Gerenciando risco em reprocessamento de produtos para Saúde: Uma metodologia para serviços hospitalares.
Keywords:
Reprocessing, Equipament design, Risk, Management.Abstract
Among the technologies in healthcare, medical devices used in supportive care are becom-ing increasingly more complex. They have contributedmuch to the quaiity of hospital care, but also have cre-ated new sources of risk, especiaily when submittedto reprocessing and re-use. This article surveys thestate-of-the-art on risk associated to the reprocessingof medical products, and proposes a methodology forrisk management in hospital services. The survey isbased on nationai (Brazilian) and international datasources, with the application of specific descriptors.The literature reviewed confirms the com piexity of riskassessment related to reprocessing medical products,both re-usabie ones as well as those meant for singieuse. In either case we find difficulties in carrying outthe usual evaluation based on dose-response. Thefindings from the survey were used as subsidy forthe design of a methodology for risk management inreprocessing medical devices, built on the principieof precaution.
References
Dalari SG. Vigilância sanitária: responsabilidade pública na proteção e promoção da saúde. In: Costa EA, organizadora. Vigilância sanitária: desvendando o enigma. Salvador: EDUFBA; 2008. Rev. SOBECC. São Paulo. abr./jun. 2013; 18(2): 33-44.
Navarro MVT. Risco, radiodiagnóstico e vigilância sanitária. Salvador: EDUFBA; 2009.
Gadelha CA. O complexo industrial da saúde: desafios para uma política de inovação e desenvolvimento. In: Brasil. Ministério da Saúde. Saúde no Brasil: contribuições para a agenda de prioridades de pesquisa. Brasília; 2006.
U.S. Food and Drug Administration (FIDA). Department of Health and Human Services, Center for Devices and Radiological Health. CDRH: overview of device regulations. Rockville; 2007.
Greene VW. Reuse of medical devices labeled for single-use. In: Mayhall GC. Hospital epidemiology and infection control. 3a ed. Philadelphia: Lippincott Williams and Wilkins; 2004. p.1535-45.
World Health Organization (WHO). Medical Device Regulations. Global overview and guiding principies[ Internet]. Genova; 2003 [ cited 2007 Fev 03]. Disponível em: www.who.gov.
Health Education and Human Services Division, Single-Use Medical Devices. Little available evidence of harm from reuso, but oversigth warrented. Washington; 2000.
National Research Council (NRC). Risk assessment in the government: managing the process. Washington: National Acaderny Press; 1983.
Klosz K. Quality management for the processing of medical devices. GMS Krankenhaushyg Interdiszip. 2008;3(3): Doc22.
Agência Nacional de Vigilância Sanitária (ANVISA). Resolução RDC n° 15, de 15 de março de 2012. Dispõe sobre o funcionamento de serviços que realizam o processamento de produtos para saúde e dá outras providências. Diário Oficial da União, Brasília, 16 mar. 2012.
International Organization for Standardization. Application of risk management to medical devices: ISO 14971. 2nd ed. Genova; 2007.
Associação Brasileira de Normas Técnicas (ABNT). NBR ISO 14971:2009. Produtos para saúde: aplicação de gerenciamento de risco a produtos para saúde. Rio de Janeiro; 2009.
Carvalho A. Implernentation of risk management principies and activities within a Quality Management System [Internet]. S.I. The Global Harmonization Task Force; 2005. (Final document - GHTF/SG3/N15R8). [cited 2009 Jun 02]. Available from: http:!/www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n1 5r8-risk-rnanagement-principles-qms-050520. pdf
Lucchese G. Globalização e regulação sanitária: os rumos da vigilância no Brasil. Brasília: ANVISA; 2008.
Padoveze CM. Riscos associados ao reprocessarnento de artigos de uso único. In: Associação Paulista de Estudos e Controle de Infecção Hospitalar (APECIH). Reprocessamento de artigos de uso único. São Paulo; 2008.
Hubner NO, Assadian O, Poldrack R, Duty O, Schwarzer H, MolIer H, et ai. Endowashers: an overlooked risk for possible post-endoscopic infections. GMS Krankenhaushyg lnterdiszip. 2011;6(1):Doc 13.
Lee RC, Berzins S, Alfieri N. Single-use device reuse risks. Can J lnfect Control. 2007;22(3):142-4.
Canadian Healthcare Association. The reuse of single-use medical devices:guidelines for healthcare faciiities. Ottawa; 1996.
Day P. What is the evidence on the safety and effectiveness of the reuse of medical devices labelled as single-use only? New Zealand Helath Tecnology Assessement. NZHTA. Tech Brief Series [lnternet] 2004 [cited 2009 Jun 021;3(2). Available from: http://nzhta.chmeds.ac. nz/medical_devices . pdf.
Denser CPAC, Lacerda RA. Reprocessamento e reutilização de material odonto-médico-hospitalar de uso único: busca de evidências pela revisão sistemática de literatura científica. Acta Paul Enferm 2006-1119(3):316-22.
Hailey D, Jacobs PD, Ries NM, Polisena J. Reuse ofsingle use medical devices in Canada: clinical and economic outcomes, legal and ethical issues, and current hospital pratice. Int J Technol Assess Health Care. 2008;24(4):430-6.
Downloads
Published
How to Cite
Issue
Section
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.
