Many companies have voluntarily established their own product registries. Alpert highlighted two of Medtronic’s voluntary databases that are being used for studies. The Systems Longevity Study is looking at survival of implanted leads to determine durability and long-term functionality. For over 27 years, she said, Medtronic has been capturing information about its cardiovascular devices. That is important because generally when a lead fails it is not extracted, so the manufacturer cannot gather forensic information on the device. She noted that information on more than 75,000 leads in 14 countries has been evaluated thus far.

The Implantable Systems Performance Registry was created in 2003 to monitor Medtronic’s infusion and neuromodulation devices (such as implanted drug pumps and spinal-cord stimulators). The registry includes data on more than 5,000 patients in 50 centers. Alpert added that Medtronic evaluates and publishes its data in semiannual product-performance reports.

Another example of device surveillance that Alpert described is Medtronic’s CareLink monitor. Many active implantable devices have electronic monitoring systems, often bedside monitors, to which the devices automatically send information about the patients and the performance of the devices every night. Through CareLink, this information can be transmitted to the provider for remote monitoring.

Alpert stressed that both industry and FDA depend heavily on physicians and end users as reporters. She asked the committee to consider how industry could interface differently with the clinical community to achieve better access, not only to information about devices in practice but to the products that need to be returned, so that forensic work can be done to assess defects.

LARRY KESSLER: ADVANCING SURVEILLANCE

Kessler offered several suggestions, directed to three constituencies, for advancing device safety and surveillance.

Congress, he said, should provide additional resources for FDA. Resources are needed to focus on the risk issues related to 510(k) products, not just the traditionally high-risk products. Development of registries may be helpful, he said, as would additional Section 522 studies. The rate-limiting factor, he said, is identification of the problems.

FDA regulation on unique device identification is critical, Kessler said. Although it was required legislatively in 2007, FDA has not yet issued a rule, and it needs to do so.

FDA should also enforce known engineering standards and foster attention throughout the centers to issues of risk, benefit, and quality systems, Kessler said. The risk-management strategies devised by manufacturers when they are developing 510(k) products should be widely available to



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