Before proposing regulations for unique device identifiers (UDIs), FDA wants to hear from all stakeholders about any barriers and incentives to UDI adoption and use. The agency is holding a public workshop September 12-13 in Bethesda, MD, and while this workshop will not address FDA’s UDI regulatory framework, it will give medical device manufacturers the chance to hear from end-users about their hopes for putting UDI to work.
Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA must issue regulations establishing a UDI system for medical devices. FDA believes that “the incorporation of UDI into various health-related databases will greatly facilitate many important public health-related activities,” the agency stated in the Federal Register on July 21. These activities include the following:
- Reducing medical errors.
- Reporting and assessing device-related adverse events and product problems.
- Tracking of recalls.
- Assessing patient-centered outcomes and the risk/benefit profile of medical devices in large segments of the U.S. population.
- Providing an easily accessible source of device identification information to patients and health care professionals.
Data could also be fed into FDA’s Sentinel Initiative. This ” national electronic system” is intended to track the safety of drugs, biologics, medical devices.
For all this to work, of course, the system must overcome real-life challenges. Thankfully, FDA is asking for frank input on the following tasks and has listed in the Federal Register several questions for stakeholders to consider under these topics:
- Documenting Device Use Using UDIs in Electronic Health Records
- The Role of UDI in Device Registries
- UDI’s Role in National and Local Data Standards
- Integrating UDI Throughout Hospital Systems
- The Role of UDI in Postmarket Surveillance and Compliance
- UDIs in Personal Health Records
Medical device manufacturers have been worrying for some time about the implications of UDI. The industry is waiting for FDA to solidify its thinking when it comes to what data to include and to requirements for certain medical device class levels and package levels.
But UDI is coming, and worry won’t make it go away. Instead, it’s time to consider how to facilitate the end-use of UDI. Its success in easing recalls alone will benefit the entire supply chain and reduce risk and liability for everyone, including medical device manufacturers. Attend (or tune in via Webcast) to hear discussions on how UDI could improve post-approval studies, recalls, and adverse event reporting, among other tasks.
For details, contact Jay Crowley, FDA, 301/980-1936, email@example.com.