MedSpa Equipment Claims: Beware of Non-FDA Approved Devices
by David Ramos, Technical Consultant
June 7, 2022
Aesthetic lasers continue to be popular tools in cosmetic treatment facilities. As supply issues and costs for medical equipment skyrocket, there is a growing trend in MedSpas around the country looking to the Chinese market for budget friendly aesthetic lasers and other equipment. The practice of importing these non-FDA approved devices into the U.S. market poses a challenge when adjusting these types of losses.
Aesthetic lasers and other cosmetic treatment devices used in the United States must be FDA approved for a MedSpa to operate legally. However, many MedSpas have been able to purchase these devices directly from the manufacturer with little to no regulatory oversight. It is important to note that the FDA regulates the devices and their intended purpose, while the states regulate who can operate them. This leaves MedSpas in a regulatory “grey area” which is very loosely monitored. We recently visited a MedSpa that had 25 aesthetic lasers in crates awaiting pick-up by other practitioners in the area. Not one of these lasers were FDA approved or tested by a qualified technician. We would expect that they’re being rolled out to facilities insured by our clients and represent several significant risks.
Practitioners are often enticed to purchase these low cost units, while little thought is given to how they will be serviced, or by whom. It has been our experience that qualified laser repair technicians refuse to repair or maintain these devices because of the liability posed by placing a non-FDA approved device back into service. When a loss occurs, a lack of available technical documentation and repair parts make repairs impossible, leaving the carrier with little choice but to replace the device.
Loss Solutions Group can help by determining an actual cause of failure. Many devices are poorly constructed using non-medical grade components and are prone to failure. What may be perceived as a covered loss such as a power anomaly, may actually be a manufacturer defect or Quality Control issue. Loss Solutions Group has worked with numerous overseas manufacturers and can help establish causation and repair/replacement options.
Please contact David Ramos, Technical Consultant, with questions or to discuss claims involving medical or dental equipment at 866.899.8756 ext. 750 or firstname.lastname@example.org.