Validation Programme for a New Bench Top Washer-Disinfector - Essay Example

An outline validation programme for a new bench top washer-disinfector which is being installed in a dental surgery Introduction: In today's world the infection is taking complicated forms and requires lot of time and cost for complete eradication. It is therefore essential to carry out surgeries in an absolute microbe free atmosphere to avoid the establishment of any kind of infection. The disinfection process is the most imperative part of the surgery as it involves direct contact of instruments with the blood of the patient and hence the biggest junction for the transfer of the microbes and enhances the chances of cross-infection. Disinfection could be achieved by thorough cleaning, either by a chemical or thermal process (Ray, 2004). The method of cleaning encompasses removal of soils and contaminants leading to the destruction of micro-organisms. It is noticeable that some but not all detergents do hold some germicidal properties but it is essential that to make the germicides totally effective, the devices must first be free of soil to allow intimate contact with the chemical (Ray, 2004). The spectrum of chemical and the duration of exposure will determine the level of disinfection achieved. Detergents employed in the cleaning of medical devices are exclusively designed to assist, beat and extricate organic soils. On the other hand, enzymatic detergents, presoaks, and foam sprays are very effective in breaking down soil and facilitating their removal in the washing process (Ray, 2004). It is observed that manual washing is less efficient and more time consuming than the machine washing, moreover each surgical equipment is washed thoroughly and with the same precision in contrast to the manual washing where everything depends on the person employed for the work and his/ her efficiency. A new washer/disinfector consists of a wash cycle geared at the removal of soil and the recommended enzymatic product required to break down soil particles for easier removal. The wash cycle is followed by a thermal disinfection rinse cycle which destroys organisms by heat and do not require a germicidal detergent (Ray, 2004). To facilitate the effective cleaning of the instruments, bench top washer-disinfectors are used and must be installed in all the clinics, hospitals and other organizations where surgery is being performed. These instruments need utmost care and precision to get best results. It is mandatory that all processing equipments ought to be evaluated for proper functioning to procure best results. Equipment servicing may be in order such as the replacement of gaskets, adjusting temperatures, and/or increasing drying times. Foreign matter left in steam lines can cause spotting (Ray, 2004). The installation of bench top washer-disinfector is therefore recommended and should be made mandatory to carry out the surgeries efficiently without giving a single chance to the infection for establishment. It is imperative that instruments in surgical sets be in good condition and function properly. Moreover, a malfunctioning instrument is more than a minor hassle (Ray, 2004); it is detrimental to the quality of patient care and could result in serious injury. Therefore it is a great responsibility from the patients' point of view that constant monitoring must be performed to assess the quality of surgical instrumentation and hence instrument inspection becomes an integral part of surgical set assembly procedure (Ray, 2004). A proficient aid for the cleaning and the thermal disinfection of all Medical, Dental and Laboratory instruments is bench top washer-disinfector. It is based on modern concepts and constructed in compliance with the guidelines indicated in the new European Norm concerning safety and hygiene. The validation for its installation lies in the fact that it can be placed on any work surface and is very simple to install. It has a built-in detergent compartment and dispenser. A good washer displays three different programs inclusive of thermal disinfection at 93C. The washer-disinfector has built-in microprocessor that guarantees the highest level of hygiene with an efficient self-cleaning system (Lava 50 Washer Disinfector). The latest generation microprocessor controls the machine's electronics as it is computerized. The microprocessor offers numerous programming to provide self-diagnosis function and it also records all the historical events (Lava 50 Washer Disinfector). It is a multifunctional aid that is competent of sharing all the receptacles used in medical and dental surgeries and in clinics. It is always advised to use the bench top washer-disinfector as the patients coming to the dental clinics or for surgery may carry infections; if instruments are not washed with precision and care to eradicate the infection then it could turn out with dangerous consequences affecting other patients and also the workers who are cleaning the instruments, and may result in severe complications. It is therefore validated that bench top washer-disinfector must be used to avoid such complications. It is also important to emphasize that numerous safety features are incorporated in these instruments that aid in providing security to the personnel employed for washing these surgical equipments. These features encompass- door lock for entire duration of cycle, disinfection check, acoustic alarm, indicators of any kind of faults and chemical control (Lava 50 Washer Disinfector). One more reason for the validation of the bench top washer-disinfector is it displays flexible programming. This enable the operator to change the schedule as per the needs and according to the kind of surgical equipments being cleaned or any other specific requirement (Lava 50 Washer Disinfector). For e.g. it is a common observation that many doctors' surgeries and departments within hospitals depend heavily on Central Sterilization Service Departments (CSSD) to sterilize their surgical instruments. This has great advantage and far supremacy over other manual washing methodologies. Bench top autoclaves provide 'on the spot' solutions to