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Regulation and safe adoption of new medical devices and procedures
1Chairman 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
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.
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Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...