More than just a sticky drape, Ioban antimicrobial incise drapes are designed to help reduce the risk of SSIs. They are applied to a patients skin at the site of a surgical incision to create a sterile surface and deliver broad – spectrum antimicrobial activity throughout the surgical procedure.
When choosing an incise drape, there are many factors to consider in terms of effectiveness and patient safety.
In accordance with the EU Medical Device Directive, Ioban drapes are classified as a Class III medical device. This is because the iodine in the incise drape is a drug which works in the deeper layers of a patient’s skin to reduce the risk of SSI.
To be awarded a class III status, the manufacturer must present evidence to prove both the device and drug component are safe and effective.
Class II incise drapes do not offer the same level of assurance. Their drug component has not been assessed for safety of efficacy as the manufacturer submitted evidence that the drug component does not act on the human body.
Ioban drapes have been used in millions of procedures worldwide for over 30 years. Its eﬀectiveness has been documented in numerous clinical studies dating from the 1980’s until the present day. No other incise drape oﬀers this level of assurance.
Clinical studies have shown that Ioban drapes are eﬀective at reducing wound contamination, surgical site infections, and most recently, cost.
Incise drapes are usually sterilised using either gamma irradiation or ethylene oxide.
The method used can have an impact on the chemical composition of the iodine contained within the drape.
It is well-documented that when products containing iodine come into contact with ethylene oxide, ethylene iodohydrin can be produced. This can be a skin irritant and is why 3M sterilises Ioban Incise Drapes using gamma irradiation.
3M is dedicated to providing customer education and training to ensure the right product is used at the right time.
Contact your local 3M representative to arrange:
1. Medical Device Directive 93/42 (EEC)
2. Yoshimura et al. Plastic iodophor drape during liver surgery operative use of the iodophor impregnated adhesive drape to prevent wound infection during high risk surgery. World J. Surgery. 2003; 27:685-688.
3. Rezapoor M, Tan TL, Maltenfort MG, Parvizi J. Incise draping reduces the rate of contamination of the surgical site during hip surgery: a prospective, randomized trial. J Arthroplasty. Im Druck.
4. Bejko et al. Comparison of efficacy and cost of iodine impregnated drape vs. standard in cardiac surgery: study in 5100 patients. J Cardiovasc Trans. Res. 2015; 8:431-437.
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