Certification - FDA
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Tags: Software Engineering
Slide 1 - Certification: FDA
- Emerson Murphy-Hill
Slide 2 - Background: Therac-25
- Use radiation to destroy cancer tissue
- X-rays produced by hitting metal target with high-energy electrons
- Patient dosed inside a treatment room; operator stands outside
- 11 Units installed in US and Canada; hundreds of patients treated
- Six massive overdoses occurred in 1985-1987; recalled in 1987
Slide 3 - Background: Therac-25
- In Texas, 1986, a man received between 16,500-25,000 rads in less than 1 sec, over an area of about 1 cm.
- He lost his left arm, and died of complications 5 months later.
- In Texas, 1986, a man received at least 4,000 rads in the right temporal lobe of his brain.
- The patient eventually died as a result of the overdose.
- In Washington, 1987, a patient received 8,000-10,000 rads instead of the prescribed 86 rads.
- The patient died of complications of the radiation overdose
Slide 4 - FDA Regulations
- Medical device classification
- Class I: General Controls
- e.g., hand-held dental instruments, examination gloves
- Class II: General Controls with Special Controls
- e.g., x-ray machines, powered wheelchairs, infusion pumps, surgical needles
- Class III: General Controls and Premarket Approval
- e.g., replacement heart valves, implantable pacemaker pulse generators
- Before a company can market a new device, manufacturer must obtain from the FDA:
- 510(k) premarket clearance, or
- premarket approval (PMA), or
- Unless the device is exempt
- http://www.fda.gov/cdrh/index.html http://en.wikipedia.org/wiki/Medical_device