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Reprocessing and Reuse of Single-Use Medical Devices Used During Hemodynamic Procedures in Brazil: A Widespread and Largely Overlooked Problem

Published online by Cambridge University Press:  02 January 2015

Jorge M. Buchdid Amarante ,
Cristiana M. Toscano ,
Michele L. Pearson ,
Virginia Roth ,
William R. Jarvis  and
Anna S. Levin
Jorge M. Buchdid Amarante
Affiliation:
Hospital Samaritano de São Paulo, Brazil
Cristiana M. Toscano
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia Expanded Programme on Immunization, World Health Organization 20 Ave Appia, Geneva 1211, Switzerland
Michele L. Pearson
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia
Virginia Roth
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia Infection Prevention and Control Program, Ottawa Hospital, University of Ottawa, Division of Infectious Diseases, Ottawa, Canada
William R. Jarvis
Affiliation:
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia Jason and Jarvis Associates, 135 Dune Lane, Hilton Head Island, South Carolina
Anna S. Levin*
Affiliation:
University of São Paulo, Brazil
*
Rua Banibas 618, São Paulo SP 05460-010, Brazil (gcih@hcnet.usp.br)
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Abstract

Background.

Several medical devices used during hemodynamic procedures, particularly angiographic diagnostic and therapeutic cardiac catheters, are manufactured for single use only. However, reprocessing and reuse of these devices has been reported, to determine the frequency of reuse and reprocessing of single-use medical devices used during hemodynamic procedures in Brazil and to evaluate how reprocessing is performed.

Design.

National survey, conducted from December 1999 to July 2001.

Methods.

Most of the institutions affiliated with the Brazilian Society of Hemodynamic and Interventional Cardiology were surveyed by use of a questionnaire sent in the mail.

Results.

The questionnaire response rate was 50% (119 of 240 institutions). Of the 119 institutions that responded, 116 (97%) reported reuse of single-use devices used during hemodynamic procedures, and only 26 (22%) reported use of a standardized reprocessing protocol. Cleaning, flushing, rinsing, drying, sterilizing and packaging methods varied greatly and were mostly inadequate. Criteria for discarding reused devices varied widely. Of the 119 institutions that responded, 80 (67%) reported having a surveillance system for adverse events associated with the reuse of medical devices, although most of these institutions did not routinely review the data, and only 38 (32%) described a training program for the personnel who reprocessed single-use devices.

Conclusions.

The reuse of single-use devices used during hemodynamic procedures was very frequent in hospitals in Brazil. Basic guidance on how to reuse and reprocess single-use medical devices is urgently needed, because, despite the lack of studies to support reusing and reprocessing single-use medical devices, such devices are necessary in limited-resource areas in which these practices are current.

Type
Original Article
Information
Infection Control & Hospital Epidemiology , Volume 29 , Issue 9 , September 2008 , pp. 854 - 858
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2008

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References

1.Greene, VW. Reuse of disposable medical devices: historical and current aspects. Infect Control 1986;7:508–513.CrossRefGoogle ScholarPubMed
2.US General Accounting Office. Single-use medical devices. Little available evidence of harm from reuse, but oversight warranted. Report to Congressional Requesters. Washington, DC: US General Accounting Office; 2000: HEHS 2000.Google Scholar
3.Mak, K-H, Eisenberg, MJ, Eccleston, DS, Cornhill, JF, Topol, EJ. Reuse of coronary angioplasty equipment: technical and clinical issues. Am Heart J 1996;131:624–630.CrossRefGoogle Scholar
4.Favero, MS. Requiem for reuse of single-use devices in US hospitals. Infect Control Hosp Epidemiol 2001;22:539–541.Google Scholar
5.Hôpital Sacré-Coeur du Montreal. Réutilisation des catheters diagnos-thiques en cardiologie: efficacité de nettoyage et de stérilisation à l'oxyde d'ethylène. Montreal: Hôpital Sacré-Coeur du Montreal; 1992.Google Scholar
6.Jarvis, WR. Outbreaks associated with reprocessed medical devices: the Hospital Infections Program, Centers for Disease Control and Prevention Experience, January 1986-April 1996. In: International Symposium on Disinfection, Sterilization and Antisepsis in Health Care. New Orleans: Association for Professionals in Infection Control and Epidemiology (APIC); 1997:17–23.Google Scholar
7.ECRI Institute. Special report on reuse of single-use medical devices: making informed decisions. Plymouth Meeting, PA: ECRI Institute; 1997.Google Scholar
8.Canadian Hospital Association. The reuse of single-use medical devices: guideline for healthcare facilities. Ottawa: CHA Press; 1996.Google Scholar
9.Dettenkofer, M, Daschner, FD. Nosocomial infections associated with cardiac catheterization and other invasive procedures in cardiology. In: May-hall, CG, ed. Hospital Epidemiology and Infection Control. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 2004:1117–1124.Google Scholar
10.Ministry of Health of Brazil. Oficio Circular 033-CAB/SVS/MS. Diário Oficial da União 1998; November 16. São Paulo: Ministry of Health of Brazil; 1998.Google Scholar
11.Tessarolo, F, Caola, I, Caciagli, P, Guarrera, GM, Nollo, G. Sterility and microbiological assessrhente of reused single-use cardiac electrophysiology catheters. Infect Control Hosp Epidemiol 2006;27:1385–1392.CrossRefGoogle ScholarPubMed
12.Fedel, M, Tessarolo, F, Ferrari, P, et al.Functional properties and performance of new and reprocessed coronary angioplasty ballon catheters. J Biomed Mater Res B Appl Biomater 2006;78:364–372.CrossRefGoogle Scholar
13.Duffy, RE, Couto, B, Pessoa, JM, et al.Improving water quality can reduce pyrogenic reactions associated with reuse of cardiac catheters. Infect Control Hosp Epidemiol 2003;24:955–960.CrossRefGoogle ScholarPubMed
14.Alfa, MJ, Castillo, J. Impact of FDA policy change on the reuse of single-use medical devices in Michigan hospitals. Am J Infect Control 2004;32:337–341.CrossRefGoogle ScholarPubMed
15.Ministry of Health of Brazil. Agênda Nacional de Vigilância Sanitária (ANVISA). Resolução- RE 2606. Diário Oficial da União 2006. São Paulo: Ministry of Health of Brazil; 2006.Google Scholar
16.Collignon, PJ, Graham, E, Dreimanis, DE. Reuse in sterile sites of single-use medical devices: how common is this in Australia? Med J Austral 1996;164:533–536.Google Scholar