Regulation and safe adoption of new medical devices and procedures

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Abstract

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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