempos de CEC mais longos (> 2 a 3 horas), pode-se
qual reflete com precisão o fluxo entregue ao paciente
considerer a manutenção de concentrações de heparina mais
durante a CEC (p. ex., distal à “purge line”).
altas e/ou específicas para o paciente durante a CEC, para
reduzir a ativação do sistema de coagulação e o consumo de
Standard 8: Anticoagulação
plaquetas e proteínas de coagulação, assim como evitar ou
Standard 8.1: O perfusionista, em colaboração com o cirurgião reduzir a transfusão de hemoderivados (Classe IIb, Nível de
responsável, deve definir o algoritmo pretendido para o manejo evidência B)[13].

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Guideline 8.5: A reversão da heparina deve ser confirmada Standard 10.2: Os dispositivos utilizados para medir a troca
por TCA, tromboelastrograma e/ou titulação da heparina/ gasosa devem ser calibrados de acordo com as instruções de
protamina. uso do fabricante.
Standard 10.3: A análise sanguínea dos gases (gasometria)
Standard 9: Manuseio transfusional
deve ser realizada e anotada de acordo com o protocolo.
Standard 9.1: O perfusionista deve aderir às práticas
Guideline 10.1: Exames realizados com dispositivos “point-
recomendadas para minimizar a hemodiluição e evitar
of-care” devem ser considerados para propiciar informações
transfusões de sangue desnecessárias[13].
precisas e instantâneas para análise de gases no sangue[14].
Standard 9.2: O perfusionista deve minimizar o tamanho do
Guideline 10.2: O cálculo da oferta e consumo de oxigênio
circuito de CEC no intuito de reduzir o volume do prime[13].
deve ser utilizado para avaliar e otimizar a troca gasosa[15]:
Standard 9.3: O perfusionista deve calcular e comunicar à Oferta de oxigênio: DO2 = 10 x IC x CaO2
equipe cirúrgica o hematócrito/hemoglobina pós-dilucional
Consumo de oxigênio: VO2 = 10 x IC x (CaO2 – CvO2)
previsto para o paciente antes de iniciar a CEC.
Em que:
Guideline 9.1: As definições dos protocolos de transfusão
CaO2 (conteúdo de oxigênio arterial) = (Hb x 1,36 x SaO2) +
de hemoderivados (patient blood management – PBM)
(0,0031 x PaO2)
devem incluir[13]:
e
• Participação do perfusionista nas discussões (briefings)
CvO2 (conteúdo de oxigênio venoso misto) = (Hb x 1,36 x
pré-operatórias com toda a equipe cirúrgica (Standard 5.1)
SvO2) + (0,0031 x PvO2)
em relação às estratégias de transfusão e valores “alvos” de
hematócrito. HB = hemoglobina
• Participação do perfusionista no grupo multidisciplinar de IC = índice cardíaco
PBM. PaO2 = pressão parcial de oxigênio no sangue arterial
PvO2 = pressão parcial de oxigênio no sangue venoso
Minimizar a hemodiliução por meio de: SaO2 = saturação arterial de oxigênio
• Seleção do tamanho do circuito de CEC compatível com o SvO2 = saturação venosa de oxigênio
tamanho do paciente.
• Preenchimento do circuito com sangue autólogo, Standard 11: Fluxo de perfusão
incluindo enchimento retrógrado do circuito com sangue
(retrograde autologous priming – RAP). Standard 11.1: O fluxo de perfusão alvo deve ser
• Utilização de tubos com revestimento biocompatível/ determinado antes de iniciar a CEC de acordo com o
bioativos em todos os componentes de CEC. protocolo institucional. Obs.: superfície corpórea x índice
• Recuperação perioperatória de células sanguíneas (cell cardíaco = fluxo sanguíneo calculado, no qual a superfície
savage) e reinfusão após processamento adequado. corpórea em metros quadrados é igual à raiz quadrada da altura
• Recuperação do sangue do circuito de CEC ao final do vezes o peso dividido por 3.600 (√altura × peso/3.600), utilizando
procedimento (“blood cell savage” do “prime” do circuito). altura em centímetros (cm) e peso em kilogramas (kg).

