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Module 5 Group Case Therac 25 (Software (Sensors can go bad and and give…
Module 5 Group Case Therac 25
Background Information
Facts
Real time software that uses machine language
March 1983 AECL performs safety test however they do not test software of the Therac-25
Therac-25 medical linear accelerator used for treating cancer using radiation
Doctor prescribes number of treatments and dosage for patient in RADS (radiation absorbed dose)
Summer 1985 within two month span AECL received two different complaints
Stakeholders
Patients
Kennestone Regional Oncology Center
AECL
Yakima Valley Memorial Hospital
East Texas Cancer Center
FDA
CDRH
Policies and changes to prevent this issue from occurring
Implement extra safeguards. Always have hardware safeguards in addition to software safeguards
Have multiple people review the software before releasing it for use.
Develop improved software using good pieces from the Therac-20, but not the exact program.
Software
Real time software interacts with the world on the world's schedule.
Software is reading and responding to sensors about the state of the world
This software is hard to write and maintain.
Sensors can go bad and and give incorrect information.
When they do fail this the software needs to be able to detect those problems and react accordingly so life is not endangered.
While the software is responding to changes that need to be made in one area, changes might need to occur in another area that might need attention .
Dilemma; What options does the programmer have, and what are his ethical responsibilities in this case?
Utilize safeguards, review the Therac-20 software, and get input from others before releasing the Therac-25 for use.
Pros of this action
ability to determine how the Therac-20 software worked and how to ensure that it continues to work
best possible treatment for cancer patients
greater chance of errors being detected
lower risk of injury even if the software does have errors
Most likely higher percentage of success for the hospital
Cons of this action
more time that the Therac-25 is not helping people with cancer
More money must be spent
Many more people must be found
The cancer patients have even hire medical bills having to wait for their treatments
The families who rely on the sick family members income have to live without that it for even longer
Who is benefitted
The people being treated by the Therac-25 are safer
The Hospitals/Operators can handle the Therac-25 with more confidence
The programmer holds significantly less legal responsibility in the case of an accident
Who is harmed
AECL loses money the later it releases the Therac-25
The families of the patients who may be relying on the individual who is diagnosed to support the family and need the income they usually bring home
Patients who need immediate treatment
The hospital needing to staff the amount of nurses and doctors needed to care for these people until they get their treatments
Rights abridged
People in need of treatment as soon as possible are unable to get the treatment they need when they need it possibly costing them their life.
What if everyone took this action
Companies would have to spend more money to develop safe software, and it would often take much longer for possible lifesaving programs to be approved for use.
People would have much more trust in the reliability of software, and fewer accidents would occur.
Put out the Therac-25 with complete confidence and reliance in re-purposed software from the Therac-20.
Pros of this action
avoids extra expenses
The re-purposed software has been field tested
Cancer patients who are in need can get treatment quicker
Therac-25 is released for use sooner
Could possibly get some patients well enough to return to their jobs and support their families
Cons of this action
too much confidence in programming results in denial of problems
no backup plan in the case of errors
greater chance for errors to go undetected
risk of liability could make shareholders pull funds
Client could have to stay in the hospital longer anyway because of complications or something going wrong with the treatment
Who is benefitted
AECL
People that need immediate cancer treatment
The companies
Clinicians
Who is harmed
Clients who experience consequences of software errors
The doctors reputation for offering the technology
The programmer in the case of a negligent error
The medical insurance companies who have to cover anything that could possibly go wrong with this treatment not being full proof
Rights abridged
violation of a person's right for the most accurate treatment of their cancer for a quicker launch of a repurposed old product.
What if everyone took this action
There would be many more accidents as a result of software errors, this could result in a reversal of public opinion about the reliability of computers
Companies would be able to spend less money on programs, potentially giving them resources to develop even more programs. It would not take as long for beneficial software to be approved for use.
Which action should be taken?
Safeguards should be set, and there should be reviews of the software by multiple people before it is used in the Therac-25
Even though there were no standards at the time for how to properly create and test software, the programmer should recognize the dangers that errors would have and take every precaution possible.