The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Safe Medical Devices for Children
Thus, they include both serious adverse events and close calls. Accredited health care organizations are expected to have internal policies and procedures for analyzing and responding to sentinel events, including the application of a root-cause analysis.
Certain sentinel events are reviewable by the Joint Commission when voluntarily reported by hospitals or when otherwise identified (e.g., through a newspaper story or a patient report). One type of reviewable event is a perinatal death that is not related to a congenital condition in an infant with a birth weight greater than 2,500 grams. A root-cause analysis of the 84 such events reported between 1995 and 2004 found that the most frequent contributing factor was communication problems (JCAHO, 2004).
Between 1995 and the end of 2004, the Joint Commission reviewed nearly 3,000 sentinel events (JCAHO, 2005b). The organization continues to be concerned about a low level of voluntary reporting, which limits the utility of the effort as a source of information about the nature and causes of events. One early review of the Joint Commission program suggested that if it had had the same yield as New York’s event reporting program, it would have received as many as 21 times the reports it actually did during the period reviewed (Wald and Shojania, 2001a).
The most comprehensive private program of adverse event reporting and analysis related to medical devices is maintained by ECRI, a private nonprofit health services research and technology assessment organization. Among other activities related to patient safety, ECRI gathers and investigates reports of incidents involving medical devices from health care providers, patients, and manufacturers around the world. It provides investigative and consulting services to health care providers, governmental health agencies, and other organizations. Each year the organization receives more than 1,000 high-quality reports of medical device adverse events and publishes scores of original hazard reports on specific device models as well as problems generic to classes of medical devices. In 1973, ECRI’s problem reporting program served as a model for the newly emerging FDA Device Experience Network.
ECRI’s monthly journal, Health Devices, includes independent medical device evaluations (e.g., recent evaluations of infusion pumps [ECRI, 2004c]) and reports on device safety. Another publication, Health Devices Alerts, provides weekly reports on medical device hazard and recall information, product safety alerts, reported problems and recommended responses, and published research on medical devices. In addition to the reports on circumcision clamps cited earlier, a number of ECRI reports