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Medical Device Tracking Needed to Improve Safety

Defective medical devices contribute to approximately 3,000 deaths annually. Yet the United States still does not have an effective way to track medical device safety.

As highlighted in a recent New York Times article, it wouldn’t be that hard to do. This is particularly true given the patient harm that could potentially be avoided.

While the federal government tracks prescription drugs for quality and safety, the same procedures do not apply to defibrillators, hip implants, and other medical devices. Moreover, safety concerns are common for medical devices.

Over the past few years, hundreds of patients got sick because defective duodenoscopes could not be properly sterilized. The outbreaks went largely undetected by the U.S. Food and Drug Administration (FDA) until three California patients died. The United States was also slow to address concerns about metal-on-metal hip implants. Surveillance systems in Britain and Australia detected issues well before the FDA launched its own investigation and mandated that the devices be recalled.

Under current law, healthcare facilities and medical device manufacturers are required to notify the FDA of device safety issues. However, as evidenced by the failure of Olympus to report infections tied to its scopes, the current system is unreliable. When recalls do occur, they are not always successful at removing dangerous products from the market. According to the Government Accountability Office, the majority of recalls involving high-risk devices do not result in the removal or repair of all impacted devices.

In order to implement an effective surveillance program, all medical devices must contain unique device identifiers, and the information must be included in standardized medical claims data. While high-risk medical devices are already equipped with bar codes, the identifiers are not currently linked to patients. While the FDA and several members of Congress support creating a medical device surveillance system, the barrier appears to be cost. However, given the predicted benefits for patient safety, the burden on hospitals seems worth it.

If you or someone you care about has suffered serious harm due to a dangerous or defective medical device, don’t hesitate to contact a San Diego injury lawyer at the Law Offices of Robert Vaage for a free consultation. Our legal team has successfully represented clients against manufacturers and distributors of medical devices for more than 30 years.