Frequently asked questions
General
- What is a Hospital Acquired Infection / Nosocomial Infection?
- What is MRSA?
- What is Clostridium difficile?
- When was GAMA Healthcare established?
- What makes GAMA Healthcare different to other wipe manufacturers?
Clinell Universal Sanitising Wipes
- Why is the product referred to as a Universal wipe?
- Why is it important to clean in addition to disinfecting?
- What are the active ingredients in Clinell Universal Sanitising Wipes?
- Does using disinfectants increase the chance of resistance occurring with germs?
- What does the term “contact time” mean?
- Why is the kill count important to know?
- Does the mechanical action of the wipe play an important part in the disinfection process?
- Does the wipe retain some of the disinfectant?
- What can you use the Universal wipes on?
- What products does this wipe replace?
- What germs does the Universal wipes kill?
- Where was the testing conducted for this wipe?
- What are the wall mounted dispensers?
- What different formats are available for the Clinell Universal Sanitising Wipes?
- Are there any special disposal requirements?
- How would you summarise the benefits of Clinell Universal Sanitising Wipes?
Clinell Sporicidal Wipes
- There are many different sporicidal wipes on the market. Why is Clinell Sporicidal different to them?
- How are the wipes presented?
- What happens when the wipes are activated?
- Why can the wipes not be wet and therefore save the activation step?
- Is Peracetic Acid safe to use?
- Where was the testing conducted for this wipe?
- What products does the wipe replace?
- Chlorine is much cheaper then Clinell Sporicidal Wipes. Why should I use Clinell Sporicidal over hypochlorite based products?
- What organisms does this wipe kill?
- What would happen if the activated wipe touches my skin?
- Is there a need to wear a face mask?
- What are the uses of this wipe?
- Do I need to clean first before using this wipe?
- Can resistance occur with this wipe?
- Are there any disposal or storage requirements?
- How would you summarise the benefits of Clinell Sporicidal Wipes?
Clinell Chlorhexidine Wash Cloths
- What are the ingredients of this wipe?
- What are the uses for this wipe?
- Why use chlorhexidine?
- Who developed this product?
- In what format is the wipe available?
- Can the wipes be microwaved before use?
Clinell Alcoholic 2% Chlorhexidine Wipes
- What is CA2C200?
- What is CA2C200 used for?
- What regulation does CA2C200 fall under?
- Can CA2C200 be used on skin?
- Why can’t the product be used on medical devices and skin?
- Is the wipe sterile?
- How consistent is the percentage of chlorhexidine available from the wipe?
- What are the EPIC2 Guidelines?
- What are the Saving Lives Guidelines?
- Is the product latex free
- Can you sterilize the wipes?
Clinell Alcoholic 2% Chlorhexidine Skin Wipes
- 1. What is CA2CSKIN
- 2. What is CA2CSKIN used for?
- 3. What regulation does CA2CSKIN fall under?
- 4. Can CA2CSKIN be used as part of a medical procedure?
- 5. Is the wipe sterile?
- 6. How consistent is the percentage of chlorhexidine available from the wipe?
- 7. Is the product latex free
- 8. Can you sterilize the wipes?
Clinell Bed Bath Wipes
- What makes Clinell Bed Bath Wipes better then other bed bath wipes currently on the market?
- Can the wipes be microwaved before use?
- What format does the wipe come in?
- How will using this product benefit a hospital?
Clinell Continence Care Wipes
- What makes Clinell Continence Care Wipes better then other continence care wipes currently on the market?
- Can the wipes be microwaved before use?
- What products does this wipe replace?
- What format does the wipe come in?
Clinell Detergent Wipes
- What are the advantages of using this product over other detergent wipes?
- What different formats are available for this product?
- What products does this wipe replace?
- Do I need to wear gloves when using this product?
Clinell Clean Tape
- What is Clinell Clean Tape?
- How does Clinell Clean Tape work?
- What format does the product come in?
- How will using this product benefit a hospital?
General
1. What is a Hospital Acquired Infection / Nosocomial Infection?
These are infections which are a result of treatment in a hospital or a healthcare service unit, but secondary to the patient's original condition. Infections are considered nosocomial if they first appear 48 hours or more after hospital admission or within 30 days after discharge. This type of infection is also known as a hospital-acquired infection.
