MEDICAL DEVICE SAFETY
HCRQ’s early contracts, in system safety and software safety, involved medical devices of various types.
HCRQ continues to support the medical device sector including the provision of system safety and software safety courses and webinars and, as a result, is well known by FDA and Health Canada.
A FEW OF OUR PAST MEDICAL DEVICE CONTRACTS
AECL MEDICAL - THERAC-25 CANCER THERAPY MACHINE
We received a call from the medical products division of Atomic Energy of Canada Limited to meet with them on June 12, 1986. Incidents involving patient injury and death, due to severe radiation overdoses administered by their THERAC-25 computer-controlled cancer therapy machine, prompted this call for help.
The first death occurred following an accident at the East Texas Cancer Clinic in Tyler, Texas on March 21, 1986 while the second followed an accident on April 11, 1986. This machine, based on a linear particle accelerator, had delivered lethal doses of radiation (estimated to be 16,500 to 25,000 rads) to patients within fractions of a second. Another accident was to follow at the Yakima Valley Memorial Hospital in Yakima, Washington on January 17 of the following year.
These accidents were widely publicized and, even to this day, they are a topic of conversation amongst software safety engineers.
HCRQ performed exhaustive analyses of the software. Extensive recommendations were provided to AECL Medical's management as well as to a special task force known as the "THERAC-25 Safety Check Committee". Our assessments not only focused on the software, but its maintenance, verification, development environment, and documentation. Needless to say, this work was very sobering.
HCRQ's support of AECL Medical, the THERAC-25, and other products continued for years. Overall, HCRQ had a very positive effect on these products and takes pride in the fact that its influence led to significantly increased patient safety.
Very few people have been aware of HCRQ's role in connection with the THERAC-25.
The first death occurred following an accident at the East Texas Cancer Clinic in Tyler, Texas on March 21, 1986 while the second followed an accident on April 11, 1986. This machine, based on a linear particle accelerator, had delivered lethal doses of radiation (estimated to be 16,500 to 25,000 rads) to patients within fractions of a second. Another accident was to follow at the Yakima Valley Memorial Hospital in Yakima, Washington on January 17 of the following year.
These accidents were widely publicized and, even to this day, they are a topic of conversation amongst software safety engineers.
HCRQ performed exhaustive analyses of the software. Extensive recommendations were provided to AECL Medical's management as well as to a special task force known as the "THERAC-25 Safety Check Committee". Our assessments not only focused on the software, but its maintenance, verification, development environment, and documentation. Needless to say, this work was very sobering.
HCRQ's support of AECL Medical, the THERAC-25, and other products continued for years. Overall, HCRQ had a very positive effect on these products and takes pride in the fact that its influence led to significantly increased patient safety.
Very few people have been aware of HCRQ's role in connection with the THERAC-25.
BAXTER DIAGNOSTICS' IMMUNOASSAY SYSTEM SAFETY ANALYSIS
Analyzed hazards included false-positive and false-negative diagnoses. EDS commended our work - "Excellent service, responsiveness and extreme attention to detail. We were quite impressed and had them take over the project completely. The project was completed on time and, above all, our customer was very pleased."
AASTROM CELL PRODUCTION SYSTEM SAFETY ANALYSIS
The Aastrom CPS is an integrated system of instrumentation and single-use consumable kits that implements Aastrom's patented "single-pass perfusion" process in a fully automated, closed fluid path culturing system to optimize cell growth and viability.
This proprietary system provides nutrients to cells by mimicking the natural cell-growth environment, and enabling human cells to grow while retaining high biological function. In addition, this system provides GMP-compliant manufacturing and automated process control for the commercial-scale production of cells to be used in medical practice.
We performed FMEAs, software hazard analyses, fault tree analysis, and verification cross-reference matrix on the CPS incubator, processor and system manager.
This proprietary system provides nutrients to cells by mimicking the natural cell-growth environment, and enabling human cells to grow while retaining high biological function. In addition, this system provides GMP-compliant manufacturing and automated process control for the commercial-scale production of cells to be used in medical practice.
We performed FMEAs, software hazard analyses, fault tree analysis, and verification cross-reference matrix on the CPS incubator, processor and system manager.
Do you need help with:
Medical device fault tree analysis? You could not have come to a better place.
- Medical Devices - Application of Risk Management to Medical Devices - ISO 14971,
- Medical Devices - Application of Risk Management to Medical Devices, Rationale for Requirements - ISO 14971,
- Medical Electrical Equipment - Part 1-4: General Requirements For Safety - Collateral Standard: Programmable Electrical Medical Systems - IEC 60601-1-4,
- Medical Device Software - Software Life-Cycle Processes - IEC 62304,
- Guidance For The Content Of Premarket Submissions For Software Contained In Medical Devices, Food and Drug Administration,
- General Principles Of Software Validation - Final Guidance For Industry And FDA Staff, Food and Drug Administration,
- Guidance For Industry, FDA Reviewers And Compliance On Off-The-Shelf Software Use In Medical Devices, or
- ***Safety Assurance Cases***.
Medical device fault tree analysis? You could not have come to a better place.
- HCRQ has been performing fault tree analysis for over 25 years.
- HCRQ uniquely defined acceptance/rejection criteria for fault tree analyses.
- HCRQ teaches fault tree analysis.
- Over half of the medical device fault trees analyses HCRQ has seen have been (how can we say this politely?) poor. This is usually due to lack of skills either of the medical device manufacturer analysts or of the consultants that have been used.