FDA Initiative Addresses Post-Market Monitoring Problems
With about 15,000 medical device manufacturers selling nearly 100,000 products in the U.S. market, post-market monitoring of medical device safety remains a major challenge for the FDA.
A report titled “Ensuring the Safety of Marketed Medical Devices: CDRH’s Medical Device Post-market Safety Program” lists the challenges of monitoring and assessing the safety of medical devices after they’ve been sold. Many medical devices remain in use for 10 to 20 years. The challenges include:
CDRH InitiativeCDRH intends to improve the way it monitors the safety of medical devices through a program called Post-Market Transformation Initiative, according to Daniel Schultz, M.D., CDRH director. The initiative will allow the agency to identify, analyze, and solve problems more quickly, and to alert the public about potential medical device issues sooner.
- Adverse events related to medical devices are widely under-reported. Even when a problem is detected, under-reporting makes it difficult to assess the true public health risk.
- Although the FDA’s Center for Devices and Radiological Health (CDRH) receives tens of thousands of adverse events reports annually, most of them provide sketchy information, making it difficult to assess the nature of the problem and distinguish between separate problems that may affect the same device.
- Health-care providers generally don’t document device use in patient records, making it difficult to identify the specific device involved when an adverse event occurs.
- Medical devices lack unique identifiers and manufacturers continually produce modified versions of their products.
- Devices are often used off-label, meaning they are used for indications and patient populations not included in the product’s pre-market testing and approval.
- Medical devices are not just being used in hospitals and clinics but in patients’ homes, which means more non-professionals are involved. This adds an element of uncertainty in diagnosing the cause of a problem and identifying possible solutions.
The report, released last year, listed four areas designated for improvement:
- Develop a culture of collaboration on post-market safety within the center.
- Develop world-class data sources and systems.
- Enhance risk/benefit communication efforts.
- Focus improved enforcement strategies on post-market issues.
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