Nosocomial infections are even more alarming in the 21st century. The main reason are the followings:
- Hospitals house large numbers of people who are sick and whose immune systems are often in a weakened state;
- Increased use of outpatient treatment means that people who are in the hospital are sicker on average;
- Medical staff move from patient to patient, providing a way for pathogens to spread;
- Many medical procedures bypass the body's natural protective barriers;
- Sanitation protocol regarding uniforms, equipment sterilization, washing, and other preventative measures may be either unheeded by hospital staff or too lax to sufficiently isolate patients from infectious agents.
- Patients are often prescribed antibiotics and other anti-microbial drugs to help treat illness; this may increase the selection pressure for the emergence of resistant strains.
Thorough hand washing by all medical personnel before each patient contact is one of the most effective ways to combat nosocomial infections. Environmental disinfection can also help reduce these infections but this is not as well documented.
<< top2. What is MRSA?
Methicillin-resistant Staphylococcus aureus (MRSA) is a bacterium responsible for difficult-to-treat infections in humans. MRSA is by definition a strain of Staphylococcus aureus that is resistant to a large group of antibiotics called the beta-lactams, which include the penicillins and the cephalosporins.
MRSA is a resistant variation of the common bacterium Staphylococcus aureus. It has evolved an ability to survive treatment with beta-lactamase resistant beta-lactam antibiotics. MRSA is especially troublesome in hospital-associated (nosocomial) infections. In hospitals, patients with open wounds, invasive devices, and weakened immune systems are at greater risk for infection than the general public. Hospital staff who do not follow proper sanitary procedures may transfer bacteria from patient to patient. Visitors to patients with MRSA infections or MRSA colonization are advised to follow hospital isolation protocol by using the provided gloves, gowns, and masks if indicated. Visitors who do not follow such protocols are capable of spreading the bacteria to cafeterias, bathrooms, and elevators.
<< top3. What is Clostridium difficile?
Clostridium difficile or "C. diff", is a species of Gram-positive bacteria of the genus Clostridium and are spore-forming rods. This is the most serious cause of antibiotic-associated diarrhea (AAD) and can lead to pseudomembranous colitis, a severe infection of the colon, often resulting from eradication of the normal gut flora by antibiotics. The C. difficile bacteria, which naturally reside in the body, become overgrown: The overgrowth is harmful because the bacterium releases toxins that can cause bloating, constipation, and diarrhea with abdominal pain, which may become severe. Latent symptoms often mimic some flu-like symptoms. Discontinuation of causative antibiotic treatment is often curative. In more serious cases, oral administration of metronidazole or vancomycin is the treatment of choice.
<< top4. When was GAMA Healthcare established?
GAMA Healthcare was established in 2004 by two medically qualified doctors who had a special interest in microbiology. GAMA specialises in antimicrobial wet wipes for the healthcare sector and all the products come under the brand name Clinell.
<< top5. What makes GAMA Healthcare different to other wipe manufacturers?
GAMA is run by medically qualified doctors who have clinical experience of the difficulties facing healthcare professionals in dealing with infection control policies and reducing Hospital Acquired Infections. The majority of our products are designed to make infection control policies easier to adhere to, increase compliance and at the same time save a hospital money in doing so.
Clinell Wipes are the most innovative and advanced in the world and many of the products have patents and unique features that make them different to the other wipes currently on the market.
Clinell Universal Sanitising Wipes
1. Why is the product referred to as a Universal wipe?
This is because the wipe functions as a disinfectant and detergent wipe simultaneously and can be used on hands, all surfaces and all ward based equipment.
<< top2. Why is it important to clean in addition to disinfecting?
Dirt creates a barrier between the surface and the disinfectant on the wipe which can prevent the surface from being disinfected. Our wipes are designed to remove the dirt and disinfect at the same time. Many hospitals currently purchase detergent and disinfectant wipes as 2 separate products and Clinell Universal Sanitising Wipes will perform both jobs at the same time.
<< top3. What are the active ingredients in Clinell Universal Sanitising Wipes?
The formulation in Clinell Universal Sanitising Wipes is a patented antimicrobial solution developed by GAMA Healthcares medical team and microbiologist.
It contains 6 different biocides, including 2 quaternary ammonium compounds, and these are designed to work synergistically together. This means that the effectiveness of the biocides is increased by many multiples when working in tandem together. This ensures a wide antimicrobial activity and a high kill count with this wipe.
