Skin Preparation

Every skin antiseptic has been authorized for professional healthcare use.

Scare

Not every skin antiseptic meets the updated recommendations of the Guidance Document: Human-Use Antiseptic Drugs.11 In fact, standards pre- and post-2009, when the guidance document became effective, differ. Post-2009, manufacturers are required to submit clinical information to support their efficacy and safety claims for antiseptics intended for professional healthcare use. 3M™ SoluPrep™ Skin Antiseptic Products were the first skin antiseptics authorized for professional healthcare use.*

* Statement as of May 1, 2017

Skin antiseptic products need to be sterile.

Scare

No matter how hard you try, you can’t sterilize skin! Preoperative skin antiseptics should, per recommendations:12

• significantly reduce microorganisms on intact skin
• be non-irritating to the skin
• be broad-spectrum
• be fast-acting
• have a persistent effect
• remain effective in the presence of organic material
• be cost effective
• be distributed in a single-unit dose

Please note there is no requirement in the Health Canada Guidance Document11 that human-use antiseptic drugs must be “sterile”.

When it comes to 3M™ SoluPrep™ Skin Antiseptic Products, nonsterile doesn’t mean contaminated.

Truth

A skin antiseptic product labelled as “nonsterile” does not suggest the product is contaminated with microorganisms.

3M’s standard for all skin antiseptics products is that no organism will be detected.

Placing skin antiseptics inside a kit that goes through a sterilizer results in a sterile antiseptic.

Scare

The packaging (foil pouch or glass ampoule) protects the antiseptic during the sterilization process. Exposing the product directly to some types of sterilization results in degradation of the active ingredient. Only the outside of the package or exterior of the applicator is “sterile”. The antiseptics within are not.

Quality standards for skin antiseptics are stringent.

Truth

The 3M Canada quality assurance testing allowance for total aerobic microbial count (TAMC) is < 10 cfu/mL. That’s 10 times more stringent than the North American Standard of < 100 cfu/mL. The 3M™ SoluPrep™ Brand microbial release testing method can detect a single cfu of bacteria/mL of antiseptic. 3M Canada’s standard for all skin antiseptics is that no growth will be observed.13*

* Statement as of May 1, 2017

Organisms tested don’t stand a chance against 3M™ SoluPrep™ Skin Antiseptic Products with 2% CHG / 70% IPA solution.

Truth

3M has not found an organism that could survive and grow in 3M™ SoluPrep™ Skin Antiseptic Products with 2% CHG / 70% IPA solution (based on test organisms identified by Health Canada for professional healthcare use14 using test method EN13727 and EN 13624 and 3M internal challenge studies using 3M Canada test methods based on current USP and cGMP Health Canada).