Regulation and safe adoption of new medical devices and procedures

Br Med Bull. 2013;107:5-18. doi: 10.1093/bmb/ldt022. Epub 2013 Jul 29.


Background: Recent problems with medical devices have highlighted the need for improved surveillance. New procedures are largely unregulated.

Sources of data: 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.

Areas of agreement: 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.

Areas of controversy: How best to protect patients from harm while allowing rapid access to potentially beneficial interventions.

Growing points: Establishing systems for good data collection on the use of devices and procedures.

Areas timely for developing research: How to accrue more and better evidence about devices and procedures through clinical trials and various avenues of observational data collection.

Keywords: evidence development; medical devices; new procedures; patient safety; post-market surveillance.

MeSH terms

  • Device Approval / legislation & jurisprudence*
  • Device Approval / standards
  • Equipment and Supplies / adverse effects
  • Equipment and Supplies / standards*
  • Evidence-Based Practice
  • Guideline Adherence
  • Humans
  • Marketing / legislation & jurisprudence
  • Patient Safety / standards*
  • Physician's Role
  • Product Surveillance, Postmarketing
  • Risk Assessment
  • Social Control, Formal / methods*
  • United Kingdom