Vol. 19 No. 2 (2020)
Literature Review

Legal and biological safety of legal reprocessing of medicalhospital materials

Published 2021-01-04

Keywords

  • Single use of catheters,
  • Ablation catheter,
  • Hospital infection,
  • Catheter cleaning and sterilization,
  • Quality control

How to Cite

1.
Z. P. F. Pinto P, Massini N. Legal and biological safety of legal reprocessing of medicalhospital materials. BJHBS [Internet]. 2021 Jan. 4 [cited 2024 Oct. 11];19(2):130-41. Available from: https://bjhbs.hupe.uerj.br/bjhbs/article/view/79

Abstract

Introduction: Procedures using disposable materials in the health area began to be performed, for example in cardiac catheterization, which has a high prevalence of morbidity and mortality. Objective: To justify and reaffirm the reuse of sin-gle-use catheters in surgeries, as it is justified by the economic benefit gained from replacing the purchase of new materials by reusing them. Materials and methods: A bibliographic and documentary narrative review was carried out using LILACS and NCBI as database, with previously defined filters and selection criteria. Resultados: Decontamination, disinfection, conditioning, sterilization, and quality control tests are critical stages and, therefore, require training. Each of these stages also has characteristic risks, which must be minimized. In order to ensure the quality of the catheter reuse process, after the clean-ing and sterilization process, techniques beyond microscopic and visual evaluation of the device are required. A diversity of techniques is addressed so that the quality of the process is assured. Although legislation and supervision are divergent around the world, many countries choose to adopt reprocess-ing with economic justification in most cases. The reuse of hospital devices involves several physico-chemical processes, which must be performed with quality and safety. Conclusion: The need for greater rigor in the norms and guidelines that address this practice is clear and urgent, as well as the greater intensity and rigidity of the responsible inspection agencies. The use of luminol as an indicator of organic contaminants may generate a false positive result. Therefore, 3M™ Clean-Trace ™ is the best instrument found in the world market to ensure that the material that has been reused is free of organic waste, and thus fit for use in hospitals.

Metrics

Metrics Loading ...

