A bill filed just a few weeks ago in Congress, H.R. 2118 is yet another attempt by medical equipment OEMS to avoid competition from independent repair. This bill asks that independent repair businesses register with the FDA, follow the same regulations as those of OEMs, including record keeping and reporting of all patient injuries of deaths. The text of the bill and filed testimony is available online at this link.
The purpose is ostensibly to reduce the potential for patients to be harmed by incomplete or incompetent repair, and to force independents to suffer the same irritation of being regulated as manufacturers. OK on the surface -- no one wants patients to be hurt.
Lets assume that patients are being hurt, and that poor quality repairs may have been a contributing factor. Is there a trend? Does the data suggest that certain product categories have a higher incidence of repair-related injuries or infections? Since all hospitals and care facilities are already required to report all injuries and deaths to the FDA, how is it that the FDA hasn't already taken action? If independent repairs were a chronic cause of patient harm - why on earth would any facility continue to do business with that vendor?
As it turns out - the FDA has been studying exactly these questions for over a year, and it is not the FDA that is proposing new regulations, but medical device manufacturers. These are the same companies that have been making repair, even by hospital personnel, impossible. We're also hearing the same arguments made in opposition to Fair Repair legislation, so the discussion is timely.
Some background on the FDA/CMS and regulations is necessary. Manufacturers are regulated by the FDA because the FDA approves their products for use - including confirming safety of use and subsequent error correction. This is similar to the role of the EPA and NHSTA regulations for motor vehicles. When problems are reported to the regulators, usually in some pattern, the regulators do their jobs and require recalls.
Only the OEM can fix defects of design or manufacturing - which the FDA might appropriately require. Under federal regulations, no one is supposed to modify or tinker with approved products without filing as a manufacturer and going through the approval process. Makes sense.
OEMS proclaim that they only want repair providers to be subject to the same rules -- which sounds reasonable until one realizes that repair is a wholly separate business from manufacturing. OEMS are manufacturers first, and not all of them even engage in the business of repair. Repair businesses are not manufacturers -- and if they were the registration requirement is already in place. It is illegal under anti-trust law for manufacturers to tie the two businesses together -- as dramatically proven in April with GE having been found to be a repair monopolist in federal court.
Repair is simply restoration of broken equipment to service and is not, in the context of medical equipment, tinkering or customization. Even when the US Copyright Office permits tinkering, the FDA/CMS does not. FDA rules still apply.
Nor is the business of technology repair the same business as sterilization or preparation for invasive procedures. Some service providers may offer those services as well, but the technology parts will have been repaired and then evaluated by hospital technology managers before being used. We're limiting our discussion to repair and not further processing.
There may well be shoddy repairs being made and the industry would benefit from an ethics process such as that already provided by Repair.org member IAMERS. The fact is that users have total control of which vendors they select, what types of SLAs they request, the types of technician skills and services they require and ultimately the power of the purchase order to change providers. Bad vendors do not stay in business in a competitive marketplace.
All we want is the opportunity to compete.