MIKE PALIN argues that important aspects have not been included in NICE guidance on SSIs in relation to surgical clothing and drapes.
He provides an insight into key considerations, including the Medical Devices Directive and the evaluation of barrier performance.
NICE published a clinical guideline1 on the prevention and treatment of surgical site infection (SSI) in October 2008. Clinical guidelines are defined as “systematically developed statements which assist clinicians and patients in making decisions about appropriate treatment for specific conditions.” Different versions of the guideline are available to reflect the particular interests of healthcare professionals, patients and carers. The guideline follows the patient through pre-operative, intra-operative and post-operative phases of surgery. It excludes prophylaxis and management of antibiotic-resistant bacteria, management of the operating theatre environment and environmental factors, or anaesthetic factors relating to SSI. Using available evidence, the guideline assesses the risk associated with the non-use or use of certain (non-surgical) procedures and products, draws conclusions where sufficient information is available and makes recommendations for action and, where evidence is not available, for future research. However, although some of the products mentioned may be classed as medical devices, there is no mention in the guideline of the Medical Devices Directive, the qualification of medical devices through appropriate testing or their obligatory labelling using the CE marking procedure. This is particularly true for wound dressings and operating theatre drapes and gowns. The latter are the subject of this article.
NICE guideline CG74 and surgical drapes and gowns
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