Report Details National Medical Device Surveillance System Plan

February 23, 2015 in News

On Monday, FDA and the Brookings Institution released a new report outlining a seven-year, $250 million plan to develop a national medical device surveillance system, FierceHealthIT reports (Hall, FierceHealthIT, 2/23).

Background

In April 2013, FDA published an updated strategy, detailing the steps it would take to create a National Medical Device Postmarket Surveillance System (Shuren/Gross, “FDA Voice,” 2/23).

In its modernization plan, FDA called for the creation of an automated surveillance system that would leverage electronic health data, such as:

  • Patients’ electronic health records;
  • Patients’ bills;
  • Insurance databases; and
  • Medical device company data (iHealthBeat, 4/24/13).

In September 2013, FDA issued a final rule establishing a unique device identification system for tracking medical devices, with the aim to:

  • Enable quick and efficient recall of medical devices;
  • Improve the accuracy and specificity of adverse event reports;
  • Provide a secure, global distribution chain to address counterfeiting and diversion; and
  • Offer a clear path for documenting device use in electronic health record systems and clinical information systems (iHealthBeat, 9/20/13).

Report Details

The report was written by the Engelberg Center for Health Care Reform at the Brookings Institution, which FDA commissioned to help oversee the surveillance system.

Overall, the plan calls for a voluntary public-private partnership to avoid “top-down” regulatory decisions from FDA.

According to FDA, the national system would help:

  • Generate data to support premarket clearance or approval of new devices and new uses for previously approved devices;
  • Identify poorly performing devices; and
  • Share accurate risk and benefit information on real-world device performance (FierceHealthIT, 2/23).

The report lists eight core principles to help the surveillance system achieve FDA’s goals:

  1. Follow FDA’s device surveillance priorities to address questions of device risks and benefits;
  2. Focus on patient and clinician needs;
  3. Build upon and integrate with existing infrastructures;
  4. Incorporate data generated by multiple stakeholders, including device manufacturers, providers, insurers and patients;
  5. Be “forward-looking and continually evolving” so that it can adapt to health care industry changes;
  6. Set clear expectations and keep communication transparent;
  7. Maximize utility, while limiting the burden of data collection; and
  8. Ensure data privacy and security (Daniel et al., Brookings Institution report, February 2015).

Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, and Thomas Gross, director of FDA’s Office of Surveillance and Biometrics, in a blog post wrote, “We will be able to leverage these capabilities not only to quickly identify poorly performing devices, but also to facilitate device approval/clearance and patient access, to reduce postmarket data collection for manufacturers, and to better inform health care decisions by providers and patients alike” (“FDA Voice,” 2/23).

The report also outlines a two-stage approach to develop the system:

  • In years one and two, FDA should create an incubator project tasked with developing a five-year MDS implementation plan; and
  • In years three through seven, work should focus on carrying out the incubator’s implementation plan by establishing performance measures, finalizing and overseeing the system’s development priorities and starting to build broader stakeholder participation (Brookings Institution report, February 2015).

Next Steps

In the blog post, Shuren and Gross wrote that “stakeholders will be able to share their feedback on the report through a public docket.” In addition, they noted that additional reports from the Medical Device Registry Task Force are expected in the coming months to address issues such as “defining effective registry governance and data quality practices” (“FDA Voice,” 2/23).

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