In addition the wipe contains surfactant to act as a detergent, glycol for a residual effect as well as a moisturizing effect on skin and chelating agents.
<< top4. Does using disinfectants increase the chance of resistance occurring with germs?
Because there are 6 different biocides and each functions to kill germs by using a different mechanism of action there is no risk to resistance occurring over long term use.
<< top5. What does the term “contact time” mean?
This is the time required for the disinfectant to act on germs and is basically how long it takes for the disinfectant to work. The contact time varies greatly with different germs but for MRSA it is 10 seconds.
<< top6. Why is the kill count important to know?
Apart from how fast it takes a disinfectant to work i.e. contact time, it is also important to determine what happens when the contact time is reached and how much a particular germ has been killed. It wouldn’t be much use to have a fast contact time but a low kill count that allowed the majority of the microbe to be still active.
This reduction in germs or kill count is expressed in a log form and basically the log number is the number of nines that is expressed in a percentage reduction. For example, 2 log reduction is 99%, 4 log reduction is 99.99% and so on.
Clinell Universal Sanitising Wipes have demonstrated a 5 log kill count (99.999%) of most germ groups in the contact time specified. This information is available to review as downloadable pdf files from this link http://www.gamahealthcare.com/products-universal-wipes-data.asp
<< top7. Does the mechanical action of the wipe play an important part in the disinfection process?
The mechanical action of the wipe enhances the level of disinfection by removing soil and bioburden to allow the disinfectant to reach the surface directly. The soil and bioburden in the wipe are then killed by the disinfectant that remains on the wipe.
<< top8. Does the wipe retain some of the disinfectant?
Generally wipe materials contain certain molecules that can hold and lock the wipe formulation into the wipe and prevent release. In other words the disinfectant liquid that is put into a wipe is not the same as when extracted off a wipe. Therefore testing must be done on the run off from the wipe rather then the formulation itself. GAMA Healthcare is one of the very few companies that ensures this is done on all our products.
<< top9. What can you use the Universal wipes on?
The wipe is designed to be safe to use on all surfaces and will not damage rubbers, plastics or metals. Alcohol based wipes tend to damage materials after prolonged use but this will not occur with Clinell Universal Sanitising Wipes. It can also be used on all non-invasive equipment as well as hands.
<< top10. What products do this wipe replace?
This wipe will replace all detergent and disinfectant wipes and by doing so will help standardize wipe usage in a hospital. This will save time and money and help prevent confusion as regards what type of wipe is required. It will also replace hand wipes, medical device wipes (non-invasive medical devices) and surface cleaners.
<< top11. What germs does the Universal wipes kill?
In addition to knowing the contact time and kill count it is very important to know what germs the formulation released from the wipe is active against. The testing behind Clinell Universal Sanitising Wipes is very extensive and has been conducted at many UK University Accredited Laboratories. The wipes have been shown to be active against all germ groups except for spores.
This includes all gram positive and gram negative bacteria, all enveloped and non enveloped viruses, fungi, protozoans, mycobacteria and the kill count and contact time will vary depending on which particular organism is being targeted. All the test data for this wipe can be found by pressing this link http://www.gamahealthcare.com/products-universal-wipes-data.asp
<< top12. Where was the testing conducted for this wipe?
Many tests have been conducted on this wipe including EN tests such as En1276, prEn12054 and EN1500. In addition, the wipes have also been tested specifically against certain pathogens. The wipes have been dermatologically tested and have also been tested against a wide variety of materials showing their safety as well.
The tests have been conducted at various UK University Laboratories or institutions all of who are accredited and the test data we openly display outlines the test method and all results are validated.
<< top13. What are the wall mounted dispensers?
These are plastic dispensers that can be drilled permanently onto a wall and are designed to hold the large flow wrap packs of wipes in the Clinell range. This includes the 200 flow wrap pack of Clinell Universal Sanitising Wipes, the 140 flow wrap pack of Clinell Universal Sanitising Maceratable Wipes and the 200 flow wrap pack of Clinell Detergent Wipes.
The wall mounted dispensers are available for free to all hospitals in the UK and installation (which is also free) can be arranged but this must be booked in with the GAMA Healthcare sales team. The dispensers are ordered directly through GAMA Healthcare.
