MEDICAL DEVICES: GOING MEDICAL DEVICES: GOING HOMEHOME

Food and Drug AdministrationFood and Drug AdministrationCenter for Devices and Center for Devices and

Radiological HealthRadiological Health

June 2004June 2004

BACKGROUNDBACKGROUND• 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

CDRH WORKING DEFINITIONCDRH WORKING DEFINITION

Devices used in the home environment:Devices used in the home environment:-by persons who are ill or disabled or by -by persons who are ill or disabled or by

providers of careproviders of care-users need education and/or other related -users need education and/or other related

health care services to use and maintain the health care services to use and maintain the devices safely and effectivelydevices safely and effectively

EARLY ACTIONSEARLY 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

Aging PopulationAging 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

Safe & Effective HomeCare

Safe & Effective Home Care

Safe & Effective Home Care

Patient/Caregiver Abilities/ResourcesPatient/Caregiver

Abilities/ResourcesHome

EnvironmentHome

Environment

Communication w/ Health Care TeamCommunication w/ Health Care Team

Medical Device CharacteristicsMedical Device Characteristics

Patient’s Medical Condition

Patient’s Medical Condition

Elements of Safe Home Care

Device Industry Growth by Specialty

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 '00 '01

Calendar Years

Num

ber

of M

anuf

actu

rers

Instrument

Surgical

Dental

X-Ray

Electromedical

Ophthalmic

Diagnostics

Note: 1998 & 2001 used Dun & Bradstreet Data; Other years used Dept. of Commerce Data to include secondary products..

STRATIFICATION OF HOME USE STRATIFICATION OF HOME USE DEVICESDEVICES

REQUIREDCOMPETENCE

Instructionse.g., tampons,Thermometers,Heating pads

TrainingAnd Certification; e.g., Glucose meters, implants apnea monitors telemedicine

Training, certification, and oversighte.g., infusion therapy, peritoneal and Hemodialysis, ventilators

ACCOMPLISHMENTSACCOMPLISHMENTS

• Representation on:– Telehealth committee for DHHS– CMS Section 702 for devices used in the

home

ACCOMPLISHMENTS (cont.)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

ACCOMPLISHMENTS (cont.)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

ACCOMPLISHMENTS (cont.)ACCOMPLISHMENTS (cont.)

• Websites– CDRH Home Healthcare committee

website developed in 2003 and revised 2004

– CDRH Home Healthcare committee infusion therapy website under development

ACCOMPLISHMENTS (cont.)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

Effect of Regulatory Policy On Devices Effect of Regulatory Policy On Devices During the Product Life CycleDuring the Product Life Cycle

Discovery Distribution Use

Promote Grants Reimbursement Consumer& Contracts Advertisement

Reduce Quality Standards KnowledgeError Systems Management

Inhibit Regulation Assessment Evidence BaseDecisions

Note: Adapted from Susan Bartlett Foote: Managing the Medical Arms Race