Single Use, Single Patient Use, and Limited Use Medical Devices Policy

Introduction

The reprocessing and reuse of single-use medical devices is a longstanding practice, although the MHRA advises against this. Users often justify the reprocessing of such devices based on economic and environmental benefits. These perceived benefits are questionable as many of the processes required to ensure that the device is safe and fit for its intended purpose cannot be undertaken by the reprocessor (a person who undertakes the reprocessing of a medical device). Many single-use devices are also reused without adequate evaluation of the increased risks to patients.

This policy is based on current recommendations made by the Medical Devices Agency (MDA) (now known as the Medicine and Healthcare Product Regulatory Agency MHRA)) which clearly states that "A device designated as single use must not be re-used" (MHRA DB 2006 (04) v2.1 December 2013)

It has also been formulated to meet Department of Health guidelines, which state ‘Never re-use medical devices designated for single-use’ (NHS Executive 1999).

Aim

The aim of this policy is to set out the legal issues and implications of improper use associated with medical devices that have been designated as Single-Use, Single Patient Use and Limited Use Medical Devices Items.

Policy Details