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Caveat Emptor: Ten Reasons Not to Buy from Used Laser Brokers - A Litigator’s Perspective
By Marisa A. Trasatti and Zachary A. Miller
Once involved in litigation, the UML may be subject to the usual disruptions caused by litigation, including inspections by the various attorneys and their experts and evidentiary mandates from the court preventing the medical practice’s continued use of the UML until the litigation is completed.
Marisa A. Trasatti
Sciton, Inc.
A medical laser can have a significant impact on an individual’s medical practice. It can expand offered treatment modalities and generate significant income and, if maintained properly and regularly, can last for many years. Unfortunately, there are many companies in the marketplace selling used medical lasers (UMLs) to unsuspecting medical practices attracted by the perceived cost savings from buying the used device as compared to a new one. Although UMLs will likely carry the original manufacturer’s (OEM) logo, the
risk from buying a used UML is significant. There is a good chance, for example, that the UML has not been recently serviced by the OEM and it will likely consist of unauthorized parts and other changes. This article will address some of the inherent risks to purchasers when buying used medical devices.
Safety Issues
Used devices that have not been certified by the OEM put patient safety and user safety at risk. Many UML companies’ websites will claim that their products have been “certified.” This type of certification, if it exists at all, has likely not been approved by the OEM and is not subject to the same rigorous specifications of the OEM.
In addition, in some instances, a UML dealer will often change the configuration of the device, presenting at least two serious legal issues for the dealer and the unsuspecting UML purchaser:
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First, by changing the configuration of a device, the UML company
may be selling an adulterated device under 21 U.S. § 351, thereby converting the used device into a “new” product. This would require the UML company to make a 510(k) premarket submission to the FDA for its “new” device to demonstrate that the device is at least as safe and effective as a legally-marketed device that is not subject to premarket