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Safe Medical Devices for Children
The New York program is more comprehensive than FDA’s medical product reporting in that it covers problems not related to medical products, for example, surgery on the wrong patient or wrong part of the body. In contrast to MedWatch, which focuses on manufacturer analysis of problems, New York puts more demands on facilities to investigate and report incidents in a systematic fashion that supports problem identification and quality improvement activities. Information is shared with facilities, but individual reports are protected from public disclosure. The New York program thus has some features in common with FDA’s pilot MedSun program.
One problem that the New York program shares with FDA is underreporting of events. A recently released audit of the program documented underreporting of serious events and late or missing investigation reports of serious occurrences (Hevesi, 2003). Of the nearly 5,800 reports that the audit said should have been reported within 24 hours, 84 percent were not.
Private Reporting Programs
A variety of other private organizations concerned with health care quality and patient safety include some attention to safety problems with medical devices. For example, the Institute for Safe Medication Practices has described hazards linked to the design or use of medical devices used to administer medications. Patient safety and quality improvement initiatives sponsored by consumer groups such as the National Consumers League and professional societies such as the American College of Cardiology (ACC) and the American Thoracic Society may likewise cover device issues. For example, the ACC was a joint sponsor of a conference that considered shortcomings in postmarket surveillance of cardiovascular devices (O’Shea et al., 2004). (Other sponsors included FDA, the Agency for Healthcare Research and Quality, and the trade group AdvaMed.)
The Joint Commission on the Accreditation of Healthcare Organizations is best known for its long history of accrediting and setting detailed standards for hospitals and other health care organizations. Many of these standards involve the safe use of medical equipment.
As part of its standards, the Joint Commission has also identified a set of sentinel events that are subject to reporting and review. Sentinel events, which are incidents that “signal the need for immediate investigation and response,” are defined as unexpected occurrences that involve “death or serious physical or psychological injury, or the risk thereof” and do not result from the patient’s medical condition (JCAHO, 2005a, unpaged).