Page 99 - Demo

Litigation Disruption
Once a UML is implicated in an injury, the patient may bring a lawsuit against the medical practice and/ or the UML dealer and OEM. 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. This will interrupt the medical practice from a patient-care standpoint and a financial standpoint.
Who Will Train the User?
When an individual purchases a new medical device, it is important that the purchaser receives the proper training on how to use the device. When purchasing a UML, however, the clinical training needed to properly use the device will not be provided by the OEM. Although some UML dealers claim to offer “advanced on-site clinical training” on how to use an OEM’s device, this claim is misleading. By receiving the clinical training from the UML dealer instead of the OEM, the purchaser may end up violating 21 C.F.R. § 820.25 of the FDA’s Current Good Manufacturing Practices (CGMP) if the UML broker (and ultimately, the practice’s employees) lacks the necessary education, background, training and experience to assure that all treatment modalities are correctly performed.
UML brokers are not yet subject to the same FDA rigors as manufacturers. They are not in business to advance technology; they simply move used product from one office to another in the secondary market.
Insights SPRING2021 95