Analysis of Davenport Disaster 1972 - Term Paper Example

Davenport disaster 1972 The Davenport disaster also often called the Davenport incident refers to an industrial lapse that resulted in the manufacture and circulation of non-sterilized bottles into the market. The hitch led to the circulation of substandard drugs thus exposing patients to varied side effects and the death of five people. The dextrose infusion bottles spread throughout the expansive region. Although the United Kingdom newspapers first reported the incident in 1972, the manufacture of the bottles took place in 1971 implying that for a period of more than a year the population used non-sterilized drug bottles without knowing until the death of five people in the city. Following public outcry, the government set up a commission to investigate the incident and inform future government actions. The report’s findings revealed major industrial management discrepancies, which facilitated the release of the non-sterilized bottles into the market for public consumption. Drug bottles have an elaborate manufacturing process that ends with their sterilization, the sterilization process ensures that the drug stored in such bottles maintains the fidelity required by the stakeholders in the industry. Drugs are chemicals that easily react with any other element they meet; this nature of the drugs thus commands an effectively monitored manufacturing recess and the eventual sterilization to eliminate any other chemical or substance that could contaminate the bottles thus impair the quality of the drugs (DiCenso 66). The Clothier report blamed poor operational practices in the manufacture and sterilization of the bottles. Apparently, the manufacturing companies do not check the quality of their machinery. Such result in the use of cheap substandard plants that do not achieve the desired bottle quality. Additionally, the report revealed that the companies hire unskilled personnel to operate the machines thus creating room for fraudulent application of the manufacturing process. The extent of the disaster portrayed the government’s laxity in monitoring plant operations within the country. As companies continually operate, they get comfortable with their operations owing to the success they register with their past operations. The handling of the machines thus comes naturally out of routine instead of the appropriate directives of the manufacturers. Such cases of laxity resulted in the lack of supervision of the operational process thus eliminating the need for professional engineers to manage and operate the process. Companies thus began hiring unskilled personnel to operate highly sophisticated machines that required effective understanding and constant operations. Bottle sterilization if an intensive process that involves the use of high-pressure steam of up to one hundred and twenty one degrees to kill any pathogen living on such surfaces. However, such machines require appropriate operations in order to ensure that they operate at optimum levels. This way, they delivered the desired results as set by the medicine’s board in the country (Ashley and Kevin 12). The Davenport disaster was therefore a result of both an administrative and industrial lapse. The government is responsible for the human lives and must therefore safeguard the safety of the population. To ensure this, the English government has several ministries that deal which such issues as health. The ministries must ensure that the public access high quality drugs. Through the ministry, the government monitors both the process of manufacturing the drugs and the bottle in order to ensure that they meet the set standard for manufacturing similar products. The fact that the government did not monitor the process of manufacturing the bottles resulted in the laxity that resulted in the disaster. The same was expected of the bottle manufacturers. The report indicated that the machines operators had limited skills most of which were irrelevant to their job descriptions. Additionally, they had minimal supervision thus permitting them to take charge of the entire manufacturing process. The lack of professional training and supervision resulted in the failure to sterilize the bottles effectively as the workers assumed that the process was conventional, as they had done in the past. In retrospect, the root causes of the Davenport disaster in the United Kingdom included ineffective legislations to superintend the manufacture and sterilization of the bottles as required by the constitution. Health is a constitutional right in the United Kingdom thus commits the government to ensure that the public access quality medicinal products. Additionally, the problem was a result of ineffective organizational structures in the manufacture and sterilization of the bottles. The hiring and use of unskilled personnel coupled with the evident lack of effective supervision led to the manifestation of the problem in the region. Corrective and preventive actions It became a responsibility of the government to contain and rectify the situation in time in order to contain the death of the people as had begun. The first stage to ensuring success in doing this was to increase the public’s awareness of the infiltration of the bottles into the market. While such would create panic among the population, the people would become conscious of the drugs they buy. This way, the government ensures that the public becomes conscious of the drugs they buy from the stores among other health facilities. The media in the country leaked the story thus performing the task; The Daily Telegraphy issue on March 7, 1972 ran the story that warned the public of the non-sterilized bottles circulating in the public as had been communicated by the ministry of health. Apparently, the ministry had sounded a warning informing the public of the bottles’ circulating. This way the government through the ministry would increase the public safety by informing the people on the kind of bottles to look out for, there were about five hundred non-sterilized drip feed bottles in circulation. After sounding the alarm thus making the public aware of the situation, the government would stop the manufacture of any more