Guideline 9.2: Monitoração da hemostasia por meio de Standard 11.2: O perfusionista deve trabalhar em estreita
“point-of-care” deve ser utilizada na minimização da perda colaboração com a equipe cirúrgica na manutenção da taxa
sanguínea. de fluxo sanguíneo definido/calculado durante a CEC.
Essa monitoração deve incluir: Guideline 11.1: As variações do fluxo sanguíneo definido/
• International normalized ratio (INR ou RNI); calculado devem ser comunicadas ao médico/cirurgião
• Tempo de tromboplastina parcial ativada (TTPa); responsável.
• Tempo de protrombina (TP);
Guideline 11.2: O fluxo de perfusão adequado deve ser
• Tempo de trombina (TT);
definido pela avaliação de:
• Tromboelastograma;
• Contagem de plaquetas; e/ou • Balanço ácido-base;
• Agregação plaquetária. • Excesso de bases (BE);
• Nível anestésico;
Standard 10: Troca Gasosa • Pressão sanguinea arterial;
• Oximetria cerebral (NIRS);
Standard 10.1: A troca de gás deve ser mantida durante a
• Nível de lactato;
CEC de acordo com o protocolo, considerando:
• Entrega e consumo de oxigênio (observar a fórmula no
• Características individuais do paciente e perfil de risco; Guideline 10.2);
• Tipo de oxigenador, design e instruções de uso; e • pO2 venosa;
• Fluxo sanguíneo, temperatura e demanda metabólica. • pO2 arterial;

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• Concentração de hemoglobina; • Bombas

• Saturação arterial de oxigênio; • Timers
• Resistência vascular sistêmica; • Monitores de pressão
• Temperatura; e • Monitores de temperature
• Saturação venosa de oxigênio (SaVO2). • Alarme de nível
• Detector de ar/bolhas
Standard 12: Pressão arterial • Sensores de fluxo sanguíneo
Standard 12.1: O perfusionista, em conjunto com o médico/ • Trocador de calor (heater-cooler)
cirurgião responsável, deve definir e comunicar o algoritmo • Vaporizador de anestésico
de tratamento pretendido para o gerenciamento da pressão • Misturador de gases e fluxômetro
arterial antes da CEC, incluindo seus níveis aceitáveis. Obs.: • Analisador de oxigênio
em muitas circunstâncias, o médico responsável pode • Equipamentos auxiliaries
direcionar o perfusionista para modificar a administração da • Pressão intra-arterial
pressão arterial pretendida para atender às circunstâncias • Dispositivos de assistência circulatória
que ocorrem durante o procedimento de CEC. • Dispositivos de recuperação sanguínea (cell salvage device)

