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U.S. Department of Health and Human Services

Medical Devices

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Medical Device Use in the Home Environment Guidance Workshop, May 24, 2010 - Breakout Session Notes: Physical Environment

  • Physical Environment – Home Use Workshop
    • IEC 60601-1-11 has collected a fair amount of information on the environment.
      • Doesn’t apply to all home use medical device but its principles (environmental properties, human factors) DO apply. [IEC 60601 only applies to electromedical equipment]
      • Does 1-11 cover integration issues with cell phones (as a data collection hub or processor)?
      • Cell phone as a source EMI.
      • Stand alone software covered by 1-11?
      • Generation of patient ID and name.
    • Electrical supply
      • Lower mains voltage, three prong plug – how do we design devices safely in this light?
      • Transient electrical testing handled by EMC standard.
      • What is the medical device industry doing with the building infrastructure industry?
      • Devices built over the last decade have higher immunity.
        • IEC 60601-1-2
          • Adequacy for home care
        • Some devices do need a protective earth – they must be installed properly
    • Power consumption
      • Battery backup?
        • 1-11 has disclosure requirement and need sufficient time in order to use other measures
    • Hazards due to CFLs
      • Filters, industry standards
      • LEDs are coming
    • Potential for a device to injury property
      • Safety standards do deal with emission of substances
    • Process
      • Disconnect in definition in guidance doc and standard
      • FDA definition of home health device missed some important elements
      • Recommendation that FDA move to leverage the standard more completely
        • Home health care environment definition
    • FDA oversight of home health care agencies
      • Use of devices is outside the scope of the medical device law
    • Environment
      • Temperature, pressure, humidity – 601 has requirements
    • Deficiencies in IEC 60601-1-11
      • Immunity levels for home (work in progress)
    • Hazardous situations resulting from convergence of equipment
      • The combination of all the monitors causes an assault on the patients
      • Harmonic technology eliminates the convergence – spins cancel