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Can We Trust the Computer?. Case Study: The Therac-25 Based on Article in IEEE-Computer, July 1993. Introduction. More computers introduced into safety-critical systems results in more accidents One of the most widely reported accidents involved the Therac-25 radiation therapy machine

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can we trust the computer

Can We Trust the Computer?

Case Study: The Therac-25

Based on Article in IEEE-Computer, July 1993.

introduction
Introduction
  • More computers introduced into safety-critical systems
  • results in more accidents
  • One of the most widely reported accidents involved the Therac-25
    • radiation therapy machine
    • June 1985 and January 1987
  • Six known accidents - massive overdoses
    • causing deaths and serious injuries
  • Worst accidents in 35 year history of medical accelerators
introduction 2
Introduction(2)
  • Mistakes made not unique to this manufacturer
  • fairly common in other safety-critical systems
  • “A significant amt of SW for life-critical systems comes from small firms, especially in the medical industry; firms that fit the profile of those resistant to or uninformed of the principles of either system safety or software engineering.”
introduction 3
Introduction(3)
  • These problems are not limited to medical industry
  • Common belief that a good engineer can build SW, regardless of whether they are trained in state-of-the art SW-Engineering procedures
  • Many companies build safety-critical SW w/o using proper procedures from a SW-Eng and safety-engineering perspective
genesis of the therac 25
Genesis of the Therac-25
  • Medical linear accelerators accelerate electrons to create high-energy beams that can destroy tumors w/ minimal impact on surrounding healthy tissue
  • shallow tissue is treated w/ accelerated electrons; deeper tissue requires converting the electron beam into X-ray photons
the builders
The Builders
  • Early 70’s, Atomic Energy of Canada Limited (AECL) and a French company (CGR) collaborated to build linear accelerators
  • They developed 1) Therac-6 a 6MeV accelerator producing only X rays, and
  • 2) Therac-20, a 20-MeV dual mode(X Rays or electrons) accelerator
  • SW functionality was limited in both machines, it added convenience to existing hardware
  • Industry-standard hardware safety features and interlocks in the hardware were retained
developing therac 25 1
Developing Therac-25(1)
  • Mid 70’s, AECL developed a new double-pass concept for electron acceleration
  • needs less space to develop similar energy levels
  • AECL developed Therac-25, dual-mode linear accelerator
  • more compact and versatile than Therac-20
  • Therac-6,20,and25 controlled by PDP 11
  • Therac-25 takes advantage of computer control from outset while Therac-6 and 20 designed around machines already having histories of clinical use w/o computer control
  • Therac-25 has more responsibility for maintaining safety than SW in previous machines
safety issues new and old therac s
Safety Issues : New and Old Therac’s
  • Therac-20 had independent protective circuits to monitor electron-beam scanning
  • Therac-20 also had mechanical interlocks for policing machine and ensuring safe operation
  • Therac-25 relies more on SW for these functions
  • AECL took advantage of computer’s abilities to control and monitor HW
    • decided not to duplicate all existing HW safety mechanisms and interlocks
  • This approach is becoming more common
    • companies choosing to cut cost by avoiding extra HW interlocks and backups
    • Maybe they are placing more faith in SW
therac 25 development
Therac-25 Development
  • 1st hardwired Therac-25 developed in 1976
  • Completely computerized commercial version available in late 1982
  • March 1983, AECL performed a safety analysis in form of a fault tree and EXCLUDED SOFTWARE!
the safety analysis report before release of product
The Safety Analysis Report (before release of product)
  • Programming errors have been reduced by extensive testing on a HW simulator and under field conditions on teletherapy units. Any residual SW errors are not included in the analysis
  • Program SW does not degrade due to wear, fatigue, or reproduction process
  • Computer execution errors are caused by faulty HW components and by “soft” (random) errors induced by alpha particles and electromagnetic noise.
  • The fault tree does include computer failure but only hardware failures
