Certification - FDA

Software Engineering

Certification - FDA

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  1. Certification: FDA

    Slide 1 - Certification: FDA

    • Emerson Murphy-Hill
  2. Background: Therac-25

    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
  3. Background: Therac-25

    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
  4. FDA Regulations

    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