title: Regulation and safe adoption of new medical devices and procedures.
abstract: BACKGROUND
  Recent problems with medical devices have highlighted the need for improved surveillance. New procedures are largely unregulated.
  
  
  METHODS
  Information 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.
  
  
  RESULTS
  More 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.
  
  
  RESULTS
  How best to protect patients from harm while allowing rapid access to potentially beneficial interventions.
  
  
  CONCLUSIONS
  Establishing systems for good data collection on the use of devices and procedures.
  
  
  CONCLUSIONS
  How to accrue more and better evidence about devices and procedures through clinical trials and various avenues of observational data collection.
authors.affiliation: Chairman Interventional Procedures and Medical Technologies Advisory Committees, National Institute for Health and Care Excellence, 10 Spring Gardens, London SW1A 2BU, UK. bruce.campbell@nice.org.uk
authors.forename: Bruce
authors.initials: B
authors.lastname: Campbell
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D055317:Evidence-Based Practice; D019983:Guideline Adherence; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence; D061214:Patient Safety / Q000592:standards*; D010819:Physician's Role; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D012926:Social Control, Formal / Q000379:methods*; D006113:United Kingdom
keywords: evidence development; medical devices; new procedures; patient safety; post-market surveillance