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Validation Program for a New Benchtop Steam Sterilizer

Introduction

The decontamination process mainly seeks to eliminate and reduce the level of all unwanted and contagious materials from reusable medical devices. It is for this purpose that steam sterilizer type B has been invented in order to facilitate the decontamination process. The decontamination process includes cleaning, disinfection and sterilization of the reusable medical devices to enhance safe treatment. The overall purpose of the decontamination process is to make medical devices and equipment safer for reuse on the patients. The growing risk of infections due to contamination has made medical practitioners be keener when dealing with reusable medical devices and equipment.

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The basic reasons why medical devices should be decontaminated

The growing hospital-acquired infections around the various medical centers have made the practice a concern to many. It is estimated that 9% of hospital in-patients acquire some infections while still undergoing their normal treatments. The major infections mainly occur in the urinary and respiratory tract. Patients with chronic illness are also more susceptible to hospital-acquired infections (Wilson, 2006, p.339). It is also believed that approximately 15-35% of these hospital-acquired infections can be prevented through realistic infection control practices. However, a lack of proper and effective decontamination procedures can further result in a severe range of infections.

There is also some epidemiological evidence that suggests that there can not be infections due to normal social interactions. These suggestions, therefore, end up posing a great risk of iatrogenic transmissions such as vCJD infections (Mayhall, 2004, p.1130). Such infections are mainly transmitted through neurosurgery and also during the injection of human growth hormone. The infections are therefore generally connected to the surgical treatment that patients regularly undergo to improve their health status. The CJD infections are mostly said to cause tonsils, spleen and lymph nodes from the ailing patient. The PrP infections which are mostly associated with the CJD infections can be prevented if the medical devices and equipment are exposed to 134ºC steam heat for a duration not less than 18 minutes. It is believed that only such a sterilization process can enhance safety as it effectively removes the protein substances which cause the infections (Pankhurst & Coulter, 2009, p.97). The respective governments, therefore, have established some committees in order to ensure safe treatments in all medical centers. For instance, the UK government works closely with the Spongiform Encephalopathy Advisory Committee (SEAC) in order to ensure effective decontaminations of the surgical devices. This committee also works in conjunction with the Advisory Committee on Dangerous Pathogens (ACDP) as the core government advisors on the surgical infections issues (Davey & Diba, 2005, p.437).

The decontamination processes

This is the overall cycle that medical devices, equipment and surfaces ought to undergo in order to ensure safety when re-used. This process differs depending on the medical appliances involved. The sanitary appliances, laundry and crockery are mostly cleaned with detergents in order to ensure the removal of all germs and infections (Agalloco & Carleton, 2007, p.401). According to Medtronic (n.d), the U.K Health Technical Memorandum 2030 and 2010 for washers-disinfectors and sterilization respectively provide guidelines for cleaning and sterilization of the various surgical instruments; however, ultrasonic washer is prohibited in this process.

Basic processes through which the new steam sterilizer (Type B) should undergo during the installation process

Quality management stage

This is the initial stage that the medical devices should first undergo. The stage mainly ensures that the devices are effectively made to suit their function. In this case, the sterilization machine ought to completely have undergone some proper production techniques. Proper documentation and manuals for the target users ought to be officiated in order to enhance user-friendliness (Carleton and Agalloco, 1999, p. 27). The medical centers are also required to prepare quality management system manuals in order to tell whether the device is effectively functioning (Reichert & Young, 1997, p.14).

The system manual should therefore have well-outlined procedures on how the device should be used. It should also explain how the overall process interacts with medical practices. In this case, the description will contain the overall impacts which the device will bring into the healthcare sector. It is also equally important to ensure that the scope of the system is well defined. This definition will assist in the regulation and implementation of the device in the health center. Indeed, the Directive 91/356/EEC requires validation of manufacturing practice of medicinal products for human use to ensure laid down principles and guidelines are complied with (Griffin, 2009, p. 737).

The overall scope of the device activities should be justified in order to ensure conformity. The scope excluded from the specified span should also be clearly explained in order to avoid conflicts. In order to ensure quality maintenance of the sterilization device proper record keeping should be enhanced. These records should assist the medical practitioners to check the viability of the device in the overall medical process. The records should also be user-friendly in order to act as a guide to the new practitioner who may intend to use the device. For a medical device such as the steam sterilizer (Type B) to be effective, it should meet the customer’s requirements. And in this case, the customer will be the medical center. The needs may range depending on the purpose that the machine was intended to be used for. The device should also meet the requirements of the health standards. This will ensure that the device offers quality services to the medical centers in the market. The medical device should therefore assist the organization to realize its objectives. This is mainly by efficiently serving in the decontamination process and serves as a requirement of the ISO13485, validation of the quality of medical devices (Press, 2003, p. 2-9).

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In order to ensure that the machine effectively decontaminates all the medical devices, the medical facility should develop a quality management system that should assist in monitoring the progress. This is the stage that approves the viability of the machine in the health institution. If the machine is deemed beneficial then the institution will proceed and purchase it but if not then no such capital investment should be made. The quality management system should then be implemented in order to enhance safety in the medical centers. Improvements and modifications should also be regularly done in order to ensure that the device performs properly.

