When patient is delivered unsafe amount of radiation

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Reference no: EM132211549

Case Study

'Accidents occur when a patient is delivered an unsafe amount of radiation. A radiation therapy machine is controlled by software that monitors the machine's status, accepts operator input about the radiation treatment to be performed, and initializes the machine to perform the treatment. The software turns the electron beam on in response to an operator command.

The Therac-25 accidents are associated with the non-use or misuse of numerous system engineering practices, especially system verification and validation, risk management, and assessment and control. In addition, numerous software engineering good practices were not followed, including design reviews, adequate documentation, and comprehensive software unit and integration tests.

The possibility of radiation accidents increased when AECL made the systems engineering decision to increase the responsibilities of the Therac-25 software for maintaining safety and eliminated most of the hardware safety mechanisms and interlocks. In retrospect, the software was not worthy of such trust. In 1983 AECL performed a safety assessment on the Therac-25. The resulting fault tree did include computer failures, but only those associated with hardware; software failures were not considered in the analysis.

The software was developed by a single individual using PDP-11 assembly language. Little software documentation was produced during development. An AECL response to the FDA indicated the lack of software specifications and of a software test plan. Integrated system testing was employed almost exclusively. Leveson and Turner (1993) described the functions and design of the software and concluded that there were design errors in how concurrent processing was handled. Race conditions resulting from the implementation of multitasking also contributed to the accidents.

AECL technical management did not believe that there were any conditions under which the Therac-25 could cause radiation overdoses, and this belief was evident in the company’s initial responses to accident reports. A one time, the AECL technical support supervisor responded to the hospital in early 1986: “After careful consideration, we are of the opinion that this damage could not have been produced by any malfunction of the Therac-25 or by any operator error… there have apparently been no other instances of similar damage to this or other patients.”

Identify 3 risks associated with your selected case study.

For 1 of the 3 risks, develop a Risk Reporting matrix and Identify:

i. The specific risk and its rating

ii. A mitigation strategy to address the risk

iii. An estimated updated risk and rating with an explanation as to why the risk has been reduced

Reference no: EM132211549

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