Safety and efficacy of interventional procedures

Scrutinising the evidence and issuing guidelines without stifling innovation

Throughout the world, systems are in place to ensure that any new drug is subjected to rigorous trials, appraisal, and approval before unrestricted use on patients. Medical devices are also subject to scrutiny and approval. By contrast no system exists for interventional procedures, many of which are done by surgeons but increasingly by other specialists as well. Recent press reports of surgical scandals and heightened public concern have led to political and consumer pressure for formal systems to assess new interventions.

In the United Kingdom, initial moves were made in 1996 by the setting up of the Safety and Efficacy Register for New Interventional Procedures (SERNIP). It was founded by the royal colleges, with limited funding from the NHS, and was entirely voluntary. The register gradually accumulated a list of new procedures and allocated each to a category signifying its perceived degree of safety and efficacy, but the profile and impact of this register were limited. Australia followed suit with the Australian Safety and Efficacy Register for New Interventional Procedures—Surgical (ASERNIP-S)—established by the Royal Australasian College of Surgeons …