1. By Dr. Allen Hanouka ALCOHOLIC 2% CHLORHEXIDINE WIPES

2. Product Overview & Uses Guidelines Licensing Issues Study Questions & Issues Competitors Summary This presentation will cover the following topics: Presentation Layout

3. Product Overview This presentation is about 2 products of which both contain exactly the same formulation: 2% Chlorhexidine Gluconate, 70% Isopropyl Alcohol The green box is Clinell Alcoholic 2% Chlorhexidine Wipes and has a product code of CA2C200. The blue box is called Clinell Alcoholic 2% Chlorhexidine Skin Wipes and has a product code CA2CSKIN.

4. Product Overview Both are made from non woven material which makes it easier to manipulate around the intended area of use. Both are manufactured in the UK. Both wipes contain 200 individually wrapped sachets in a box. The wipe sizes do vary between the green and the blue version. The green one is 195x105mm The blue one is 105x105mm. > >

5. Clinell 2% Chlorhexidine (CA2C200) (Wipes Size: 195 x 105mm) 200 individually wrapped sachets

6. Clinell 2% Chlorhexidine Skin (CA2CSKIN) 200 individually wrapped sachets (Wipes Size: 105 x 105mm)

7. Uses of the Two Products Used for disinfecting medical devices prior to access and for blood culture bottles. This includes intravenous catheters, invasive lines and blood culture bottles. This product is primarily designed for use on skin as a preinjection swab. It does not have a medicinal license in the UK as a preinjection swab and as such the packaging states it is for cleaning small areas of dirty skin after dressing and plaster removal. Clinell Alcoholic 2% Chlorhexidine (CA2C200) Clinell Alcoholic 2% Chlorhexidine Skin (CA2CSKIN)

8. Background Most countries still use just 70% alcohol (very occasionally they may use 0.5% chlorhexidine to supplement the alcohol) on skin and also on intravenous catheters prior to access. There is a lot of data emerging in the last few years showing the benefits of using 2% chlorhexidine on skin and on medical devices with studies outlining an 80% drop in infection rates. In the USA and UK these products have been incorporated into the national guidelines and are recommended by many infection control guidelines. The data showing the benefits is very conclusive and validated.

9. Guidelines In the UK there are two guidelines that recommend the use of such products: EPIC stands for Evidence-based Practice in Infection Control and was started in 1998 by the Richard Wells Research Centre at Thames Valley University and funded by the Department of Health. This was a publication in 2005 by the Department of Health to help hospitals reduce infection rates and again is evidence based. Saving Lives Guidelines. EPIC 2 Guidelines.

10. EPIC 2 Guidelines EPIC2 is the Evidence-based Guidelines for Preventing Healthcare Associated Infections in NHS Hospitals in England 2007. 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. 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)

11. Saving Lives Guidelines It was updated in 2007 and a set of guidelines called High Impact Interventions (HII) were defined. High Impact Intervention No 1 (Central venous catheter care bundle –Catheter access) Use aseptic technique and swab ports or hubs with 2% chlorhexidine gluconate in 70% isopropyl alcohol prior to accessing the line for administering fluids or injections. 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.

12. Saving Lives Guidelines High Impact Intervention No 2 (Peripheral intravenous cannula care bundle – 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 – Catheter access) Use aseptic technique and swab ports or hub with 2% chlorhexidine gluconate in 70% isopropyl alcohol prior to accessing the line.

13. Saving Lives Guidelines 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 and 70% isopropyl alcohol impregnated swab. Allow the alcohol to fully evaporate before proceeding with bottle inoculation. Taking Blood Cultures - A Summary of Best Practice

14. Licensing Laws in the UK In the UK it is not possible to have a product which is a medical device and at the same time can also be used on skin as a pharmaceutical product. This means that you cannot have one product that is designed for use on a medical device and thus has a CE mark and also that is used in a specific manner on skin and thus requiring a medicinal (pharmaceutical) license. It is not possible to have one product for both scenarios.

15. Study: A fall in bloodstream infections followed a change to 2% chlorhexidine in 70% isopropanol for catheter connection antisepsis. This was done (on the green wipes) at Great Ormond Street Children’s Hospital by Dr James Soothill, Microbiologist. Published in the American Journal of Infection Control 2009 Oct -37-8-626-30 Aim to see if using these wipes will reduce the incidence of infections through central lines. Infections cause: death, illness, longer hospital stay and increased costs. The study is available on request from the export department.

16. Previous to our wipes, 70% alcohol was used on hubs and ports. Numbers of catheter-related bloodstream infections before and after the change were monitored as were the numbers of catheter days experienced by patients. Done on 5 wards. Result: All 5 wards showed a drop in line infection rates. All 5 wards showed a decrease in positive blood cultures. The infection rate before the change was 12 per 1000 catheter-days, and, following the change, this fell to 3 per 1000 catheter-days (P =.004). Similar falls followed the introduction of chlorhexidine to other wards. Study: A fall in bloodstream infections followed a change to 2% chlorhexidine in 70% isopropanol for catheter connection antisepsis.

17. CONCLUSION: These results support the 2007 UK guidelines recommending 2% chlorhexidine in 70% isopropanol as a disinfectant of needleless connectors and hubs of central venous catheters Study: A fall in bloodstream infections followed a change to 2% chlorhexidine in 70% isopropanol for catheter connection antisepsis.

18. Questions and Issues Q What is CA2C200 Used for? 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. >

19. Questions and Issues Q What regulation does CA2C200 fall under? A. CA2C200 is a class IIa medical device regulated under the Medical Device Directive 93/43/EEC under the supervision of notified body number 0473, AMTAC certification services. >

20. Questions and Issues Q Can CA2C200 be used on skin? According to licensing laws in the UK the answer is No. The answer may be different in other countries and this needs to be looked into by the distributor. CA2C200 can only be used on medical devices. In the UK products such as these can either be regulated under the medical device directive or have medicinal licenses. CA2C200 is a class IIa medical device regulated under the Medical Device Directive and as such can only be used on medical devices. >

21. Questions and Issues Q Are either of these wipes sterile? No. The wipes are not sterile. There are a few reasons for this: Chlorhexidine is very difficult to sterilize as the sterilization process breaks down the molecule. Therefore you cannot get 2% Chlorhexidine wipes which are sterile. There is no real need for this type of product to be sterile as it is antibacterial in its natural action 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 this data is available for review if requested. > > >

22. Questions and Issues Q 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: You need to allow for some degree of adsorption on to surfaces and de-activation by hand soaps to deliver a true 2% level of chlorhexidine. Over time chlorhexidine breaks down so you need to be above 2% to guarantee a 2 year shelf life. > >

23. Questions and Issues Q What is the difference between your product and other wipes with the same formulation? The main difference is our wipe has published clinical data showing a reduction in catheter related blood stream infections. Our wipe is made from high grade non woven. We have a CE mark and as such have strict guidelines on manufacture that must be adhered to. We maintain very competitive prices. >

24. Questions and Issues Q What is CA2CSKIN used for? It is used to disinfect small areas of dirty skin. Q What regulation does CA2CSKIN fall under? CA2CSKIN is regulated under the Biocidal Products Directive (BPD) 98/8/EC and is subject to the procedures set out in the Biocidal Products Directive (BPD) 98/8/EC. It does not have a drug product license (medicinal license). Most countries may not require such a license for this product and can sell it without any restrictions.

25. Competitors There is only one competitor in the UK: PDI’s Sani-Cloth CHG 2%. They released their version of the wipes a few months after we released ours. Both are quite similar in quality although we have published data behind our brand. Clinell brand is manufactured in the UK.

26. Questions?