Medical Device Decontamination - Assignment Example

Medical device decontamination in a general dental practice: An Audit Tool Customer Inserts His/Her Name Customer Inserts Grade Course Customer Inserts Tutor’s Name Insert Date Here (Day, Month, Year) Decontamination is a process according to which items that needed to be reused in the dental process are made safe to be used again on patients. It is also ensured that items are safe and very easy to handle. Decontamination is a necessary requirement to reduce the risk of spread of the infections across patients and between patients and staff. To decontaminate the instruments is also not a very easy job as it occurs in several stages like cleaning, disinfecting the instruments, process of inspection and sterilization. It is very important that every stage of the process of decontamination is carried out in the most appropriate manner and very effectively as any unsafe procedure could pose risk to the health of patients and also could be life threatening. Decontamination process decreases the quantity of microorganisms on instruments rendering them safe to use. Every stage in the decontamination process relies on the exact location of the decontamination area, availability of the resources, equipment and instruments required, management in the process, polices and methods adopted for the decontamination and the government rules and procedures under which decontamination should take place. Verification of the effectiveness of decontamination process could be only made with the proper management and documentation involving different processes, equipments, facilities and management. There are two kinds of processes for decontamination in a general dental practice, which are generally practiced, one is sterilization process and the other is washer disinfector. Sterilization is a process that involves killing or removing of contaminated diseases like fungi, bacteria, viruses or spore forms from the surfaces of equipments used for medical purposes. But the sterilization process does not completely remove prions, and can be materialized through heat, chemicals, irradiation, high pressure and filtration. In general terms, surgical instruments and medications, which made entry into the sterilized parts of bodies like blood or under the skin should have high rate of sterility assurance level. The instruments are like scalps, hypodermic needles etc. The most appropriate method to be used in the heat sterilization process is known as autoclave. These are used for heating of steams to 121 °C or 134 °C. To attain the sterility level of time of at least 15 minutes at 121 degree C is required. If the autoclave treatment is used effectively then it can inactivate all fungi, bacteria, viruses and spores, which are quite resistant and it would also remove all prions. Other heat methods could be used are faming, incineration, boiling and using dry heat. Other method used is water disinfection method. Recently there has been increasing awareness for the need for the improvement of the steams required for the sterilization process. This concern has been raised on account of the statutory requirements. The quality of a steam required for sterilizer could have an adequate influence on the efficacy of the sterilization process, the quality in the way sterile product can be used and the longevity and serviceability of the sterilizer. To give the high quality of steam process, there is a requirement for the regulation of the sterilization process. Annex 1 of the rules formulating the medicinal products in the European community states that, “Care should be taken to ensure that steam used for sterilization is of suitable quality and does not contain additives at a level which could cause contamination of product or equipment.” (Health Technical Memorandum 2031, 1997: 11) It should be seen that the quality of the steam should not be very high where the product do not come into direct contact with steam. This should be the case with the aqueous products like the method of sealing their containers, which has been validated and could produce quantified risk. Hereby the assurances generally require the need for testing and performing of monitoring of the containers, which could be put to use in the smaller hospital pharmacies. It should be more of cost-effective to bring out the fact that the steam should be of good quality and any failure on the part of the seal should not have any adverse impact on the product. Annex 1 of the Medical Devices Directive shown by the Medical Devices Regulations 1994, ensures the list of many requirements for the manufacture process of medical devices. The section 7.2 of the act requires the fact that devises should be “designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product.” (Medical Device Control Office 2005: 2) This has clear implications on the quality of steam necessitating them to be used in the process of sterilization processes. In all the practical purposes, the steam sterilization process and the medical devices should be produced and brought into the direct contact with the steam and therefore it becomes very necessary to keep the control on the quality of the steam. It is also of great concern in the ethylene oxide sterilizers whereby steam can be used for humidification and therefore can again appear into the direct contact with the equipments. The Health Technical Memorandum groups require the necessity for the use of sterilizers into two groups: clinical sterilizers and laboratory sterilizers. These clinical sterilizers are designed to produce the medical devices, goods, products and materials which are used for clinical care of patients whereas laboratory sterilizers are used for processing of goods which could not be directly used to give clinical care to patients. Their use should be made separately, and the loads required in the process for clinic sterilizer should not be placed in the laboratory sterilizer and vice-versa and the sterilizers could also be put under the classification on the basis of the sterilizing agent. These sterilants used are high temperature steam, low temperature steam and formaldehyde and ethylene oxide. (Health Technical Memorandum 2010 1994: 7) There are also sterilizer equipments like unwrapped instruments and utensils and these kinds of sterilization processes are used for process of unwrapped surgical components meant for immediate use. These sterilization processes could be achieved through the process of the direct contact of the component with the process of the saturated steam at an appropriate temperature of 134 degree C. These sterilizers should never be involved in the process of wrapped instruments and utensils whereby the wrapping could pose hindrance in the process of removal of air and the penetration of steam. These also should not be used for unwrapped instruments and utensils with narrow lumens where the removal of air and steam penetration could be impaired. (Health Technical Memorandum 2010 1994: 8) Since the sterilized instruments and utensils get exposed to the air when they are removed from the chamber, they are easily susceptible to immediate recontamination. These sterilizers are therefore quite conducive for clinical use only within the precinct of the immediate environment whereby the instruments