Continuity and contingency planning for medical devices

The Medical Device Agency's (MDA) key aim is to take all reasonable steps to protect the public health and safeguard the interests of patients and users by ensuring that medical devices and equipment meet appropriate standards of safety, quality and performance and that they comply with relevant Directives of the European Union. It is expected that some computers and other electronic equipment will malfunction because of the Year 2000 date change (and other related dates). MDA's involvement is where such equipment is a medical device. Medical device manufacturers are better placed than manufacturers in some other sectors to identify and rectify whatever date-related problems may exist with their products. However they generally do not know exactly which versions of which products are in service in which places. These factors led MDA to identify an appropriate division of responsibility: manufacturers needed to assess each of their products (including any variants of the same model incorporating different software versions or different hardware), to identify any which were affected by year 2000 problems, and to make this information available to users, MDA and other interested parties, with an indication of the appropriate remedial action; users needed to identify what devices they have, by make and model, and if necessary also by serial number and/or software version, and then to contact the manufacturers for information; MDA needed to provide appropriate advice, to encourage manufacturers to provide compliance information, and to investigate any reported non-compliances that might adversely affect the safety of patients or users.