1. MEDICAL DEVICES: GOING HOME Food and Drug Administration Center for Devices and Radiological Health June 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 DEFINITION Devices 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. Safe & Effective HomeCare Patient/Caregiver Abilities/Resources Home Environment Communication w/ Health Care Team Medical Device Characteristics Patients Medical Condition Elements of Safe 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 REQUIRED COMPETENCE Instructions e.g., tampons, Thermometers, Heating pads Training And Certification; e.g., Glucose meters, implants apnea monitors telemedicine Training, certification, and oversight e.g., infusion therapy, peritoneal and Hemodialysis, ventilators

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 DiscoveryDistributionUse Promote GrantsReimbursementConsumer & ContractsAdvertisement Reduce QualityStandardsKnowledge Error SystemsManagement Inhibit RegulationAssessmentEvidence Base Decisions Note: Adapted from Susan Bartlett Foote: Managing the Medical Arms Race