line clinicians may know little or nothing about the history of a device (e.g., whether it has been refurbished), and they may not be aware of the difference between a device brand and a specific device model. If not documented at or near the time of an event, these kinds of details may be difficult to reconstruct or collect later. Details about generic, seemingly innocuous products such as many kinds of tubing may be practically unavailable.

In addition, concerns about liability related to possible errors in the use of a device may affect whether professionals and user facilities report a problem, how they characterize the nature and source of the problem (e.g., use error versus design problem), and whether they provide a manufacturer with a device for evaluation.3 This concern exists despite the confidentiality protections offered by FDA’s statute and regulations for patients, physicians, and other initial reporters of events, and (in most situations) user facilities (21 USC 360i(b)(2); 21 CFR 803.9; 21 CFR 20.63(f)). Identifying information about these reporters is not included in the public MAUDE database, and such information in the internal FDA database is not releasable in responses to requests under the Freedom of Information Act. Internal facility records documenting an adverse event and its investigation are not so protected.

In contrast to user facilities, the names of manufacturers and devices are included in the public MAUDE database. Such information is a necessary means of identifying problems with specific devices (including use errors) and disseminating that information to clinicians, user facilities, and patients. Anonymous reporting, which may be constructive for some purposes, is not appropriate in this case. Notwithstanding regulatory requirements and public health arguments, manufacturers may understandably be concerned that their reports will attract attention from lawyers who specialize in medical product and malpractice litigation (see, e.g., Quinley, 2001).

Moreover, competing companies have access to the public MAUDE reports. One long-time observer of medical device regulation suggested that competitive pressure “is a powerful deterrent [to reporting events], leading companies to file no more than the least amount necessary under a law—

3  

MedSun training materials distinguish between accident (adverse event) investigations and forensic investigations. “The goals of an accident investigation are to determine what happened, why it happened, and which corrective actions and preventive measures can be taken. The goal is not to assign blame…. Forensic investigations are performed in relation to litigation, arbitration, and contract issues…. [The goal] is to provide a clearly stated, reasonable biomedical engineering or medical opinion on the cause of the accident at deposition or trial…. Some investigators see the assignment of blame as one fundamental goal of a forensic investigation. In this regard, however, it is important to remember that in the end, legal liability is determined by juries and courts” (FDA, 2002n, p. 3-2).



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