The impact of standards on UK biomedical engineering

The subject of standards occupies a prominent position in the lives of biomedical engineers in the UK. Most importantly, they relate to matters connected with safety, performance (or efficacy) and cost. The long history of involvement by the UK National Health Service (NHS) in medical technology has meant that the growing volume of legislation related to medical devices has largely been anticipated and actions planned. Alongside all other EU members, the UK has participated in a programme of action aimed at the harmonisation of standards, in order to remove obstacles to free trade. There are significant direct and indirect costs associated with the development and implementation of the wide range of standards now confronting the profession. In the long term, the impact and indeed the value of standards must be assessed in terms of their influences on the delivery of healthcare to patients. In this regard, biomedical engineers and medical physicists must take proactive roles in monitoring costs, performance and outcomes.