CDRH Advisory Committee Meeting: to discuss and make recommendations on medical device supply chain resiliency and shortage issues, including the 506J Device List

During the February 6, 2024 - FDA - General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting, during the open session, I presented the following information and the need for the GUDID to have a 506J Device flag.

Docket: FDA-2023-N-4807

Presentation by: Joan Melendez, President/Founder | Xcelrate UDI, Inc.

Good morning, esteemed members and guests, my name is Joan Melendez, President/Founder of Xcelrate UDI. To clarify upfront, I have no financial interests to disclose.

We inadvertently compromise patient safety in several ways. For instance, patient harm occurs not only through direct device failures but also from systemic issues such as inadequate identification, delays in issuing recalls, and the continued sale of devices officially removed from the market, including those on the 506J. These problems are further aggravated by our reactive responses to device shortages and disruptions in manufacturing.

To address challenges in device shortages and disruptions, it's essential that we elevate the safety of our patients by enhancing our ability to manage medical devices more effectively. A key strategy involves establishing a link between the 506J Device List and the Global Unique Device Identification Database, the GUDID. This link is crucial for improving device identification, ensuring device availability and safety from the time of manufacturing to the final disposition. Embedded in the ONC's Implantable Device List framework, The GUDID and the medical devices Unique Device Identification, the UDI, offers an example of a proactive approach, ensuring comprehensive device tracking and patient safety.

Consider the FDAs call to action to be "Recall Ready." The challenges managing recalls underscore the need for precise identification and labeling (including the IFU). Incorporating a 506J flag into the GUDID is vital to ensuring a medical device is approved for sale and to quickly identify and address issues with devices, especially in times of shortages or health crises. A move towards immediate access to complete device data through the use of the medical devices UDI-DI, and the GUDID can help facilitate the identification of suitable replacements where a product code is too broad of a classification.

The UDI-DI associates the devices global medical device nomenclature, the GMDN, to further pinpoint an appropriate replacement should a product on the 506J be in shortage. The GUDID combined with the IFU, offers critical guidance for a device and can help determine an appropriate substitute or if the device is merely a part listed under the same classification code. The IFU contains every detail about devices from shipping restrictions and storage temperature to cleaning, reprocessing and prep steps and include the manufacturer’s contact in the event of a shortage, need or failure —fundamental elements for patient care and device safety.

In summary, creating a 506J Device List flag in the GUDID, and linking the IFU, is fundamental to achieving a comprehensive medical device management system. This system not only ensures device safety and availability but also strengthens our healthcare system's resilience against challenges, paving the way for a proactive stance for device shortages and manufacturing disruptions and ensuring pandemic preparedness and patient safety.

Thank you for your time and attention, and for the opportunity to share these important considerations with you today.

Joan Meléndez

President/Founder

Xcelrate UDI, Inc.