Background on 

Background on 

Home Use Med

Home Use Med

Device Initiat

Device Initiat

Presented by Mary Presented by Mary Weick

-Brady, MS

Brady, MS

Senior Policy Analyst Senior Policy Analyst

Center for Devices and Radiological 

Center for Devices and Radiological 

May 2011 May 2011
Objectives Objectives

 Understand current home car

Understand current home car

 Describe why the Agency is in

Describe why the Agency is in

home use devices home use devices

 Explain risks with medical dev

Explain risks with medical dev

in the home environment in the home environment

 Understand the FDA Home Us

Understand the FDA Home Us

Initiative Initiative

 Identify Agency actions with t

Identify Agency actions with t

Use Device Initiative Use Device Initiative
Home Care Tren

Home Care Tren

 17,000 home care organizations (9284 M

17,000 home care organizations (9284 M

certified) certified)

 7.6 million individuals in home care 7.6 million individuals in home care $57.6 billion per year $57.6 billion per year Growing 20% per year Growing 20% per year 75% receive skilled nursing 75% receive skilled nursing 69% > 65 years old 69% > 65 years old 44 million are caregivers of someone >1

44 million are caregivers of someone >1

 2/3 are women 2/3 are women By 2030, 71.5 million over 65 By 2030, 71.5 million over 65 1/5 US adults report a disability (47.5 mi

1/5 US adults report a disability (47.5 m

(National Association for Homecare 2008 and BCC Research 2010
Cost of Inpatient Ca

Cost of Inpatient C

Compared to Home C

Compared to Home C

(Per Patient Mont

(Per Patient Mont

Conditions show where devices play a m

Conditions show where devices play a m

(NAHC 2008)

Conditions Conditions Hospital Cost Hospital Cost Home Care Home Care Cost 

Ventilator dependent Ventilator dependent adults

$21,570 $21,570 $7,050 

Oxygen dependent Oxygen dependent children children

$12,090 $12,090 $5,250 

Chemotherapy for Chemotherapy for children children

$68,870 $68,870 $55,950 $55,950 

Congestive heart failure in Congestive heart failure in adults

$1,758 $1,605 

IV antibiotic therapy IV antibiotic therapy $12,510 $12,510 $4,650 
Impact of Healthcare T

Impact of Healthcare T

on Home Care on Home Care

 Economic Forces Economic Forces

 Patients being sent home sicker, quicker, 

Patients being sent home sicker, quicker, 

technology technology 

 Caregivers Caregivers

 Vary from clinicians to family to the care 

Vary from clinicians to family to the care 

 Medical Technology Medical Technology

 Devices are more complex, smaller, and 

Devices are more complex, smaller, and 

 Devices used in the clinical setting are m

Devices used in the clinical setting are m

home

 Patient (Care Recipient) Patient (Care Recipient)

 More knowledge about healthcare option

More knowledge about healthcare option

 More empowered and active in the decisi

More empowered and active in the decisi

 Setting Setting

 Hospital directly to home Hospital directly to home
Why is the Agency In

Why is the Agency In

in Home Use Devi

in Home Use Devi

 Untrained and inexperienced 

Untrained and inexperienced 

 Economic forces Economic forces Advanced medical devices a

Advanced medical devices a

home

 The home is an uncontrolled The home is an uncontrolled 

environment with additional 

environment with additional 
Medical Devices Mi

Medical Devices Mi

Into the Home Into the Home – 

– Ne

Ne

 Environment Environment

 Children Children Electromagnetic Interference (EMI) Electromagnetic Interference (EMI) Location Location Noise Pets and vermin Pets and vermin Power outages and sources Power outages and sources Public emergencies Public emergencies Safety Sanitation Sanitation Space Temperature, air quality, humidity Temperature, air quality, humidity Waste Water 
Medical Devices Migrating 

Medical Devices Migrating 

Home – 

– New Risks (co

New Risks (co

 Use

 Compatible with lifestyle and usefu

Compatible with lifestyle and usefu

 Instructions for use are poor or no

Instructions for use are poor or no

 Interface and ease of use Interface and ease of use Off label use Off label use Ruggedness of the device Ruggedness of the device Selling Rx devices on the internet Selling Rx devices on the internet User’s educational level s educational level User’s cognitive abilities s cognitive abilities User’s physical abilities s physical abilities User’s emotional stability s emotional stability
Home Use Medical D

Home Use Medical D

Initiative Initiative

FDA launched the FDA launched the Home Use Medical Device 

Home Use Medical Device 

to address the safe use of m

to address the safe use of m

devices in the home. devices in the home.
Home Use Medical D

Home Use Medical D

Initiative Initiative 

1.Establish guidelines for manufactur

Establish guidelines for manufactur

use devices use devices

2.Develop a home use device labeling 

Develop a home use device labeling 

3.Partner with home health accreditin

Partner with home health accreditin

support safe use support safe use

4.Enhance postmarket oversight Enhance postmarket oversight5.Increase public awareness and edu

Increase public awareness and edu
Establish Guideline

Establish Guideline

Manufacturers Manufacturers 

 Develop Guidance Develop Guidance  Public workshop held May 24, 

Public workshop held May 24, 

collect information for Guidanc

collect information for Guidan

 Also to address the definition of 

Also to address the definition of 

device

 Guidance currently being draf

Guidance currently being draf
Develop a Home 

Develop a Home 

Device Labeling Rep

Device Labeling Rep

 Medical devices labeled for ho

Medical devices labeled for ho

 10 month pilot 10 month pilot  Manufacturers submit their lab

Manufacturers submit their lab

electronically electronically

 Public Workshop April 7, 2011 Public Workshop April 7, 2011

 Pros and cons surrounding posti

Pros and cons surrounding posti

package inserts on one website package inserts on one website

 Identify informational needs Identify informational needs
Partner With Home 

Partner With Home 

Accrediting Bodi

Accrediting Bodi

Support Safe Hom

Support Safe Hom

 Working with 3 main accrediti

Working with 3 main accredit

 Will work to incorporate medi

Will work to incorporate medi

into their accreditation standa

into their accreditation standa

 Encouraged the development 

Encouraged the development 

and CME to include medical d

and CME to include medical d

reporting to FDA reporting to FDA
Enhance Postma

Enhance Postma

Oversight Oversight

 Difficult to ascertain adverse events w

Difficult to ascertain adverse events w

devices used in the home devices used in the home

 We received over 10,000 reports whe

We received over 10,000 reports whe

“home

” was used in the narrative was used in the narrative

 Challenging to obtain information abo

Challenging to obtain information abo

home setting home setting 

 Self-blame Fear of reporting Fear of reporting

 Work with MedSun to encourage repo

Work with MedSun to encourage repo

health care agencies health care agencies
Increase Publ

Increase Publ

Awareness and Edu

Awareness and Edu

 Partnerships Partnerships Social Media Social Media Presentations and webinars Presentations and webinars Training modules Training modules Standards Standards

Educate all stakeholders about 

Educate all stakeholders about 

devices and the responsibilities e

devices and the responsibilities e

has to assure their safe use in th

has to assure their safe use in t
Summary Summary

 Home Care Trends Home Care Trends Agency’s interest in home 

s interest in hom

medical device safety medical device safety

 Risks associated with hom

Risks associated with ho

 FDA’s Home Use Initiativ

s Home Use Initiativ

 FDA’s Actions s Actions