bottles as it sets out to recover the non-sterilized bottles from the public. Stopping the manufacturing process helps contain the spread of the risk by adding more non-sterilized bottles to the few already in circulation. Additionally, the stoppage also helps the government determine the cause, nature and extent of the problem. After the death of five people, the effects of the spread would turn more tragic thus informing the need for effective investigation into the manufacturing process with the view of determining the nature of the manufacturing process and the cause of the problem. This would run concurrently with speedy recall of all the drugs packed in any similar bottle. The government has access to all the drug dispensers in the country. Such include chemists, pharmacies and health facilities. This implies that the government can easily recall all the drugs circulating in the market thus increasing the chances of containing the spread of the contaminated drugs. With the successful reclamation of all the contaminated drugs from the market, it becomes possible for the government to investigate and determine the nature of the contamination thus devise effective corrective measures. Investigating the bottles would easily reveal the source of contamination. After the determination of the source of contamination, which was evidently at the sterilization stage, the government should destroy the drugs but would possibly save the bottles to take them through the process instead of destroying the bottles as well. After the above steps, it thus becomes prudent to prevent such mistakes from recurring in future. In preventing the recurrence of such cases, the government would simply formulate and implement policies depending on the lessons learnt from the present disaster (Smith 71). Such preventive measures would include the use of safer and more effective methods to sterilize the bottles. Apparently, the previous heating was not as effective as had been assumed. The government ought to have developed and recommended the use of another more effective sterilization. This would eliminate the tedious and more labor-intensive previously existing method that had resulted in the disaster. Additionally, the government should develop policies that ensure a dedicated and constant supervision of the manufacturing process of microbiology products. The government should have revamped its dedication to keep the public safer by interacting with the manufacturers to ensure that they maintain integrity in the process. Such stringent supervision of both the of the drugs manufacturers and those manufacturing other pharmaceutical products should therefore result in a society free from such disasters as the Davenport’s. Another equally important policy to help curb the prevalent of such mistakes would be in the labor sector of the economy. Disaster resulted from laxity in the manufacturing process; the government should therefore develop and implement policies that certify manufacturers of pharmaceutical products and their employees. The companies required professionals to operate the machines used in the manufacture of the bottles. The disaster was therefore a result of the employment of unskilled laborers. The policy would therefore ensure that all companies maintain a high standard of manufacturing key among which would include the employment of professionals with valid credentials thus capable of operating the machines effectively. The supervision of the companies would also include the observation of the organizational structures to ensure that the operators had adequate supervisors and worked in friendly environments thus minimizing fatigue. Motivation is management factor that affects the quality of output exhibited by employees in a company. The new policy should therefore regulate the structure of pharmaceutical manufactures by steering the importance of their operations thus the need for both fidelity and integrity. The employees should therefore take oaths to maintain the two and keep their work environment bot safe and secure. However, the liberalization of the market cleared such issues as companies currently compete for the single market thus compelling them to employ high quality services in order to increase their market share. In brief, corrective measures aim at correcting the mistake that had resulted in the disaster; such included the media messages, the destruction of contaminated drugs and the replacement of the sterilization machines (Jacob, Rekha and Jadhav 22). Preventive measures on the other had are long term and seek to safeguard the safety of the public for longer by ensuring that such mistakes do not recur. Such preventive measures are mostly legislative and include the formulation and implementation of effective policies to address the issues raised by the disaster. Such include the radical labor laws, the supervision of the manufacturing process and the possible determination of a better and high quality sterilization method. Validation of an autoclave An autoclave is a device manufactured in 1679 and first used1879 to sterile equipment. The device works by subjecting the equipment to steam at degrees of between one hundred and twenty and one hundred and thirty for approximately ten to fifteen minutes thus inactivating all the bacteria, viruses among other pathogens. The devices kills such thus resulting in a surgically safe equipment used to package drugs for transportation. The sizes of autoclaves vary depending on the load they sterilize at any moment. The process of sterilization is often repeated since the device functions on the same principle. The repetitive nature of the machines operations implored the development of a mechanism to ensure that it operates on uniformly. A validation is therefore a documented program that ensures that the machine provides an assurance that it will operate consistently and provide a uniform result throughout its repeated operations. The process, method and system must therefore consistently produce results that meet predetermined acceptance and assessment criteria. Just as explained above, autoclave validation is therefore the process of determining the efficiency and fidelity of the operation of the sterilization