A WORRYING 13% increase in the number of injuries and deaths related to medical devices has led to the announcement of changes to the way reports are investigated.
The new approach to ‘adverse incident’ report handling follows a review by the Medicines and Healthcare products Regulatory Agency (MHRA) earlier this year. Reports will now be subject to a new risk assessment and triage system and the method of identifying, analysing and acting upon emerging patterns and trends is to be expanded and developed.
The news comes as the MHRA publishes its Report on Devices Adverse Incidents for 2010, which shows an increase in reports from 9,099 in 2009 to 10,280 – a 13% rise. Since 2000 this number has shot up by a total of 42%.
While the nature of the devices concerned is wide ranging, key problem areas include beds and bed accessories, wheelchairs and children’s buggies, hoists and slings, and bath and shower aids.
An adverse incident is defined as ‘an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons’. Reasons for this include unsuitable storage and use, inadequate servicing, design or manufacture problems, a failure to follow manufacturers’ instructions, inappropriate local modifications, poor device selection, and poor user instructions or training.
The statistics in the report are based on incidents passed to the MHRA by patients, members of the public, clinicians, social workers and device manufacturers themselves.
Of the 10,280 incidents in 2010, 301 involved a fatality, compared with 202 in 2009. A further 2,382 resulted in serious injury (1,885 in 2009); 2,227 prompted an indepth investigation by the regulator (2,222 in 2009); and a further 4,256 incidents were investigated directly by the manufacturer under MHRA supervision (3,539 in 2009).
As a result of the inquiries, 100 Medical Device Alerts were issued by the MHRA, 403 field safety corrective actions were undertaken, and 294 safer device guidance papers were issued or improved training demanded. In addition, in 730 cases manufacturers undertook to improve design, manufacturing processes or quality control systems. In 2,064 cases, no immediate action was considered necessary.
The MHRA report states: “No medical device should ever be considered 100% safe. Constant effort is therefore required to reduce both the rate at which adverse incidents occur, and the severity of the outcome. Reporting all adverse incidents to the MHRA provides valuable information that may be directly responsible for preventing similar incidents from happening again.”
Commenting on the new approach to investigating incident, it adds: “These changes enable us to focus our specialist resources directly upon those issues which present the greatest risk to patient safety and where our active intervention will make a positive difference to the resolution of the problem.
“From 2012, the MHRA’s two annual publications, Reporting Adverse Incidents and Disseminating Medical Device Alerts and Report on Devices Adverse Incidents, will be published as a single document. This will remove the current duplication of content between the two existing publications and ensure, for medical device liaison officers in particular, that all key information is located in a single reference document.”
Of the reports in 2010, 1,495 incidents involved assistive technology devices, including 30 fatalities. There were 4,361 adverse incidents involving bioscience and implant technologies such as barrier contraceptives, woundcare products and insulin injection devices. And 4,242 incidents involved imaging and acute care devices such as anaesthetic and breathing systems, diagnostic equipment and dialysis technologies. In this category, 1,200 warranted indepth investigation by the MHRA.
Other key safety issues included:
As well as changing the way it handles reports, the MHRA is appealing to healthcare staff to increase their level of reporting.
The report states: “The upward trend in reporting by medical device manufacturers has continued, with almost 1,000 more reports received in 2010. This can be attributed both to our ongoing, pro-active contact with manufacturers and to the continuing increase in the range and volume of medical devices available and in use.
“However, despite the overall upward trend in reporting, we remain concerned at the level of reporting from health and social care staff. The previously reported downward trend may have leveled off, but the number of reports received still remains below the peak reached 10 years ago. In our continuing efforts to address this problem we have, once again, used our reporting guidance publication Reporting Adverse Incidents and Disseminating Medical Device Alerts to emphasise the need for full incident reports to be an integral part of local systems for the safe management and use of medical devices. This is reinforced by reference to the Care Quality Commission’s essential standards for the quality, safety, availability and suitability of medical devices.”
Following an investigation, the MHRA has a number of powers, including initiating enforcement measures, removing devices from the market and issuing national warnings and recommendations.