Biocompatibility for Medical Devices

Later this month, Informa’s KNect 365 hosts a Conference centered around biocompatibility for medical devices. Held in Amsterdam, the conference will focus on regulatory changes shaking up the field, as well as insights from Notified Bodies and industry alike. Within that mix will be AMDR. Dan Vukelich, AMDR President, will be both attending the conference and presenting a session addressing the new European Medical Device Regulation and potential impacts with regard to biocompatibility testing.

Medical devices need to be safe for patient use, including reprocessed ones.  Commercial medical device reprocessors and remanufacturers have long focused on biocompatibility issues and, as a matter of practice, ensure that nothing from the initial clinical use of the device, subsequent cleaning, or repair or sterilization processes adversely impacts the ability of that device to perform as intended.  After all, in returning a device to a hospital that has been used, the reprocessor or remanufacturer must provide a  device that is as safe and as effective as the original device.

In the U.S., for devices labeled by the original equipment manufacturer (OEM) as “single use,” the Food and Drug Administration holds subsequent reprocessors to the same standard as medical device manufacturers and arguably higher standards for device cleaning, sterilization and functional performance testing.

Now, with the passage in April of the European Medical Device Regulation (MDR), Europe too will regulate the reprocessing of single-use devices (SUDs).  Specifically, Article 17 of the MDR outlines that entities that reprocess SUDs are now manufacturers, subject to all the same requirements applicable to any other medical device firm.  Already the UK and Notified Bodies have recognized this new approach to reprocessing and have adopted the term “SUD remanufacturing” to apply to regulated commercial firms meeting manufacturer standards as distinct from hospital “reprocessing” operations.

There is a caveat in the Regulation that hospitals will be allowed to reprocess SUDs in-house if certain forthcoming Common Specifications are met.  At this time, we don’t yet know what those are, but we do know from the text of the Article 17 that it will at least include requiring that hospitals have a robust risk management system including evaluation of device construction and material, reverse-engineering, procedures to detect design changes, a quality system, among others, and all is to be certified by a Notified Body.

So this is a big change.  At least with regard to SUDs, upon implementation of the MDR, hospital reprocessors and commercial remanufactures must meet the MDR’s requirements.  Members of the Association of Medical Device Reprocessors (AMDR) are up for the challenge as they have long demonstrated that they meet these standards.  Indeed, SUD remanufacturers have advanced reverse engineering, testing, cleaning, functional performance and sterilization processes that likely exceed that of many original equipment manufacturers.

Now that the reprocessing of SUDs will be regulated in Europe, we expect Members States will instruct their hospitals, as Britain has already done, that in-house SUD reprocessing is NOT allowed, but that outsourcing to regulated, commercial firms which specialize in this field and meet MDD or MDR requirements, is encouraged.

By contracting with SUD remanufacturers, hospitals can safely and dramatically reduce their costs for many medical devices and reduce waste—getting more value out of the devices they already own.