Single-use Medical Devices: Implications & Consequences of Reuse

Key Points
1. Devices designated for ‘single-use’ must not be reused under any circumstances.

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

3. The reuse of ‘single-use’ devices has legal implications:

(a) 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.

(b) 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.