CMC Critique

Document Type:Presentation

Subject Area:Philosophy

Document 1

In 1954, AECL helped Canada to build its first nuclear power plant. AECL went further and developed Therac-6 which was its first device for radiation treatment. Afterwards, it developed Therac-20 and Therac-25 and brought them to the market. Therac-25 caused several accident incidents. After these issues occurred, the medical division was privatized and finally named Best Theratronics. The problem or issue that involved CMC with regards to the Therac-25 machine Earlier on, CMC had developed Therac-6 and Therac-20 which were successful models. Therefore the development of Therac-25 was based on the productivity of the previous two models 6 and 20. The production of Therac-6 and Therac-20 was done in partnership with a French company, CGR. When Therac-25 was being designed, the partnership had been dissolved. A computer was not needed by Therac-6 and Therac-20 in their operation because AECL designed them to operate as standalone devices. When in manual mode, various parts of the machine would be physically set up by the radiotherapy technician. When in electronic mode, the beam would be spread out using scanning magnets so that it could easily cover a larger area. When in X-ray mode, an object was put in the electron beam with electrons striking the object to produce X-ray photons directed at the patient. Therac-6 and Therac-20 had hardware interlocks; they help in preventing the operator from performing a dangerous activity. In the designing of Therac-25, Atomic Energy of Canada Limited (AECL) used computer control only. They decide to do away with both the hardware interlocks and manual controls.

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The computer was used to keep track of the setup of the machine, and in case it detected any dangerous situation things would be shut down. The software malfunctioned, and six patients were seriously injured, three patients later died. A brief of the accidents incidents description may include; The First Accident Patient Linda Knight occurred on June 3, 1985, at Kennestone Regional Oncology Center - Marietta, GA. • Radiation made the breast of a 61-year-old female patient to be removed. The Fifth Accident Patient Daniel McCarthy occurred on April 11, 1986, at East Texas Cancer Center - Tyler, TX • A month after the first “Malfunction 54” by the same irresponsible operator, a male patient receiving radiation on his face made a loud noise and was moaning. • The operator heard and then ceased the treatment. • The damage had already been done, following a coma and suffering severe neurological damage; the patient died three weeks after the overdose.

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The Sixth Accident Patient Anders Engman occurred on January 17, 1987, at Yakima Valley Memorial Hospital - Yakima, WA. • While a patient on the turntable was receiving small radiation doses, the machine malfunctioned and displayed that the prescribed “7 rad” was administered. • The dose administered to be clearly shown to the operator. • Editing keys will be limited to reduce any accidental type-ins. • All manuals will be rewritten to show new changes. A detailed proposal regarding what can and should be done to prevent this problem from happening (remedies) • Actions agreed on the final Correction Action Plan (CAP) should be implemented. They include; • AECL should fix user documentation. In this document, actions of CMC were analyzed using ethical analysis. CMC acted ethically because they followed the pre-market notification which was part of the FDA guidelines; from a duty based ethical point of view, their decision was not morally wrong.

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From a Utilitarianism point of view, CMC did not act unethically because CMC did not do anything intentional that was not for the greater good. They designed the new Therac-25 for the operators to get more time with the patients. According to CMC, the software was tested properly, and they followed all the regulations put across by FDA. This action was done for the greater good because the communication was communicated to all the users. CMC also did not make decisions that were morally wrong; there were acknowledgement communications issues, but these were not intentional, and there is no sign of any decision made by CMC to hide anything. Finally, According to this case, I would acquit CMC even though it is highly criticized for designing Therac-25. CMC designed Therac-25 because Therac-6 and 20 had functioned properly.

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It did this as a greater good to the operators and patients so that they could spend more time together.

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