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DISCUSSION PAPER
Introduction:
Computing technology has helped a lot in the medical field but making everything depends on software has his negative side too. It was observed in various cases where error in software cost heavy loss of machinery, money and time. The complex rocket design of France’s Ariane 5 was based on the software which when altered for safety precaution malfunctioned and was destroyed. A similar error in the security check software caused many troubles to the passengers. There are several other examples of software errors which caused discomfort. All these errors are also caused because of the reuse of the old software and approximating it for better improved results.
The most prominent case discussed in this paper is of Therac – 25 used for cancer treatment. It was a software operated radiation therapy machine and thus was able to cause much discomfort to people due to its malfunctioning. There were many cases reported which caused severe injuries to patients and many people died of the drug overdose. Within the span of two years, from 1985 to 1987 Therac – 25 gave massive overdoses to six patients in four medical centers. It was due to the wrong machine’s display which indicated no dose even when one or two doses were given to the patients. Three patients died of the overdose as it was estimated to be 100 times the intended dose.
Issues with Therac – 25:
 The severe radiation overdoses were contributed to many factors like insufficient testing, bugs in the software, errors in reporting the accidents and lapses in design. The bugs in the Therac – 25 made it shut down and blown fuses but there were no overdoses, but it affected general working of the machine. It was the fault of the manufacturers as well, either they were not aware of the consequences or totally ignored the repercussions. The company was overconfident of its achievement and as the first incident was reported it was not taken seriously even when the patient said that it burnt him.
There were many problems with the machine as it malfunctioned frequently. There were many instances for underdoses as well. There were as many as 40 malfunctions of the machine for underdoses reported in a day. This was due to many problems in the design of the operator interface. There were many problems in the software and a lot of responsibility was that of the manufacturer. The manufacturer was overconfident with the product even when it was good as the software has many problems. There was much less documentation of the software specifications in the development of the program.
There was weird error messages reported like “Malfunction 54” or “H – tilt”. It can be due to less memory space which was common for old computers as they have to manage mass storage with less memory space. The old computer based equipments were tedious to use, there was an explanation to every error message and one has to look into the manual to get the meaning of that obscure error message. For Therac – 25 however, there were no explanations in the manual and thus it was more faulty and difficult to fix. The error considerations were categorized by the time lapses as it depicts the extra effort machine takes to start. For some errors the machine starts after a pause while for some bigger errors it suspended operation for a while. There was much unpredictability and it was very harmful for the patients and thus there were many incidences of underdoses and overdoses reported.
Radiation Overdoses:
Therac – 25 was made to help in cancer treatment but due to its software based technology it was prone to making errors. The injuries and death of the three out of six people within a span of two years was contributed mainly to the overdoses given by the machines. It was investigated and it was found that the overdoses were contributed to the main two software errors which were reported due to the bugs. It required an understanding of the programming. The problem was in the flag variable which made the machine ready for treatment. It was stored in just one byte and thus when following the 256th call to the routine it tend to bring it back to zero. This can happen at the time of use of the electron beam when no protective covering was used to attenuate the electron beam. The electron beam was very harmful and it should be inhibited to have full exposure and when it is given uninhibited, it may lead to problems and severe injuries.
The other cases of overdose made the machine ignore changes or corrections which were made by the operator. The machine was much complex and thus there were problems of disorientation. Many a times due to bugs in the system the changes made were not followed by all the working systems of the machine. The operator typed in the information for treatment and the program shifts the devices to many places according to the command. The bugs in the program made the information available to only few parts of the machine while others were programmed for the old function. Thus if in the previous case the machine was programmed for more dose it was given to the next patient ignoring the corrections which could have been an overdose to the other. Similarly, in a much complex machine like Therac – 25 there can be many such bugs which affect the working of the machine resulting in overdoses.
Company and entity involved:
Therac – 25 was invented for the treatment of cancer patients and thus it has significance in improving the quality of life but due to its health hazards there were many concerns over the safety risks of the machine. Radiation treatment came as a boon for cancer patients as long as people were not aware of the severe consequences of the malfunctioning of the machine. All this was contributed to the working of the software installed in the machine. Radiation therapy require controlled and accurately monitored exposure of radiations to the patients which is entirely dependent on the working of a software which can be easily altered by bugs and sometimes even programming errors.
The case of Therac – 25 was also of the documentation of the software program as it was also not much explained from the manufacturers which were Atomic Energy of Canada Ltd. (AECL). There is no doubt that it has improved the life of many cancer patients but it has also made it worse for some as it resulted in injuries and deaths. There was a need of hiring better professionals which were more aware of the computer programming and bugs to fix the software program when it requires debugging. The company was overconfident of its achievement and as the first incident was reported it was not taken seriously even when the patient said that it burnt him. It was sheer carelessness, and avoidance of responsibility which contributed to the risks pertaining to the working of Therac – 25. These kinds of man made errors can be easily managed by paying attention and keeping responsible people at work. This applies for hiring professionals as well for the operation of the machine.
Quality of life vs safety risks:
Cancer patients require much care and support as their treatment is itself a terrible process which is only enhanced by problems related to the machine. Radiation therapy is itself a difficult process and cases of overdose and irregularity and carelessness should be reported but only after the consent of the patient. The integrity of the patient should never be compromised. There should be management experts hired for managing difficult situations like this as they are trained in dealing with extreme consequences. There is term used in management for organizing problematic situations. High reliability organization (HRO) works extremely well in conditions where others might fail as they are specialized in trouble tracking. There is a need of applying professional techniques to produce good systems which can improve the performance and minimize errors. Good software engineering techniques can cover for the losses made by the machines.
