Every trackable device must be listed in patient medical records, in the hospital's purchasing or accounting system, and in manufacturer's records. Hospitals must inform manufacturers of patient names, identity of devices, lot and serial numbers, and implantation dates. Surgery nurses complete and return the self-mailer report, and put the sticker with the date in the patient operative records. The Rule is reasonable in terms of which devices are tracked. Instead of tracking of all implantables, which would include single orthopedic screws, a short list is provided of specific implantable devices that are to be tracked.
Cardiovascular devices are the most common.
They create as many questions as they answer. The bulk of the reports filed under this Act are of little interest to plaintiffs because they involve trivial incidents. However, there are major events with serious injury to patients or employees. These are likely to be litigated. As risk manager for fifteen years, I received an average of one report a month of a serious device-related event.