New Interventional Procedures

The safety and efficacy of new interventional procedures in the UK were previously assessed by the Safety and Efficacy Register for New Interventional Procedures (SERNIP).  A UK-wide review recommended that the pilot system needed stronger and more formal links to clinical governance and should be relocated within the National Institute for Health and Clinical Excellence (NICE).

In January 2004, Scotland became a full participant in the Interventional Procedures Programme (IPP) and Scotland is included in the circulation of IPP guidance directly from NICE (See NHS HDL (2004) 04).

This HDL states that no new interventional procedure can be implemented without notification to and approval from the Clinical Governance Committee.

NICE makes recommendations about whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use.

NICE’s Interventional Procedures Programme remit is to:

• • Assess the efficacy and safety of interventional procedures, with the aim of protecting patients and helping clinicians, healthcare organisations and the NHS to introduce procedures appropriately.
  • Enable clinical innovation to be conducted responsibly, by reviewing evidence, consulting widely, facilitating data collection and analysis, and providing guidance on the efficacy and safety of interventions. No interventional procedure is entirely free from risk, but the IPP gauges the extent of uncertainties and makes recommendations on their implications.
  • Issue guidance on interventional procedures to help ensure that:
  • patients and carers are reassured that new interventional procedures are being monitored and reviewed to protect patient safety, and that they have access to information about procedures
  • clinicians, healthcare organisations and the NHS as a whole are supported in the process of introducing new procedures
  • innovation is fostered by providing advice on the efficacy and safety of new procedures, recommending training and other conditions for their use in the NHS, facilitating data collection and analysis, and arranging systematic reviews.

Nearly all the procedures that the IPP investigates are not well established in clinical practice, but the IPP can also scrutinise more established procedures if there is reason to be uncertain about their efficacy and/or safety.

To fall within the remit of the IPP, a notified interventional procedure must:

• • Involve an incision or a puncture or entry into a body cavity, or the use of ionising, electromagnetic or acoustic energy, and
  • be available within the NHS or be about to be used for the first time in the NHS, outside formal research, and
  • be either not yet generally considered standard clinical practice or a standard clinical procedure, the safety or efficacy of which has been called into question by new information.