Dear Colleagues,

Medical Device or Medicinal Product?
Is an antiseptic alcohol wipe for skin disinfecton a medical device or a medicinal product? I think it's a medical device.
This is relevant in relation to production standards and regulations. We are reviewing clinical protocols and taking a risk management approach. Many prepacked impregnated wipes are non-sterile products. Alcohol, although a biocide, is not neceserily sterile. I believe the micro-organism B.subtilis is used in the production process of alcohol. Correct me if I'm wrong. If wipes and or alcohol are non-sterile, they could constitute an infection risk for immunologically suppressed patients, especially those with in-dwelling Hickmann catheters and the like. Changing dressings around catheter sites is an aseptic proceedure, it therfore seems to me inconsistent to use some non-sterile products, whilst others items in the proceedure, dressings, forceps and gloves are sterile. It breaks a principle. Maybe someone from the pharmaceutical industry can help me?
Thanks in anticipation!

Linda Ashurst

Dear Mrs. Ashurst,

We believe that there is no holistic, satisfying answer to your question(s). We would hence like to comment two aspects that you address:

1. Legal status of hand and skin antiseptics

The differentation of the legal status of medicinal products and medical devices is regulated, at least in the European Union: hand and skin antiseptics for "intended medicinal use" ("health care products") in the European Union are usually looked at as "medicinal products" according to 2001/83/EU. Products for the use on patients (skin disinfectants) are always regarded as "medicinal products".

Hand and skin antiseptics in the European Union can also be human hygiene "biocides" or "biocidal products" according to 98/8/EU, for example, when they are used in food industry and not in health care surroundings. However, not all countries follow the European guidelines up to now and national regulations may overrule them.

In so far, wipes for skin disinfection may have a different legal status from country to country, depending on their claims and on national regulations. A common regulation on a European level has so far not been established and thus, a common recommendation on how skin disinfection wipes have to be categorized cannot be given. Some countries even allow a registration as cosmetics or medical devices (CE products).

2. Alcoholic disinfection of hands and skin is a widespread technique in Europe as alcoholichand and skin antiseptics offer an extensive effect on bacteria, fungi and viruses, combined with excellent skin compatibility.

Yet, alcohols are not sterile and do not eradicate spores - which is a commonly known gap in their spectrum of effect. Some manufacturers of hand and skin antiseptics have therefore taken measures to bring their products close to the status sterility: They even integrate a spore filtration of the finished product in their production procedure.

The use of alcoholic hand and skin antiseptics is therefore not inconsistent with other preventive measures for aseptic procedures.


In any case, you should always reassure yourself of the quality of the products you use.

Kind regards

BODE Chemie GmbH & Co.
www.bode-chemie.com

Dr Michael Stengele Annette Rittich
Regulatory affairs/Documentation Marketing