FDA Approved

Prevention Challenges

Why Have Warning Letters to Device Manufacturers Plunged, And Will That Continue?

Look for warning letters to tick back up, CDRH Associate Director of Compliance and Quality Erin Keith told MedTech Dive.

Warning letters from the Food and Drug Administration to medical device manufacturers could jump in 2020 after a dramatic four-year decline.

That’s the prediction of a compliance director at the FDA, according to a report in MedTech Dive. One reason for the drop was a reorganization at the Center for Devices and Radiological Health that kicked off in spring 2019 and proved to be disruptive for the compliance office.

Look for warning letters to tick back up, CDRH Associate Director of Compliance and Quality Erin Keith told MedTech Dive – an inspection report backlog is clearing out as the center’s reorganization takes hold and enables more efficient work.

This is significant because the FDA issues warning letters to manufacturers – including companies developing endoscopes – found to have significantly violated agency regulations. Warning letters issued by CDRH decreased from 81 in fiscal 2015 to 9 last year, a 90 percent drop, according to FDA data analyzed by MedTech Dive.

Patient safety advocates worry the decrease is less a result of restructuring and more about the agency being too close to industry. There’s a perception among some agency critics that a focus on “customer service” has equated to “making life easier” for manufacturers, according to MedTech Dive.

The CDRH is tasked with assuring the safety, effectiveness, performance, and quality of medical devices and radiation-emitting products used to treat, prevent, and diagnose disease.

A  top regulatory science priorities and released in summer 2019 deemed the risk of patient infection from improperly processed medical devices a “critical concern.”

The complexity of endoscopes—with their unwieldy, long, narrow channels, right-angle turns and small crevices—make them extremely difficult to clean. Hospitals experience high demand for patient-ready bronchoscopes compared with other endoscopy programs and to meet that need they keep large inventories of the instruments on hand. That creates a host of reprocessing challenges.

The FDA’s medical device database, called MAUDE, also houses medical device reports from manufacturers, hospitals, health care professionals, and patients.

Along with warning letters, CDRH has tried new types of communication with manufacturers in hopes of getting ahead of company deliberations over quality improvements and patient outcomes. That’s opposed to only addressing regulatory compliance – and when that falls short, issuing a letter. One way is with safety communications, such as the one issued in April 2019 by CDRH Director Dr. Jeff Shuren on efforts to assess contamination risks from reprocessed duodenoscopes.

Four months later the FDA recommended that manufacturers and health care facilities transition to duodenoscopes with disposable components.

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