<< top14. What different formats are available for the Clinell Universal Sanitising Wipes?
The Clinell Universal Sanitising Wipes come in a variety of formats as outlined:
- Clinell Universal Sanitising Wipes 200 flow wrap — CW200
- Clinell Universal Sanitising Wipes 40 flow wrap — CW40
- Clinell Universal Sanitising Wipes Maceratable 140 flow wrap — CUSWM140
- Clinell Universal Sanitising Wipes Bucket 225 — CWBUC225
- Clinell Universal Sanitising Wipes Tub 100 — CWTUB100
- Clinell Antibacterial Hand Wipes — CAHW100 (this is a box of 100 single individually wrapped sachets for patients food trays)
15. Are there any special disposal requirements?
Used wipes should be disposed of in the clinical waste bin as per infection control policy. The maceratable wipes can be put into a macerator.
<< top16. How would you summarise the benefits of Clinell Universal Sanitising Wipes?
The main points to summarise are:
- The Universal nature of the wipes. Not only is it a detergent and disinfectant wipe combined but it can be used on hands, all surfaces and all equipment. All other detergent wipes require gloves to be worn.
- A very extensive data package with all test protocols published and validated from accredited UK laboratories.
- Broad range of antimicrobial activity in that it will kill all germ groups except for spores.
- In addition it has a very fast contact time for most pathogens and a very high kill count as well.
- It will make infection control policies easier and faster to follow for the healthcare professionals on the wards and departments.
- Due to the standardization that can be achieved with this wipe it will allow a hospital to save money on their wipe purchases.
- GAMA Healthcare’s customer support includes custom made posters, free wall mounted dispensers, free installation of the dispensers, ward based training and patient information leaflets.
Clinell Sporicidal Wipes
1. There are many different sporicidal wipes on the market. Why is Clinell Sporicidal different to them?
In the last couple of years there have been many companies who have released a wipe which they claim to sporicidal. The problem herein lies with the testing method that has been conducted on the wipe, the institute that has conducted the actual testing and the regulations of disinfectants in the UK.
It is very important to look at the test method that a product has been subjected to in order to make a sporicidal claim. Most companies use a test method called prEn13704 which is not a fully approved test method to date. To pass this test a product is required to kill spores in a 60 minute contact time and to a 3 log kill level (99.9%). This contact time is of no practical benefit to hospitals who aim to prevent spread and further contamination in instances where C.diff is suspected or proven. In addition it requires that the formulation remains wet on the surface for 60 minutes to allow it to take effect. Again this is not achievable in reality. Finally if the contact time is ever achieved it will only have reduced the spore count by 3 log which again is not much gain for such a long waiting time and will not prevent transmission.
In addition to all this, the laboratory used to do the test must be investigated. Many companies use non accredited laboratories in the UK because they are cheaper and because they can get the test results they require. Unfortunately there is no governing body in the UK who can prevent this from happening and it is up to hospitals to assess each product and make their own conclusions.
These unaccredited laboratories will often test the formulation being put into the wipes as opposed to the wipes themselves containing the formulation in question. What goes into a wipe is not necessarily what come off a wipe and this is due to the wipe material binding certain molecules and preventing release when required. Therefore it is imperative to test the wipe itself as this is what is being used by the hospitals.
Clinell Sporicidal Wipes which contains patented technology developed by the GAMA Healthcare medical team have been tested at The Hospital Infection Research Laboratory in Dudley Road, Birmingham by Ms Christina Bradley. The test method used was not the prEn13704 due to a low kill count and a non-practical or achievable contact time. Ms Bradley chose to use the Babb et al test method which requires a maximum contact time of 5 minutes and a kill count of at least 5 logs (99.999%) to be achieved.
Clinell Sporicidal achieved a greater then 6 log kill count (99.9999%) in a 1 minute contact time in dirty conditions. This makes Clinell Sporicidal the most powerful wipe in the world to date.
Finally, Clinell Sporicidal utilizes peracetic acid to kill spores and this is one of the best known antimicrobial agents around. The reason it is not used more regularly is because of its unstable nature but Clinell Sporicidal uses a patented delivery system to generate the peracetic acid on demand. In other words, we have not created a new chemical but have found a new delivery mechanism for generating peracetic acid. Many of the other products on the market claim to have developed a “new chemical” and don’t disclose any information about this when questioned further.
