The Therac-25 Accidents - Case Study Example

THE THERAC-25 CASE STUDY THE THERAC-25 CASE STUDY Introduction The Therac-25 accidents are considered tobe one of the most serious computer software related medical accidents to date (Turner, 1993). The Therac-25 was a radiation machine manufactured by a Canadian firm to aid in the treatment of cancer. What made it unique was its design, software and an advanced programming that eased the set up process and monitored the safety of the radiation levels emitted by the machine. The machine was involved in at least six accidents where the patients received an overdose of radiation despite the safety programming. The overdose was to the extent that some patients received doses a thousand times greater than the prescribed radiation doses resulting in serious injuries and even death. The machine was intended to be operated on two modes the, photon mode, a high powered electron beam mode and the proton mode, a low powered electron beam mode. When the accidents occurred, the machine was supposed to be operating under the low beam mode but the high powered mode got activated instead striking the patients with an overdose of the radiation. The patients reported what felt like a shock, seeing a flashing light and hearing a buzzing sound. This indicated an overdose but the engineers insisted that the machine was incapable of delivering the unintended doses given its software safety programming. A few days later the patients showed symptoms of excess radiation exposure and three of the patients died as a result of the overdose while the other three sustained serious injuries leading to the loss of some of their body parts (Goans & Wald, 2014). While these accidents were caused by the errors in programming, various entities can be blamed for being either indirectly or directly involved in the negligence that resulted in these accidents. The AECL manufacturer who made the machine is one of the obvious person who is to blame. The manufacturer is reported to have assigned only a single software developer the task of creating the complex software that the machine would rely on for its functioning. Additionally, very little testing was done for the machine and the software specifications were never written down (Goans & Wald, 2014). Moreover, the manufacturer’s claims that the machine was free of defects even after complaints were made were baseless. The manufacturers ought to have taken the matter seriously and actively searched the source of the malfunction before approving the use of the machine. Apart from the manufacturers who are the obvious entities to take the blame, other parties can also be identified who acted negligently in the whole matter. The machine operators and technicians contributed to these accidents in that they continued to use the machines on patients even though they got frequent error messages. In one instance, Turner (1993) states that the machine caused a treatment pause and gave out an error message but the operator continually pressed the “p” button every time it shut down given that the machine indicated that no dose had been delivered. It is reported that the machines would give up to forty error messages in a single day. Thus, in my opinion, the technicians were grossly negligent in continuing to use the machines in spite of these obvious red flags that would have alerted any rational human being to question the safety of the machine. The federal government also is to blame for the accidents. The government ignored all the obvious defects in the machine and sanctioned its usage issuing a statement to the effect that the manufacturers need not notify the purchasers of the defects in the machine. The federal Authority instead observed that the benefits of the machine outweighed its inconveniences and should therefore be used. This is totally unexpected of the body whose primary mandate is to protect the people from such malpractices. The Therac-25 case presents some ethical issues for consideration key among them being the tradeoff that can be made between the improvement in the lives of patients and the risks involved in the achievement of these results. In many instances, considerable risks are involved in administering treatment to patients. There is always a risk that the medicine taken may cause adverse effects or that the patient may not make it through the surgical procedure. However, these must never be avoidable risks. These risks should be made known to the patient who then decides to accept the risks involved in their treatment or decline to be treated. In the Thurac-25 case, the patients had the assurance that the machine was the safest given its unique design and advanced software capabilities. On the contrary, the machine ended up causing them severe injuries and in other cases death. Such a tradeoff that puts the lives of humans in danger is unethical and improper. To eliminate such risks, an independent body ought to be set up to carry out periodic checks on hospital equipment and machines to ensure that they do not present any significant risks to the patients and that any unavoidable risks are brought to their attention before they accept to go through with the procedures. Another key question that arises out of the case is whether a patient’s records may be made available without their consent to facilitate investigation of the accidents and to discover what went wrong. It is my proposition that when the situation warrants it, the records can be availed to aid in the protection of other lives and patients who would otherwise be exposed to the same risks. All efforts must, however, be made to convince the patient that it is in good faith that the request for the records are being made. Certain scenarios may also require the manufacturers of a product or equipment to present their intellectual property for inspection putting their invention at a risk of being copied by other manufacturers. A question thus arises as to whether such manufacturers can be compelled to do so if their equipment poses risk to patients or the users. It would be very unethical to continue operating equipment that is causing harm to the public in the name of intellectual property rights. As such, when the question arises as to whether to opt for safety or property rights then safety should prevail. In the pursuit for better healthcare for the public, companies may develop new inventions. It is also true that companies are in business to make a profit. The development of new products usually requires a lot of expenses in the form of research development and testing costs. When safety regulations are strict, the company may have to incur more costs in the form of safety trials and meeting various compliance requirements. These costs when transferred to the users may make the costs of services prohibitive to them resulting in their failure to use the services. A dilemma thus arises calling for a tradeoff between the strict regulation of the development of new equipment to ensure safety or the relaxation of the requirements to allow all to afford the services. In my opinion it would be unethical to subject human beings to unsafety situations in the interest of profitability. It would be better for the companies to cut down on their profitability than to expose people to risks that could easily be avoided. Sometimes employees also get caught between choosing to be loyal to their companies and performing their moral obligations to the society. Such employees include engineers, the management and sales persons who may have to choose between marketing their products and disclosing the defects in them. It is my proposition that such employees owe a duty of care to the public and should disclose any safety defects that have the potential of causing severe injuries to the public. In this regard, it would be groundless to sell unsafe equipment or offer risky services to clients without disclosing to them the risks that they are exposed to in the name of company loyalty. Ultimately the question is, can such accidents occur in the modern setting? Given the technological advancement today allowing for simulations of the functioning of a machine and early diagnosis of malfunctions, the kind of design and operation flaws in the Therac-25 can be avoided. This is further ensured by the strict control and regulation of the invention of medical equipment and software. The errors in software programing could easily be identified given the regulations requiring formal documentation of all software and the precautions taken to ensure that error messages are clearer for easier diagnosis of malfunctions. This would ensure any defects are rectified in time. A similar software related malfunction was however seen on September 14, 2004, when Microsoft software bug heightened by human error caused a failure in the radio system resulting in the loss of communication between the Los Angeles International airport traffic control center and the airplanes. The situation was however soon resolved quickly. References Goans, R. E., & Wald, N. (2014). Radiation accidents with multi-organ failure in the United States. Turner, N. L. (1993, July 26). The investigation of the Therac-25 accidents. Computer, pp. 18-41. Read More