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Good News for Medical Device Safety

As San Diego product liability lawyers, we are pleased that the Centers for Medicare & Medicaid Services (CMS) has changed its position on the inclusion of medical device identifiers on insurance claim forms. As we have previously discussed on this San Diego Injury Blog, defective medical products contribute to approximately 3,000 deaths annually. However, the federal government has yet to establish an effective way to track medical device safety.

In order to implement an effective surveillance program, all medical devices must contain unique device identifiers (UDIs), 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 supports creating a medical device surveillance system, CMS initially declined to support the system, citing it would be too costly to implement.

Thankfully, the agency has reversed course. In a joint letter to the standards development organization tasked with updating insurance claim forms, officials from CMS and the FDA expressed support for new insurance claim forms that include UDI data for certain medical devices, namely implantable devices. “HHS is committed to improving the quality and safety of health care provided to all Americans, and believes that monitoring medical device product safety and performance is critical for ensuring public health and safety,” the agencies stated in their letter.

We are hopeful that the tracking system becomes a reality. As highlighted by the infection outbreak tied to defective duodenoscopes, the United States is often slow to respond when medical devices pose risks to patients. Including identification data on claim forms would make it easier to track medical devices and alert patients of recalls or other safety issues.

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 product liability 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.