Standard 12.2: O perfusionista deve trabalhar em conjunto Standard 14.2: A manutenção preventiva do equipamento
com a equipe cirúrgica para manter a pressão arterial de de perfusão deve ser realizada e documentada de forma
acordo com os protocolos da CEC. regular pela equipe de perfusão e/ou equipe de engenharia
biomédica apropriadamente treinada e qualificada.
Guideline 12.1: A variação entre a pressão arterial definida/
calculada e a atingida deve ser documentada e comunicada Qualquer um ou todos os seguintes itens pode determinar o
ao médico responsável para permitir alterações no plano de intervalo dessa manutenção:
manejo da pressão arterial.
• Recomendações do fabricante;
Standard 13: Avaliação e Melhorias na Qualidade • Recomendaçõnoes das agências de acreditação; e/ou
• Protocolos institucionais.
Standard 13.1: O perfusionista deve participar ativamente
dos programas institucionais e departamentais de controle e Obs.: em equipamentos consignados, o proprietário
melhoria da qualidade. da máquina de CEC é responsável pela manutenção no
Guideline 13.1: O perfusionista deve coletar dados relativos equipamento de perfusão, e todas as responsabilidades e
à condução da perfusão por meio de um registro clínico ou questões legais serão imputadas a ele. Em caso de evento
banco de dados. adverso decorrente do uso deste equipamento, quando
comprovada falha, mesmo com provas de manutenção
Guideline 13.2: O perfusionista deve usar esses dados para adequada e não relacionada ao uso indevido por parte do
projetos de controle e melhoria de qualidade[16,17]. perfusionista, o dono do equipamento, e não a instituição,
Guideline13.3: O perfusionista deve avaliar em ficha padrão deverá ser responsabilizado.
(Appendix E) o pós-operatório do paciente, armazendo
Portanto, deve existir um documento atualizado para cada
dados para avaliações periódicas da perfusão no serviço[18].
um dos equipamentos utilizados, com as datas e os detalhes
Guideline 13.4: Reuniões específicas e periódicas devem ser de manutenção preventiva e corretivas e que deve ser
realizadas para a revisao de erros evitáveis que ocorram no arquivado na unidade de perfusão ou de engenharia clínica
serviço. da instituição[20].
Guideline 13.5: Todo e qualquer evento adverso deve Standard 14.3: A instituição deve ter o procedimento
ser notificado por escrito ao setor responsável, o qual dará padrão por escrito documentando as falhas potenciais
encaminhamento às agências regulatórias e demais orgãos e ocorridas no equipamento de perfusão, bem como as
competentes após apuração. O serviço deve incentivar a condutas a serem adotadas ou correções implementadas[21].
realização constante das notificações, estabelecendo uma
linha de comunicação direta entre a equipe e a gerência de Standard 14.4: Os suprimentos necessários de perfusão de
risco, garantindo seu sigilo[19]. “backup” devem estar prontamente disponíveis.

Standard 14: Manutenção Obs.: quando a máquina de CEC não é propriedade

da instituição (em caso de equipamento consignado),
Standard 14.1: O perfusionista deve assegurar que o o proprietário do equipamento será responsável pela
equipamento utilizado na condução da CEC tenha sua substituição e terá responsabilidade legal em caso de evento
manutenção corretamente realizada e em perfeito estado de adverso decorrente do uso deste equipamento, quando
funcionamento, incluindo (mas não limitado a): comprovada falha não relacionada ao uso indevido por parte
• Máquina de CEC do perfusionista.

