| Advanced Incident Monitoring System | A system developed by the Australia Patient Safety Foundation and used by 200 Australian healthcare organisations for voluntary report submission. It uses the Healthcare Incident Types classification system, which elicits detailed information from the reporter regarding incident types, contributing factors, outcomes, actions and consequences. Statistical analysis of the relationship between the 1 million potential permutations of data describing each incident becomes useful. |
| Medicines and Healthcare Products Regulatory Agency in the UK | Healthcare professionals, industry and the public relay concerns about medical devices and medicines. In 2007, there were 8634 adverse incidents investigated related to medical devices, including packaging failures compromising sterility, faulty point of care/home tests (eg, those used for glucose monitoring) and pregnancy testing kits displaying false-negative results.32 Although their investigations suggest that the responsibility lies as often with the healthcare establishment and end user as it does with the manufacturer, Medicines and Healthcare Products Regulatory Agency issued Medical Device Alerts on products such as vascular and dialysis devices, counterfeit condoms and infusion and feeding pumps. |
| Japan Council for Quality Health Care | Voluntary reporting of adverse events—particularly sentinel events with root cause analysis |
| National Electronic Injury Surveillance System in the USA | This monitors the safety of medical equipment in the community by recording the details of injuries caused by consumer products that require attendance at an emergency department. Between July 1999 and June 2000, there were 454 383 attendances, mostly caused by physical trauma from wheelchairs, scooters and other walking devices.33 |