scholarly journals Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology

10.5772/13582 ◽  
2011 ◽  
Author(s):  
Francesco Tessarolo ◽  
Iole Caola ◽  
Giandomenico Nollo
Keyword(s):  
Medical Devices ◽  
Interventional Cardiology ◽  
Critical Issues ◽  
Single Use

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

2008 ◽  
Vol 29 (9) ◽  
pp. 854-858 ◽  
Author(s):  
Jorge M. Buchdid Amarante ◽  
Cristiana M. Toscano ◽  
Michele L. Pearson ◽  
Virginia Roth ◽  
William R. Jarvis ◽  
...  
Keyword(s):  
Adverse Events ◽  
Medical Devices ◽  
Surveillance System ◽  
Response Rate ◽  
Limited Resource ◽  
Interventional Cardiology ◽  
Questionnaire Response ◽  
Brazilian Society ◽  
Cardiac Catheters ◽  
Single Use

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.

Single-Use Medical Devices

2000 ◽  
Vol 25 (5) ◽  
pp. 280-290
Author(s):  
Janet Heinrich ◽  
Elizabeth A. Bradley ◽  
Marcia Crosse ◽  
Martin T. Gahart ◽  
Janina R Johnson ◽  
...  
Keyword(s):  
Medical Devices ◽  
Single Use

scholarly journals Towards sustainable design for single-use medical devices

2009 ◽  
Author(s):  
J.J. Hanson ◽  
R.W. Hitchcock
Keyword(s):  
Medical Devices ◽  
Sustainable Design ◽  
Single Use

Reuse of single use medical devices in Canada: Clinical and economic outcomes, legal and ethical issues, and current hospital practice

2008 ◽  
Vol 24 (04) ◽  
pp. 430-436 ◽  
Author(s):  
David Hailey ◽  
Philip D. Jacobs ◽  
Nola M. Ries ◽  
Julie Polisena
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Medical Devices ◽  
Coronary Angioplasty ◽  
Ethical Issues ◽  
Economic Outcomes ◽  
Health Events ◽  
Adverse Health ◽  
Single Use ◽  
Adverse Health Events ◽  
Legal And Ethical Issues

Objectives:The aim of this study was to assess the evidence that reuse of medical devices marketed for single use only (SUDs) is safe, effective and cost-effective, and to consider the use and health services impact of this practice in Canada.Methods:A systematic review was performed of studies that reported clinical or economic outcomes following reuse of SUDs in humans. Direct costs of adverse health events associated with SUD reuse and indications of budget impact were obtained using data for devices for laparoscopic cholecystectomy and coronary angioplasty. Legal and ethical issues were reviewed, drawing on material relevant to Canada. Data on current reuse of SUDs were obtained through a survey of Canadian acute care hospitals.Results:Studies of variable quality suggested that SUD reuse could be safe and effective, and would give cost savings, if there were no adverse events. Eliminating reuse of SUDs for laparoscopic cholecystectomy and coronary angioplasty would add less than 0.1 percent to costs of the procedures over 1 year. Adverse health events associated with device reuse create liability risks; patients should be informed of any known or foreseeable risks of reuse. Most of the 28 percent (111/398) of acute hospitals that reprocess SUDs do so in-house. Some do not have a written policy or an incident reporting mechanism.Conclusions:There is insufficient evidence to establish the safety, efficacy and cost-effectiveness of reusing SUDs. Legal and ethical issues require attention to minimize liability and maintain patient safety and trust. Some hospitals that reprocess SUDs do not have adequate documentation. These findings do not support the reuse of SUDs in Canadian hospitals.

scholarly journals Reprocessing and reuse of single-use medical devices in China: a pilot survey

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Duojin Wang ◽  
Jing Wu
Keyword(s):  
Medical Devices ◽  
Pilot Survey ◽  
Single Use

Reuse of single‐use medical devices: how often does this still occur in Australia?

2004 ◽  
Vol 180 (1) ◽  
pp. 46-47 ◽  
Author(s):  
Sandy J Berenger ◽  
John K Ferguson
Keyword(s):  
Medical Devices ◽  
Single Use

scholarly journals GAO Issues Report on Reuse of Single-Use Medical Devices

2000 ◽  
Vol 21 (9) ◽  
pp. 574-574 ◽  
Author(s):  
Gina Pugliese ◽  
Martin S. Favero
Keyword(s):  
Medical Devices ◽  
Single Use
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