Regulation and safe adoption of new medical devices and procedures

Abstract

BackgroundRecent problems with medical devices have highlighted the need for improved surveillance. New procedures are largely unregulated.Sources of dataInformation from regulators. Guidance produced by the National Institute for Health and Care Excellence Interventional Procedures and Medical Technologies Advisory Committees and the evidence used in their evaluations.Areas of agreementMore and better evidence is required for new medical devices and procedures when they are introduced into practice. Routine collection of observational data on outcomes should be improved.Areas of controversyHow best to protect patients from harm while allowing rapid access to potentially beneficial interventions.Growing pointsEstablishing systems for good data collection on the use of devices and procedures.Areas timely for developing researchHow to accrue more and better evidence about devices and procedures through clinical trials and various avenues of observational data collection.