References

  1. Bomfim FM, Lima SG, Guimarães V. Análise do reprocessa-mento de cateteres de hemodinâmica em uma capital brasilei-ra. Rev Bras Cardiol. 2013;26(1):33-39.
  2. Ministério da Saúde (Brazil). DATASUS. Informações de Saúde. Sistema de Informações Hospitalares do SUS [accessed in 21 aug 2018]. Available at: www.datasus.gov.br
  3. Crawford TC, Eagle KA. Reuse of catheters and devices labelled for single use: evidence, recommendations and over-sight. Heart Asia. 2018;10(2).
  4. Mansur AP. Favarato D. Mortalidade por doenças cardiovas-culares no Brasil e na região metropolitana de São Paulo. Arq. Bras. Cardiol. 2012;99(2):755-761.
  5. Costa EA. Gerenciando risco em reprocessamento de produtos para Saúde: Uma metodologia para serviços hospitalares. Revista SOBECC 2013;18(2):33-44.
  6. Buckley BS, Fader M, Macauley MS. Giving intermittent cathe-ter users more choice. Br J Gen Pract. 2015;65(637):419
  7. Kapoor A, Vora AM, Natarai G, et al. Guidance on reuse of cardio-vascular catheters and devices in India: A consensus document. Indian Heart J. 2017;69:357-63.
  8. Agência Nacional de Vigilância Sanitária (Brasil). Portaria nº 3 de 7 de fevereiro de 1986.
  9. Agência Nacional de Vigilância Sanitária (Brasil). Portaria nº 4 de 7 de fevereiro de 1986.
  10. Agência Nacional de Vigilância Sanitária (Brasil). RE nº 2605 de 11 de agosto de 2006.
  11. Agência Nacional de Vigilância Sanitária (Brasil). RE nº 2606 de 11 de agosto de 2006.
  12. Agência Nacional de Vigilância Sanitária (Brasil). RDC nº 156 de 11 de agosto de 2006.
  13. Agência Nacional de Vigilância Sanitária (Brasil). Portaria nº 8 de 8 de julho de 1988.
  14. Agência Nacional de Vigilância Sanitária (Brasil). RDC nº 15 de 15 de março de 2012.
  15. Baffi, SH. Reprocessamento e reutilização de cateteres em he-modinâmica: a busca de qualidade nesta prática. [Dissertação de doutorado em Enfermagen] – Universidade de São Paulo; 2001.
  16. Meijs AP, Ferreira JA, DE Greeff SC, et al. Incidence of surgical site infections cannot be derived reliably from point prevalence survey data in Dutch hospitals. Epidemiol Infect. 2017;145(5):970-980.
  17. Humphreys, H. Preventing surgical site infection. Where now? J Hosp Infect. 2009;73:316-22.
  18. Ribeiro SM. Reprocessamento de cateteres de angiografia cardiovascular após uso clínico e contaminados artificialmente: avaliação da eficácia da limpeza e da esterilização. [Tese de doutorado em Enfermagem] – Universidade de São Paulo;2006.
  19. Smith JJ, Henderson JA, Baim DS. The Food and Drug Ad-ministration and reprocessing of single-use medical devices: a revised policy and new questions. J Vasc Interv Radiol 2002;13(12):1179-1182.
  20. Costa EA, Costa EA, Graziano KU, et al. Reprocessamento de produtos médicos: uma proposta de modelo regulatório para hospitais brasileiros. Rev Esc Enferm USP. 2011:45(6):1459-1465.
  21. Duffy RE, Couto B, Pessoa JM, et al. Improving water quality can reduce pyrogenic reactions associated with reuse of cardi-ac catheters. Infect. Control Hosp. Epidemiol. 2013;24(12):955-960.
  22. Kuniyoshi RR, Sternick EB, Nadalin E, et al. Reprocessing of Medical Products in Electrophysiology. Arq Bras Cardiol. 2017;108(2):169-172.
  23. Mender RR, Albuquerque GS, Silva MN, et al. Reutilização de cateteres cardíacos de eletrofisiologia. RELAMPA, Rev. Lat.-Am. Marcapasso Arritm. 2011;24(3):151-160.
  24. 3M. 3M Surface Test para Mercado Hospitalar [accessed in 21 aug 2018]. Available at: https://www.3m.com.br/3M/pt_BR/3m-do-brasil/todos-os-produtos-3m-do-brasil/~/To-dos-os-Produtos-3M/Limpeza-e-Monitoramento-da-Esteriliza%C3%A7%C3%A3o/Sa%C3%BAde/Mercado-Hospitalar/Surface-Test/?N=5002385+8707795+8707798+8711017+87110 99+8717846+3294857441&rt=r3>.
  25. Sato A, Nakamura I, Fujita H, et al. Peripheral venous cath-eter-related bloodstream infection is associated with severe complications and potential death: a retrospective observational study. BMC Infect Dis. 2017;17(1):434.
  26. Amaranta JM, Toscano CM, Pearson ML, et al. Reprocessing and reuse of single-usemedical devices used during hemody-namic procedures in Brazil: a widespread and largely over-looked problem. Infect. Control Hosp. Epidemiol. 2008;29:854–858.
  27. Silva MV, Martinez MB, Andreoli J. Microbiological evaluation of reused catheter guides in a Brazilian hospital. PDA J. Pharm. Sci. Technol. 2006;60:356–365.
  28. Popp W, Rasslan O, Unahalekhaka A, et al. What is the use?An international look at reuse of single-use medical devices. Int J Hyg Environ Health. 2010;213:302–7.
  29. Wang D, Wu J. Reprocessing and reuse of single-use med-ical devices in China: a pilot survey. BMC Public Health. 2019;19(1):461.
  30. Costa EA. Panorama internacional do reprocessamento de pro-dutos médicos de uso único. Revista SOBECC. 2016;21:203.
  31. Ischinger TA, Neubauer G, Ujaky R, et al. Wiederverwendung von medizinischen Einwegprodukten nach qualitätsgesicherter Wiederaufbereitung: ein Modell zur Kostendämpfung? Z. Kardi-ol, 2002;91:889–898.
  32. European Commision. European Commission: synthesis document – Outcome of the first public consultation on the reprocessing of medical devices. May 2008; EAMDR (European Association for Medical Device Reprocessing; SUPROMED 200.7
  33. European Comission. European Commission: synthesis docu-ment. Outcome of the first public consultation on the reprocess-ing of medical devices. Brussels, 2008b.
