To market a Class III medical device under the Medical Device Regulation (MDR)1 or Medical Device Directive (MDD)9 the manufacturer must present evidence to prove both the medical device and drug component are safe and effective. 3M meets these criteria, and continuously updates technical and clinical evidence to substantiate the effectiveness of Ioban drapes and secure Class III status.
Ioban is the only Class III antimicrobial incise drape that is clinically proven with published studies across multiple specialties2-6, trusted by surgeons around the world to protect patients in millions of procedures.
Guidelines recommending the use of an iodophor-impregnated drape7,8 are grounded on studies specifically comparing the effectiveness of Ioban antimicrobial incise drapes in the reduction of surgical site infections (SSIs) versus clear incise drapes5 or surgical preps alone.6
A prospective randomised study reported an SSI rate of 1.9% in patients which received Ioban drapes compared with 6.5% SSI rate for patients which received standard drapes.5
A cost analysis demonstrated that although the upfront cost of an Ioban incise drape was greater than a standard incise drape, once the additional costs associated with SSI were accounted for, the use of the Ioban incise drapes offered cost savings of up to €957 per patient.5
Ioban drapes have been used in millions of procedures. Its eﬀectiveness has been documented in numerous clinical studies over the last 30 years. 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 cost.
Discover how to position incision management in the patient care pathway, define Surgical Site Complications and the difference compared to Surgical Site Infection.
Understand the most important reasons for using an antimicrobial incise drape, along with evidence and guidelines, and explore the purpose and advantages of Closed Incision Negative Pressure Wound Therapy (CiNPWT).
Ioban Antimicrobial Incise Drapes are classified as Class III medical devices. This is because the iodine incorporated into the incise drape is a drug which works in the deeper layers of a patient’s skin1 to reduce the risk of surgical site infections (SSI).5,6
In accordance with the Medical Device Regulation1 (Rule 14, MDR 745/2017) and the European Medical Device Directive9 (Rule 13, Annex IX, MDD 93/42/EEC), all devices containing a drug component (as defined in 2001/83/EC) which is liable to act on the human body with action ancillary to that of the device, are in Class III.
Ioban is the only Class III antimicrobial incise drape that has published clinical evidence across multiple specialites to support its use,2-6 trusted by surgeons around the world to protect patients in millions of procedures.
Class lla and llb incise drapes have another intended use in comparison with Class III medical devices. These products are not classified as incorporating an active drug component that can penetrate the patient’s skin.
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 here to help with science-centred solutions and clinical evidence-based therapies to improve efficiency, prevent complications and deliver better patient outcomes. Every patient. Every time.
Find out more about how 3M can support you in the prevention of surgical site complications from patient preparation, to surgical intervention, and enhanced recovery.
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