FDA’s next-gen medtech surveillance bets heavily on unique device identifiers

FDA with magnifying glass

The FDA laid out plans to revamp its postmarket surveillance of medical devices, and a large part of that has to do with finalizing and implementing a long-awaited Unique Device Identifier program to better track and monitor devices.

The federal watchdog agency aims this year to finalize a UDI rule, building on a proposal released in July 2012. The rule would require most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety.

The UDI system will include a publicly accessible global UDI database, incorporation of UDI into electronic health records, a pilot UDI demonstration in a multi-hospital information system and a think-tank report to inform full implementation, according to a new FDA report.

The FDA’s 2012 proposed UDI rule laid out a 5-year approach to implementing the program, focusing 1st on the highest-risk devices and exempting lower-risk products from some or all of the requirements. Congress initially approved the UDI program in 2006 to enable tracking of medical implants and to add medical devices to the Sentinel post-market surveillance program that currently monitors prescription drug safety.

Current Sentinel system records "lack manufacturer or brand-specific device identifiers and therefore cannot currently be leveraged to perform meaningful medical device postmarket surveillance," the FDA said in its latest update, but the UDI system can help fix that.

"Ultimately, we envision a medical device postmarket surveillance system using distributed data sources, focusing on electronic health information containing UDI and registries linked to, or integrated with, other longitudinal data sources," according to FDA’s report, entitled "Strengthening our National System for Medical Device Postmarket Surveillance: Update and Next Steps."

In addition to initiatives like the newly released iPhone and iPad adverse event reporting app, the UDI program will provide the "foundation" for a more robust and modernized postmarket surveillance program for medical devices, an area of regulatory oversight that the FDA says "presents unique challenges compared to drugs and biologics." The agency hopes to leverage transparency, collaboration and new technologies to modernize the system.

The agency hopes to accomplish that by finalizing and implementing the UDI program, establishing a "multi-stakeholder Medical Device Postmarket Surveillance System Planning Board," fostering national and international registries for certain devices, updating adverse event reporting and analysis and revamping its data generation and analysis.

RSS From Medical Design & Outsourcing

  • GlobTek presents its latest level VI AC/DC adapter and connverter
    T-43086-WWVV-X.X-Q Model is an addition to GlobTek’s Level VI compliant GT-43086 family and represents GlobTek’s 6 Watt wall plug-in series of AC/DC adapters (power supplies and chargers) with International Interchangeable blades. GlobTek’s changeable input blade system with individual field replaceable input plugs, including: North America and Japan NEMA 1-15P, Australian, UK BS 1363, European CEE […]
  • Sanmina’s familiarity with FDA gets skin treatment product to market fast
    The medical market for cosmetic devices is booming. However, quickly launching new products to meet demand is becoming more challenging because device manufactures face increased regulatory scrutiny. To help meet regulatory requirements, aesthetic and other medical-device OEMs are partnering with electronics manufacturing services (EMS) companies that also offer expertise with the FDA filings necessary to […]
  • Fluid connectors and quick disconnects for IVD equipment from CPC
    Colder Products Company (CPC) offers thousands of tubing connectors, quick disconnects and fittings for smart fluid handling in IVD and analytical equipment. Non-spill connectors speed testing throughput by eliminating drips, preventing air inclusion and increasing operator safety. Panel mount connectors can be added to existing equipment or bottle caps to provide secure, leak-free connections. Puncture […]
  • 310 Watt desktop medical power supply meets efficiency level VI requirements
    Power Partners releases a new 310 Watt medical grade desktop power supply from their PEAMD Series of AC and DC adapters. The 310 Watt unit is packed for ideal performance inside a compact case measuring 7.8 x 4 x 2 in. with a weight of only 3 lbs. The PEAMD310 Series is approved to the latest […]
  • Saelig introduces Multiple Instrument System MIS4 universal test system
    Saelig Company has introduced the ABI Electronics’ Multiple Instrument Station MIS4, an all-in-one testing tool that provides all commonly required test instruments in one compact programmable hardware module, mounted in a compact case or installed in a PC-drive bay. Controlled by ABI’s sophisticated SYSTEM 8 Ultimate PC software with a simple yet programmable operator interface, […]
  • AssurX announces document management software update for small to mid-size companies in FDA regulated industries
    AssurX, an enterprise quality management, risk and regulatory compliance solution provider, announces the release of the latest update to their AssurX document management software. The document management solution provides a cost-effective solution for small to medium sized companies faced with streamlined operations and is fully compliant for FDA regulated industries. Ideal solution for small to […]
  • Saelig presents new Amplicon Impact-R 1100F series computer
    Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]
  • Gerresheimer to acquire Centor
    Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]
  • Methods Machine Tools presents the new Nakamura-Tome NTRX-300
    Methods Machine Tools, a developer of precision machine tools and automation, has introduced the new Nakamura-Tome NTRX-300, a multitasking turning center featuring complete parts machining in one operation, with a built-in load and unload automation system and advanced operator recognition management software. The NTRX-300 features true opposing twin spindles: an 8 in. A2-6 25 HP or […]
  • MSC Apex Diamond Python and Smart Midsurface speeds modeling to validation
    MSC Software announced a new release of MSC Apex, the company’s award-winning next generation Computer Aided Engineering (CAE) platform. The MSC Apex Diamond Python release introduces: · The fourth release of MSC Apex Modeler is a CAE Specific direct modeling and meshing solution that streamlines CAD clean-up, simplification and meshing workflow. New in this release is […]
  • Quality Metrics: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications
    Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]

Leave a Reply