Home Use Med

Home Use Med

Devices: New R

Devices: New R

Presented by Janette Collins Presented by Janette Collins

-M

M

MT, MS, RN MT, MS, RN

Nurse Consultant Nurse Consultant

Center for Devices and Radiolo

Center for Devices and Radiol

Health

May 2011 May 2011
Objectives Objectives

 Understand Regulatory Defini

Understand Regulatory Defini

 Provide Examples of Common 

Provide Examples of Common 

Devices and Emerging Techn

Devices and Emerging Techn

 Reiterate Emerging Trends in 

Reiterate Emerging Trends in 

 Identify Risks in the Home En

Identify Risks in the Home En

 Describe device design consi

Describe device design consi
 Definition Definition

An instrument, apparatus, implement, mac

An instrument, apparatus, implement, mac

contrivance, implant, in vitro contrivance, implant, in vitro reagent, or o

reagent, or o

related article, including a component part

related article, including a component part

 Intended for use in th Intended for use in the diagnosis of 

e diagnosis of 

conditions, cure, mitigation, treatme

conditions, cure, mitigation, treatme

prevention of disease prevention of disease 

 Intended to affect the stru Intended to affect the structure or a

cture or a

the body of man or other animals the body of man or other animals

U.S. Food and Drug Administration. Food, Drug and Cosmetic Act. Section 201(h) definition of dehttp://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/s/ucm086297.htm.

Medical Devic

Medical Devic
 Definition Definition

▪ Intended for users in any enviro

Intended for users in any envirofrom the professional healthcar

from the professional healthcar

emergency medical services emergency medical services

▪ May require training for the use

May require training for the use

healthcare professional to assu

healthcare professional to assueffective use. effective use.

Home Use Devi

Home Use Devi
Home Device U

Home Device U

 Definition

▪ A care recipient or patient, an

family member 

▪ A qualified healthcare profess

licensed or non-licensed healprofessional


Common Home Common Home 

Use Devices Use Devices

 Capital Equipment and A

Capital Equipment and A

Technology Technology 

 Medical beds, bedrails, wh

Medical beds, bedrails, wh

walkers, patient lifts, show

walkers, patient lifts, show

 Home Therapeutics Home Therapeutics

 hemodialysis, infusion pum

hemodialysis, infusion pum

 Instruments Instruments

 glucose meters, pulse glucose meters, pulse oxim

oxi

insulin pumps insulin pumps
Common Home Common Home 

Use Devices Use Devices

 Monitoring Systems Monitoring Systems

 patient call systems patient call systems

 Disposables & Accessories Disposables & Accessories

 ventilator breathing circuits, filters, 

ventilator breathing circuits, filters, 

IV catheters, IV tubing, gloves IV catheters, IV tubing, gloves

 Implantables Implantables

 defibrillators, hip/knee implants, dru

defibrillators, hip/knee implants, dru

 Computerized Medical Systems Computerized Medical Systems 

 Hardware and Software Hardware and Software

 Reagents Reagents

 Fecal occult blood tests Fecal occult blood tests
Examples of Emerg

Examples of Emerg

Technologies for the H

Technologies for the H

 Health Informatics Health Informatics Nanotechnology Nanotechnology Smart Homes and Intero

Smart Homes and Intero

Technology Technology

 Telehealth Telehealth Wireless Technology Wireless Technology
Emerging Home Emerging Home 

Care Trends Care Trends 

 By 2030, 71.5 million over 

By 2030, 71.5 million over 

 69% > 65 years old 69% > 65 years old 1/5 US adults report a disa

1/5 US adults report a disa

million) million)
Emerging Home Care 

Emerging Home Care 

(cont.) (cont.)

 7.6 million individuals in hom

7.6 million individuals in hom

 20,000 home care organizatio

20,000 home care organizatio

Medicare certified) Medicare certified)

 44 million are caregivers of s

44 million are caregivers of s

>18
Impact of Healthcare 

Impact of Healthcare 

on Home Care on Home Care

 Setting Setting 

 Hospital to home Hospital to home

 Caregiving Caregiving responsibility responsibility

 Clinicians to family to care re

Clinicians to family to care re
Impact of Healthcare 

Impact of Healthcare 

on Home Care on Home Care co

 Medical Technology Medical Technology 

 Device size Device size 

 Health Information Health Information

 Patient empowered Patient empowered 
Medical Devices Mig

Medical Devices Mig

Into the Home Into the Home – 

– New 

New 

 Environmental considerations Environmental considerations

 Location Location Housing structure, Space, Sanit

Housing structure, Space, Sanit

Temperature, Air Quality, Humid

Temperature, Air Quality, Humid

 Power Outages and sources Power Outages and sources  Electromagnetic Interference (E

Electromagnetic Interference (E
Medical Devices Mig

Medical Devices Mig

Into the Home Into the Home – 

– New 

New 

 Environmental considerations Environmental considerations

 Children, Pets, Dust and ver

Children, Pets, Dust and ver

 Safety, Noise Safety, Noise Public emergencies Public emergencies
Use considerations:

 Emotional Stability  Physical Capability Education Cognitive Abilities 

Medical Devices Mig

Medical Devices Mig

Into the Home Into the Home –New 

New 
 Use considerations

 Educational variances  Skilled Users  Training 

 Labeling Labeling 

Medical Devices Mig

Medical Devices Mig

Into the Home Into the Home –New 

New 
Design of Home 

Use Devices Use Devices .

User Considerations User Considerations

 Calibration and Calibration and 

Operation Operation

 Device maintenance Device maintenance Troubleshooting Troubleshooting Device replacement parts Device replacement parts
Design of Home Use 

Use 

Device Considerations Device Considerations

 Language Language Print Format Display Display 

 Ambient lighting Ambient lighting
Design of Home Use 

Use 

Device Considerations Device Considerations

 Labeling Instructions Labeling Instructions

 Information and Information and 

instructions for use instructions for use

 Packaging Packaging
Home Use Device

Home Use Device

Should be Should be

...

 Useful Usable Iterative Iterative
Home Use Device

Home Use Device

Should be Should be

...

 Intentional Intentional

 Intuitive Intuitive Integratable Integratable
Home Use Devices Shou

Home Use Devices Sho

 Informative Informative Address the risks unique to t

Address the risks unique to t
Summary Summary

 Regulatory Definitions Regulatory Definitions Examples of common hom

Examples of common hom

devices and emerging tec

devices and emerging tec

 Emerging home care tren

Emerging home care tren

 Identified risks unique to 

Identified risks unique to 

setting setting

 Device design considerat

Device design considerat