What is the evidence on the safety and effectiveness of the reuse of medical devices labelled as single-use only?
Record ID 32004000661
The aim of this Tech Brief was to review the evidence for the safety and effectiveness of the reuse of medical devices labeled as single-use devices (SUD).
Authors' recommendations: The evidence for the safety and effectiveness of reusing SUDs is anecdotal with few studies evaluating outcomes directly related to patients. There is a lack of data on patient exposure to cross-infection, loss of device functionality, and resulting adverse patient outcomes. Much of the literature is set in laboratory contexts evaluating surrogate outcomes such as contamination and device integrity, so the overall evidence is indirect. The literature often forms more of a theoretical basis for these concerns than any firm scientific evidence. There are conflicting results from the studies reviewed. Some studies conclude that the reuse of SUDs is potentially safe and effective with strict reprocessing protocols and standards, while others do not recommend reprocessing and reuse because of the identification of contaminated and faulty devices. In the broader literature, there is support for the reuse of some devices such as electro-physiology catheters under strict cleaning and sterilisation protocols. Adverse events related to the reuse of medical devices have been reported such as iatrogenic Creutzfeldt-Jakob disease (CJD), however there are few reported cases linked to contaminated medical devices. Research continues into CJD infection control as this requires unique disinfection and sterilisation methods given the strong resistance of prion disease to conventional decontamination methods. The only certain way to avoid the risks (though not quantifiable at present) of reprocessed SUDs as being vectors of transmissible prions is to make all medical devices disposable. Improved awareness and changes in clinical practice have helped to minimise transmission risks. The controversy remains regarding hemodialyser reuse practices as this is extensive in countries such as the USA. The risks associated with reusing SUDs in patients have not been adequately documented because of a lack of data on the incidence of cross-infection and device malfunction. Such events may be underreported due to a lack of surveillance and device tracking methods, and the possibility of legal liability issues. The literature reviewed is very device-specific and the reliability of the results is limited because of the diversity of SUDs and methods used to evaluate reprocessing and reuse. It is recognised that greater research is required. The implementation of stricter regulatory environments will improve patient safety and monitoring of reuse practices but not necessarily improve cost-effectiveness.
Authors' methods: Systematic review
Project Status: Completed
URL for project: http://nzhta.chmeds.ac.nz/publications.htm
Year Published: 2004
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: New Zealand
- Disposable Equipment
- Equipment and Supplies
- Equipment Reuse
Organisation Name: New Zealand Health Technology Assessment
Contact Address: Department of Public Health and General Practice, Christchurch School of Medicine and Health Sciences, University of Otago, P.O. Box 4345, Christchurch, New Zealand. Tel: +64 3 364 1145; Fax: +64 3 364 1152;
Contact Name: firstname.lastname@example.org
Contact Email: email@example.com
Copyright: New Zealand Health Technology Assessment (NZHTA)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.