Hospitals Should Have the Right to Fix Ventilators, Senator Says
Hospitals Should Have the Right to Fix Ventilators, Senator Says
(Bloomberg) -- Hospitals should be able to fix the breathing machines needed for coronavirus patients even if those repairs violate manufacturer contracts, Senator Ron Wyden said as he introduced legislation on the topic.
The Oregon Democrat’s measure would remove barriers that manufacturers impose on hospitals seeking to quickly repair machines in-house or through third-party repair firms, known collectively as independent servicing organizations. The devices in question include ventilators and imaging devices.
“It’s a racket,” Wyden told reporters on Thursday. “Blocking repairs now, during a pandemic -- there are a lot of short-sighted laws on the federal statute list, but I really think this one just about takes the cake.”
Manufacturers such as General Electric Co. and Medtronic Plc initially maintained long-standing policies regarding access to manuals, software codes and parts when the Covid-19 pandemic spread to the U.S. But as the scope of the crisis grew, some began easing restrictions by posting service manuals on their websites.
Inconsistent Practice
Still, the easing of policies has been inconsistent from company to company. Wyden’s measure would cover all equipment needed in the pandemic, no matter who makes it.
The bill would allow hospitals and third-party service providers to get the information needed to diagnose and repair machines, and to fabricate patented parts as long as the purpose is to make the devices function, not to profit.
It also requires manufacturers to give hospitals and repair services access to service materials at no cost beyond printing expenses, and to offer them tools for fixing machines at the most favorable costs and terms the manufacturer provides.
The Medical Imaging & Technology Alliance, the lobbying group for manufacturers, said it would oppose the bill. It would give “unregulated” third-party technicians the right to work on “sophisticated, highly regulated” equipment, the group said.
“While the intention of the bill’s sponsors is to protect patients, the unintended consequences of this legislation would increase the risk to patient safety,” Patrick Hope, the group’s executive director, said in a statement.
In a survey of 222 biomedical professionals released in July by the U.S. Public Interest Research Group, nearly half reported they’d been denied access to “critical repair information, parts or service keys” since March. Some 30% said they had equipment which couldn’t be used as a result.
Wyden was joined on a call with reporters Thursday by backers of his legislation, including the American College of Clinical Engineering and the California Association of Medical Instrumentation.
A companion bill will be introduced in the House on Friday, a spokesperson for Wyden’s office said in an email.
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