Single Use Medical Devices

A single-use Medical Device 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.

The aim of this policy is to set out the implications of improper use of single- use medical devices. The policy defines a ‘single-use Medical Device’ and informs staff that a Medical Device designated for ‘single-use’ must not be reused.

The reuse of single-use devices can affect their safety, performance and effectiveness, exposing patients and staff to unnecessary risk.

The reuse of single-use medical 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 2002 as the original manufacturer of the device