Incident: Radiation Overdoses in Cancer Treatment Due to Software and Training Failures

Published Date: 2010-01-26

Postmortem Analysis
Timeline 1. The software failure incident happened in September 2006 at the Veterans Affairs Medical Center in East Orange, New Jersey [17].
System unknown
Responsible Organization 1.
Impacted Organization 1. Patients at the Veterans Affairs Medical Center in East Orange, New Jersey [17] 2. Patients at Akron General Hospital in Ohio [17]
Software Causes 1. Lack of proper training and experience in using new software-controlled machines, leading to miscalculations and overdoses [17]. 2. Hospitals failing to follow basic checking protocols in software and operation, allowing errors to go undetected [17]. 3. Manufacturers selling machines with software bugs before identifying and removing them [17]. 4. Software glitches in treatment planning software leading to miscalculations affecting multiple treatments [17]. 5. Incorrect magnification factor entered into treatment planning computer causing overdoses [17]. 6. Poorly designed software, glitches, and lack of fail-safe features in equipment causing incorrect treatment [17]. 7. Lack of national standards and guidelines for the use of advanced technologies like I.M.R.T. [17].
Non-software Causes 1. Lack of experience in using a machine that generated high-powered beams of radiation by the medical team [17]. 2. Failure of hospitals to quickly identify errors due to the absence of a system in place to catch errors [17]. 3. Overworked medical physicist who failed to detect a mistake in the radiation dosage [17]. 4. Lack of proper training and knowledge among medical personnel to safely administer treatments using new technology [17]. 5. Inadequate quality control, lack of safety procedures, and absence of follow-up for patients receiving treatments [17]. 6. Errors in treatment planning and execution due to unfamiliarity with new treatment planning software [17]. 7. Failure to promptly report mistakes and overdoses to the appropriate authorities [17].
Impacts 1. Patients at the Veterans Affairs Medical Center in East Orange, New Jersey, were overradiated and subjected to errors in technique due to a lack of training and knowledge to safely administer I.M.R.T. treatments, leading to serious radiation injuries and complications for the patients [17]. 2. A patient at Mary Bird Perkins Cancer Center in Baton Rouge, Louisiana, experienced stomach ulcers, anemia, urethral stricture, and required surgery due to a miscalculation in the treatment planning software, resulting in incorrect radiation doses over 38 treatments [17]. 3. Myra Jean Garman, a breast cancer patient at Akron General Hospital in Ohio, received twice her prescribed dose five separate times due to an incorrect magnification factor entered into the treatment planning computer, leading to severe pain, broken ribs, and ultimately suicide [17].
Preventions 1. Implementing basic checking protocols and following accident reports could have caught many of the mistakes related to overradiation incidents in hospitals [17]. 2. Ensuring that hospitals provide necessary financial support to operate sophisticated devices safely and that medical personnel receive adequate training on new technology could have prevented errors in treatment planning and delivery [17]. 3. Requiring licensing or registration for medical physicists in all states could have improved oversight and accountability in ensuring patient safety during radiation treatments [17]. 4. Conducting independent checks on new radiation therapy equipment installations, like those done by the Radiological Physics Center, could have detected errors in machine calibration and treatment planning software, preventing overdoses [17]. 5. Enforcing consistent and comprehensive reporting and investigation procedures for radiation errors, as well as implementing national standards and guidelines for advanced technologies like I.M.R.T., could help prevent errors and ensure safe radiation therapy practices [17].
Fixes 1. Implementing more stringent regulations and oversight by government agencies to ensure proper training, quality control, and adherence to safety protocols in the use of advanced medical radiation technology [17]. 2. Requiring licensing or registration for medical physicists in all states to ensure competency and accountability in overseeing radiation treatments [17]. 3. Enhancing quality assurance measures in hospitals, including regular checks and evaluations of equipment setup, treatment plans, and treatment delivery processes [17]. 4. Improving communication and reporting mechanisms within hospitals to promptly address and rectify errors in radiation treatments, as well as ensuring transparency with patients regarding any mistakes made [17]. 5. Enhancing training programs for medical personnel on new technologies and treatment procedures to reduce errors caused by lack of familiarity with software and equipment [17].
References 1. Medical physicists and radiation therapists who set up and monitor radiological devices [17] 2. Manufacturers who sell machines before all software bugs are identified and removed [17] 3. Government regulators who have been slow to respond to radiation accidents [17] 4. The Radiological Physics Center, a federally financed testing service [17] 5. The American Association of Physicists in Medicine [17] 6. National Cancer Institute officials [17] 7. The American College of Radiology [17] 8. The Food and Drug Administration [17] 9. The Nuclear Regulatory Commission [17] 10. State radiology officials [17] 11. The Ohio Bureau of Radiation Protection [17]

