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September 12-13, 2002 Public Meeting on Home Health Care and Medical Devices

Presentation: Home Use of Medical Devices

See Related

Janine A. Purcell
Cognitive Engineer
VA National Center for Patient Safety

A Buffet of Methods regarding Home Use of Devices

Roadmap

Why the VA is interested

Devices Used in VA Population at Home2,3

HFMEA™ -- Prospective Ranking of Severity and Frequency

www.patientsafety.gov

HFMEA™ -- Severity

Catastrophic Event
(Traditional FMEA Rating of 10 - Failure could cause death or injury)
Major Event
(Traditional FMEA Rating of 7 – Failure causes a high degree of customer dissatisfaction.)
Patient Outcome: Death or major permanent loss of function (sensory, motor, physiologic, or intellectual), suicide, rape, hemolytic transfusion reaction, Surgery/procedure on the wrong patient or wrong body part, infant abduction or infant discharge to the wrong family
Visitor Outcome: Death; or hospitalization of 3 or more.
Staff Outcome: * A death or hospitalization of 3 or more staff
Equipment or facility: **Damage equal to or more than $250,000
Fire: Any fire that grows larger than an incipient
Patient Outcome: Permanent lessening of bodily functioning (sensory, motor, physiologic, or intellectual), disfigurement, surgical intervention required, increased length of stay for 3 or more patients, increased level of care for 3 or more patients
Visitor Outcome: Hospitalization of 1 or 2 visitors
Staff Outcome: Hospitalization of 1 or 2 staff or 3 or more staff experiencing lost time or restricted duty injuries or illnesses
Equipment or facility: **Damage equal to or more than $100,000
Fire: Not Applicable – See Moderate and Catastrophic

HFMEA™ -- Severity

Moderate Event
(Traditional FMEA Rating of “4” – Failure can be overcome with modifications to the process or product, but there is minor performance loss.)
Minor Event
(Traditional FMEA Rating of “1”– Failure would not be noticeable to the customer and would not affect delivery of the service or product.)
Patient Outcome: Increased length of stay or increased level of care for 1 or 2 patients
Visitor Outcome: Evaluation and treatment for 1 or 2 visitors (less than hospitalization)
Staff Outcome: Medical expenses, lost time or restricted duty injuries or illness for 1 or 2 staff
Equipment or facility: **Damage more than $10,000 but less than $100,000
Fire: Incipient stage‡ or smaller
Patients Outcome: No injury, nor increased length of stay nor increased level of care
Visitor Outcome: Evaluated and no treatment required or refused treatment
Staff Outcome: First aid treatment only with no lost time, nor restricted duty injuries nor illnesses
Equipment or facility: **Damage less than $10,000 or loss of any utility? without adverse patient outcome (e.g. power, natural gas, electricity, water, communications, transport, heat/air conditioning).
Fire: Not Applicable – See Moderate and Catastrophic

HFMEA™ – Probability Rating

HFMEA™ – Hazard Scoring Matrix

Probability Severity
  Catastrophic Major Moderate Minor
Frequent 16 12 8 4
Occasional 12 9 6 3
Uncommon 8 6 4 2
Remote 4 3 2 1

Define the expected user of a given Medical Device

Matching technology to the patient -- North Florida/South Georgia VISN 83

  • Multiple unstable DX
  • Auscultation required
  • Multiple patients within one facility
  • Wound visualization
  • Unable to read
 Telemonitor
  • Mildly unstable chronic DX
  • Single, Co-morbid, or tri-morbid disease related to available dialogues
  • Able to read or Caregiver to read to patient
 Disease Management / Health Buddy Device
  • Moderate to mild unstable DX
  • Has computer skills
  • Chat rooms
  • Need for face to face contact
 Personal Computer
  • Mildly unstable DX
  • Need for face to face
  • Unable to read
 Video Phone
  • Specific wound care need
  • Able to use camera
  • Submit pictures every 1-2 week minimum
 Instamatic Camera
With grid film
  • Unable to read
  • Unwilling or unable to use technology
  • Mildly unstable disease
 Telephone / No tech

“Many advances in technology are needed, but none are more important than a concentrated focus on hardware usability by patients.”4

Design it right

Design it right

Design it right

How can the culture of device design be explicitly changed? (User-centered aspects)

Website for VA National Center for Patient Safety

www.patientsafety.gov

References

  1. “Roswell Sworn in as VA Under Secretary for Health April 2002.” http://www.pva.org/NEWPVASITE/newsroom/PR2002/pr02032.htm
  2. Ryan, P., Kobb, R., and Roswell, R. “Identifying Veterans’ Needs for Home Telehealth.” In review for publication, 2002.
  3. Department of Veterans Affairs, Veterans Health Administration Manual M-5, “Geriatrics and Extended Care,” Part V, “Hospital Based Home Care” Change 1. November 1992.
  4. Kobb, Rita. Personal Communication. August, 2002.
  5. Darkins, A. and Cary, M. Telemedicine and Telehealth: Principles, Policies, Performance, and Pitfalls. Springer Publishing Company Inc., 2000.
  6. Gardner-Bonneau, D. and Gosbee, J. “Health Care and Rehabilitation”, in Handbook of Human Factors and the Older Adult. Fisk, Arthur D., and Rogers, Wendy, eds. Academic Press, 1996.

Updated 9/19/2002

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