Medtech remanufacturing is the new battleground for right-to-repair advocates

Regulatory NewsRegulatory News
| 26 April 2022 | By Ferdous Al-Faruque 

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Medical device remanufacturing is the new front in the right-to-repair fight according to advocates who want users to have the ability to fix their own devices rather than rely on the manufacturer. While advocates continue to lobby for legislation locally and nationally on the issue, they warn that medtech industry groups are trying to find other ways to limit the ability of individuals and third-parties to repair devices.
 
When US lawmakers proposed draft legislation to reauthorize the Medical Device User Fee Amendments (MDUFA V) earlier this year, right-to-repair advocates say medical device groups tried to introduce language that would have made it illegal to make any changes to their products according to Kevin O’Reilly, campaign director for the US Public Interest Research Group’s (US PIRG) Right to Repair campaign.
 
In a letter dated 25 March to the chair and ranking member of the House Energy and Commerce (E&C) committee, US PIRG warned that language floated by the medtech industry to be included in the user fee reauthorization bill could further increase health care costs and reduce access to treatments.
 
"The trade association legislative draft being circulated would drop from the definition of an equipment change deemed to be 'remanufacturing' the word 'significant.' This proposed change should be declined as it hardly clarifies,” wrote O’Reilly. “Rather it might well have the practical effect of making every change, however small, remanufacturing.”
 
In the end Rep. John Joyce (R-PA) did propose a rider to the reauthorization bill called the Clarifying Remanufacturing to Protect Patient Safety Act that tries to expand the definition of a medical device remanufacturer. The proposed bill however kept the word “significant” alleviating O’Reilly’s concerns. [Related: FDA’s legislative wish list includes device cybersecurity, a generic exclusivity fix, and more, 4 April, 2022, Regulatory Focus]
 
Sens. Ben Luján (D-NM), Cynthia Lummis (R-WY) and Ron Wyden (D-OR) recently proposed the Fair Repair Act of 2022 in March, which is identical to a bill proposed by Rep. Joseph Morelle (D-NY) in the US House last year. The bills would require original equipment manufacturers (OEM) to make diagnostic, maintenance and repair equipment available to independent repair providers but they notably exclude medical devices.
 
The language in the bills is similar to that of a bill sponsored by Morelle when he was a congressman in the New York state legislature that also excluded medical devices.
 
O’Reilly says he’s excited about the Fair Repair Act bills because even though they exclude medical devices, they would provide people to fix products such as consumer electronics and farm equipment.
 
“Frankly, medical devices just face higher political headwinds, the opposition is very politically powerful,” he said. “Understandably, [legislators] are a bit more hesitant [with medical devices] because it has higher stakes than just repairing the screen on your phone. There's a little bit more of a mountain that the medical device Right to Repair campaign has to climb over than some of these other industries.”
 
The two main adversaries in their right-to-repair fight according to O’Reilly are the medtech lobby groups Medical Imaging and Technology Alliance (MITA), and AdvaMed, who he says are now also trying to use the medical device remanufacturing issue as another front to stop users from repairing their own products.
 
A medtech industry advocate who spoke with Regulatory Focus on background disagreed with that assessment.
 
"Third-party repair advocates want it to be viewed as a right-to-repair issue but it isn't," they argued.
 
They said that legislation, such as the 21st Century Cures Act, and FDA have very specific language as what is considered remanufacturing, and what groups like MITA and AdvaMed are trying to do with new language in the user fee reauthorization bill is to create broader language that more clearly delineates between what is considered remanufacturing and what isn’t.
 
“Are you repurposing the device, are you restoring it, are you using it for the same intended purpose and if you're not, you’ve got to have an OEM technician,” the source argued.
 
The industry source also noted that while right-to-repair proponents say they only want manuals to fix the devices on their own, the issue is more complicated than that. There’s a risk they may post the manuals online, either maliciously or not, and then someone can use that manual to not just do minor fixes but potentially perform more serious changes such as reprogramming the device they argued.
 
"Who polices that and how?” the source asked.
 
The source noted that unlike other consumer goods, poorly repairing medical devices could and have had fatal repercussions. They said that while state lawmakers have proposed broad right-to-repair bills, their lobbyists have been busy going to those lawmakers and reasoning with them to exempt medtech products from such bills.
 
“We’re still fighting those issues, but I think it’s becoming more and more difficult,” the medtech advocate admitted, adding they have specifically discussed keeping medical devices exempt from right-to-repair legislation with the House E&C committee.
 
Another place where the remanufacturing issue is being played out is FDA’s 2021 draft guidance on the medical device remanufacturing that tries to spell out what constitutes servicing a medical device and what constitutes remanufacturing. (RELATED: FDA explains when device 'servicing' becomes 'remanufacturing', 17 June 2021 Regulatory Focus)
 
Right-to-repair advocates like O’Reilly see it as another front where medtech groups are trying to restrict third-party vendors from fixing their own devices. He notes that FDA itself acknowledged that servicing devices by third-party vendors has not posed any significant risk to patients.
 
“Equipping clinical engineers and biomedical repair technicians (biomeds) with technical, functional, performance and safety specifications is critical to their ability to effectively and safely repair medical devices when they break,” O’Reilly wrote in comments to the draft guidance. “Providing biomeds with recommended maintenance activities and schedules will allow them to keep equipment in fine condition, while descriptions of error codes will enable biomeds to quickly respond in the event of an unplanned problem.”
 
“It is especially important that this information is included in labeling so that all biomeds can access it, regardless of whether they work for a health delivery organization (HDO), an independent service organization (ISO) or an Original Equipment Manufacturer (OEM),” he added.
 
O’Reilly also urged FDA to require manufacturers to provide biomeds with parts necessary to fix medical devices.
 
Patrick Hope, executive director of MITA, also wrote to FDA on the draft guidance voicing concerns about third party servicers and independent service organizations (ISOs) who are not regulated by the agency.
 
“Until FDA removes its enforcement discretion, requires all third-party servicers and ISOs to comply with registration, regulatory, quality and safety requirements, and proactively exercises appropriate oversight (i.e, inspections) and enforcement policies, the current servicing activities actually constituting unregulated remanufacturing of medical devices will continue,” he argued.
 
Hope also said FDA’s draft guidance demonstrates that servicers often cross into remanufacturing during their work that result in changes that affect device performance and patient safety.
 
“These servicing entities should be known to FDA and have proper oversight prior to interaction with a regulated medical device,” he added. “Without FDA removal of enforcement discretion and enforcement of quality, safety, and regulatory requirements, a significant number of remanufacturing activities will continue to be unknown to and unregulated by the FDA.”
 
Whichever way FDA goes on the issue, the agency has said it plans to finalize the remanufacturing guidance some time this year. (RELATED: CDRH outlines guidance plans for FY2022, 26 October 2021, Regulatory Focus)

 

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