Reuse and reprocessing of single-use medical devices: is the risk acceptable ?

Authors

  • Eliana Auxiliadora Magalhães Costa Enfermeira, Mestre em Organização de Serviços de Saúde pela Escola de Enfermagem da Universidade Federal da Bahia (UFBÁ), Doutoranda do Instituto de Saúde Coletiva da UFBA, Professora Assistente da Universidade Estadual da Bahia (UNEB).
  • Ediná Alves Costa Médica Veterinária, Mestre em Saúde Comunitária pela UFBA, Professora Associada do Instituto de Saúde Coletiva da UFBA, Doutora em Saúde Pública pela Universidade de São Paulo. Coordenadora do Centro Colaborador em Vigilância Sanitária do Instituto de Saúde Coletiva da UFBA.

Keywords:

Sterilization, Reuse, Safety of the equipment, Health Services

Abstract

The practice of reusing and reprocessing singie-use medical products has raised objections, especially with respect to the risk for infection and problems with its integrity and functionality. Objectives: To review the state-of-the-art regarding risks associated to reprocessing of single-use medical products, in order to subsidize these practices. Method: bibliographic research, without restrictions on date or language, using national and intemational sources with specifics keywords. It was found that most research on this topic use different methodologies and get variable results. In face the state-of-the-art about reuse and reprocessing, is possible to conclude that the implementation of these practices should consider two critical conditions: the possibility of complete cleaning and the possibility of testing the product as to its integrity and functionality. Without these conditions,hospitais should not reuse disposable products under the risk of causing heaithhazards to its patients

References

Greene VW. Reuse of medical dcv iceslabeled for single-use. In: Mayhall GC.Hospital epidemiology and infectioncontrol. Philadelphia: Lippincott Willianisand Vilkins: 2004. p.1535-45.

Health Canada. Therapeutic productsdirectorate health cross: reprocessing ofreusable and single-use medical devices.Ottavva. Ontário: Tovver B: 2004.

Graziano KU, Bálsamo AC. LopesCLBC, Zotelii MFM. Couto AT, PaschoalMLH. Critérios para avaliação dasdificuldades na limpeza de artigos deuso único. Rev Latino-am Enferm2006:14(1 ):70-6.

Tessarolo F. Caola 1. NolIo G, AntoliniR. Guarrera GM. Caciagli P. Efflciencyiii endoxina remov aI hy a reprocessingprotocol for eletrophysiology cat!ietersbased ou hydrogen peroxide plasmasterilization. Int J Hyg Env iron Health.2006:209(6):557-65.

Czeresnia D. Risco epidemiológico evigilância sanitária. In: Costa E. organi-zador. Vigilância sanitária: desvendandoo enigma. Salvador: EDUFBA; 2008.

Luiz OC, Cohn A. Sociedade de risco erisco epidemiológico. Cad Saúde Pública.2006,22(11):2339-48.

Navarro MVT. Conceito e controle deriscos à saúde em radiodiagnóstico: umaabordagem de vigilância sanitária [tese single-use devices: review priorization artificial [tese de mestrado]. São Paulo: de doLitarado]. Salvador: Universidade scherne. Rockville: 2000. Escola de Enfermagem, Universidade de Federal da Bahia: 2007. São Paulo; 2006.

Agência Nacional de VigilânciaSanitária, Resolução RDC n. 2, de 25de janeiro de 2010. Dispõe sobre ogerenciamento de tecnologias em saúdeem estabelecimentos de saúde. DiárioOficial da União. Brasília, 25 jan. 2010Seção 1, p. 79.

National Research Council. Riskassessment in the government: rnanagingthe process. Washington: NationalAcademy Press; 1983.

International Organization forStandardizatíon. Medical devices:application of risk management tomedical devices - ISO 14971. 2 Genova:2007.

Food and Drug Admistration.Department of 1-Iealth and HumanServices. Enforcement priorities forsingle-use devices reprocessed bythird parties and hospitais. Rockville: 2000.

Food And Drug Administration.Department of Health and FlumanServices. Reprocessing and reuse of

Canadian Healthcare Association.The reuse ofsingle-use medical devices:guidehnes for healthcare facilities. Ottawa.Ontario; 1996.

Day P. What is the evidence on thesafety and effectiveness of the reuse ofmedical devices labelled as single-useonly? NZHTA Tech Brief Series [serialon the Internet]. 2004 [cited 2009 Jun02];3(2). Available from: http://nzhta.chmeds.ac.nz/puhlications/medicaldevices.pdf

Denser CPAC, Lacerda RAReprocessamento e reutilização dematerial odonto-médico-hospitalar de usoúnico: busca de evidências pela revisãosistemática de literatura científica. ActaPaul Enferm. 2006; 19(3):3 16-22.

Health Education and HumanServices Division. Single-use medicaldevices: little available evidence ofharrn from reuso but oversigth warrented.Washington; 2000.

Lopes CLB. Avaliação da esterilidadede instrumentais laparoscópicos de usoúnico reprocessados após contaminação

Ribeiro SMCP. Reprocessamento decateteres de angiografia cardiovascularapós uso clínico e contaminados artificial-mente: avaliação da eficácia da limpeza eda esterilização. [tese de doutorado]. SãoPaulo: Escola de Enfermagem, Universi-dade de São Paulo; 2006.

Hailey D, Jacobs PD, Ries NM,Polisena J. Reuse of singie use medicaldevices in Canada: clinical and economicoutcomes, legal and ethical issues, andcurrent hospital pratice. Int J TechnolAssess Health Care. 2008:24(4):430-6.

World Health Organization. Medicaldevice regulations: global overviewand guiding principies [homepage naInternet]. Geneva: 2003. [cited 2007 Fev03]. Available from: www.who.gov

Downloads

Published

2011-06-30

How to Cite

Costa, E. A. M., & Costa, E. A. (2011). Reuse and reprocessing of single-use medical devices: is the risk acceptable ?. Revista SOBECC, 16(2), 50–56. Retrieved from https://revista.sobecc.org.br/sobecc/article/view/202

Issue

Vol. 16 No. 2 (2011)

Section

ORIGINAL ARTICLES

License

By publishing in Revista SOBECC, authors retain the copyright of their article and agree to license their work using a Creative Commons Attribution (CC BY 4.0) International Public License, thus accepting the terms of this license. The CC BY 4.0 license allows others to distribute, remix, adapt, and create from the published article, even for commercial purposes, provided they give due credit to the creators of the work (authors of the article).

The authors grant to Revista SOBECC the right of first publication, to identify itself as the original publisher, and grant to the journal a non-exclusive license to use the work in the following ways: (1) to sell and/or distribute the article in hard copies and/or in electronic format; (2) to distribute parts and/or the entire article in order to promote the journal through the internet and other digital and printed media; (3) to record and reproduce the article in any format, including digital media.

With this license, authors can enter into separate contracts for non-exclusive distribution of the article (e.g., publishing in an institutional repository or as a book chapter), with acknowledgement of authorship and initial publication in Revista SOBECC. Authors are encouraged to publish and distribute their work online after publication in the Revista SOBECC, as this can increase the article's visibility and impact.

In line with the journal's policies, each published article will be assigned a CC BY 4.0 license, which will be visible on the abstract page and in the PDF of each article with the respective link to the license terms.