machine through its repetitive nature of operations. The installation and predetermination of the operational features of an autoclave will require the change of the entire environment to ensure that the personnel do not re- infect already sterilized equipment. To achieve such and environment the facility must change the nature of the operations to include the assessment of their operations with the view of minimizing contact with pathogens, which later contaminate the already sterilized equipment. Changing the environment begins with the provision of concealed dustbins in which they dump any used and contaminated equipment. This way, they eliminate the pathogens by concentrating them inside the safe bins. Additionally, the personnel must have adequate gloves and use them when handling the equipment. They change the gloves and dump them in the dustbin after every operation in order to minimize recontamination. They should also have disinfectants, which include flowing warm water and soap that they use to wash their hands after handling the equipment thus reducing the chances of contamination. Validation protocol for the validation of an autoclave Introduction A validation protocol refers to a written program that explains the operations of the validation process and the necessary acceptance criteria. A protocol therefore explains the critical processes involved in the validation, identifies the equipment used in the validation and the product features. The protocol should also include the number of runs in the validation process since an effective validation requires reconfirmation procedures to ensure that the process is effective. Finally, the protocol outlines the test features available for the validation. It is essential that the products be tested to determine the effectiveness of the validation process. Validation of an autoclave As explained earlier, autoclave is a device used to sterilize equipment especially in health facilities. It subjects the equipment to steam for a specified duration a period within which the high temperature of the steam deactivates all the present pathogens thus resulting in a clean and safe equipment capable of storing pharmaceutical products. Validation of an autoclave thus includes the indication of the degree of the steam, the duration within which the equipment last during the validation, the number of validation runs and the tests to prove the success of the sterilization. The activation of the autoclave instigates the introduction of steam into the chamber containing the load. Drug bottles among the lightest loads for the autoclave yet the most essential in the practice. The Davenport disaster that claimed five lives was a result of poor sterilization of the drug bottles. This implies that the process must be effective and eliminate all the pathogens present in the containers. An exposure of twenty minutes is enough to eliminate all the pathogens in the bottles. The validation of the autoclave thus begins with the placement of the load on the chamber then activating the autoclave. However, before the activation of the autoclave and the inception of the sterilization process, it is important to remove all the air inside the autoclave. Air is a poor conductor of heat and therefore jeopardizes the sterilization process since it interferes with the flow of heat in the steam to eliminate the pathogens. Among the processes used to eliminate the air from the chamber include steam pulsing, vacuum pumps, supertonic cycles. Whichever method one uses it is fundamental to eliminate all the air from the chamber before the sterilization process begins. The sterilization process begins by placing the load in the chamber then setting the required temperature to the desired level such as one hundred and thirty for the sterilization of the drug bottles (Boyle, Edwin and Stephen 41). After the placement of the load, the next stage is to activate the autoclave then watch as steam fills the chamber. Observe the light indicating the process of sterilization. The lights turn green when the time limit is due thus signaling the end of a sterilization process. Repeat the process by reactivating the autoclave and letting it sterilize the bottles for the second time before removing them. The bottles are virtually ready for use but it is fundamental to test them for the effectiveness of the sterilization process. Autoclaves have several indicators that help the user know if the machine has met the set condition. The chemical indicators for example will automatically change color to signal the end of a sterilization process. Conclusion The Davenport disaster in 1972 was a turning point in the practice od medicine in the united kingdom. The disaster portrayed major industrial flaws that resulted in the death of five people a loss that the country could not sustain. Such preventable deaths resulted from substandard manufacture of equipment used to handle and dispenser drugs thus influencing the use of better and more secure technology to ensure effective sterilization of the pharmaceutical equipment. The use of autoclave provides a secure sterilization method that safeguards the interests of the public by ensuring the use of safer and cleaner containers. It also provides solutions to the fears of recontamination since it has automated tests to ensure that the sterilization process is effective and that the equipment are clean and ready to use. Through the validation protocols, the machines require minimal human supervision yet promise effective results. Works cited Ashley, Benedict M, and Kevin D. O'Rourke. Ethics of Health Care: An Introductory Textbook. Washington, D.C: Georgetown University Press, 2002. Print. Boyle, Philip J, Edwin R. DuBose, Stephen J. Ellingson, and al Et. Organizational Ethics in Health Care: Principles, Cases, and Practical Solutions. New York: John Wiley & Sons, 2001. Internet resource. DiCenso, Alba. Evidence-based Nursing: A Guide to Clinical Practice. St. Louis, Mo. ;London: Mosby, 2005. Print. Jacob, Annamma, Rekha R, and Jadhav Sonali. Clinical Nursing Procedures: The Art of Nursing Practice. New Delhi: Jaypee Brothers Medical publishers, 2007. Print. Smith, Doug. Davenport. Charleston, SC: Arcadia Pub, 2007. Print. Read More