The Centers for Medicare & Medicaid Services (CMS) will continue to mandate that hospitals service medical equipment, including imaging and radiation therapy equipment, according to the device manufacturer’s standards. An earlier proposal had recommended allowing some leniency here as manufacturer’s standards were thought by some to be overly conservative. However, that idea drew a sharp rebuke in November from lawmakers’ concerned about patient safety.
“We are concerned the agency is meeting and speaking with those organizations that support loosening current guidelines, while largely ignoring the many stakeholders who have substantial patient safety concerns about this approach,” wrote five U.S. House representatives in a November letter to CMS.
The lawmakers who signed the letter were primarily from Pennsylvania, which has a large medical device manufacturer industry. They were Reps. Tim Murphy (R-Pa) Allyson Schwartz (D-Pa), Chris Gibson (R-NY), Mike Kelly (R-Pa) and Keith Rothfus (R-Pa).
The updated CMS hospital equipment maintenance requirements are scheduled to take effect on January 22.
In a statement, the Medical Imaging & Technology Alliance (MITA) applauded CMS for how it elected to write the updated hospital equipment maintenance guidance and noted that following manufacturers’ maintenance standards “will help promote the safety of patients and equipment operators, while also preserving equipment performance and image quality.”
According to MITA, manufacturer-recommended maintenance standards are the best standards to use because they are “developed as part of the Food and Drug Administration’s clearance process for medical devices, and the standards are continually reviewed and updated throughout the product life cycle to ensure the equipment is serviced appropriately.”