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. Home Environment Patient/Caregiver Abilities/Resources Patient’s Medical Condition Communication w/ Health Care Team Medical Device Characteristics 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