Infection Control and Cleaning Guide for all medisort devices Dec 2009

1, PAE de Sorinnes, Route de la voie Cuivrée BE- 5503 Sorinnes - BELGIUM TEL: +32 82 22 30 20 FAX: +32 82 22 33 34 email: [email protected] GROUP CARDIO-RESPIRATORY INSTRUMENTATION

The 2005 ATS – ERS guidelines covered the aspects of Infection and control for laboratory users based upon the recommendations of the manufacturer of the instrumentation. The goal of infection control is to prevent the transmission of infection to the patients/subjects and staff during respiratory function testing. There is such a small number of documented cases of infection transmission proven to arise from the instrument, he risk is higher in the waiting areas and common areas of the hospital, however the potential is real and must not be ignored. The recommendations focused on the type of equipment used to measure spirometry, diffusing capacity and Lung volumes, the main line Pulmonary Function Testing instruments. Laboratories using other testing involving invasive measurements such as blood analysis will be governed by clinical laboratory practice applicable to those laboratories. The respiratory protection to instrument and subject is provided by a single use single subject barrier filter, these have a stated efficiency 99.99999% or greater, these devices are of a hydro-static nature attracting the water droplets likely to carry airborne contamination that may enter the instrument. Basic protection should be performed by laboratory staff with the use of gloves for removing subject mouthpieces that may have become contaminated by blood from dry lips or mouth ulcers. Noseclips should be of single use to avoid skin infections being transmitted. The Physiologist should avoid being in a direct line with a subject as many of the tests performed will promote coughing and may cause airborne particles to emit from the subject, whilst reassurance is necessary to promote good lung function so the application of mask and eye protection is not recommended, sensible care with this type of subject is to be observed. The barrier filter is a proven effective deterrent to cross-contamination and a necessary evil in the prevention of cross infection. The filter will have some degrading of the signal this has been in the maximum order of – 44 ml for the FEV1 and -0.47 l/s on the PEF. The inline resistance and back pressures should be known and entered on the system. The filter manufacturer should provide the data to show measurements remain unaltered. The filter protecting the instrument at the subject connection point then only leaves routine hygienic cleaning to maintain the system, this is to ensure the system is fresh and not to become stale with use. The system may be cleaned with alcohol wipes, (NOTE: when using alcohol wipes with fast gas infra-red analysers, this can cause interference in the infra-red spectrum, ensure the wipe and any vapours are not retained near the sample system). The system can be cleaned with mild detergents and bleaches to maintain the external appearance, anti-static cleaners and polishes will reduce dust build up. Where permitted and the correct disposal facilities exist cold sterilisation procedures can be performed to all breathing circuit parts, the valves are designed to stand in the cleaning solution free of any electrical contacts, tubing, hoses and mouthpieces may be cleaned in a similar manner. Hot washing can be performed in the range 82 – 90 degrees commonly, this may degrade the life of the materials and may also involve replacement of ‘O’ rings and rubber based seals. Also drying should be

Last update December 2009. Page 2of 5

1, PAE de Sorinnes, Route de la voie Cuivrée BE- 5503 Sorinnes - BELGIUM TEL: +32 82 22 30 20 FAX: +32 82 22 33 34 email: [email protected] GROUP CARDIO-RESPIRATORY INSTRUMENTATION

