FDA calls for medical device oversight

'Access to reliable and meaningful information about the safety, effectiveness and quality of devices is essential'
By Bernie Monegain
08:54 AM
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Chalk one up for patient safety. A new report commissioned by the FDA and authored by the Brookings Institution is calling for the creation of a national surveillance system for medical devices.

The report comes on the heels of patient deaths tied to the use of endoscopes that hospital officials said in a Feb. 19 statement exposed patients to the superbug CRE at UCLA Medical Center.

[See also: Two dead, 179 exposed to superbug at UCLA Medical Center.]

A recent news report from Reuters claims that U.S. health regulators have known since at least 2009 that the medical devices at the center of the UCLA outbreak could transmit lethal infections, but failed to recommend any new safety requirements, a lapse that threatens patient safety, according to experts in healthcare-acquired infections.

The $250 million plan put forth in the Brookings report would create a national surveillance system that would unfold in two stages over seven years.

The report calls for creating a collaborative system capable of supporting the development, regulation, and use of innovative medical devices.

"Medical devices play a critical role in health care," the report authors write. "Access to reliable and meaningful information about the safety, effectiveness, and quality of devices is essential to inform care and improve patient outcomes. While the Food and Drug Administration (FDA) has a public health mission to monitor the safety and effectiveness of devices, everyone has a vested interest in improving information about medical products."

The surveillance system would have these characteristics:

  • Be a component of the emerging national health information infrastructure.
  • Minimize burden by using data captured as an integral part of care to efficiently generate meaningful and reliable information about medical devices.
  • Must be driven by the need to improve public health and patient care.

Years 1-2: Initiate an incubator project tasked to develop a five-year implementation plan for MDS through fact-finding activities and pilot programs. The Board recommends that the incubator project should be initiated by FDA, adequately staffed and resourced, and guided by a multi-stakeholder group with relevant medical device experience.

Years 3-7: The second phase of work will focus on the MDS implementation plan produced by the incubator project. Once selected, the MDS PPP’s leadership should set and oversee the system’s strategic development priorities, begin to build and sustain broader stakeholder participation, oversee implementation of the organizational plan, and establish system performance measures.

Some of the important challenges the MDS PPP must address during implementation include:

  • Supporting a multi-pronged approach to ensure widespread adoption and use of Unique Device Identifications – UDI – in electronic health care data
  • Minimizing the burden of data capture and sharing
  • Developing policies to ensure the protection of patients and their privacy
  • Building the capabilities to provide value to a broad group of stakeholders

[See also: Kaiser, Weill Cornell show importance of device registries.]

Read the Brookings report here.