Medical Devices (includes In Vitro Diagnostics)
This session will provide observations, updates and challenges from three different perspectives: regulator, health care facility, and industry. It’s been six years since the FDA UDI Regulation was finalized, establishing the first formal UDI program for the medical device industry. Over these six years, the FDA have made adjustments to the program as both medical device manufacturers and health care facilities shared feedback and concerns. While medical device manufacturers work towards meeting the requirements by the compliance dates, the FDA has been driving towards the next phase of UDI implementation – core-data interoperability of UDI through its use in health care supply ordering, Durable Medical Equipment (DME) supply order and tracking, support for recalls and safety alerts, and applicability of use cases.
As the US UDI program matured, the FDA identified the need to accelerate UDI adoption across the health care field by actively engaging with a coordinated, action-oriented, and early UDI adopter community. The ARHMM Learning UDI Community (LUC) was created as a broad-based coalition comprised of health care leaders across sectors whose goal is to develop a common understanding and approach to UDI adoption within the health care setting. Attendees will hear from the health care facility perspective about the impact and challenges HCF are facing with UDI adoption, the need for improved and standardized data quality, the affect data quality has on their ability to use the data, and what medical device manufacturers should consider to enable better adoption in the US.
And as the US UDI regulation heads into its final implementation phase of the initial rule, other countries are ramping up their efforts to design and implement similar, yet different, UDI regulations of their own. Of key concern is UDI as part of the EU MDR and IVDR with implementation dates in 2020 and the EUDAMED database that still under development. All of this is being steadily chased by Japan, Republic of Korea, China, Japan and the Kingdom of Saudi Arabia, along with many others.