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Standard 15: Horas de Serviço 10. Wadhera RK, Parker SH, Burkhart HM, Greason KL, Neal JR, Levenick
KM, et al. Is the "sterile cockpit" concept applicable to cardiovascular
Standard 15.1: O perfusionista pode ser contratado pelo surgery critical intervals or critical events? The impact of protocol-driven
hospital ou por empresa de serviços médicos, respeitando as communication during cardiopulmonary bypass. J Thorac Cardiovasc
leis trabalhistas de acordo com o vínculo firmado. Surg. 2010 Feb;139(2):312-9. doi: 10.1016/j.jtcvs.2009.10.048.
11. Whyte S, Cartmill C, Gardezi F, Reznick R, Orser BA, Doran D, Lingard
Standard 15.2: É sumariamente proibido que o perfusionista
L. Uptake of a team briefing in the operating theatre: a Burkean
seja contratado para realizar perfusão e exerça outra função dramatistic analysis. Soc Sci Med. 2009 Dec;69(12):1757-66. Doi:
no serviço com o mesmo contrato trabalhista. 10.1016/j.socscimed.2009.09.054
Guideline 15.1: O perfusionista deve ter um mínimo de 8 12. de Vries EN, Prins HA, Crolla RM, den Outer AJ, van Andel G, van Helden
SH, et al. Effect of a comprehensive surgical safety system on patient
horas de período de descanso para cada período de trabalho
outcomes. N Engl J Med. 2010 Nov 11;363(20):1928-37. doi: 10.1056/
consecutivo de 16 horas[22-24]. NEJMsa0911535.
13. Ministério da Saúde (MS), Agência Nacional de Vigilância Sanitária
(ANVISA). Resoluçao RDC n. 302, de 13 de outubro de 2005. Dispõe
sobre Regulamento Técnico para funcionamento de Laboratórios
Clínicos [Internet]. Brasília: República Federativa do Brasil; 2005 [cited
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hospitalar [Internet]. Florianopolis (SC): Coren; 2016 [cited 2019 Feb estabelecimentos em saúde [Internet]. Brasilia: República Federativa
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22. Lipschultz A. Environment of Care Essentials for Health Care. Biomed 6. Nome da enfermeira(s)
Instruct Technol. 2012;46(5):384. 7. Número da sala de cirurgia
23. The Society of Clinical Perfusion Scientists of Great Britain and 8. Comentários/eventos (recomendado)
Ireland, The College of Clinical Perfusion Scientists of Great 9. Equipamento:
Britain and Ireland. Standards of Practice Document. Standards
a. Máquina de CEC
of practice document [Internet]. London: The Society of Clinical
Perfusion Scientists of Great Britain & Ireland; c 2018. Available b. Cell saver (autotransfusão)
from: HYPERLINK "http://www.scps.org.uk/index.php?option=com_ c. Trocador de calor (heater-cooler)
content&task=view&id=25&Itemid=40"www.scps.org.u
Nota: os itens a-c são geralmente identificados (p. ex.,
24. Accreditation Council for Graduate Medical Education (ACGME). Policies
and procedures [Internet]. Chicago (IL): ACGME; Sep 29, 2018 [cited
Máquina (Bomba) 1, 2, 3 etc.). Os números de série de cada
2019 Feb 24]. Available at: https://www.acgme.org/Portals/0/PDFs/ um dos componentes (bomba de rolete, vaporizadores,
ab_ACGMEPoliciesProcedures.pdf blender etc.) devem estar documentados e arquivados em
local apropriado.
10. Descartáveis:
a. Oxigenador
Appendix A (Portuguese version) b. Reservatório de cardiotomia
Informação do paciente c. Circuito de tubos e filtro arterial
d. Bomba centrífuga
1. Número do registro médico e. Sistema de cardioplegia
2. Nome e sobrenome do paciente f. Circuito de autotransfusão (cell saver)
3. Dados demográficos: g. Hemofiltro
a. Idade (data de nascimento) h. Cânulas arteriais
b. Sexo i. Cânulas venosas
c. Altura j. Cânulas de cardioplegia
d. Peso k. Aspiradores e vent(s)
e. Superfície corpórea (SC) Nota: o fabricante, modelo, número de série e/ou número
4. Tipo sanguíneo do lote devem ser documentados em cada um dos itens (a-
5. Dados laboratoriais: k) utilizados.
a. Hemoglobina/hematócrito
b. Hematócrito predito em CEC
c. Leucócitos Appendix C (Portuguese version)
d. Contagem de plaquetas Parâmetros fisiológicos do paciente e ações do perfusionista
e. Tempo de protrombina parcial ativada (TTPa) documentadas com frequência definida pelo protocolo
f. Sódio Institucional
g. Potássio
h. Ureia/creatinina 1. Fluxo sanguíneo de perfusão (RPM)
i. Glicemia 2. Pressão arterial
j. Outros valores laboratoriais relevantes 3. Pressão da linha arterial
6. Alergias do paciente 4. Pressão venosa central ou pressão da artéria pulmonar
7. Procedimento cirúrgico planejado 5. Retorno venoso assistido com vácuo (VAVR):
8. História médica e fatores de risco (recomendado): a. Pressão do reservatório venoso/da linha venosa
a. Cardiovascular b. Pressão negativa do dispositivo de vácuo
b. Pulmonar 6. Gasometria arterial e venosa
c. Renal 7. Saturação venosa de oxigênio
d. Neurológico 8. Temperaturas do paciente, incluindo:
e. Gastrointestinal/endócrino a. Temperatura central (ao menos)
I. Nasofaríngea
Appendix B (Portuguese version) II. Vesical
Informações básicas para descrição detalhada do III. Esofágica
procedimento, pessoal (equipe) e equipamento utilizado IV. Retal e/ou
V. Timpânica
1. Data do procedimento VI. Temperatura do miocárdio (opcional)
2. Tipo de procedimento 9. Temperaturas da CEC:
3. Nome do perfusionista(s) I. Linha de retorno venoso
4. Nome do cirurgião(ões) II. Linha arterial
5. Nome do anestesista(s) III. Da água do trocador de calor (opcional)

