MEDICAL DEVICES: GOING HOME Food and Drug Administration Center for Devices and Radiological Health June 2004 - PowerPoint PPT Presentation

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MEDICAL DEVICES: GOING HOME Food and Drug Administration Center for Devices and Radiological Health June 2004

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Title: MEDICAL DEVICES: GOING HOME Food and Drug Administration Center for Devices and Radiological Health June 2004


1
MEDICAL DEVICES GOING HOMEFood and Drug
AdministrationCenter for Devices and
Radiological HealthJune 2004
2
BACKGROUND
  • Strategic plan 2001
  • Migration of devices into the home
  • Safe and effective use outside of hospital
  • Learn from stakeholders
  • Increase awareness of FDA regulatory authority
  • Communicate our vision to stakeholders

3
CDRH WORKING DEFINITIONDevices used in the
home environment-by persons who are ill or
disabled or by providers of care-users need
education and/or other related health care
services to use and maintain the devices safely
and effectively
4
EARLY ACTIONS
  • Interviewed CDRH subcommittees
  • Assessed current documents, workshops,
    publications, standards
  • Identified stakeholders
  • Focus groups and focused sessions
  • Rapid response survey
  • Public meeting
  • Website (www.fda.gov/cdrh/cdrhhhc

5
Aging Population
  • Age 2003 2025
    2050
  • 0- 4 y 6.5 6.0
    5.7
  • 5-14 y 14.3 12.2
    11.5
  • 15-24 y 13.8 12.1
    11.7
  • 25-64 y 52.9 50.9
    49.4
  • 65-74 y 6.4 11.0
    10.1
  • 75 6.1 7.8
    11.7

Source CDC estimates based on projections by UN
World Population Prospects, The 1998 Revision
6
Elements of Safe Home Care
Safe Effective HomeCare
Safe Effective Home Care
7
Device Industry Growth by Specialty
Note 1998 2001 used Dun Bradstreet Data
Other years used Dept. of Commerce Data to
include secondary products..
8
STRATIFICATION OF HOME USE DEVICES
Training And Certification e.g., Glucose
meters, implants apnea monitors
telemedicine
Training, certification, and oversight e.g.,
infusion therapy, peritoneal and Hemodialysis,
ventilators
Instructions e.g., tampons, Thermometers, Heating
pads
REQUIRED COMPETENCE
9
ACCOMPLISHMENTS
  • Representation on
  • Telehealth committee for DHHS
  • CMS Section 702 for devices used in the home

10
ACCOMPLISHMENTS (cont.)
  • Presentations
  • Open public meeting - Sept 2002
  • Advamed device manufacturer regulations staff
    training April 2003
  • Food and Drug Law Institute annual educational
    conference June 2003
  • FDA Science Forum poster May 2004
  • Catholic University Symposium April 2004
  • IEEE/Mitretek/Intel Public Policy Symposium
    June 2004
  • IEEE International Standards Conference Sept
    2004

11
ACCOMPLISHMENTS (cont.)
  • Publications
  • Article FDLI Update magazine Medical Devices
    Going Home Sept/Oct 2003
  • Home Healthcare Medical Device checklist brochure
    2003
  • Home Healthcare Medical Devices blood glucose
    meters brochure 2003
  • Home Healthcare Medical Devices Infusion Therapy
    brochure in development
  • Home Healthcare Medical Devices infusion therapy
    checklist laminated card for device distributors

12
ACCOMPLISHMENTS (cont.)
  • Websites
  • CDRH Home Healthcare committee website developed
    in 2003 and revised 2004
  • CDRH Home Healthcare committee infusion therapy
    website under development

13
ACCOMPLISHMENTS (cont.)
  • Other
  • Guidance document for infusion pumps
  • Infusion pump labeling warehouse
  • Wish list
  • User interface developed for pumps
  • Work with Great Britain
  • Continuing education for health care
    professionals
  • Increase speaking engagements

14
Effect of Regulatory Policy On Devices During the
Product Life Cycle
  • Discovery Distribution Use
  • Promote Grants Reimbursement Consumer
  • Contracts Advertisement
  • Reduce Quality Standards Knowledge
  • Error Systems Management
  • Inhibit Regulation Assessment Evidence Base
  • Decisions

Note Adapted from Susan Bartlett Foote
Managing the Medical Arms Race
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