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# Call for Better Medical Device Safety Monitoring
- URL: https://www.fdaweb.com/call-for-better-medical-device-safety-monitoring/
- Published: 2017-06-08T12:00:00.000Z
- Updated: 2026-09-14T22:28:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138884

Clinical pathologist and medical microbiologist **Diane Alame** says that poor monitoring of the safety of medical processes is a major problem in the nation’s medical system. Writing in a *Stat* online opinion [piece](https://www.statnews.com/2017/06/07/medical-device-monitoring/?ref=fdaweb.com), Alame discusses the “superbug outbreak involving duodenoscopes that seriously sickened 350 people and killed at least 20.

She writes that once a medical device gains FDA approval, post-market surveillance is supposed to gauge how well and how safety it performs in the real world. “It is a mostly passive system in which manufacturers and users voluntarily report serious device-related adverse events,” she says.

Alame says that CDRH director **Jeffrey Shuren** has acknowledged that the tools the agency uses for post-market surveillance are limited. He has said that passive surveillance “relies on people to identify that a harm occurred or a risk is present, recognize that the harm or risk is associated with the use of a particular device, and take the time to report it.”

The article reviews that Disclosure and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017, legislation that has been introduced to strengthen requirements for device manufacturers to report any changes made to a device or its reprocessing instruction. It also would require manufacturers to report to FDA within five days any communication with foreign healthcare providers about safety concerns. (Alame reports that duodenoscope manufacturer Olympus had been warning European health facilities about design issues with the scope but decided not to warn U.S. hospitals or FDA.)

While the legislation may help, Alame says, what is really needed is for FDA to move beyond passive surveillance processes. She describes the National Evaluation System for health Technology (NEST) envisioned by FDA that could rapidly identify safety issues by aggregating data from electronic health records, existing device registries, and other sources to look for safety signals.

She describes an FDA-funded study that examined Mynx, that uses gel to seal the incision made into an artery in the groin or wrist needed for cardiac catheterization. Alame writes the device had been used in more than 70,000 patients and researchers used electronic surveillance to identify a significant safety risk within nine months of monitoring the device use. Specifically, they found a higher absolute risk of complications such as significant bleeding compared to devices that use pressure or other mechanical means to close the incision.

“Making NEST a reality requires successfully implementing many complex steps, such as ensuring interoperability between different electronic data sources and collecting the necessary information during the normal course of routine clinical care across the country,” the article concludes. “Another significant challenge is the need for financial and material cooperation between healthcare facilities, industry, and government.”

Alame says that extending the reach of NEST from one device to the many already in use and those newly cleared or approved each year would require substantial investment. And with FDA budget cuts proposed by the Trump administration, “the near-term realization of NEST may be hard to reach. Even so, it shouldn’t take more tragedies like the one linked to the faulty Olympus duodenoscope for us to insist upon a more effective active surveillance safety reporting system such as the one that NEST could provide.”