Request:         Requirements for Clinical Adoption 

I understand Medicines Management within Clinical Commissioning Groups base their commissioning and prescribing recommendations on an evidence-based approach which balances the safety, tolerability, effectiveness, cost and simplicity of treatments.  The aim of this approach means that patients receive better, safer more convenient care and scarce resources are optimally allocated.

I wonder if you could let me know the level of clinical evidence, cost effectiveness data and other supporting evidence the Medicines Management team require to consider recommending its adoption by the clinical commissioning programs or its incorporation into local guidelines for an ISO accredited Class IIA medical device?

Specifically we are collating a portfolio of information for Accel-Heal, an electroceutical medical treatment device designed to improve and accelerate healing rates, reduce pain and exudate in patients with complex wounds when used alongside standard dressings.  Accel-Heal is certified as a Class IIA device under the medical directive 93/42/EEC.  It has full Medical Devices Directive approval under ISO 13485:2003.

Synapse Electroceutical Ltd, the company behind Accel-Heal wishes to fulfil the suitability criteria for a Medicines Management consideration so being specific about the type and level of information required is necessary.

Response – Please see the attached document.