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
- Interactive process
- What does training need to look like
- Large font
- Identify appropriate patient population
- Dexterity –
- User’s physical abilities
- Is device disability friendly?
- 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)
- 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
- 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?
- Nature of User
More on what user training would look like…..
- Training itself – type of delivery
- Set of instructions – static on paper or on screen (IFUs – artwork, AEDs – on device training – intensely self-directed
- Interactive – practice kit or…….?
- 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.
- 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
- Hospice Agencies
- Insurance companies
- 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”)
- More we cut, harder to provide services such as value addded services
- CMS and FDA need to be on same page
- 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