What are the ramifications of making modifications to devices, vehicles and other products after you’ve purchased them? Do so-called “after-market modifications” raise legal issues with liability, warranties or other risk areas? The answer typically depends on a multitude of factors, including the type of modification, the manufacturer’s warranty, state law and others.
Before making any modifications to a product, especially a medical device, it’s always good to start by reviewing the manufacturer’s warranty and other literature provided with the product at or prior to the time of sale. Be aware that some of the manufacturer’s terms and conditions of sale might be found on their website, and state law may give a purchaser additional rights, which vary from state to state.
Nevertheless, knowing the manufacturer’s stated warranty is a good place to start. A warranty is merely a contract between the manufacturer and the purchaser or end user, and the terms of that warranty are subject to wide variation between manufacturers and types of products. For instance, the warranty on a vehicle’s drivetrain might be unaffected by modifications made to the body of the vehicle, but the warranty on a medical device might be voided by any after-market modifications made by the user.
Vehicle warranties generally permit a greater degree of flexibility in user maintenance and modifications than those for medical devices. For instance, having a vehicle serviced by a non-dealer-affiliated mechanic typically won’t void a warranty; vehicle owners are usually free to have their vehicles serviced anywhere they like. In addition, modifications to areas outside those covered by the warranty should have no effect on the warranty, unless somehow the modifications affect a covered component. The warranties on medical devices are typically far less flexible. Many device manufacturers specify that any tampering with sealed components, replacement of non-user replaceable parts, use of non-manufacturer replacement parts, or even servicing by an unauthorized third party technician will void the product’s warranty. This is true because most states recognize a form of “strict liability” when it comes to injuries caused by defective products.
In addition to the warranty considerations, EMS agencies should consider the liability ramifications of after-market modifications. Modifications to permit the use of a product in a manner other than that which is intended can create liability for the agency. Likewise, liability can arise through negligent maintenance and repair of medical equipment. For this reason, agencies should carefully consider the purpose of the modification of the repair and thoroughly document the repairs or modifications made, the qualifications of the technicians performing the services, the type of parts used, and whether the repair or modifications were done with the authorization or advice of the manufacturer. Consulting manufacturer’s technicians can assist an agency in ensuring modifications or repairs are appropriate and that they don’t endanger the end user or the patient.
At the end of the day, there are inherent risks–both financial and legal– that can result from after-market modification of vehicles, devices and other products. Proceed carefully, with reference to your state’s laws and to the product’s warranty, manuals and other written materials before deciding whether to undertake any after-market modifications.