Anaesthesia equipment safety in Canada: the role of government regulation.
Medical device problems as detected by the Health Protection Branch (HPB) of Health and Welfare Canada were studied in order to examine the frequency and safety priority of problems in the subgroup of anaesthesia devices. Data pertaining to the time period from April 1, 1987 to November 30, 1992 were gathered from the Medical Devices Notification Database and the DAFFY Reporting System. The Medical Devices Notification Database contains all notifications for newly marketed medical devices in Canada and the DAFFY Reporting System keeps record of all submitted problem reports and manufacturer recalls along with their designated safety priority status. When an important safety hazard is associated with a medical device as determined from information submitted to HPB, an Alert-Medical Devices may be issued to inform hospitals and health care professionals of the problem. During the studied time period, the percentages of problem reports and recalls as well as Alerts were compared with the percentage of newly marketed anaesthesia devices. It was found that although only 2.3% of the newly marketed medical devices were classified as anaesthesia devices, 8.6% of all problem reports/recalls and 37.5% of all Alerts originated from the field of anaesthesia devices. Comparison of the percentages of problem reports/recalls (8.6%) and Alerts (37.5%) with the percentage of marketed devices for anaesthesia (2.3%) showed differences (P < 0.05). As well, the percentage of class I priority (the highest safety priority) problem reports/recalls for anaesthesia devices was 10.2% compared with 4.9% for non-anaesthesia devices (P < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
Gilron
I
I
Department of Anaesthesia, McGill University, Montreal, Quebec.
D000776:Anesthesiology / Q000145:classification / Q000295:instrumentation* / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D002170:Canada / Q000453:epidemiology; D004868:Equipment Failure / Q000706:statistics & numerical data; D004869:Equipment Safety / Q000145:classification / Q000706:statistics & numerical data; D006077:Government Agencies / Q000331:legislation & jurisprudence; D006801:Humans; D015994:Incidence; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D011635:Public Health Administration / Q000331:legislation & jurisprudence