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approval. [See 21 C.F.R. § 807.81, 21 C.F.R. § 807.20, and 21 C.F.R. § 807.92(a)(3)]. Because the UML will typically contain non-OEM parts, it will not have an OEM’s most updated technology; nor will it be able to comply with its product standards. The UML’s performance and safety specifications will likely be so compromised, that obtaining 510(k) clearance for the “new” UML becomes doubtful.
• Second, an adulterated UML may present a substantial risk to patient safety during use. If a patient is injured while being treated with the adulterated UML and the patient sues the medical office, the OEM and/or treater, the OEM will inevitably demand that the medical office and treater defend and indemnify it under the threat of a more formal cross-claim, while also starting a third- party claim against the UML seller.
In order to address the risks posed by adulterated medical devices, the Safeguarding Therapeutics Act (H.R. 5663) was signed into law on January 5, 2021. The Act is written to ensure that counterfeit devices are not used on patients and it defines a “counterfeit” device as a medical device with packaging or labeling that bears an unauthorized trademark or any other identifying mark of another manufacturer. In addition, this Act will give the FDA the authority to seize a counterfeit medical device and either store or destroy the used device at the UML dealer’s expense.
Confidence
A UML will likely lack a complete service history, including information about how long the laser has been in use and where it has been used. Without any maintenance or service history, the device will likely be considered out of warranty by the OEM. This is true even if the used device reflects the OEM’s logo and has the imprimatur of the OEM’s good manufacturing practices, since the device will not be operating up to the OEM’s standards.
By using a device that is out warranty and has not been serviced, inspected or examined regularly by the OEM, the medical practice may be potentially misrepresenting to its patients that the device is safe when, in fact, the UML may not be operating up to the OEM’s standards and may present a danger to patients who are treated with it. In the event of a personal injury lawsuit arising from use of the device, the lack of a service history for the UML could impact the purchaser’s defense and could lead to coverage issues from its insurance company.
The only way that a medical practice can safeguard that its medical laser meets the OEM’s current standards and specifications is to purchase the medical laser only from the OEM. This will help ensure that the medical device is working properly and is safe for use on the medical practice’s patients.
Latest Modalities
The warranty contained in the contract issued by the OEM will typically provide coverage for defects in material and workmanship, as well as the replacement of defective material or parts. Because a UML will often not contain the OEM’s updated technology, however, the device may be considered out of warranty by the OEM. The manufacturer may not provide warranty protection for defective parts and needed repairs. This creates a risk for the on-going use of a substandard UML that is out of warranty and cannot be, or has not been, repaired by the OEM. That presents a risk of injury to the patients who are treated with this used device.