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Accessibility to Genuine OEM Parts
UML brokers typically do not have access to an OEM’s genuine parts. The broker will often try to access OEM parts through failed distributors that are overseas or through a “laser chop shop” that maintains an inventory of harvested component parts from unrepairable, or even obsolete, systems. Using parts gathered from third-party sources renders the UML dangerous to the user and to the user’s patient.
An OEM establishes quality control standards for its medical devices to protect its name, to comply with FDA regulations, and to protect users and their patients from injury. There are no such incentives in place as far as sales of UMLs by brokers.
Access to Key Opinion Leaders/Consultants
Many medical device manufacturers provide their customers with access to Key Opinion Leaders or the manufacturer’s consultants who can provide valuable technical advice and information as to how to use the device. In the case of a UML, however, the purchaser will not be provided access to these Key Opinion Leaders or consultants. By not having access to these resources, a UML purchaser will likely not have the necessary education, background, training and experience to assure that all treatments and modalities with its medical device are being correctly performed. Thus, as previously stated, a UML purchaser may be in violation of 21 C.F.R. § 820.25 of the FDA’s CGMP for lacking the requisite training on how to use its medical device.
This article has hopefully demonstrated to the reader the inherent risks associated with buying UMLs while identifying those considerations to keep in mind before doing so. Purchasing a medical device from the OEM can not only help prevent a practice from potential personal injury claims, but also help protect the practice from the OEM’s demand for protection should a personal injury claim arise from the use of the laser device. It is truly a matter of “Buyer Beware”. Therefore, before placing money, reputation and patients’ safety on the line by trying to save a few dollars, it is important to know the inherent risks. Forewarned is forearmed in this instance.
Marisa A. Trasatti is General Counsel of the California-based dermatological laser and light medical device company Sciton, Inc. and a partner at national law firm Wilson Elser. Her practice focuses primarily on civil litigation, with an emphasis on products liability litigation, including cases involving drugs and medical devices. She has authored articles and/or presented on the topics of cybersecurity, GDPR, social media and the learned intermediary defense. Marisa also is a Past President of Maryland Defense Counsel, her local Defense Bar Association; current President of CLM’s Maryland Chapter; a member of the Board of FDCC;
a member of Maryland Governor Hogan’s Judicial Disabilities Commission; and the DRI Maryland State Representative. Contact her at marissa.trassatti@wilsonelser.com
Zachary A. Miller, an associate litigation attorney at Wilson Elser, has considerable experience representing individuals and businesses in a variety of civil litigation matters. Zachary concentrates his practice in complex tort and general casualty, products liability, negligence-based torts and commercial litigation claims. He completed his law degree at the University of Maryland School of Law, after which he served as a judicial law clerk to the Honorable Melissa M. Phinn, Circuit Court for Baltimore City.
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