To summarise, Clinell Sporicidal is different to most other sporicidal agents on the market in terms of speed of action, strength of sterilizing and reputable laboratory data with a recognized test method and full validation.
<< top2. How are the wipes presented?
The wipes come as 25 applications in a pack and each wipe consists of 2 dry wipes stuck together with a range of different powders sandwiched between the 2 dry non woven material.
Each wipe is 21x30cm and consists of absorbent airlaid non woven material which is maceratable.
<< top3. What happens when the wipes are activated?
Clinell Sporicidal Wipes are inactive and dry in the pack and need to be activated prior to use. Gloves must be worn before activation and the wipes require only water or any body fluid to activate them. When activated the powders protected between the 2 wipes will instantaneously produce hydrogen peroxide and this will interact with the Tetra Acetyl Ethylene Diamine (TAED) to product peracetic acid.
The sporicidal benefit comes from both the hydrogen peroxide and the peracetic acid although the latter is the main agent.
The peracetic acid produces a characteristic odour of vinegar (acetic acid) which will be apparent immediately on activation and this will become more apparent after a few minutes as more peracetic acid is produced.
<< top4. Why can the wipes not be wet and therefore save the activation step?
Peracetic acid is a very unstable chemical and will breakdown very easily and very quickly. It is one of the best antimicrobial agents ever discovered but the fact that it is unstable makes it very hard to utilize it in practical terms.
Ideally a bottle of peracetic acid would be given to all wards and told to use it as and when need in cases of C.diff but unfortunately the peracetic acid would break down to acetic acid (vinegar), water and carbon dioxide very quickly.
To overcome this problem, Clinell Sporicidal will produce peracetic acid as and when needed so that this problem of it breaking down is overcome. Therefore in the pack of wipes when inactive there is no peracetic acid which is why the wipes are dry in the pack and need to be activated with water (or any body fluid).
<< top5. Is Peracetic Acid safe to use?
Peracetic acid is an ideal antimicrobial agent due to its high oxidising potential. It is broadly effective against microorganisms and is not deactivated by catalase and peroxidase, the enzymes which break down hydrogen peroxide. It also breaks down food to safe and environmentally friendly residues (acetic acid and hydrogen peroxide), and therefore can be used in non-rinse applications. It can be used over a wide temperature range (0-40 °C), wide pH range (3.0-7.5), in clean-in-place (CIP) processes, in hard water conditions, and is not affected by protein residues.
<< top6. Where was the testing conducted for this wipe?
Clinell Sporicidal was tested at various UK accredited laboratories. The bulk of the testing was done at The Hospital Infection Research Laboratory by Ms Christina Bradley.
Further testing was done to ensure compatibility with different materials, user safety, water loading tests and tests to identify timescales of activity.
All the test data for this product can be accessed and downloaded by pressing this link (PLEASE PUT A LINK HERE FOR THE CLINELL SPORICIDAL TEST DATA)
<< top7. What products does the wipe replace?
This is a high level sterilizing product and primarily replaces chlorine based compounds that are used to kill spores.
It is not designed as an everyday wipe (which is what Clinell Universal Sanitising Wipes are) but more as a specialised wipe that is used in specific situations.
<< top8. Chlorine is much cheaper then Clinell Sporicidal Wipes. Why should I use Clinell Sporicidal over hypochlorite based products?
Clinell Sporicidal has many advantages over hypochlorite (chlorine) based products and includes the following:
- Clinell Sporicidal is safer for the end user and anyone who is in close proximity to the wipes. Chlorine releases toxic fumes which can be carcinogenic, cause respiratory problems and
- Chlorine is time consuming to prepare and also requires precise measurements to ensure that the concentration is good enough to kill spores. Clinell Sporicidal can be activated in less then 5 seconds and is not subject to precise measurements.
- By saving time and having a safer option for users this will in turn increase compliance which can help reduce the rates of Clostridium difficile. This reduction in rate will actually save a hospital more money then the switch to Clinell Sporicidal from chlorine initially.
9. What organisms does this wipe kill?
This wipe will kill all germs but is marketed as a sporicidal wipe as spores are the hardest bacteria to kill. This wipe is a very specialised product and is not designed for everyday use.
<< top10. What would happen if the activated wipe touches my skin?
