U.S. PIRG delivered a letter to congressional lawmakers on Monday, May 18, signed by 326 hospital repair experts, calling for manufacturers to stop withholding what HTM professionals need to repair medical equipment, such as ventilators. It’s part of U.S. PIRG’s larger Right to Repair Campaign, which aims to remove unnecessary barriers to repair that drive up costs for product owners and increase electronic waste.
“Keeping equipment working under the stress of the COVID-19 pandemic is a matter of life and death,” says Campaign Director Nathan Proctor. “This is no time to squeeze hospitals into paying extra for proprietary repairs.”
“We believe that every organization that purchases medical equipment or services them should have the right to get trained and be able to procure parts to repair the equipment they own,” says Ilir Kullolli, president of the American College of Clinical Engineering. “This will make healthcare delivery better, faster, and safer—especially during a pandemic or a national emergency!”
Echoing the biomeds’ comments, a group of state treasurers sent a similar letter to manufacturers calling for them to “release all service manuals, service keys, and schematics during this crisis,” for ventilators.
“Manufacturers frequently refuse to provide needed service documentation and tools for repairing medical equipment purchased—not only for life support ventilators, but other critical devices. This is a continual trend and has gotten worse. It’s time for manufacturers to cooperate with the healthcare technology management community in the interest of patient care and safety. Having on-site repair systems reduces downtime and saves money and lives,” says Jonathan Lee, HEM, senior consultant-HTM Consulting Network.
Manufacturers claim that these restrictions are in place to ensure safety, U.S. PIRG officials say. But in 2018, the U.S. FDA found third-party repair carries no additional risk and that both they and manufacturers “provide hig- quality, safe, and effective servicing of medical devices.” Instead of restricting third-party repair, the FDA says: “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.”
Third party involvement would seem essential in medical devices involved in an incident, involving patient or staff injury or death. Properly trained third party biomeds with necessary testing equipment would remove any appearance of bias during an investigation. Comments ?