Device control and monitoring

This mainly assists in checking the effectiveness of the medical device. It is mainly aimed at ensuring that the steam sterilization machine ensures proper cleaning and decontamination of the devices. The process is also undertaken in order to ensure that the proper actions are enhanced to remedy the previous hospital-acquired infections. The process also ensures that the steam sterilizer is used only to serve its purpose. Any other role which contravenes this should not be performed using the machine. Only authorized users should also be allowed to use the machine in order to ensure accountability within the management (Medina,2003, p. 76).

In order to ensure that the steam sterilizer is used to facilitate the decontamination process, it is important to define the products or the devices which should be cleaned using the machine. In addition, the microbiological quality and quantity should be well defined in order to ensure proper use. The packaging system of the sterilized products should be improved in order to ensure no further contaminations are observed. For efficiency purposes, the steam sterilizer should have its own detailed dissembler, cleaning assembly, and enough packaging and sterilization instructions which the medical practitioner should follow when decontaminating the medical devices.

Regular inspections and check-ups should be scheduled to ensure that the machine effectively performs its tasks. If the management enhances proper record keeping, then the control and monitory process will be easier as the records will show in case of deviations. But if no proper recording of the machine operations, then the overall monitoring process may be difficult for the organization or the institution. It is therefore much advisable that proper recording and instructions follow up is adhered to in order to enhance efficiency and effectiveness of the machine. This process also enables medical practitioners to enhance safety in their operations. As the steam sterilizer machine will effectively decontaminate the medical devices and equipment which they use on the patients (Haslam & Laycock, 2007, p.280).

The machine validation

This process ensures that the steam sterilizer machine effectively meets the stipulated needs. The process is however done in various stages. The installation qualification is the initial stage which requires the mechanical expertise to handle the machine technicalities. This stage also requires the medical center to have the relevant infrastructures that the machine might use.

Among the possible infrastructures that might be important for the machine is constant power which will be used to run the machine. The operation and performance qualifications are the other stages that are involved in the validation process. The operation stage in this case specifies the responsible person who will be entitled to running and operating the machine. This is usually done in order to ensure that the decontamination process is professionally done thus guaranteeing safety.

The operation stage aims at ensuring that the machine effectively decontaminates all the prescribed medical devices and equipment. Considering the increased risk of contamination in health institutions it’s important to ensure that the steam sterilizer machine will effectively increase healthcare safety.

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Conclusion

There is a significant need for the steam sterilizer in the respective health institutions as the machine will assist in the decontamination process which will increase safety and efficiency. It is estimated that 9% of hospital in-patients acquire some infections while still undergoing their normal treatments. The major infections mainly occur in the urinary and respiratory tract. There are other surgical infections that need a steam sterilizer to decontaminate the reusable surgical materials. The PrP infections which are mostly associated with the CJD infections can be prevented if the medical devices and equipment are exposed to 134ºC steam heat for a duration not less than 18 minutes. It is believed that only such a sterilization process can enhance safety as it effectively removes the protein substances which cause the infections. The medical centers are also required to prepare quality management system manuals in order to tell whether the device is effectively functioning. The system manual should therefore have well-outlined procedures on how the device should be used. It should also explain how the overall process interacts with medical practices.

Reference list

Agalloco, J.P. & Carleton, F.J., 2007. Validation of Pharmaceutical Processes. New York, CRC Press. Web.

Carleton, F. J. and Agalloco, J. P., 1999. Validation of pharmaceutical processes: sterile products. Informa Health Care.

Davey, A & Diba, A., 2005. Ward’s anaesthetic equipment. London, Elsevier Health Sciences. Web.

Griffin, J. P., 2009. The Textbook of Pharmaceutical Medicine. London, John Wiley and Sons.

Haslam, J & Laycock, J., 2007. Therapeutic Management of Incontinence and Pelvic Pain: Pelvic Organ Disorders. London, Springer. Web.

Henretig, F.M. & King, C., 1997. Textbook of pediatric emergency procedures. Philadelphia, Lippincott Williams & Wilkins.

Mayhall, C.G., 2004. Hospital epidemiology and infection control. Philadelphia, Lippincott Williams & Wilkins. Web.

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Medina, C., 2003. Compliance handbook for pharmaceuticals, medical devices, and biologics. Informa Health Care.

Medtronic. N.d. Technical Bulletin Cleaning and Sterilization for United Kingdom & Europe: HTM 2030 and HTM 2010. Web.

Pankhurst, C & Coulter, W., 2009. Basic Guide to Infection Prevention and Control in Dentistry. London, Wiley-Blackwell. Web.

Press, D., 2003. Guidelines for failure mode and effects analysis for medical devices. CRC Press.

Reichert, M & Young, J.H., 1997. Sterilization technology for the health care facility. Maryland, Jones & Bartlett Publishers. Web.

Wilson, J., 2006. Infection control in clinical practice. London, Elsevier Health Sciences. Web.

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StudyCorgi. (2022, February 17). Validation Program for a New Benchtop Steam Sterilizer. Retrieved from https://studycorgi.com/validation-program-for-a-new-benchtop-steam-sterilizer/

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StudyCorgi. (2022, February 17). Validation Program for a New Benchtop Steam Sterilizer. https://studycorgi.com/validation-program-for-a-new-benchtop-steam-sterilizer/

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StudyCorgi. 2022. "Validation Program for a New Benchtop Steam Sterilizer." February 17, 2022. https://studycorgi.com/validation-program-for-a-new-benchtop-steam-sterilizer/.

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StudyCorgi. (2022) 'Validation Program for a New Benchtop Steam Sterilizer'. 17 February.

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