Always wear gloves when using Clinell Sporicidal Wipes but should it accidentally touch your skin do not worry.
The majority of individuals will not feel anything if the activated wipes touch their skin, but a small minority will get a slight tingling sensation on their skin which may slightly blanch in colour for a few minutes. This will wear off by itself but should this occur then just wash the skin with lots of water and that should be sufficient in most cases. If irritation persists then seek medical assistance.
<< top11. Is there a need to wear a face mask?
Most people will not require a face mask but should the smell of the wipes cause mild irritation then a face mask should overcome this particular problem.
<< top12. What are the uses of this wipe?
These are highly specialised wipes and the main uses include:
- Commode cleaning
- Environmental and equipment sterilising in proven or suspected cases of Clostridium difficile.
- Blood Spills
- Terminal Cleaning
13. Do I need to clean first before using this wipe?
You do not need to clean before using this wipe because the wipes contain detergent already. This allows you to use the wipe in highly soiled areas immediately.
<< top14. Can resistance occur with this wipe?
The action of peracetic acid is non selective and so should not give rise to resistance.
<< top15. Are there any disposal or storage requirements?
No special requirements at all with regard disposal or storage. After use the wipes should be discarded in the clinical waste bins.
<< top16. How would you summarise the benefits of Clinell Sporicidal Wipes?
In summary:
- Most powerful wipe in the world today
- Kills all known germs
- Kills spores in 1 minute contact time with a greater then 6 log kill count
- The only wipe to effectively replace chlorine based compounds
- Environmentally friendly
- No toxic fumes so can be used next to patients.
- Works in highly soiled conditions.
- No dilution necessary (as with chlorine) so should save time
- Ease of use will improve compliance which will also help reduce Clostridium difficile rates.
Clinell Chlorhexidine Wash Cloths
1. What are the ingredients of this wipe?
This wipe contains 2% Chlorhexidine Gluconate BP, as well as skin conditioners and moisturizers.
<< top2. What are the uses for this wipe?
These wipes are used for preadmission patients prior to them coming into hospital. They can also be used for ITU bed baths on a regular basis.
<< top3. Why use chlorhexidine?
Chlorhexidine (2-4%) has good activity against most vegetative bacteria, yeasts and enveloped viruses. Chlorhexidine is a new biocide that is being recommended by many different guidelines. It sticks to the skin leaving a residual antimicrobial action and this leave a protective barrier on the skin of patients.
<< top4. Who developed this product?
This product was developed by the GAMA Healthcare team in conjunction with The Royal Free Hospital Infection Control Department.
<< top5. In what format is the wipe available?
The wipes come as packs of 4 wipes which is enough to wipe over the whole body. Each box has 12 packs of these 4 wipes in it and this is designed to be a desk ready box to place in preadmission clinics or on ITU worktops.
<< top6. Can the wipes be microwaved before use?
Yes they can. Place the whole pack of wipes in the microwave on a setting of 750W for 15 seconds. Please ensure that the wipes are not too hot before using it on the skin. GAMA can provide a hospital with free microwaves.
Clinell Alcoholic 2% Chlorhexidine Wipes
1. What is CA2C200?
Clinell Alcoholic 2% Chlorhexidine is disposable disinfection wipe for medical devices presaturated with 70% alcohol and 2% Chlorhexidine gluconate.
<< top2. 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.
<< top3. 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.
<< top4. 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.
<< top5. 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.
<< top6. Is the wipe 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 because of this you will find all other 2% Chlorhexidine wipes on the market are not sterile either.
- There is no real need for this type of product to be sterile as it is antibacterial
- 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.
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:
- 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.
- 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.
<< top8. 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.
<< top9. 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.
<< top10. Is the product latex free
Yes. We can send you a declaration on this if you wish.
<< top11. 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.
Clinell Alcoholic 2% Chlorhexidine Skin Wipes
1. What is CA2CSKIN
Clinell Alcoholic 2% Chlorhexidine Skin is a disposable cleaning wipe for skin presaturated with 70% alcohol and 2% Chlorhexidine gluconate.
<< top2. What is CA2CSKIN used for?
In Europe it is only intended for use to clean small areas of dirty skin after dressing and plaster removal.
In some other countries it can be used as part of a medical procedure, e.g. as a pre-injection swab, according to local regulations.
<< top3. 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.
