Adverse incident reporting

The Medicines and Healthcare products Regulatory Agency (MHRA) investigated over 10,000 reports of adverse incidents involving medical devices in 2010. As a result of those investigations manufacturers undertook to improve the designs, manufacturing processes or quality systems in 730 cases and gave advice on safer use and training in 294 cases. In 2010, the MHRA issued 100 Medical Device Alerts, providing advice to device users in the health service. A single report of a problem from a medical device user can, therefore, really make a difference to the future safety of the medical devices in use everyday. A medical device is any product, other than a medicine, used for the diagnosis, prevention, monitoring, treatment and alleviation of illness or injury or the prevention of conception. This includes imaging equipment, hip implants, infusion pumps, condoms, contact lenses, walking sticks, dialysis machines and so on. The MHRA is the UK regulator of manufacturers of medical devices. The system of regulation is European Union wide. A manufacturer wishing to bring a new medical device to market needs to demonstrate compliance with essential requirements laid down in European Directives. For devices in all but the lowest risk category an independent notified body in one of the member states pumps, condoms, contact lenses, walking sticks, dialysis machines and so on. The MHRA is the UK regulator of manufacturers of medical devices. The system of regulation is European Union wide. A manufacturer wishing to bring a new medical device to market needs to demonstrate compliance with essential requirements laid down in European Directives. For devices in all but the lowest risk category an independent notified body in one of the member states particularly important in detecting generic problems affecting a group of devices, for example infusion devices. The MHRA uses the information taken from the reports to seek improvements in medical devices, warn users when user error has occurred to try and prevent recurrence and commence regulatory action against the manufacturer if required. Adverse incidents can be associated with problems with the medical device itself, problems with the way it is used or both. A medical device may have an actual design flaw that goes undetected until it is in widespread use, or there may be a problem during manufacture allowing devices not to the intended specification to reach the end user and cause problems. In either of these cases once detected by the manufacturer’s own post market surveillance activity or by analysis of user and manufacturer reports by competent authorities, a field safety corrective action may be required. This involves the manufacturer circulating a field safety notice to the users of medical devices requesting specific actions. This can include a request that users cease use of the affected devices and return them (often the case with single use devices), an update to instructions or advice on requesting a software update for example for imaging equipment. The MHRA is informed of the commencement of approximately one field safety corrective action every day.

Acting on notices

It is important that the users of medical devices act on field safety notices when they receive them. The MHRA will sometimes also publish a Medical Device Alert to inform users of field safety corrective actions. For example, if there is concern about whether affected product can be successfully tracked down by the manufacturer. Medical Device Alerts are sent electronically to all NHS Trusts and social service departments via the Safety Alert Broadcasting System and contain a distribution list for suggested onwards distribution. The Safety Alert Broadcasting System includes a facility for recipients to update on progress with the actions required in alerts. Investigations into reports of adverse events associated with the incorrect use of devices can also prompt the MHRA to publish Medical Device Alerts warning users to try and help prevent recurrence (See Panel 1). The investigations can result in manufacturers enhancing the instructions, warnings or even the design of devices to help prevent further misuse (See Panel 2). Additionally the MHRA publishes One-liner, a single sheet intended to be eye catching for frontline staff, with six examples of adverse incidents associated with incorrect use and advice on future prevention.