3rd February 2026
Cormac O’Prey
Kestrel Technology Consulting
MHRA and Standards linked to reusable and sustainable products and processes.
Key Points:
- Patient safety is still the absolute top priority. Despite the environmental benefits, patient safety cannot be compromised by any reprocessing of medical devices
- “A medical device made for reuse must work as well as it did on its first use every time even after it has been reprocessed.” – MHRA
- The overall principles of reprocessing of medical devices are similar across regulatory authorities, but regulators are not entirely in agreement on the detail and there some inconsistencies.
- Regulatory guidance and mandates on reprocessing of medical devices are still evolving and subject to further changes. Different territories are at different stages and US is catching up with UK&EU
- Device design life must be specified, verified and managed during multiple usage cycles
- Device traceability must be maintained through multiple usage cycles
- The number of usage cycles shall be limited and controlled
- Device usage must remain unchanged
- All remanufacturing steps are subject to the same procedural rigour and validation as original device manufacture
- Companies selling reprocessed medical devices must now be named on the device
Reprocessing risks:
- Potential for cross-infection
- Inability to clean and decontaminate
- Residues from chemical decontamination agents
- Material alteration
- Mechanical failure
- Reactions to endotoxins (Gram-negative bacterial breakdown products which cannot be adequately removed by cleaning)
- Prions, the abnormal proteins associated with prion diseases
Future developments:
- There is a growing obligation on manufacturers to justify why they can NOT consider reprocessing, and how to dispose of used devices responsibly
- Refurbishment should still take place on devices to the extent it is safe to do so.
- MHRA is emphasising the importance of proving devices are safe to reprocess, especially by those who do not have access to the original design information and therefore don’t fully appreciate the risks