<< top4. Can CA2CSKIN be used as part of a medical procedure?
In Europe it is only intended for use to clean small areas of dirty skin after dressing and plaster removal. If you use the wipe as part of a medical procedure, e.g. as a pre-injection swab, you are using the product against our recommendations. 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) and CA2CSKIN does not have a product licence.
In some other countries it can be used as part of a medical procedure, e.g. as a pre-injection swab, according to local regulations.
<< top5. Is the wipe 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 because of this you will find all other 2% Chlorhexidine wipes on the market are not sterile either.
- There is no real need for this type of product to be sterile as it is antibacterial
- 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.
6. 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% of chlorhexidine.
- 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.
<< top7. Is the product latex free
Yes. We can send you a declaration on this if you wish.
<< top8. 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.
Clinell Bed Bath Wipes
1. What makes Clinell Bed Bath Wipes better then other bed bath wipes currently on the market?
Clinell Bed Bath Wipes are the best value bed bath wipes available to hospitals and contain a patented formula designed by the GAMA Healthcare team. They can be microwaved to give a patient a warm bed bathing experience and GAMA Healthcare provides microwaves to hospitals for free.
<< top2. Can the wipes be microwaved before use?
Yes they can. Place the whole pack of wipes in the microwave on a setting of 750W for 15 seconds. Please ensure that the wipes are not too hot before using it on the skin. GAMA can provide a hospital with free microwaves.
<< top3. What format does the wipe come in?
The wipe comes as a pack of 10 wipes whereby one wipe is used on a different part of the body. The 10 wipes are sufficient to cover the whole body so one pack is designed for one bath and this reduces cross contamination.
<< top4. How will using this product benefit a hospital?
This product is designed to save time and money when giving a patient a bed bath. It does this by replacing the need for the cumbersome traditional methods of giving a bed bath which includes preparing bowls, washcloths, soap, lotions and dry wipes. Clinell Bed Bath wipes will decrease waste, save money, save time and increase staff compliance.
Clinell Continence Care Wipes
1. What makes Clinell Continence Care Wipes better then other continence care wipes currently on the market?
Clinell Continence Care Wipes provide a 7 in 1 action
<< top2. Can the wipes be microwaved before use?
Yes they can. Place the whole pack of wipes in the microwave on a setting of 750W for 15 seconds. Please ensure that the wipes are not too hot before using it on the skin. GAMA can provide a hospital with free microwaves.
<< top3. What products does this wipe replace?
This wipe will replace all other continence care wipes as well as barrier creams, moisturising creams, cleansing foams and dry wipes.
<< top4. What format does the wipe come in?
It comes as an individual patient pack for extra convenience and to reduce cross contamination. There are 25 maceratable wipes per pack.
Clinell Detergent Wipes
1. What are the advantages of using this product over other detergent wipes?
These detergent wipes are the cheapest brand on the market and for hospitals that choose to use detergent wipes will offer them big savings on their wipe purchases per year.
<< top2. What different formats are available for this product?
The Clinell Detergent Wipes come in a variety of formats as outlined:
- Clinell Detergent Wipes 200 flow wrap — CDW200
- Clinell Detergent Wipes Bucket 225 — CDB225
- Clinell Detergent Wipes Tub 100 — CDT100
3. What products does this wipe replace?
These wipes are for multi surface cleaning and damp dusting. They will replace all detergent wipes as well as detergent liquids.
<< top4. Do I need to wear gloves when using this product?
If using this product for prolonged periods then gloves should be worn.
Clinell Clean Tape
1. What is Clinell Clean Tape?
Clinell Clean Tape is a strip of self adhesive paper indicator labels that help to implement good hygiene procedure by clearly illustrating the date that an object has been disinfected, and by whom.
<< top2. How does Clinell Clean Tape work?
After disinfecting, the label is filled out by the person that cleaned the object. They tick the ‘I am clean’, fill in their name and insert the current date to the form on the label. The strip of indicators is then looped round the object and joined by pressing the two sides firmly together to activate the adhesive on the underside of the strip.
<< top3. What format does the product come in?
The indicator labels come on a roll (approximately 85 applications)
<< top4. How will using this product benefit a hospital?
Clinell Clean Tape provides a quick and easy way to illustrate hygiene procedure, help implement hygiene systems and minimise confusion over responsibility.
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