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.