Challenging our Industry
UDI (Unified Device Identifier) is provoking many challenges for all suppliers of non-sterile medical devices. Historically, there were good reasons to organize implants in non-sterile sets. With an increase of iatrogenic provoked infections in hospitals and as a consequence higher requirements from the notified bodies, UDI becomes a standard in the medical device identification. Pre-assembled sets and sets, which are sterilized prior to each use, might be convenient in the OR planning, but critical for the required traceability and reliability of medical products. Implants, which are not used in surgical procedure, remain in set and are reprocessed over and over for subsequent use. This affects, harms, destroys or weakens the implants to a critical degree. With the need for clear and more detailed information, implants must bear a laser marking on the implants (if enough space) or carry a tag or strip for UDI application.
Suppliers of sterile medical devises, like epimedical, have recognized a while back, how important a clear supply chain will be for the safety of the patient and the ease of OR staff. That’s why epimedical only provides implants of all kind strictly single-packed sterile, where all UDI requirements can be applied and reach CE and FDA requirements already.
Additional Information: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification