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WASHINGTON -- The U.S healthcare system lacks an adequate number of working ventilators to effectively treat the expected influx of novel coronavirus (COVID-19) patients.
But it’s not just a dearth of ventilators and other critical medical equipment. We need to make sure we can properly maintain devices -- and medical equipment manufacturers have placed obstacles in the way of that.Many manufacturers do not provide access to repair documentation, limiting who can repair the equipment. That discourages third-party medical repair companies or in-house medical engineers from trying to fix things.
“In order to keep equipment that is critical to treating COVID-19 working, with the least possible downtime, medical device manufacturers should immediately release all repair documentation and software, schematics and manuals for that equipment, especially ventilators,” said U.S. PIRG Right to Repair campaign director Nathan Proctor. “The fastest repair service is when hospital technicians have what they need to do repairs in-house, or can hire qualified technicians at their discretion. Preventing repair is generally a bad idea. That is even more true in a crisis, when systems are under stress. It could mean the difference between life and death.”
Device manufacturers and trade associations actively lobby against Right to Repair reforms. For example, a website that posts service manuals for ventilators shows that some manufacturers prohibit the sharing of repair information. Service information could be especially important if hospitals decide to refurbish older equipment as demand peaks. The Society of Critical Care Medicine estimates that there are as many as 100,000 such older ventilators across the country.
“Things are changing dynamically and it's important that the whole healthcare ecosystem and, most especially, capable medical device servicers, have access to service keys and technical information needed to safely maintain the equipment to help save lives,” said Rob Kerwin, general counsel to the International Association of Medical Remarketers and Servicers, Inc. In addition to ventilators, other equipment needed to diagnose and treat COVID-19 will likely see increased use, and require maintenance. Imaging equipment, used to evaluate patients and determine pulmonary conditions, is likely to see increased maintenance requests, and also would benefit from additional repair information.
While manufacturers claim that independent repair is less safe or reliable, an in-depth study showed there are no safety issues with non-manufacturer repair. In 2018, the Food and Drug Administration investigated repair and maintenance issues, and found that non-manufacturer repair was safe, saying that independent technicians, hospital technicians and manufacturers all “provide high quality, safe, and effective servicing of medical devices.”
"Whether or not they are employed by the manufacturer, a qualified technician with the right information and tools can fix the equipment. Obviously, this is an all-hands-on-deck moment, and we should remove barriers that prevent qualified technicians from servicing medical equipment," said Gay Gordon-Byrne, executive director of Repair.org, a national coalition backing Right to Repair.
Meanwhile, iFixit, a leading source of online repair guides, is working to create a crowd-sourced catalog of service manuals for ventilators. You can see their assembled material here: https://www.ifixit.com/Device/Ventilator
“Hospitals need this information, and iFixit has decided that we would create this shared resource so that technicians can quickly find manuals,” said iFixit editor-in-chief Kyle Wiens. “We hope the manufacturers will help us by sharing the life-saving information that biomedical technicians need.”
“Manufacturer-only repair policies hamstring our medical systems. Repair information should never have been withheld. I urge manufacturers to release the information hospitals need to keep treating COVID patients -- and for government leaders to step in if they do not. In this time of crisis, we must put patients’ lives first,” added Proctor.
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