Skip to main content Accessibility help

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

  • Jorge M. Buchdid Amarante (a1), Cristiana M. Toscano (a2) (a3), Michele L. Pearson (a2), Virginia Roth (a2) (a4), William R. Jarvis (a2) (a5) and Anna S. Levin (a6)...



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.


National survey, conducted from December 1999 to July 2001.


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.


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.


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.


Corresponding author

Rua Banibas 618, São Paulo SP 05460-010, Brazil (


Hide All
1.Greene, VW. Reuse of disposable medical devices: historical and current aspects. Infect Control 1986;7:508513.
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.
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;131:624630.
4.Favero, MS. Requiem for reuse of single-use devices in US hospitals. Infect Control Hosp Epidemiol 2001;22:539541.
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.
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); 1997:1723.
7.ECRI Institute. Special report on reuse of single-use medical devices: making informed decisions. Plymouth Meeting, PA: ECRI Institute; 1997.
8.Canadian Hospital Association. The reuse of single-use medical devices: guideline for healthcare facilities. Ottawa: CHA Press; 1996.
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; 2004:11171124.
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.
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;27:13851392.
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;78:364372.
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;24:955960.
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;32:337341.
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.
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;164:533536.


Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed