The Medical Imaging & Technology Alliance (MITA) has come out against legislation that would change federal laws on service of medical devices.
MITA strongly opposes the Critical Medical Infrastructure Right-to-Repair Act of 2020 because the group believes it would give unregulated, third-party medical device service companies unrestricted access to proprietary service materials as well as tools to maintain and repair highly regulated medical devices during this pandemic.
The legislation, introduced by U.S. Senator Ron Wyden (D-OR) and Rep. Yvette Clarke (D-NY) also does not require equipment service firms to be held accountable to any U.S. Food and Drug Administration (FDA) regulations, such as adopting the quality management systems and safety standards that OEM servicers must follow, MITA said.
However, the group found no evidence medical devices lack qualified technicians to service them, and this bill would raise not only cybersecurity risks but also patient safety risks.