are used. Wherever found possible, it is very essential to cover and wrap these instruments and utensils and process in the porous load sterilizer. There are several models like transportable or bench top models that are used for electrical heating making it necessary for a socket outlet but without any piped services. These are most commonly used in dentist surgeries. Some of the clinical sterilizers are also known as dry heat sterilizers, which use hot air as sterilant. They are used for the process of materials like oils, powders and some ophthalmic instruments which can put to control high temperatures but they are more likely to get damaged and not sterilized if they come into contact with steam. They generally operate at a temperature of 160 degree C but they are not suitable to be used as drying cabinets. (Health Technical Memorandum 2010 1994: 9) To put effectively this sterilization process, management of the same is also an essential requirement. Proper management ensures the most effective use of the sterilization process from its procurement stage to its final usage. Management according to the rules should look into the facts: the kind of load required to be processed, kind of sterilizer should be needed, the type of models that are available, ensuring that all personnel connected with sterilization, whether NHS employees or contract personnel, are suitably qualified and trained for their responsibilities; ensure that sterilizers are installed correctly; to ensure that newly installed sterilizers are subject to a documented scheme of validation comprising installation checks and tests, commissioning tests and performance qualification tests before they are put into service; to ensure that sterilizers are subject to a documented scheme of periodic tests at yearly, quarterly, weekly and (in some cases) daily intervals; the placement of the sterilizer, the kind of services that are required for these sterilizers, the quantity of the sterilizers required. To ensure that procedures for production, quality control and safe working are documented and adhered to in the light of statutory requirements and accepted best practice; to ensure that procedures for dealing with malfunctions, accidents and dangerous occurrences are documented and adhered to. Further management also looks into the fact that these sterilizers should be used under which specifications like European or British. (Health Technical Memorandum 2010 1994: 5-6) Managers are assisted with HTM 2010 and other personnel. The Directives set out the essential requirements that devices must not compromise the health or safety of the patient, user or any other person and that any risks associated with the device are compatible with patient health and protection. Any side-effects must be acceptable when weighed against the intended performance. Devices meeting these requirements will be entitled to carry the “CE” marking, signifying that the device satisfies the requirements essential for it to be fit for its intended purpose. All devices except custom-made devices and devices intended for clinical trials (“investigations” in the directive), whether used in public-sector or private-sector hospitals and nursing homes, or sold in retail outlets, will have to carry the “CE” marking. Adoption of the Directives will mean that the UK’s voluntary system of manufacturer registration and product approval for controlling certain medical devices used by the NHS will eventually be replaced by a more comprehensive statutory system covering all devices used in the UK. The Medical Devices Agency (MDA) of the Department of Health, will be the competent authority to carry out the requirements of the Directives in the UK. The main role of the MDA will ensure compliance with the UK regulations, evaluate vigilance reports received from manufacturers, and carry out a preclinical assessment of devices intended for clinical investigation. The MDA is also responsible for approving the independent certification organisations (the notified bodies) that will check and prove that defined classes of medical devices meet the essential requirements and thus enable manufacturers to apply the “CE” marking to their products. Devices Directive includes a classification system whereby the level of regulatory control applied to devices is proportional to the degree of risk inherent in the device. The strictest controls will therefore only apply to the limited number of high-risk products. (Health Technical Memorandum 2010 1994: 4-5) Here another thing to be noted that where a sterilizer is to be used in the production of medicinal products, the provisions of the Medicines Act 1968 apply. The responsibilities that would otherwise be exercised by the user are divided between the production manager and the quality controller. Guidance on the duties of each can be found in the EU commission document ‘Guide to good manufacturing practice for medicinal products’. (Health Technical Memorandum 2010 1994: 23) All these factors and processes are required for the effective use of the medical devices in the decontamination process during general dental practices. The key criteria should be the proper use of the sterilization process. There is a need to see whether the equipments being used in the sterilization process meet the legal requirements or not. Further during the purchase of the same, there is also a need to see whether these equipments are meeting the requirements for which they are being bought and the main point is how the sterilization has taken place. As here the life of patient is at stake and therefore it is utmost necessary to maintain the sterilization according to the set standards. Reference List Godfrey, B. 2007. DECONTAMINATION IN GENERAL DENTAL PRACTICES. [Online] Available: http://www.dhsspsni.gov.uk/gdp_dg_2007_-_decontamination_guidance_nov_2007.pdf [6 March 2009] Health Technical Memorandum 01-05. Decontamination in primary care dental practices. [Online] Available: http://www.bda.org/advice/docs/htm-01-05.pdf [6 March 2009] Health Technical Memorandum 2010. 1994. Part 1 Management Policy: Sterilization. [Online] Available: http://www.gmpua.com/World/GreatBritain/HTM/HTM2010Part1.pdf [6 March 2009] Health Technical Memorandum 2010. 1995. Part 2 Design Considerations: Sterilization. [Online] Available: http://www.gmpua.com/World/GreatBritain/HTM/HTM2010Part2.pdf [6 March 2009] Health Technical Memorandum 2030. 1997. Washer-Disinfectors: Operational Management. [Online] Available: http://195.92.246.148/knowledge_network/documents/2030Opman_Exec_summ_20071204113441.pdf [6 March 2009] Health Technical Memorandum 2031. 1997. Clean steam for sterilization. [Online] Available: http://195.92.246.148/knowledge_network/documents/HTM2031%20Clean%20steam%20for%20sterilization%20200312315048875.pdf [6 March 2009] Medical Device Control Office. 2005. Essential Principles of Safety and Performance of Medical Devices. [Online] Available: http://www.mdco.gov.hk/english/emp/emp_trad/files/essential_principles_of_safety_and_performance_of_medical_devices.pdf [6 March 2009] Report of a Scottish Executive Health Department Working Group. 2001. Decontamination of Surgical Instruments and Other Medical Devices. [Online] Available: http://www.sehd.scot.nhs.uk/publications/dsmid/dsimd-03.htm [6 March 2009] Read More