Early1970s
|
AECL and a French Company (CGR) collaborate to build Medical Linear
Accelerators (linacs). They develop Therac-6, and Therac-20. (AECL
and CGR end their working relationship in 1981.)
|
1976
|
AECL developes the revolutionary "double pass" accelerator which
leads to the development of Therac-25.
|
March, 1983
|
AECL performs a safety analysis of Therac-25 which apparently excludes
an analysis of software.
|
July 29,1983
|
In a PR Newswire the Canadian Consulate General announces the introduction
of the new "Therac 25" Machine manufactured by AECL Medical, a division
of Atomic Energy of Canada Limited.
|
ca. Dec. 1984
|
Marietta Georgia, Kennestone Regional Oncology Center implements
the new Therac-25 machine.
|
June 3, 1985
|
Marietta Georgia, Kennestone Regional Oncology Center
Katherine (Katy) Yarbrough, a 61-year-old woman is overdosed during
a follow-up radiation treatment after removal of a malignant breast
tumor. Tim Still, Kennestone Physicist calls AECL asking if overdose
is possible; three days later he is informed it is not.
|
July 26, 1985
|
Hamilton, Ontario, Canada. Frances Hill, a 40-year-old patient
is overdosed during treatment for cervical carcinoma. AECL is informed
of the injury and sends a service engineer to investigate.
|
|
|
November 3, 1985
|
Hamilton Ontario patient dies of cancer, but it is noted on her
autopsy that had she not died, a full hip replacement would have
been necessary as a result of the radiation overdose.
|
November 8, 1985
|
Letter from CRPB to AECL requesting additional hardware interlocks
and changes in software. Letter also requested treatment terminated
in the event of a malfunction with no option to proceed with single
key-stroke. (under Canadas Radiation Emitting Devices Act.)
|
|
|
November 18, 1985
|
Katy Yarbrough files suit against AECL and Kennestone Regional
Oncology Center. AECL informed officially of Lawsuit.
|
December 1985
|
Yakima Valley Memorial Hospital, Yakima Washington. A woman being
treated with Therac-25 develops erythema on her hip after one of
the treatments.
|
January 31, 1986
|
Staff at Yakima sends letter to AECL and speak on the phone with
AECL technical support supervisor.
|
February 24, 1986
|
AECL technical support supervisor sends a written response to Yakima
claiming that Therac-25 could not have been responsible for the
injuries to the female patient.
|
March 21, 1986
|
East Texas Cancer Center, Tyler Texas. Voyne Ray Cox is overdosed
during treatment on his back. Fritz Hager notifies AECL. Company
suggests some tests and suggests hospital might have an electrical
problem. AECL claims again that overdoes is impossible and that
no other accidents have occurred previously.
|
March 22, 1986
|
Ray Cox checks into an emergency room with severe radiation sickness.
Fritz Hager calls AECL again and arranges for Randy Rhodes and Dave
Nott to test Therac. They travel to Texas and test Therac but find
nothing wrong.
|
April 7, 1986
|
ETCC has investigated electrical problem possibility, finding none,
put Therac-25 back in service.
|
April 11, 1986
|
East Texas Cancer Center. Another Verdon Kidd is overdosed during
treatments to his face. Operator is able to explain how Malfuction
54 was achieved. Fritz Hager tests computers readout of no
dose, and discovers the extent of the overdoses. Hager spends weekend
on phone with AECL explaining findings.
|
April 14, 1986
|
AECL files report with FDA. AECL sends letter to Therac-25 users
with suggestions for avoiding future accidents, including the removal
of the up-arrow editing key and the covering of the contact with
electrical tape.
|
May 1, 1986
|
Verdon Kidd, who was to have received treatments to left ear dies
as a result of acute radiation injury to the right temporal lobe
of the brain and brain stem. He is the first person to die from
therapeutic radiation accident.
|
May 2, 1986
|
FDA declares Therac-25 defective, and their "fix" letter to users
inadequate. FDA demands a CAP from AECL.
|
June 13, 1986
|
AECL produces first CAP for FDA.
|
July 23, 1986
|
FDA has received CAP, asks for more information.
|
August, 1986
|
Therac-25 users create a user group and meet at the annual conference
of the American Association of Physicists in Medicine
|
August, 1986
|
Ray Cox, overdosed during back treatment, dies as a result of radiation
burns.
|
September 23, 1996
|
Debbie Cox and Cox family file lawsuit
|
September 26, 1986
|
AECL provides FDA with more information.
|
October 30, 1986
|
FDA requests more information.
|
November 1986
|
Physicists and engineers from FDAs CDRH conducted a technical
assessment of the Therac-25 at AECL manufacturing plant in Canada
(R.C. Thompson).
|
November 12, 1986
|
AECL submits revision of CAP.
|
December
|
Therac-20 users notified of a software bug.
|
December 11, 1986
|
FDA requests more changes to CAP.
|
December 22, 1986
|
AECL submits second revision of CAP.
|
January 17, 1987
|
Second patient, Glen A. Dodd, a 65-year-old man, is overdosed at
Yakima.
|
January 19, 1987
|
AECL issues hazard notification to all Therac-25 users and told
them to visually confirm the position of the turntable before turning
on beam.
|
January 26, 1987
|
Conference call between AECL quality assurance manager and Ed Miller
of FDA. AECL sends FDA revised test plan. AECL calls Therac users
with instructions on how to avoid beam on when turntable is in field
light position.
|
February 3, 1987
|
AECL announces additional changes to Therac-25
|
February 6, 1987
|
Ed Miller calls Pavel Dvorak of Canadas Health and Welfare
department with news that FDA will recommend that all Therac 25
units be taken out of service until CAP is completed.
|
February 10, 1987
|
FDA sends notice to AECL advising that Therac is defective under
US law and requesting AECL to notify customers that it should not
be used for routine therapy. Canadian Health Protection Branch does
the same.
|
March 1987
|
Second User Group Meeting
|
March 5, 1987
|
AECL sends third revision of CAP to FDA.
|
April 1987
|
Glen A. Dodd, overdosed at Yakima, dies of complications from radiation
burns to his chest.
|
April 9, 1987
|
FDA asks for additional information regarding third CAP revision.
|
April 13, 1987
|
AECL sends update of CAP and list of nine items requested by users
at March meeting.
|
May 1, 1987
|
AECL sends fourth revision of CAP to FDA as a result of FDA commentary
at user meeting.
|
May 26, 1987
|
FDA approves fourth CAP subject to final testing and analysis.
|
June 5, 1987
|
AECL sends final test plans to FDA along with safety analysis.
|
July, 1987
|
Third Therac-25 User Group Meeting
|
July 21, 1987
|
AECL sends final (fifth) CAP revision to FDA.
|
January 28, 1988
|
Interim safety analysis report issued from AECL.
|
November 3, 1988
|
Final safety analysis report issued.
|