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Caneo LF, et al. - The Brazilian Society for Cardiovascular Surgery (SBCCV) and Brazilian Society Braz J Cardiovasc Surg 2019;34(2):239-60
for Extracorporeal Circulation (SBCEC) Standards and Guidelines for Perfusion Practice

10. Gases do oxigenador, incluindo fluxo de gases e concentração Appendix E (Portuguese version)
11. Entrada de líquidos (volume infundido), incluindo: Avaliação pós-operatória dos pacientes submetidos à
a. Prime circulação extracorpórea
b. Hemoderivados
c. Cristaloides 1. Nome do paciente
d. Solução cardioplégica 2. Número hospitalar do paciente
e. Componentes autólogos 3. Data da cirurgia
12. Cardioplegia: 4. Hora de entrada na UTI
I. Solução (proporção se diferentes) 5. Valores de CK, CKMB e troponina de 6, 12 e 24h
II. Via de administração (anterógrada, retrógrada etc.) 6. Fração de ejeção no pós-operatório
III Fluxo 7. Valores das drogas vasoativas utilizadas com 6, 12 e 24h
IV. Pressão 8. Balanço hídrico a cada 6h, até completar 48h de UTI
V. Temperatura 9. Pressão venosa central a cada 6h, até completar 48h de UTI
VI. Volume 10. Uso de hemoderivados
13. Volume das perdas, incluindo: 11. Tempo de extubação
a. Débito uninário 12. Data de alta da UTI
b. Ultrafiltrado
14. Medicações e/ou anestésicos inalatórios administrados Appendix F (Portuguese version)
através do circuito extracorpóreo Checklist
O checklist deve conferir (ao menos):
Appendix D (Portuguese version) • Integridade e funcionamento da máquina de CEC e
Resultados dos gases sanguíneos, eletrólitos e monitoração trocador de calor.
da anticogulação • Funcionamento dos sistemas de gases e as conexões com
o oxigenador.
• Identificação correta do paciente.
1. Gasometria:
• Disponibilidade de hemoderivados.
a. pO2
• Composição do perfusato.
b. pCO2
• Composição e preparo da cardioplegia.
c. pH
• Cânulas que serão utilizadas.
d. Excesso de bases (BE)
• Todas as conexões do circuito.
e. Bicarbonato
• Calibração e direção dos roletes.
f. Saturação
• Calibração dos sensores e alarmes de pressão, fluxo e
g. Concentração de potássio
bolhas.
h. Concentração de cálcio ionizado
• Calibração dos sensores de pressão de cardioplegia.
I. Concentração de sódio • Calibração e conexão do monitor de gases.
j. Lactato • Disponibilidade de materiais descartáveis e equipamentos
k. Glicemia de emergência (hand crank, luz de emergência etc.)
l. Hemoglobina/hematócrito • Dose e administração de heparina.
2. Tempo de coagulação ativado (TCA) e/ou resultados • Resultado de TCA antes de iniciar a CEC.
da concentração plasmática de heparina/protamina e/ou • Disponibilidade de fármacos, agulhas, seringas e equipos
resultado do tromboelastograma. de soro e sangue para utilização durante a CEC.

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