Title: MEDICAL DEVICES: GOING HOME Food and Drug Administration Center for Devices and Radiological Health June 2004
1MEDICAL DEVICES GOING HOMEFood and Drug
AdministrationCenter for Devices and
Radiological HealthJune 2004
2BACKGROUND
- 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
3CDRH 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
4EARLY 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
5Aging 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
6Elements of Safe Home Care
Safe Effective HomeCare
Safe Effective Home Care
7Device Industry Growth by Specialty
Note 1998 2001 used Dun Bradstreet Data
Other years used Dept. of Commerce Data to
include secondary products..
8STRATIFICATION 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
9ACCOMPLISHMENTS
- Representation on
- Telehealth committee for DHHS
- CMS Section 702 for devices used in the home
10ACCOMPLISHMENTS (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
11ACCOMPLISHMENTS (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
12ACCOMPLISHMENTS (cont.)
- Websites
- CDRH Home Healthcare committee website developed
in 2003 and revised 2004 - CDRH Home Healthcare committee infusion therapy
website under development
13ACCOMPLISHMENTS (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
14Effect 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