Right to Repair: How Developments Could Affect Aesthetics Practices
Recent action on the federal level has renewed interest in “Right to Repair” legislation, and the medical aesthetics industry is eyeing developments that might directly impact aesthetic practices and medspas.
Right to Repair legislation dates back to the 1970s, and most Americans are familiar with the concept as it relates to automobiles, notes Madison Dini, JD, commercial and business litigation attorney at Michelman & Robinson. Under current law, car owners cannot be subject to warranty exclusions or other penalties if they choose to have their vehicle serviced by a third party.
“It's always been this balance of the manufacturers' duties and liabilities on repairing and having their products in the marketplace and the consumer being able to get those repairs at a fair price but also safely, so that ultimately the consumer had a safe product that they could fairly use,” Ms. Dini says.
The Federal Trade Commission oversees existing Right to Repair laws and also provides Congress with recommendations to modify legislation to protect the interests of consumers and manufacturers. In its May 2021 report, “Nixing the Fix,” FTC signaled to Congress a need to update Right to Repair laws. According to the FTC, “Many consumer products have become harder to fix and maintain. Repairs today often require specialized tools, difficult-to-obtain parts, and access to proprietary diagnostic software. Consumers whose products break then have limited choices.”
Two months later, President Joe Biden signed an executive order on promoting competition on the American economy. Among 72 initiatives within the order, is a call for the FTC to enact regulations prohibiting manufacturers from barring the repair of equipment and devices by consumers and independent repair shops. According to the White House, the order seeks to, “Make it easier and cheaper to repair items you own by limiting manufacturers from barring self-repairs or third-party repairs of their products.”
This March, a bipartisan trio of US senators introduced a bill called the Fair Repair Act of 2022, that would require manufacturers to provide the tools and documentation necessary to enable consumers and third parties to repair electronic equipment. The bill, which has not yet been passed, is broad in both its reach and its language. Expert observers are assessing what types of products will be affected by legislation, if approved, but there is general agreement that cell phone manufacturers will be required to support third party repair services. But what about medical devices?
“My hunch is that they will carve out an exception for medical device manufacturers, but we don't know,” says Ms. Dini, noting that any medical device exception could be broad or limited only to certain types of devices.
“As I've been representing doctors separately and manufacturers separately, I understand the pains that each group goes through. Doctors/consumers are upset with the cost associated with maintaining their devices. On the other side of things, the manufacturers want the right to ensure that they have safe products out there being used on patients. There's a whole separate issue with patient safety,” Ms. Dini says. “It's a really interesting legal topic from that perspective.”
Given the potential implications for aesthetic practices and medspas, Ms. Dini encourages physicians to be aware of changes to Right to Repair legislation, but she suggests that they rely on trusted, expert advisors to help them navigate the potential impact of changes as they develop. This is especially important as they consider purchases and make decisions about warranty and service contract renewals, she says. Ms. Dini also points out that many states have additional legislation that affects Right to Repair.
Depending on what is ultimately included under the federal bill, practices may be able to turn to less expensive third-party vendors for device repairs and may be able to forego costly service warranties from manufacturers. Or manufacturers may retain the right to solely repair their devices. “We are in limbo a little bit, and it's just a really interesting thing to keep our eye on right now,” she adds.
Physicians and practices should read contracts carefully and document device maintenance, Ms. Dini suggests. “Pay close attention to what your manufacturer's warranty contracts require and whether using third party repair services might void warranty provisions."
Regardless of any changes to Right to Repair, keeping up with maintenance and ensuring that warranties are in place is important. Lapses could impact liability insurance coverage, as some insurers require that the physician/practice maintain a warranty on energy-based devices. She urges practices to keep track of all renewals and required service dates and be sure to avoid lapses.
Practices should document maintenance of each device, including regular required updates and service, in order to limit liability in the event of an unfavorable outcome. “To maintain your device and shield yourself from the most liability you can, get under warranty with the manufacturer,” Ms. Dini says. “That's going to provide you the most protection from a legal perspective. I completely understand that there's business decisions to be made about costs, but just understand your exposure. If you are out of warranty, at least get a yearly checkup on the device. If you're using any device on patients and you notice there's anything wrong with it, report that to the manufacturer immediately, regardless of your warranty status.”
Although warranties can be pricey, Ms. Dini suggests that physicians/practices recognize they are not just a sales gimmick. “There are laws requiring that they provide those to you for the safety of your patients. I think changing that perspective in the marketplace, especially in aesthetics, would help doctors understand where companies are coming from a little bit on selling those product warranty pieces.”
Ms. Dini advises against gray and black market device purchases. “You're potentially exposing yourself to liability by not going directly to the manufacturer. There are some definite benefits to buying directly from a manufacturer from that regard."