In what could be viewed as a controversial stance in the healthcare technology maintenance field, AdvaMed submitted comments to the Federal Trade Commission (FTC), expressing concern at a proposed rulemaking in favor of national “right to repair” standard.
“We do not believe there is any legal basis for the FTC to promulgate a rule regarding repairs of medical devices,” stated AdvaMed in a public comment. “Any such rule is likely to do far more harm than good. Thus, AdvaMed recommends that the FTC deny the petition to the extent it proposes a right to repair rule that includes medical devices.”
AdvaMed was responding to a request for public comment on rulemaking regarding “right to repair” policies. AdvaMed and AdvaMed’s Medical Imaging division, in comments, outlined their concerns regarding the impact of these policies as they relate to medical devices regulated by FDA.
The petition for rulemaking was submitted by the U.S. Public Interest Research Group Education Fund (PIRG) and iFixit. The petition requests that the FTC initiate a rulemaking to protect the consumer’s right to repair products they have purchased.
In its request to the FTC, U.S. PIRG, and iFixit outlined their concerns that manufacturers were increasingly restricting the ability of consumers and independent shops to repair products. As a result, they wanted the FTC to create a rule that would act as a national standard on the right to repair.
The groups also included some possible considerations for how the rule could be implemented. These proposals range from a prohibition of unfair and deceptive trade practices limiting repair activities, to a repairability labeling system that would enable consumers to make informed purchasing decisions.
“In every corner of this country, from Maine to Alaska, from Nebraska to Hawaii, Americans just want to fix their stuff,” says U.S. PIRG Education Fund’s Senior Right to Repair Campaign Director Nathan Proctor. “People have had enough unfixable products, and they want to FTC to take action to enhance their Right to Repair.”
AdvaMed holds a vastly different stance. In its public comment, the association wrote: “AdvaMed is deeply concerned that application of ‘right to repair’ policies to FDA regulated medical devices would have significant unintended consequences, presenting new and unnecessary risks to competition, patient and operator safety, device performance, and cybersecurity.”
“Safe and effective servicing is not merely acquisition of certain documentation or materials—it is the implementation of and adherence to a set of policies, practices, and procedures which consistently return the device to a state of safe and effective operation. We want our devices to always perform safely and effectively for patient care. Application of ‘right to repair policies’ to FDA regulated medical devices would, unfortunately, work counter to this objective.”
