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U.S. PIRG delivered a letter to congressional lawmakers on Monday, signed by 326 hospital repair experts, calling for manufacturers to stop withholding what technicians need to fix 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,” said 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,” said 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 technicians’ 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.
COVID-19 is putting incredible stress on our medical system, including the work of hospital biomedical repair technicians, known as biomeds or BMETs. But in some cases, manufacturers restrict access to what biomeds need. For example, as ventilators are pressed into around-the-clock use, repair and maintenance issues increase. While some ventilator manufacturers provide service information, other manufacturers make it hard to access manuals, read error logs or run diagnostic tests.
“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, saves money and lives.” Jonathan Lee, HEM, Senior Consultant-HTM Consulting Network.
Manufacturers claim that these restrictions are in place to ensure safety. But in 2018, FDA found third-party repair carries no additional risk and that both they and manufacturers “provide high 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.”
“Restrictions on repair aren’t about safety, as the FDA report shows -- everyone who is doing repairs is doing it carefully and safely. These restrictions are about control and about money,” said Proctor.
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