    • ex) One OR gate leading to the event of getting the wrong energy is labeled with a probability of 1E-11
    • ex) the gate leading to Computer selects wrong mode is labeled with a probability of 4E-9
    • The report provides NO justification of either number!
therac 25 software development and design
Therac-25 Software Development and Design
  • SW for Therac-25 developed by a single person using PDP11 ASSEMBLY language
  • Developed over several years
  • SW “evolved” from Therac-26 (which was started in 1972)
  • Very little SW documentation produced during development
  • AECL also had an apparent lack of documentation on SW specifications and a SW test plan
therac 25 sw testing
Therac-25 SW Testing
  • Manufacturer said the HW and SW were “tested and exercised separately or together over many years”
  • In deposition, QA manager explained, testing was done in two parts
    • “small amount” of SW testing done on a simulator
    • most done on system
  • Reports indicate that unit and SW testing was minimal
  • Most testing efforts directed to integrated system test
  • Same QA manager at a Therac-25 users meeting stated the SW was tested for 2,700 hours
  • Under questioning by users clarified this as “2700 hours of use”
  • Programmer left AECL in 1986, we know nothing of the programmer
  • AECL employees could not provide any information about the programmers educational background or experience
how it operates
How it Operates
  • SW responsible for monitoring machine status
  • accepts input about treatment desired, sets machine up for treatment
  • turns beam on , activated by operator command
  • turns beam off when treatment is completed, or when operator commands it OR when a malfunction is detected
  • Unit has an interlock system designed to remove power to unit when there is a HW malfunction
  • Computer monitors interlock system and provides diagnostic messages
  • depending on fault the computer either prevents a treatment from starting OR if treatment is in progress, creates a pause or suspension of treatment
accident history
Accident History
  • Eleven Therac-25’s were installed
    • 5 in US; 6 in Canada
  • 6 accidents involving massive overdoses to patients occurred between 1985 and 1987
  • Machine recalled in 1987for extensive design changes, including HW safeguards against SW errors
  • Related problems found in Therac-20 SW, not recognized until after Therac-25 accidents
    • Not detected because of Therac-20 HW safety interlocks (so no injuries occurred)
kennestone regional oncology center 1985
Kennestone Regional Oncology Center, 1985
  • Marietta, Ga
  • Accident never carefully investigated, no admission that Therac-25 caused injury until much later
  • This despite claims by patient that she had been injured during treatment,
    • obvious and severe radiation burns patient suffered and suspicions of radiation physicist involved
kennestone 2
Kennestone(2)
  • After undergoing a lumpectomy to remove a malignant breast tumor, 61 yr. Old woman was receiving follow up radiation to nearby lymph nodes on
  • The Therac-25 had been operating at Kennestone for about 6 months other Therac 25-’s had been operating w/o incident since 1983.
  • Jun 3, 1985, patient set up for a 10-MeV electron treatment to clavicle area
  • When machine turned on, she felt a “tremendous force of heat… this red-hot sensation.”
  • Technician came in, she said, “you burned me.”
  • Technician replied that it was not possible
  • No red marks on patient at the time, but the area was “warm to the touch.”
kennestone 3
Kennestone (3)
  • Patient went home, shortly afterward developed a reddening and swelling in the center of the treatment area
  • her pain increased to the point that her shoulder “froze” and she experience spasms
  • She was admitted to West Paces Ferry Hospital in Atlanta, oncologists continued to send her to Kennestone for Therac-25 treatments
  • 2 weeks later, physicist at Kennestone noticed a matching reddening on her back as though burn had gone through her body
  • her should was immobile, she experienced great pain, patients breast had to be removed due to radiation burn
  • obvious that she had a radiation burn but hospital and doctors could not provide a satisfactory explanation
  • Kennestone physicist estimated she received one or two doses of radiation in 15k-20k range (typical doses are in 200 rad range)
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