performed with care as whilst the hot was cycle may not invoke any real problems a high temperature drying cycle may be the source of damage. Where and whenever possible allow natural drying after the wash cycle has shown to prolong the life of parts subjected to this procedure. All respiratory circuits be nature must be airtight, the use of light gases such as helium and neon in the tests will stress any source of a leak. Leaks can be a result of adhesives and other seals breaking down in the life of the equipment, routine and regular maintenance by qualified service personnel should minimise this effect and ensure trouble free operation. Detailed procedures for dismantling valves and other non-user parts of the instrument are available along with advice on the lubricants to use after such procedures during reassembly. NOTE: Oxygen is used within some parts of the instrument and whilst at a low pressure within the instrument, Oxygen can present an explosion risk with oxidising lubricants and chemicals in the event of a failure. In such cases the manufacturer insists on fluorinated lubricants to avoid any such risk, failure to observe these conditions may render the instrument unsafe. When in any doubt contact your official supplier or the manufacturer for further advice and assistance. A charge may be levied for on-site consultations. Medisoft operates within good manufacturing guidelines and every effort is made to ensure durable and long life from the products. Any failures or breakdowns as a result of following the correct cleaning and infection control procedures must be reported directly for ongoing product development and improvement. The company will advise all users of improvements and updates and any cost involved to bring your instruments to full current status for the life of the instruments. Your contact points are: Medisoft P.A.E. de Sorrines Route de la Voie Cuivree 1 B-5503 Belgium www.medisoft.be Or Your Local Distributor

Last update December 2009. Page 3of 5

1, PAE de Sorinnes, Route de la voie Cuivrée BE- 5503 Sorinnes - BELGIUM TEL: +32 82 22 30 20 FAX: +32 82 22 33 34 email: [email protected] GROUP CARDIO-RESPIRATORY INSTRUMENTATION

For Cold sterilisation;

This product has a number of properties essential to good sterilisation practice and suited to use with respiratory breathing circuits. 1. 2. 3. 4. 5. 6. 7.

It is User safe in its routine handling It may be disposed of easily as it is environmentally friendly It is Aldehyde free and safe for respiratory use There are no special ventilation needs for this product Full disinfection is obtained in a 10 minute soak in the solution The chemical has wide recognition to destroying the major cross infection problems There are no regulatory problems as to its laboratory use.

The solution is made with the power and warm water, the solution will have a limited life once produced, and typically it only remains active for a period of 24 hours once the solution is formed. So it needs a daily preparation. The illustration shows the normal packaging for the product, it is dispensed in 81 gram pots, each of which will mix a 5 litre solution when fully diluted. Some of the COSH safety information is as follows; General properties; Appearance Ph Flash point

: Clear blue solution, no discernable odour : 8.0 : not flammable

Last update December 2009. Page 4of 5

1, PAE de Sorinnes, Route de la voie Cuivrée BE- 5503 Sorinnes - BELGIUM TEL: +32 82 22 30 20 FAX: +32 82 22 33 34 email: [email protected] GROUP CARDIO-RESPIRATORY INSTRUMENTATION

Hazard information: The solution has a low acute toxicity to the users of the product. Once the solution is prepared contact with the skin is unlikely to cause a problem except in cases where the individual has sensitivity to PeraSafe or some of its component compounds. If PeraSafe comes into contact with the eyes it should be treated directly without delay (see advice on first aid to users) No respiratory inhalation problems are likely under normal use conditions. The Preparation of the solution in the temperature range of 30-40 degrees Celsius can allow a minimal release in the form of vapour however this is odourless and dissipates to the atmosphere. It is not recommended to make preparations in temperatures greater than 40 degrees Celsius. First aid advice to users: Eye: Wash the eye immediately with clean water or an eye wash, Then continue to seek medical advice if the irritation continues. Skin: remove any clothing soaked or contaminated with the solution and rinse the skin with water, the clothing should be washed before re-use Ingestion: However unlikely, this must be treated directly with asking the subject to drink plenty of water and if the quantity is significant then seek medical advice. Storage, spillage and handling of the component; PeraSafe should not be kept in direct contact with strong Alkalis, Hypochlorites and cationic detergent agents. However hospital neutral detergents are acceptable and present no risk to PeraSafe. Once prepared store the solution in clean plastic containers under cool conditions and use within 24 hospital of the preparation. The solution presents no environmental problems that are serious when diluted with water to enter the waste system via the foul sewer drain.

Last update December 2009. Page 5of 5