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Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. FDA Unveils Medical Device Surveillance Vision

   Feb 23, 2015 | Law 360

   By Jeff Overley
   
   
   ...As it stands, recent litigation involving defective surgical mesh, metal-on-metal hip implants and other products have "raised questions about [the FDA’s] ability to monitor...

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. FDA Unveils Medical Device Surveillance Vision

   Feb 23, 2015 | Law 360

   By Jeff Overley

   The U.S. Food and Drug Administration on Monday released an in-depth report on the future of adverse event tracking for medical devices, potentially setting the stage for creation of an ambitious nationwide system.
   
   The report was commissioned by the FDA and prepared by an expert panel with representatives from two dozen agencies, organizations and corporations, includingMedtronic Inc., Aetna Inc. and the American Medical Association. The array of stakeholders underscored the many interests at play, and the scope of the 76-page report made clear that building a national surveillance system will be expensive and complicated.
   
   In a blog post, the FDA said that Monday's report "provides a pathway to realizing a national system that harnesses novel data sources, modern analytical techniques and the participation of all stakeholders to optimize patient care."
   
   Success will first require implementing the FDA's nascent system of so-called unique device identifiers, which are being phased in between now and 2020, the report said. Other challenges include ensuring that different types of electronic health records can communicate and devising a system that doesn't create red tape for providers. Finding adequate funding is also key, according to the report, which predicts that at least $200 million in startup cash will be needed.
   
   The fact that costs and benefits are spread across such a wide terrain means that the system should be structured as a public-private partnership with a governing board appointed through a transparent process, the report concluded. The surveillance system should begin with a two-year stage of pilot projects and then enter a five-year phase of implementation, the authors recommended.
   
   Much of the report is devoted to describing a patchwork of existing device-tracking programs, and the authors urged the FDA to make sure a new system gels with those current efforts.
   
   "Any effort to create a stand-alone, isolated system will significantly increase the work required to develop data and conduct analyses on surveillance, lowering the value of the system and threatening its viability," the report said.
   
   Despite the many challenges, the authors also said that a modernized system would have far-reaching benefits for patient safety and device maker liability. As it stands, recent litigation involving defective surgical mesh, metal-on-metal hip implants and other products have "raised questions about [the FDA’s] ability to monitor and act on potentially important safety concerns," according to the report.
   
   Improved tracking could also help providers make smarter choices about which devices to use and could assist health insurers in developing better coverage policies, the report said. It may even result in relaxed approval standards at the FDA, since unexpected problems would be more quickly spotted, according to the report.
   
   "This shift does not mean FDA accepts less evidence of safety and effectiveness, but [it] is an acknowledgement that post-market data better reflects the real world," the authors wrote.
   
   The FDA said it plans to accept public comments on Monday's report, and that a separate task force report will be released later this year to further inform its efforts being moving forward.
   
   Device makers every year submit more than 1 million reports of adverse events, of which about 5 percent involve serious injuries or deaths, according to the report.
   

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