Single-use
This article was originally published in RAJ Devices
Executive Summary
UK MHRA publicises issues surrounding single-use
UK MHRA publicises issues surrounding single-use
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an updated version of its device bulletin entitled Single-use Medical Devices: Implications and Consequences of Reuse1. The publication, issued on the MHRA website (www.mhra.gov.uk) in October 2006, replaces the device bulletin of the same name issued in 2000. The MHRA advises against the reprocessing and re-use of single-use devices which it says is “a long-standing practice”.
According to the MHRA, there are no substantial changes in the new bulletin2. The key points are:
- a device designated as single-use must not be re-used. It should only be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used again, even on the same patient;
- re-use of single-use devices can affect their safety, performance and effectiveness, exposing patients and staff to unnecessary risk;
- re-use of single-use devices has legal implications:
- anyone who reprocesses or reuses a device intended by the manufacturer for use on a single occasion, bears full responsibility for its safety and effectiveness;
- anyone who reprocesses a single-use device and passes it to a separate legal entity for use, has the same legal obligations under the Medical Devices Regulations as the original manufacturer of the device.
The MHRA said it is obliged to revise all its bulletins five years after their initial publication. With regard to this specific bulletin, there have been updates to the referencing in the revised bulletin, reflecting the publication of revised regulations since the publication of the 2000 edition.
The UK agency has also issued a leaflet for healthcare professionals to help clarify the term “single-use” and the symbol that is used to represent it (ie a circle containing the figure “2” with a line through it). The leaflet explains how to tell if a device is for single-use (it will have the symbol on the packaging); and why devices labelled as such should not be re-used. It also explains the difference between the terms “single-patient use” and “single-use”. Lastly, it warns that, while single-use devices marketed as non-sterile may require processing, in line with the manufacturer's instructions, to make them sterile and ready for use, they must not be reprocessed.
References
1. MHRA, Single-use Medical Devices: Implications and Consequences of Reuse, DB2006(04), October 2006, www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON2024995&ssSourceNodeId=386&ssTargetNodeId=572
2. Personal communication, MHRA, 24 October 2006
3. MHRA, Single-use medical devices leaflet, 18 October 2006, www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2024993&ssTargetNodeId=386