NEWS

GAMA Healthcare Disinfectant Compatibility Statement

July 2017

The Therapeutic Goods Administration (TGA) recently published a Medical Devices Safety Update (vol. 5, no. 3, May 2017) which contained an article entitled ‘Disinfectants and detergents can damage medical equipment plastics’. GAMA Healthcare are aware that this has caused a lot of concern and confusion in the Australian marketplace.

We welcome the publication of the following clarifications to the alert which is now available to view on the TGA website:

i. Certain disinfectant wipes and detergents can damage medical devices if the cleaning agent is incompatible with the device’s plastic surfaces*.
*The TGA considers cleaning agents that contain levels of benzalkonium chloride below 5-10% are safe to use on medical devices. Disinfectants generally use about 0.5% benzalkonium chloride, which is considered noncorrosive at these levels.

ii. Detergent wipes used by the hospital to clean the pumps contained the ingredient ‘benzalkonium chloride’. This is classed as a quaternary ammonium compound which is a corrosive ingredient and therefore should not be used**.
** Benzalkonium chloride is unsafe at a concentration above 10% and therefore should not be used without being diluted.

iii. When cleaning medical devices the TGA recommends that health facilities:
• Review all decontamination processes that use a disinfectant wipe or detergent containing quaternary ammonium compounds on a plastic surface***.
*** Particularly if the surface is made of polycarbonate material.

GAMA Healthcare Ltd. would like to confirm to all our customers that Clinell Universal Wipes contain benzalkonium chloride at a concentration of less than 0.5% and therefore per the TGA clarification are considered non-corrosive at this level.

We have also been advised that the wording of the alert specifically referencing detergent wipes has been interpreted to mean neutral detergent wipes. GAMA Healthcare would like to confirm Clinell Detergent wipes do not contain benzalkonium chloride.

We fully support the TGA statement that equipment manufacturers’ cleaning recommendations should be followed.

GAMA Healthcare continues to work with equipment manufacturers on material compatibility and welcomes the opportunity to collaborate on any items which require disinfection and are not currently listed on our approved equipment list.

For guidance of on using disinfectant wipes, please download the Instructions For Use below.

Statement   |   Instructions For Use


Press Release - GAMA Healthcare Ltd acquire Australian distributor, AMCLA Pty Ltd

17th May 2017

Leading infection control specialists, GAMA Healthcare Ltd, acquires the Clinell division of their Australian distributor, AMCLA Pty Ltd., in Victoria. This significant investment demonstrates GAMA's continued commitment to infection prevention - providing outstanding education, training and clinical support to healthcare professionals across the world.

Plans for growth, support and education
GAMA will take over the current office in Mornington, Victoria and will retain all AMCLA personnel. The business unveils ambitious investment plans to emulate success in the UK - aiming to double the current workforce over the next twelve months. With headquarters in Watford, England, GAMA now has offices in six cities, across three continents.

"This is a very exciting time for us, as we enhance our service in Australia", says Dr Guy Braverman, Managing Director and Co-Founder of GAMA. "As world leaders in infection prevention we are committed to empowering healthcare professionals to make the right choices to achieve the best clinical outcomes. Through our growing team of experienced clinical nurse trainers and area managers, we can increase support and after-sales service to meet the individual needs of every hospital."

In the UK, GAMA provides bespoke, local training through group sessions, ward-based training and practitioner meetings - delivered by a team of infection control specialists. "Our organisational support training programme is valued very highly by our UK customers and we look forward to implementing this in Australia," says Dr Martin Kiernan, Clinical Director at GAMA. "We have developed the most advanced and fully customisable tablet-based training suite that is free to all customers. In the last six months of 2016, we hosted over 250 training days. This support has been critical in developing new business opportunities and retaining key contracts."

Commitment to products, people and partnerships
Founded in 2004 by two medical doctors, GAMA Healthcare has become a world leading developer and manufacturer of infection prevention technology. The Clinell range is the NHS's number 1 brand, providing a range of product lines for surface care, hygiene monitoring, and patient skincare. GAMA's dedication to infection prevention is demonstrated through both product innovation and continued investment in people and partnerships.

Media enquiries
For all media enquiries and interview requests please contact Beth Lowes at ROAD Communications on: beth@roadcommunications.co.uk or call +44(0)208 995 5832.

