Keep Medical Devices and Their Repairs Regulated

On July 18, the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet held a hearing titled, “Is There a Right to Repair?” In the hearing, lawmakers questioned an assortment of panelists on the current legal landscape around the “right to repair” movement and related intellectual property issues, covering products from automobiles to consumer electronics.

Proponents of the “right to repair” movement believe that it is imperative for original equipment manufacturers (OEMs) to turn over their specific intellectual property – instruction manuals and repair equipment – necessary to conduct repairs.

While this may seem like a good idea for some products, there are instances where “right to repair” policies could have unintended consequences on products that are heavily regulated. One area is the “right to repair” in the medical field.

During the Subcommittee hearing, not much was said about the implications of giving unregulated repairpersons more access into the healthcare industry – an industry with millions of lives on the line. However, during her line of questioning Representative Deborah Ross (NC) asked if special considerations should be given to certain products like medical devices and mentioned that there may not be a “one size fits all solution” to addressing right to repair across industries.

Also, during the hearing several members reproached the system in place that keeps manufacturers involved with their products well after the sale date. It is important to note that for the medical device industry, this is not voluntary but a prerequisite. OEM’s involvement after the sale of their products is a federal requirement through the U.S. Food and Drug Administration’s Quality Management System (QMS). The QMS are a set of standards OEMs are required to adhere to not just in the production of their devices, but also in the service and maintenance of these products after they are sold to facilities.

As lawmakers gather all the information they need on the “right to repair” debate, it is crucial that they also understand what it could mean if we enact overly broad right to repair policy. New policies must ensure that the medical field and medical devices continue to see an exemption.