sterilization requirements (Medical Devices Agency, 1998). It is the responsibility of the organization in providing appropriate and safe processes and equipment for instrument sterilization and employees must use the equipments keeping all the safety features in concern. In the process of sterilization by an autoclave, complete removal or destruction of micro-organisms and spores take place. This process involves steam under pressure and therefore capable of complete eradication of microbes (Medical Devices Agency, 1998). Considering the importance of cleaning European legislation (Medical Devices Directive MDD 93/42 EC) and national guidance documents regarding decontamination of medical devices from both the Medicines and Healthcare Regulatory Agency (MHRA / MDA) and NHS Estates have devised a policy for disinfection. Scope of the policy: This policy only addresses issues involved in the processing of instruments on NHS Brent sites and therefore only applies to the Community Dental Service. Sterile instruments required by any other service must be sourced in the form of single-use, disposable instruments. Purpose: to ensure that the risk of cross infection via medical instruments is minimized. Roles and Responsibilities: Of the User: the person who operates the autoclave. He must be qualified and trained to operate bench-top autoclaves, and the clinicians nominated for each autoclave to perform daily and weekly autoclave checks. The "operator" is the clinician using the autoclave i.e. Dentist, Hygienist or Dental Nurse etc. they have the following responsibilities: To manage the use of the steriliser on a day to day basis To safely and effectively carry out the sterilisation process To perform and document daily cycle checks prior to use of the autoclave To perform and document weekly cycle checks (nominated clinician only) To ensure that the correct logbook, corresponding with the serial number of the autoclave is in use To report any breakdown or abnormality to the Estates Department. To report any accidents or incidents involving the steriliser to the Service Manager using recognised NHS Brent reporting procedures To report any removal of the steriliser from the site, and any discrepancies between the autoclave serial number and the logbook, to the user and the Estates Department. Training: It is important that all staff concerned in on-site instrument sterilisation must have a sound knowledge of the principles, functions and general safety issues involved in the use of bench-top sterilisers, ultra-sonic cleaners and washer disinfectors. All users and operators must therefore have received appropriate training and must be competent in the use of the equipment. Conclusion: From the discussion it is concluded that Washer Disinfector enables practitioners to execute high level decontamination practices with a small low cost package offering a safe, reliable, automatic alternative to manual cleaning and decontamination procedures. Automatic washing with high level thermal disinfection reduces cross infection risk or exposure to blood borne pathogenic infections. By using a Washer Disinfector it is ensured that the instruments are secure for managing conditions prior to sterilisation in this manner providing optimum safety standards for the staff and patients. Washer Disinfectors are able to combine the use of high temperatures and effective detergents thoroughly clean and disinfect instruments prior to sterilization. With the use of harmful chemicals the user may encounter significant health hazard, but with the installation of bench-top washer-disinfector, the problem can be resolved as washers ensures safe and effective hand free instrument decontamination. The Ultra Clean - Washer Disinfector is validated for installation as it bears all the features which are must to carry out the dental surgery efficiently. It is fast with 40 minute cycle with washing, thermal disinfection and drying. They are equipped with specialist dental carrier with vertical hand-piece holder. It makes the staff free to carry out other important tasks as it is an automated process and delivers consistent, effective results every time. It is convenient to use with a single programme and automatic detergent dispenser for optimum performance. Additionally, it provides all the unique control that independently monitors all critical stages of the process to prove compliance. The unit is compact and can be fitted with ease onto standard bench-tops and is simple to connect to domestic services. It has a data logger or printer optional for easy data capture, essential for compliance. The article validates the installation of a new bench-top washer disinfector to ensure peace of mind for best practice and to carry out dental surgeries without any problems. References: 1. Department of Health (1999) Varient Creutzfeldt Jakob Disease : minimising the risk of transmission. HSC 1999/178 2. Department of Health (2002) Decontamination of Medical Devices. HSC 2000/032 3. Department of Health. (2003) Transmissible Spongiform Encephalopathy Agents : Safe Working and the Prevention of Infection. 4. Department of Health (2007) CDO Letter : Advice for dentists on re-use of endodontic instruments and variant Creutzfeldt-Jakob Disease (vCJD). Gateway Approval Reference Number 8100 5. Dentaquip: http://www.dentaquip.co.uk/practice.html. Accessed on 2nd April 2009 6. Lava 50 Washer Disinfectors: 7. http://www.tuttnauer.com/category/products/dental_private_clinics_autoclaves/washers_disinfectors/lava50/main. Accessed on 2nd April 2009. 8. Medical Devices Agency (1998) The Validation and Periodic Testing of Bench - Top Vacuum Steam Sterilisers. MDA DB 9804 9. Medical Devices Agency (2002) Steam Penetration Tests in Vacuum Benchtop Sterilisers. MDA SN2002 (24) 10. Medical Devices Directive 93/42 EC 11. NICE (2006) Patient safety and reduction of risk of transmission of CJD via interventional procedures. 12. Ray, T., 2004. Washer/disinfector solutions; spots, stains and rust; damaged sets from CPD Healthcare Purchasing News http://findarticles.com/p/articles/mi_m0BPC/is_12_28/ai_n8568418/ Accessed on 2nd April 2009. Read More