Clinell Alcoholic 2% Chlorhexidine CA2C200 - Green Medical Device Wipe

Clinell Alcoholic 2% Chlorhexidine CA2C200 - Green Medical Device Wipe

Frequently asked questions


1. What is CA2C200?

Clinell Alcoholic 2% Chlorhexidine is disposable disinfection wipe for medical devices presaturated with 70% alcohol and 2% Chlorhexidine gluconate.

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2. What is CA2C200 used for?

In Europe it is used to disinfect medical devices specifically designed for — catheter hubs and ports, needle free devices, cannulas, blood culture bottle tops. It was brought out to provide disinfection under guidelines set out by EPIC2 and Saving Lives (see below).

Product use in other countries can vary according to local regulations.

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3. What regulation does CA2C200 fall under?

CA2C200 is a class IIa medical device regulated under the Medical Device Directive 93/42/EEC under the supervision of notified body number 0473, AMTAC certification services.

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4. Can CA2C200 be used on skin?

In Europe CA2C200 can only be used on medical devices. If you use the wipe on skin you are using the product against our recommendations.

Product use in other countries can vary according to local regulations.

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5. Why can’t the product be used on medical devices and skin?

In the Europe products such as these can either be regulated under the medical device directive or have medicinal licences, depending upon their intended use. CA2C200 is a class IIa medical device regulated under the Medical Device Directive and as such can only be used on medical devices, products which are intended to be used on the skin as part of a medical procedure are regulated as medicinal products and require a marketing authorisation (product licence).

Product use in other countries can vary according to local regulations.

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6. Is the wipe sterile?

No. The wipes are not sterile. There are a few reasons for this.

  1. Chlorhexidine is very difficult to sterilize as the sterilization process breaks down the molecule because of this you will find all other 2% Chlorhexidine wipes on the market are not sterile either.
  2. There is no real need for this type of product to be sterile as it is antibacterial
  3. We manufacture the wipes in a very strictly controlled environment reducing any risk of contamination of the products. We also do bioburden studies (testing the wipes for contamination) and can send you a copy of the results if you wish.
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7. How consistent is the percentage of chlorhexidine available from the wipe?

Every batch of wipes is tested at an independent UKAS accredited laboratory to have a concentration of between 2-3% chlorhexidine, the reason for having slightly more than 2% is two fold:

  1. You need to allow for some degree of absorption on to surfaces and de-activation by hand soaps to deliver a true 2% of chlorhexidine.
  2. Over time chlorhexidine breaks down so you need to be above 2% to guarantee a 2 year shelf life.

We have a letter from an independent laboratory about this and we can send it to you.

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8. What are the EPIC2 Guidelines?

EPIC2 is the Evidence-based Guidelines for Preventing Healthcare Associated Infections in NHS Hospitals in England 2007. It can be downloaded in full at the website: http://www.epic.tvu.ac.uk/epicphase/2.html

It states 2 guidelines which apply to CA2C200:

CVAD 33 A single patient use application of alcoholic chlorhexidine gluconate solution (preferably 2% chlorhexidine gluconate in 70% isopropyl alcohol) should be used and allowed to dry when decontaminating the injection port or catheter hub before and after it has been used to access the system. Unless Contra-indicated by the manufacturer’s recommendations, in which care either aqueous chlorhexidine gluconate or aqueous povidone iodine should be used

CVAD 44 When needle-free devices are used, the risk of contamination should be minimised by decontaminating the access port before and after use with a single patient use application of alcoholic chlorhexidine gluconate solution (preferably 2% chlorhexidine gluconate in 70% isopropyl alcohol), unless Contra-indicated by the manufacturer’s recommendations, in which case aqueous povidone iodine should be used.

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9. What are the Saving Lives Guidelines

Saving Lives was launched in 2005 with an aim to help give hospitals guidelines to reduce hospital acquired infections (HAIs), and was made a legal requirement for acute hospitals to follow.

It was updated in 2007 and a set of guidelines called High Impact Interventions (HII) were defined.

The guidelines can be seen at the website: http://www.clean-safe-care.nhs.uk/public/default.aspx?level=2&load=Tools&NodeID=181

The guidelines with reference to CA2C200 are:

High Impact Intervention No 1 - Central venous catheter care bundle —http://www.clean-safe-care.nhs.uk/toolfiles/14_SL_HII_1_v2.pdf

Catheter access
Use aseptic technique and swab ports or hub with 2% chlorhexidine gluconate in 70% isopropyl alcohol prior to accessing the line for administering fluids or injections.

High Impact Intervention No 2 - Peripheral intravenous cannula care bundle - http://www.clean-safe-care.nhs.uk/toolfiles/16_SL_HII_2_v2.pdf

Cannula access
Use 2% chlorhexidine gluconate in 70% isopropyl alcohol, and allow to dry prior to accessing the cannula for administering fluid or injections.

High Impact Intervention No 3 - Renal dialysis catheter care bundle — http://www.clean-safe-care.nhs.uk/toolfiles/19_SL_HII_3_v2.pdf

Catheter access
Use aseptic technique and swab ports or hub with 2% chlorhexidine gluconate in 70% isopropyl alcohol prior to accessing the line.

Taking blood cultures - A summary of best practice — http://www.clean-safe-care.nhs.uk/ArticleFiles/Files/283198BC_blood_cultures.pdf

Disinfect the culture bottle cap before transferring the sample ideally, remove the plastic cover immediately before collecting the sample; the top of the bottle will be clean but not sterile. Disinfect the tops of the culture bottles with a 2% chlorhexidine in 70% isopropyl alcohol impregnated swab. Allow the alcohol to fully evaporate before proceeding with bottle inoculation.

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10. Is the product latex free

Yes. We can send you a declaration on this if you wish.

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11. Can you sterilize the wipes?

The wipes cannot be gamma sterilized as this will break down the Chlorhexidine in the product.

The sachets are safe to be ETO sterilized, but this method would only sterilize the outside of the sachet. The foil sachet is not gas permeable and thus ETO sterilization would not penetrate the sachet.


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