Software Taxonomy of Faults

Category Option Rationale
Recurring multiple_organization (a) In the article, it is mentioned that
Phase (Design/Operation) unknown The articles do not provide specific information about a software failure incident related to the development phases of design or operation.
Boundary (Internal/External) within_system The software failure incident described in the articles is primarily related to within_system factors. The incident involved errors in the software and operation of medical radiation devices, leading to overradiation and substandard treatment of cancer patients [17]. The mistakes were attributed to the lack of experience in using the high-powered radiation machines, inadequate training, software bugs, and the failure of hospitals to implement proper checking protocols and safety procedures [17]. Additionally, the incident highlighted issues with outdated safety protocols, lack of financial support for operating sophisticated devices safely, and the sale of machines with software bugs by manufacturers [17]. These factors point to failures originating from within the system, such as inadequate training, outdated protocols, and software issues.
Nature (Human/Non-human) non-human_actions, human_actions (a) The software failure incident occurring due to non-human actions: - The articles highlight instances where software failures occurred due to factors introduced without human participation, such as miscalibrated machines that overradiated patients [17]. - In one case, a linear accelerator at a hospital was set up incorrectly, leading to the overradiation of brain cancer patients [17]. - The articles also mention cases where software glitches or design flaws in treatment planning software led to incorrect radiation doses being administered to patients [17]. - Manufacturers sometimes released new equipment with software bugs or glitches, causing incorrect treatment of patients [17]. (b) The software failure incident occurring due to human actions: - Human actions also played a significant role in software failures, such as when medical personnel compensated for using the wrong type of CT treatment scan by doing a "work around," leading to miscalculations affecting all treatments [17]. - In another case, a medical physicist failed to catch a dosage mistake made by an oncologist, resulting in a patient being overdosed with radioactive seeds [17]. - The articles also mention instances where human errors, such as entering incorrect magnification factors into treatment planning computers, led to patients receiving incorrect doses of radiation [17]. - Lack of proper training, supervision, and oversight of medical personnel contributed to software failures in radiation therapy incidents [17].
Dimension (Hardware/Software) unknown The articles do not provide specific information about software or hardware failures in the context of the incidents described. Therefore, it is unknown whether the incidents were related to hardware or software failures.
Objective (Malicious/Non-malicious) unknown The articles do not provide information about a software failure incident related to a malicious or non-malicious objective.
Intent (Poor/Accidental Decisions) poor_decisions, accidental_decisions The articles provide information related to both poor decisions and accidental decisions contributing to the software failure incidents: (a) poor_decisions: The incidents highlight poor decisions made by hospitals, manufacturers, and regulators that contributed to the software failure incidents. For example, hospitals lacked proper training and quality control for administering treatments using new technology, manufacturers sold machines with software bugs, and government regulators were slow to respond to the increasing risks associated with advanced technology [17]. (b) accidental_decisions: The incidents also involve accidental decisions or mistakes that led to software failures. For instance, in one case, a hospital used the wrong type of CT treatment scan due to unfamiliarity with the treatment planning software, resulting in miscalculations affecting all treatments [17]. Additionally, a physicist entered an incorrect magnification factor into the treatment planning computer, leading to a patient receiving twice the prescribed dose multiple times [17].
Capability (Incompetence/Accidental) development_incompetence, accidental The articles provide information related to both development incompetence and accidental factors contributing to software failure incidents: (a) development_incompetence: - The incidents highlighted the vulnerability of patient safeguards due to the lack of experience in using new machines generating high-powered beams of radiation, leading to overradiation and substandard treatment of cancer patients [17]. - Hospitals were found to lack the necessary financial support to operate sophisticated devices safely, and manufacturers sometimes sold machines before all software bugs were identified and removed [17]. - The incidents at various hospitals revealed that medical personnel lacked the training and knowledge to safely administer treatments using advanced technology like I.M.R.T., and quality control was virtually nonexistent [17]. (b) accidental: - The incidents at various hospitals, such as overdosing cancer patients with radiation, were accidental in nature, stemming from mistakes made during treatment planning and delivery processes [17]. - Errors in treatment planning software, miscalculations, and deviations from established procedures were accidental factors contributing to the overradiation and substandard treatment of patients [17].
Duration unknown The articles do not specifically mention a software failure incident that can be categorized as either permanent or temporary.
Behaviour crash, omission, timing, value, other (a) crash: The incident at the Moffitt Cancer Center in Tampa, Florida, involved a miscalibrated machine that overradiated 77 brain cancer patients by 50 percent in 2004 and 2005, indicating a crash where the system lost its state and did not perform its intended functions [17]. (b) omission: The incident at Akron General Hospital in Ohio involved a patient being overdosed with high-dose radioactive seeds due to a physicist entering an incorrect magnification factor into the treatment planning computer, resulting in the system omitting to perform its intended functions correctly [17]. (c) timing: The incident involving Landreaux A. Donaldson at Mary Bird Perkins Cancer Center in Baton Rouge, Louisiana, highlighted a timing failure where the linear accelerator delivered radiation in a radically different way, prompting medical personnel to compensate with a departure from established procedure, but due to unfamiliarity with the treatment planning software, a miscalculation affected all 38 treatments over two months [17]. (d) value: The incident at Christus Spohn Hospital in Corpus Christi, Texas, involving George Garst being overdosed and seriously injured during his prostate cancer treatment, showcased a value failure where the system performed its intended functions incorrectly, resulting in severe injuries to the patient [17]. (e) byzantine: The articles do not provide specific information about a byzantine behavior of the software failure incident. (f) other: The incident at the Veterans Affairs Medical Center in East Orange, New Jersey, revealed a failure in the behavior of the system where

IoT System Layer

Layer Option Rationale
Perception None None
Communication None None
Application None None

Other Details

Category Option Rationale
Consequence death, harm (a) death: People lost their lives due to the software failure - Frederick Stein, a cancer patient at the Veterans Affairs Medical Center in East Orange, died in 2008 after being overradiated due to a software failure incident [17]. (b) harm: People were physically harmed due to the software failure - George Garst suffered severe radiation injuries, leading to him wearing two external bags for urine and fecal matter due to a software failure incident [17]. - Landreaux A. Donaldson experienced stomach ulcers, anemia, and urethral stricture, requiring surgery after receiving incorrect radiation treatments due to a software failure incident [17]. - Myra Jean Garman received twice her prescribed dose of radiation, resulting in broken ribs and severe pain, ultimately leading to her suicide [17].
Domain health The software failure incident discussed in the articles is related to the **health** industry. The incident involved radiation treatment errors in hospitals, leading to overradiation of cancer patients and serious injuries ([17]).

Sources

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