Success of Hospital Pilot to Document Implants is First Step Leading to Data Analytics Used to Combat Dangers Stated in Netflix Documentary "The Bleeding Edge" - Seite 4

"Results from the study demonstrate that laser-marked GS1 DataMatrix codes, using GS1 globally unique identifers allow the capture of the full UDI and has been observed to be the fastest and most accurate," said Alan Gormley.

This information may be used by medical device manufacturers to manage their inventory and know where all affected devices are located, in the event of a recall. The healthcare industry will be able to use the data to help combat counterfeits and analyze performance trends of devices and surgical procedures, ensuring the appropriate implant for each patient is selected. By tracking every medical device manufacturers, hospitals and payers will save significant healthcare dollars while improving patient safety and providing better care.

FDA REQUIREMENTS

Blueberry Castle participant Jay Crowley is the Vice President of the Unique Device Identification Services and Solutions at USDM Life Sciences.  He was most recently Senior Advisor for Patient Safety in the Food and Drug Administration's (FDA) Center for Devices and Radiological Health. Crowley developed the framework and authored key requirements for FDA's Unique Device Identification system.  Crowley said, "We (the FDA) envisioned the application and scanning of laser marked data matrix codes on medical devices before the technology was available.  I am pleased to see such promising results stemming from our efforts at the FDA."

Netflix recently released a highly critical documentary titled "The Bleeding Edge," which reported on challenges facing the FDA and the medical device industry over how to determine which devices are safe for market release and which devices should be recalled from the market.  Because of the efforts of Crowley and others at the FDA, the immediate access to key data will soon be available to aide industry and regulatory agencies throughout the world to further measure the effectiveness and safety of medical devices.  

The FDA is building the National Evaluation System for health Technology (NEST) to more efficiently generate better evidence for medical device evaluation and regulatory decision-making. NEST will generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices.