FDA Launches Medical Device Postmarket Safety Initiative

With warning letters and product recalls receiving more attention from the media, healthcare professionals, industry watchdogs, and patient advocacy groups, FDA has come under increased pressure to take additional steps to ensure the safety of medical devices.

Following what the agency described as a comprehensive, year-long internal inventory of the tools used to monitor the postmarket safety of medical devices, FDA has announced that it is launching a new “postmarket transformation initiative.” The program is designed to “better protect the public health by allowing FDA to identify, analyze, and act on problems more quickly, including alerting the public sooner of potential medical device issues.”

In developing the program, FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) considered how postmarket safety problems are identified, how they are assessed, and how the agency responds to problems through both stakeholder communication and enforcement action. In strengthening the agency's postmarket surveillance, CDRH plans to develop the following.

• A “culture of collaboration” for postmarket safety within CDRH.

• World-class data sources and systems for quickly and accurately collecting, analyzing, and disseminating information about potential safety risks.

• Enhanced risk communication efforts.

• Improved coordination with FDA field staff.

“Under the leadership of our device center's expert staff, we are working to develop even better ways to evaluate new technologies to maximize benefits and minimize risk, including more-efficient ways to develop more-effective postmarket systems that can support safer medical practices as well as continued innovation,” said Scott Gottlieb, MD, FDA deputy commissioner for medical and scientific affairs.

CDRH has identified “special challenges” in implementing an effective postmarket safety program, including the following.

• Adverse events related to medical devices are widely underreported by users.

• Inadequate information regarding the way the device was used and what may have caused the problem.

• Different problems may affect the same device.

• Device usage is generally not documented in patient records.

• Devices often lack unique identifiers, manufacturers continually update and modify their products, and name changes can occur under new ownership of a product.

• Devices are often used off-label for indications and patient groups not included in the product's premarket testing and approval.

• The use of many devices is shifting from hospitals and clinics to the home, where nonprofessionals are frequently not equipped to identify problems and possible solutions.

To address these issues, the transformation initiative will work to establish an electronic reporting system for adverse medical device events, develop unique ways to identify and standardize the names of medical devices, and include more device information in patient records. The program also aims to improve internal collaboration on postmarket safety issues and identify opportunities to improve the safety of medical devices through collaborative efforts with professional organizations and the medical device industry.

Earlier this month, FDA met with industry association AdvaMed (Washington, DC) in the first of a series of public workshops on the postmarket safety of medical devices. “The medical technology industry is committed to providing safe and effective devices and recognizes the value of FDA's role in ensuring device safety both before and once a device is on the market,” said AdvaMed president and CEO Stephen Ubl. “We welcome opportunities to work with FDA to find ways to improve and refine existing systems so that patient safety is ensured, and we offer our extensive expertise and commitment to working with FDA going forward.”

According to CDRH director Daniel Schultz, MD, the agency is now approving “more and more products with more and more technological complexities, which means there's less margin for error.” The primary goal of the initiative, says Schultz, is “to promptly identify and analyze adverse events related to devices once they are on the market and to alert device users of potential risks.”

In announcing the initiative, CDRH reported that the U.S. medical device industry consists of about 15,000 manufacturers that produce nearly 100,000 individual products. Although the industry is known for short product cycles, particularly in technology-intensive applications, many devices remain in use for 10 to 20 years.

For complete information on FDA's postmarket transformation initiative, including the detailed report Ensuring the Safety of Marketed Medical Devices: CDRH's Medical Device Postmarket Safety Program, go to www.fda.gov/cdrh/postmarket/mdpi.html.

© 2006 Canon Communications LLC

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