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The safety of reprocessed medical devices marketed for single-use
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- ACKNOWLEDGEMENTS
- ABSTRACT
- EXECUTIVE SUMMARY
- 1. BACKGROUND
- 2. TERMS OF REFERENCE
- 3. LEGAL FRAMEWORK
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4. SCIENTIFIC RATIONALE
- 4.1. Introduction
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4.2. Hazard considerations
- 4.2.1. Design characteristics of the SUDs
- + 4.2.2. Procedures for removal of pathogenic agents
- 4.2.3. Treatment after use
- 4.2.4. Procedures for cleaning
- 4.2.5. Procedures for disinfection
- 4.2.6. Inspection, assembly and packaging
- + 4.2.7. Procedures for sterilization
- 4.2.8. Differences between disinfection and sterilization
- 4.2.9. Prion inactivation and/or removal
- 4.2.10. Physico-chemical hazards
- 4.2.11. Conclusions
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4.3. Risk considerations
- 5. OPINION
- 6. MINORITY OPINION
- 7. LIST OF ABBREVIATIONS
- 8. REFERENCES
- 9. STANDARDS
- + 10. GLOSSARY
One of the Directives regulating the placing on the market of medical devices in the EU is Directive 93/42/EEC on medical devices. This Directive distinguishes between those devices that are intended by the manufacturer to be reused and those which are intended for single-use. Both types of devices must comply with the essential requirements of this Directive. The use of single-use medical devices (SUDs) has considerably increased for a variety of reasons. However, some medical devices have continued to be reprocessed despite the fact that they were intended for single-use. The use of reprocessed SUDs may not be without risk. In this opinion the possible risks involved in the reprocessing and reuse of single-use medical devices have been evaluated. Several potential hazards have been identified that may eventually lead to a risk for patients on whom a reprocessed SUD would be used. As is the case for medical devices intended for re-use, the major hazard arises from the inadequate cleaning, disinfection and/or sterilization that may result in persistence of either a chemical or a microbiological contamination, the former resulting in a risk of toxic reactions, the latter in a risk of microbiological infection. Of specific concern is the hazard of the potential contamination with agents causing transmissible spongiform encephalopathies (TSEs). In addition, the interaction with the chemicals used during the various procedures may result in changes in the material characteristics which can affect the performance of the device. Other factors that may increase the risk for the patient when using a reprocessed SUD include poor traceability of a reprocessed device, and inadequate educational and training aspects for complex medical procedures. Data to quantify the risks are however scarce. Some simulation studies have shown that improper cleaning, disinfection and/or sterilization may leave a bioburden on the reprocessed SUD. There is a lack of data specifically dealing with clinical outcomes for patients treated with reprocessed SUDs. There are a few case reports showing persistence of chemical residues of cleaning agents and disinfectants, persistence of infectious agents and modifications in physical-chemical characteristics. Despite the absence of data, a number of situations in which an increased risk from using a reprocessed SUD may occur have been identified; an increased risk may be present in particular with the use of a re-processed SUD in invasive medical procedures (designated critical use), and with the use of a reprocessed SUD with certain design features that make it unsuitable for reprocessing and re-use. Some recommendations are made.
Book Details
Authors
European Commission and Directorate General for Health and Consumers
Publishers
Publication year : 2010
License: All rights reserved ©
Times read: 0
