» First Accreditation for Testing of New Blood Pressure Monitoring equipment
16 March, 2009
The United Kingdom Accreditation Service (UKAS) has accredited the Medical Physics Department at Guy’s & St Thomas’ NHS Foundation for its clinical trials to test new blood pressure monitoring equipment for use in the NHS. It is the first centre in the UK to achieve UKAS accreditation for this type of testing.
Currently, new electronic blood pressure monitors have to undergo trials in which their accuracy is compared with mercury sphygmomanometers in a large number of patients. The trials are expected to follow internationally recognised standards and protocols. They provide information on which the NHS and other healthcare providers around the world make purchasing decisions.
However, the degree of compliance with the published protocols can vary widely in different centres around the world, particularly where there are commercial pressures to complete the study. There is currently no way of assessing the quality of the trial other than examination of results after they are published. This is often inadequate to confirm whether the key requirements of the standards were met.
The new approach to approving medical equipment trials, pioneered by the Medical Physics Group, involves on-site assessments during the trial by independent experts brought in by UKAS. The assessors, following the test laboratory standard (ISO/ IEC 17025), can demand to see any records related to the study and even witness the testing in progress.
Phil Endersby, Assessment Manager said, "Achieving UKAS requirements for accreditation of such testing was a new departure. Accreditation of medical equipment trials means that the NHS can now have confidence in data on which to make purchasing decisions and that patients can be assured that the design of blood pressure monitors meets the standards recognised by the medical community. It would be good to see this approach used for other medical equipment."