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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: Human Factors


  • When the user is other than the user
  • How much training
    • Mfg?
    • Interactive process
  • What does training need to look like
    • Pictures
    • Large font


  • Identify appropriate patient population
    • Dexterity –
    • User’s physical abilities
  • Is device disability friendly?

Breakout Groups

  • List barriers that family caregivers will face
  • Sources of training
  • What does training look like?
  • Identify user groups

Group 1 – Barriers Family Caregivers will face

  • Mental strength
  • Ability to multi-task
  • Physical ability of patient
    • Disability, eyesight, hearing
  • Language and comprehension
  • Environment – physically, electrically, animals
  • Patients overall knowledge of own disease process
  • Support system – multiple care, none, one, etc. family?
  • Transportation and portability concerns (daycare to dialysis)
  • Adaptation
  • Financial/insurance burdens
  • Overwhelmed by technology
  • Delivery model coordination
    • Between patient, user, home health agency, etc for cohesive delivery

Group 2 – Sources of training

  • Training material comes from mfg
    • Sales forces – trains healthcare professional (nurse)
    • Nurse trains family or healthcare professional
    • Family then trains another family member or patients
    • Sales force to patient
  • Materials
    • Customer service line
    • Chat online
    • Video/audio over internet
  • Inability to determine “who” receives and/or uses device
  • Concern – how should non-medical professional labeling be developed?
    • Can’t necessarily be developed in a way that is useful to the user

Group 3 – What does training look like?

  • Four vectors
  • Nature of device
    • Cognitively complex
    • Manually complex
  • Delivery of care – where? Care setting?
    • Institution
    • In-transit
    • Home
  • Nature of User

More on what user training would look like…..

  • Training itself – type of delivery
    • Self-directed
      • Set of instructions – static on paper or on screen (IFUs – artwork, AEDs – on device training – intensely self-directed
      • Web-based
      • Interactive – practice kit or…….?
    • Facilitated
      • Single instance training
      • Multiple Session Training – at institution, follow-up at home, etc.

Group 4 – Who is the user?

  • Division between actual patient and caregiver
  • Caregiver – can be in flux (ex. - child – change from parent to teacher…even within family)
    • Family member
    • From outside to help
  • Range of ages, education, nationalities, language, tech literacy, literary literacy
  • In stressful situations
  • Direct emotional relationship with patient (different from docs) – may influence how the approach care
  • Not trained as “problem solvers” – not triage nurses – people who are faced with certain amt of info and have to figure out what to do.

General Comments

  • Certain devices need to be active to determine if patient can really use device – with some devices, that could present a risk – how should validation studies be approached?
  • Consideration of who the users groups earlier in the design phase – iterative process of interactions with user groups
  • Understand better how devices will be segmented as initial point of contact and how training will be conducted when devices is used between many (for example, breast pump)
  • When does iPhone become medical device?
  • Consider thinking about multiple degrees/classes of home use medical devices – also consider level of training – could be different
  • Method of training –so many different paths for the way the devices gets into the users hand – labeling can be missing
  • Don’t have all of the partners-need to have them all in the room
    • Homecare agencies
    • Home medical equipment orgs
    • Pharmacies
    • Hospice Agencies
    • Insurance companies
    • CMS?
  • Labeling/Mfg
    • FDA guidance on specificity
    • Industry willing to help with developing classifications/degress of home use devices
  • Need to be mindful of the cost
  • Sometimes there is a direct line from mfg to user (“neophyte”)
  • Reimbursement
    • More we cut, harder to provide services such as value addded services
    • CMS and FDA need to be on same page
  • Training
    • Have to assume that no one gets more than ½ of what is taught
    • Important that materials that go home are useful and something that user can refer to
  • Can mfg separate what is required for user and clinically?
    • Have risk management, clinical instructions
    • Have quick start guide – critical steps included
  • FDA device classification – need to use easy words for user, but required to use language that is designed for physician – want to use “plain and simple language”
  • Social Media – How can you leverage the user base from collective experience and learning – and how can mfg use this information – how do you enable access to that kind of information with industry participation?
  • Older Devices existing in the field-
    • Some were never designed to be used in the home
    • What needs to be done to bring up older/existing devices up to a safer bar?
    • Who is responsible for that?
  • Differentiating between devices intended for at home monitoring versus those producing active therapy

Summary – Human Factors Discussion

Four Questions Presented to Group

  • When the user is other than the patient
  • Sources of Training
  • What does training need to look like
  • Barriers to Training