  34. Tessarolo F. Reuse of single-use medical devices for interven-tional cardiology. Appl Surf Sci. 2004;238:341- 46.
  35. Quirck M. Most US hospitals avoid reuse of single-use devices. Lancet Infect. Dis. 2002;2:714.
  36. United States Government Accontability Office (United States of America) 2008. Report to the Committee on Oversight and Government Reform, House of Representatives. Reprocessed single-use medical devices. FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk. GAO-08-147.
  37. Alfa MJ, Castillo J. Impact of FDA policy change on the reuse of single-use medical devices in Michigan hospitals. Am. J. Infect. Control. 2014;32:337–341.
  38. The Association of Perioperative registered nurses. AORN guidance statement: reuse of single-use devices. AORN J. 2006;84:876–884.
  39. Jacobs PD, Polisena J, Hailey D, et al. Economic analysis of reprocessing single-use medical devices: A systematic literature review. Infect. Control Hosp. Epidemiol. 2008;29(4):297-301.
  40. Koh AL, Kawahara K. Current practices and problems in the reuse of single-use devices in Japan. J. Med. Dent. Sci. 2005;52:81–89.
  41. World Health Organization. The Joint Commission, Joint Com-mission International: Single use of Injection Devices. WHO: Geneva; 2007.
  42. Hutin YJ, Hauri AM, Armstrong GL. Use of injections in health-care settings worldwide, 2000: literature review and regional estimates. BMJ. 2003;327:1075–1078.
  43. Collignon PJ, Dreimanis DE. Beckinha WD. Reuse of single-use medical devices in sterile sites: how often does this still occur in Australia? MJA. 2003;179:115–116
  44. Hailey D, Jacobs PD, Ries NM, et al. Reuse of single use med-ical devices in Canada: clinical and economic outcomes, legal and ethical issues, and current hospital practice. Int. J. Technol. Assess. Health Care. 2008;24:430–436.
  45. Department of Health (Australia). Infection control guidelines for the prevention of transmission of infectious diseases in the health care setting. [accessed in 21 aug 2018]. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/DEF2A0D0C4D47A69CA257BF0001B0827/$File/icg-rescinded. pdf
  46. Therapeutic Goods Administration (Australia). Australian reg-ulatory guidelines for medical devices. Version 1.1, May 2011.[accessed in 21 aug 2018]. Available at: https://www.tga.gov.au/sites/default/files/devices-argmd-01.pdf
  47. Schmid GP, Buvé A, Mugyenyi P, et al Transmission of HIV-1 in-fection in sub-Saharan Africa and effect of elimination of unsafe injections. Lancet. 2004;363:482–488.
  48. Jama ZV, Chin A, Badri M, et al. Performance of re-used pace-makers and implantable cardioverter defibrillators compared with new devices at Groote Schuur Hospital in Cape Town, South Africa. Cardiovasc J Afr. 2015;26(4):181-7.
  49. World Health Organization. Regional. Infection prevention and control in health care: time for collaborative action. WHO: Com-mittee for the Eastern Mediterranean; 2010.
  50. Raposo M. CME - O coração do hospital: Uma investigação er-gonômica em centrais de materiais esterelizados em unidades públicas de saúde. [Dissertação de mestrado em Design] -PUC-Rio de Janeiro: 2007.
  51. Kapoor A, Vora A, Nataraj G, et al. Guidance on reuse of cardio-vascular catheters and devices in India: A consensus document. Indian Heart J. 2017; 69:357-63.
  52. Oliveira AC, Gama CS. Avaliação da adesão às medidas para a prevenção de infecções do sítio cirúrgico pela equipe cirúrgica. Belo Horizonte: Rev Esc Enferm USP. 2015;49(5):767-74.
  53. Veras BM, Senna KM, Correia MG, et al. Análise de custo-efetividade do reuso de cateteres de cinecoronariografia sob a perspectiva de uma instituição pública no Município do Rio de Janeiro, Brasil. Cad. Saúde Pública, Rio de Janeiro. 2013;29:S110-S120.
  54. Leite FB. Central de material esterilizado: projeto de reestru-turação e ampliação do hospital regional de Francisco Sá. Brasília (DF): Ministério da Saúde; 2008.
  55. Lucas CT, Barbosa MP, Oliveira AC. Validação do reprocessamento de cateteres cardíacos angiográficos: uma avaliação da funcionalidade e da integridade. Rev Esc Enferm USP. 2010; 44(4):947-955.
  56. Patel G, Hopwood AJ. An evaluation of luminol formulations and their effect on DNA profiling. J. Legal Med. 2013;127(4):723-729.
  57. Mathews KC, Holde KE. Bioquímica. 2 ed. Madrid: McGraw-Hill/Interamericana de España; 2000.
  58. Ferreira AM, Andrade D, Rigotti MA, et al. Avaliação da desin-fecção de superfícies hospitalares por diferentes métodos de monitoramento. Rev. Latino-Am. Enfermagem. 2015;23(3):466-474.
  59. Agência Nacional de Vigilância Sanitária (Brazil). Resolução –ANVISA/DC nº 48, de 2 de junho de 2000.
  60. Bergervoet PW, Riessen NV, Zwet WC. Application of the forensic Luminol for blood in infection control. J Hosp Infect. 2008;68(4):329-333.
  61. Dilbeck, L. Use of Bluestar forensic in lieu of luminol at crime scenes. Journal of Forensic Identification 2006;56(5):706.
  62. Association for the Advancement of Medical Instrumentation (United States of America). Comprehensive guide to steam sterilization and sterility assurance in health care facilities 2017.
  63. Associação Brasileira de Normas Técnicas (Brazil). Esteril-ização de produtos para saúde - Indicadores biológicos - Parte 1: Requisitos gerais. [accessed in 21 aug 2018]. Available at: http://www.abnt.org.br/noticias>