§ Lord Carterasked Her Majesty's Government:
How many deaths in National Health Service hospitals in the last 28 months resulted from the malfunction or misuse of medical apparatus of the type which relates to pumps or syringe drivers and what action has been taken by the Medical Devices Agency in connection with any such deaths.
103WA
§ The Parliamentary Under-Secretary of State, Department of Health (Baroness Cumberlege):Over the last 28 months there have been no deaths reported to the Medical Devices Agency resulting from malfunction of infusion devices, however there have been seven deaths reported associated with the misuse of infusion devices.
The Medical Devices Agency has investigated all reported incidents involving infusion devices and issued individual safety warning notices and recommendations for corrective action to hospitals as necessary. Also the agency has persuaded manufacturers to improve the design of infusion devices and participated in national and international safety standards committees. In addition, the agency has issued revised comprehensive advice to the Health Service (Device Bulletin DB9503 May 1995) which includes recommendations, based on experience gained from investigating reported incidents and evaluating new devices, on training, purchasing and management, including user record keeping. Copies of this document are available in the Library. Two comparative evaluation reports covering infusion devices currently for sale are about to be published.