Individual rights and privacy:
Individual rights to privacy should be respected under all circumstances. The consent of the patient is necessary under all sorts of investigation and accidents. This comes under the individual human rights to protect personal information to be used up for professional uses. The investigation of the accidents made by the medical equipment like Therac – 25 should be entirely over the consent of the patients as it is totally their prerogative whether or not they want to reveal their personal details or not. There can be cases which have legal interruption as well but they also cannot deny the individuals from exercising human rights. The information is related to the health considerations and thus can have implications which require it to be discovered or not. Although, patients can always have legal claims if they were treated wrong or for any carelessness on the part of the hospitals or machine operator.
Property/ Intellectual rights:
A manufacturer is required to be answerable if its product has harmed the consumer. Although there is a requirement of revealing its intellectual property open for inspection in the name of safety but it is applicable only when there is a legal situation or there someone is being harmed by its products. The intellectual property of a manufacturer is sort of his private asset and it is not liable to justification unless and until it is demand because of some legal proceeding or part of a controversial issue. There are rules for all sorts of claims. The case discussed in this paper can be taken as an example where patients are suffering injuries and dying due to overdose due to malfunctioning of the radiation therapy machine. This case represents a situation where the manufacturer atomic Energy of Canada Ltd (AECL) is expected to be answerable. They have not provided the specifications of the software program which is malfunctioning. This can be the cause of death of many patients. The malfunctioning of the radiation therapy machine was an indication of the software problems.
Therac – 25 have reported six cases of severe injuries three of which died due to overdoses given because of the malfunctioning of the machine. The result can be also due to the carelessness of the operator or hospital employees and it should be investigated. Since the machine reported many cases of overdoses, so it is liable to a security check. Security check and checking of the intellectual property becomes necessary in cases of irresponsibility and credibility issues. The manufacturers of the radiation therapy machine Therac – 25 have not specified about the software details which shows a lack of professionalism. They also do not have many explanations in the manual which is a sort of security flaw because lack of it can lead to malfunctioning and accidents if the operator is not well equipped with the working of the system. The programming essentials should also be asked if there are some major flaws in the working of the machine’s software. As it was found in the case of Therac – 25, there were some flaws on the manufacturer’s level and the software was not good for carrying out a responsible task of radiation therapy.
Equity and Access:
Companies need to make profits to develop and sustain new technologies and to thrive in the marketplace and in this process they have to be responsible for the services which they provide. The company was overconfident of its achievement and as the first incident was reported it was not taken seriously even when the patient said that it burnt him. It was sheer carelessness, and avoidance of responsibility which contributed to the risks pertaining to the working of Therac – 25. There is a necessity to sustain in the market and thus there are some ethical obligations that each company should follow. The companies should be responsible for their services and products and flawed products should be changed or corrected very often.
Safety of the patients and in general consumers should be paramount and every company should be aware and concerned about that. Following good programming techniques will help greatly in the case discussed in the paper. In case of Therac – 25 there were many software errors which lead to developments of bugs in the system which affected the working of the machine and resulted in accidents. It is the duty of the company to provide the consumers with best quality equipment and minimize any chances of accidents or malfunctioning.
Honesty and Deception:
Salespeople, engineers, management have to report misleading claims or gaps in safety as they are responsible for maintaining ethical working scenarios in various companies. It is important for people to be responsible and apply better working habits to avoid any accidents or ill mannerism. Societal obligation is important as it maintains the responsibility of the manufacturers and companies towards consumers. The manufacturers of the Therac – 25 back in 1985 was a good example where the manufacturers were not responsible for the software specifications and programming techniques. There were problems of bugs which were very frequent and it resulted in malfunctioning of the machine which claimed even lives. They also do not have many explanations in the manual which is a big flaw because lack of it can lead to malfunctioning and accidents if the operator is not well equipped with the working of the system.
Implementation flaws:
The design and implementation flaws in the Therac – 25 would be less likely to occur today because there is much advance and technologically developed models available in recent times. Technology has been improvising since 1987 and thus it is expected with the better management programs and software development techniques that number of accidents will be much less than previous years. There is a question of the ethical understanding of the software developers as they are answerable to the flaws of the machine which is having lives at stake. The manufacturer should take responsibility to fix the problem and be honest with the specifications of the software program. These days much awareness is spread in this regard as management experts use high reliability organization (HRO) for companies which operate in much difficult situations than normal.
The case of radiation therapy machine Therac – 25 which required extreme precision to operate as patients can have severe injuries and even death by the overdoses. One characteristic of this type of working environments was the “preoccupation with failure”. It is a sort of contingency plan which remains prepare for an emergency and anything unexpected can be tackled. Although the risks can remain because of the complexity of the software programming, but there are better technology than old times to deal with problems and companies recognize their responsibility to the consumers. The legal system is also supportive of the consumers if they are harmed by any service or product. The modern day example like Therac is the flaw in the security check software at airport which caused many troubles to the passengers. The software did not correct the changes and kept picking the passengers with specific name initials which were previously on the “No fly” lists. This caused considerable trouble of security checks to the passengers with same initials as the names of the terrorists in the “no fly” lists.
References:

  1. Case study: The Therac – 25.
  2. Lee Andresen, Ruth Cohen, 2004, Equity of access to health care: outlining the foundations for action, Vol 4, Issue 2, pg 225 – 239.