About GAMA Healthcare
Formed in 2004 by two medical doctors, GAMA Healthcare is a world leading developer and manufacturer of infection prevention products for the healthcare sector. Their focus remains on quality, innovation and continual improvement. We work closely with our customers, identifying their needs and providing solutions to real problems. Our new and continually evolving product lines - specialising in surface care, hygiene monitoring, patient skin care and easyclean computer accessories - offer market leading solutions to infection control problems found throughout healthcare provision.

GAMA Healthcare products are marketed under the brands Clinell, Carell and Cleanall and are widely used in many hospitals in around the worldwide. In the last 13 years, they have become the largest supplier of wet and dry wipes in the United Kingdom, with at least one of their products used in every National Health Service hospital. They distribute to over 60 countries around the world and the list continues to grow.

www.gamahealthcare.com
www.clinell.com
www.clinell.com.au

About AMCLA
Since 2007, AMCLA - a family owned specialist import and distribution company, have brought world class healthcare delivery solutions through their two key sales divisions: medical and pharmaceutical. AMCLA have built a reputation for supplying innovative, high quality products to healthcare markets.


TGA alert

1st May 2017

On 1st May, the Australian Government Therapeutic Goods Administration (TGA) issued an alert regarding disinfectants and detergents damaging medical equipment plastics. This follows on from an earlier web statement alert in March from the Victorian Managed Insurance Authority which raised the issue of cleaning products damaging medical equipment.

For more information on the TGA alert click here. The alert states that health facilities should review all decontamination processes that use a disinfectant wipe or detergent containing quaternary ammonium compounds (QACs) on a plastic surface. QACs are a popular choice for healthcare disinfectants because of their ability to also act as detergent; this allows manufacturers to formulate products that clean and disinfect in one-step – vital for improving staff compliance and ensuring Infection Prevention and Control policies are implemented.

The key points we wish to highlight from the alert are:

  • The alert states “Detergent wipes used by the hospital to clean the pumps contained the ingredient 'benzalkonium chloride'. This is classed as a quaternary ammonium compound which is a corrosive ingredient and therefore should not be used”. Benzalkonium chloride is considered to be safe by the TGA Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) at a concentration of under 5% – disinfectant products generally contain a concentration of 0.5%. This is a globally used surfactant/disinfectant and the most widely used agent in the UK and the USA. The TGA, in suggesting that it should not be used at all, is the first agency in the world to make such a statement.
  • We support the TGA, both in raising awareness of this issue and in requesting that organisations review decontamination processes to ensure all products used to clean and decontaminate items used in healthcare are compatible with, and used in accordance with, manufacturer’s instructions. However, we would exercise caution in purely targeting the disinfection process as the predominant issue rather than the need to use compatible products in an approved manner. Responsible equipment manufacturers understand this, using polymers that can be effectively cleaned and disinfected. We feel that in targeting disinfectants, as opposed to misuse, a blanket withdrawal of a well-accepted and well-tolerated disinfectant will have a negative impact on patient safety.
  • We fully support recommended actions to identify all device decontamination processes that include using a detergent and/or disinfectant wipe on a plastic surface and ensure that you have systems and processes in accordance with the device manufacturer’s instructions. We also feel that this should feed into the procurement process and this should be a key question during the pre-procurement process for purchasers of any item to be used in a healthcare setting that may require cleaning and or disinfection. This review should also include those items that previously may not have been given such a high priority due to not being classed as medical devices. Remember that ‘domestic’ items such as light switches, plug sockets, etc. may require decontamination when used in a clinical setting and it was many of these types of items that were highlighted by the earlier the VMIA Alert.
All Clinell disinfectant wipes have undergone extensive material safety testing to show long-term compatibility with a wide variety of surfaces. Whilst our testing shows our wipes are safe on a wide variety of plastics, the notice stipulates you need to follow the device manufacturer’s decontamination instructions for use. If unsure, you should contact the device manufacturer and ask them for their decontamination policy. If they are unable to provide this information, you may wish to consider an alternative manufacturer. The mantra should be “if you can’t clean it, don’t buy it”.

GAMA Healthcare also provide free and comprehensive training on all products that we supply. The content and format will be agreed with customers in advance and will be tailored to meet the education and training needs of the organisation. Please contact us for more details.

If you would like a copy of our material safety testing or any more information, please email us at info@gamahealthcare.com.

To download the 'Decontamination of healthcare equipment' white paper click here.


ABOUT

In this section you will find Clinell and GAMA Healthcare Australia's news articles.


ARCHIVE