Medical device safety: A path forward

The medical device community is far behind other fields in its ability to alert patients about safety concerns--there's no national system that identifies concerns about things like implantable devices and glucose meters, according to a post by Gregory Daniel, managing director for evidence development and innovation, at the Brookings Institution's Engelberg Center for Health Care Reform.

The article points out that patients are "bombarded" by news stories about device recalls, but have no exact way of knowing whether their device is a cause for concern unless they have its serial number at the ready. And because most medical device procedures take place in hospitals, providers often lack this critical information. 

"Clearly, the current health care information infrastructure does not yet support a robust surveillance system," Daniel says. "This limits the ability of FDA, providers, payers and manufacturers to respond quickly and directly when safety issues arise."

Daniel and his colleagues propose a "path forward" to medical device patient safety. Key stakeholders recognize the importance of building an accessible, user-friendly national surveillance system; two critical steps toward doing so are happening already:

  • Standardized coding:  Congress mandated the development of the Unique Device Identifier System (UDIs) in September 2013.
  • Design and strategy for system design: The National Medical Device Postmarket Surveillance System Planning Board laid out its objectives in a 2012 FDA report.

"Building such a system will come at a cost and it will be important to ensure it is sustainable and worth the investment," Daniel says. "Ultimately, this system can play a major role in improving public health by facilitating the development of novel medical devices; identifying opportunities to improve quality of care; and ultimately saving health care costs through more effective treatments."

Recalls of medical devices have doubled in the past decade--the number of recalls grew from 604 in 2003 to 1,190 in 2012, an increase of 97 percent, according to recent a U.S. Food and Drug Administration report. The rate actually lags the rate of growth in the med tech market overall, as FierceMedicalDevices points out.

Class I recalls-the FDA's most serious category, reserved for potentially deadly defects--rose from seven in 2003 to 57 in 2012.

The FDA in February published a proposed final rule requiring device manufacturers and importers submit adverse event reports for medical devices electronically in a bid to improve its data collection and analysis times.

To learn more:
- read the full Brookings post

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