SAFE AND RELIABLE DEVICES LEAD TO LIVING WELL THE HOME AND MEDICAL DEVICE TECHNOLOGY Presented by Mary Weick-Brady, MSN, RN April 20, 2012 Great Lakes Biomedical Conference on Home and Mobile Health WHAT I WILL COVER Home care facts FDA Home Use Initiative 5 areas to consider when designing a home use device Other areas FDA covers related to home use Mobile apps, software, interoperability, wireless EMERGING TRENDS 44 million caregivers of someone over 18 69% > 65 years old 20% US adults report a disability 15% of the global population is disabled 7.5 million people in home care 20,000 agencies NAHC 2008, BCC Research 2010 INCREASED INTEREST Emergency Care Research Institute (ECRI) Top 10 issues (patient centered care conference last November) ISO/IEC 60601-1-11 AAMI committee on home use Summit next spring National Research Council Human Factors and Ergonomic Society DEVICES ARE MIGRATING Borrowed Already in the house Purchased at a retailer Provided by hospital at discharge Provided by physician s office Procured through a third party Rent to purchase 1
INPATIENT CARE AND HOME CARE (Per Patient Month) (NAHC 2008) where devices play a major role Conditions Hospital Cost Home Care Cost Savings Ventilator dependent adults $21,570 $7,050 $14,250 Oxygen dependent children $12,090 $5,250 $6,840 Chemotherapy for children $68,870 $55,950 $13,920 Congestive heart failure in adults $1,758 $1,605 $153 IV antibiotic therapy $12,510 $4,650 $7,860 FDA DEFINITION OF HOME USE a home use device is a medical device intended for users in any environment outside of a professional healthcare facility. (includes devices intended for use in both professional healthcare facilities and homes) HOME USE DEVICES ARE: Capital Equipment /mobility/assist medical beds wheelchairs lifts Home Therapeutics home hemodialysis negative pressure wound therapy infusion pumps Instruments glucose meters pulse oximeters insulin pumps Self Diagnostic and Monitoring Systems telemedicine blood pressure monitors medical mobile apps HOME USE DEVICES ARE: Disposables & Accessories ventilator breathing circuits, filters oxygen therapy related devices needles, syringes, IV catheters, tubing, foley catheters, gloves Implantables defibrillators, hip/knee implants drug-eluting stents Computerized Medical Systems hardware software Reagents fecal occult blood tests Lyme Disease tests HOME USE DEVICES MUST BE Useful Usable Iterative Intentional Intuitive Integratable Informative Be able to address risks unique to the home HOME USE MEDICAL DEVICE INITIATIVE We will: 1. Establish guidelines for manufacturers of home use devices Develop Guidance for premarket design Public workshop held May 24, 2010 to collect information for Guidance document Incorporate home health into 510(k) guidance for intended use and human factors guidance 2
HOME USE INITIATIVE HOME USE INITIATIVE 2. Develop a home use device labeling repository; Medical devices cleared/approved for home use. Pilot program for 10 months where manufacturers submitted their labeling Tested labeling for electronic transmission Start putting up labeling on a website 3. Partner with home health accrediting bodies to support safe use; Meeting with accrediting bodies to incorporate medical devices into their standards. The main three accrediting bodies are on board with us: ACHC, CHAP, and The Joint Commission HOME USE INITIATIVE 4. Enhance postmarket oversight focus groups on instructions for use with health care practitioners and consumers studies on design of labeling for the health care practitioner monitor adverse event reports closely for location of event follow up on unusual problems seen outside of the clinical environment encourage reporting of product problems HOME USE INITIATIVE 5. Increase public awareness and education. Public meeting on home use May 2010 (helped formulate guidance) Public meeting on labeling April 2011 (helped formulate our thoughts for electronic submission) CDRH Learn Website (www.fda.gov/homeusedevices) Power outage brochure Webinar for FDA Basics HOME USE MEDICAL DEVICES User Environment Device Human Factors Labeling USER Physical capabilities Cognitive capabilities Retention of instructions Reading ability Emotional stability Motivation to use the product 3
home care recipient ENVIRONMENT Co-morbidities 19 medications Can walk 20 feet without assistance Monthly home visits Picc line for 7 years Full disability Performs infusion therapy Recuperating from surgery Unable to drive Self-monitors Air quality humidity, temperature, particles Electrical 3 or 2 prong outlets, fuses, lighting Children Pets and non-pets Water quality city water, well water Type of home single family, apartment Location of home Travel and Transport work, school, train, plane A typical home environment HUMAN FACTORS Device and user must interact safely in their environment Interface is important Feedback is important Simplicity is important You cannot assume they will use it how you want them to use it http://www.fda.gov/medicaldevices/deviceregulat ionandguidance/guidancedocuments/ucm25974 8.htm Amazing Work-Arounds LABELING Includes the label and the labeling Design labeling for the conditions under which it will be used Design it to eliminate or reduce potential harm to the user Do not design labeling to use as a substitute for a poorly designed device Include training and certification when needed Help users to produce specific outcomes safely effectively, and confidently 4
Poor labeling equals poor compliance FDA IS ALSO ADDRESSING: Mobile Apps Software Interoperability Wireless 500 MILLION SMART PHONE USERS WILL USE HEALTH APPS BY 2015 CDC: Smartphones Could Increase Disease Surveillance In Developing Countries Doctors Believe Using Health Apps Will Cut Down on Visits Research2Guidance 2010 http://www.fda.gov/medicaldevices/productsandmedicalprocedures/u cm255978.htm Apps help you monitor your own health If it meets the definition of a medical device, it is a medical device (201(h)) Mobile medical apps Proposed Scope for Oversight Enforcement Discretion Other mobile apps that meet device definition FDA scope mobile medical apps MEDICAL DEVICE SOFTWARE Component of a medical device Accessory to a medical device Stand alone No regulatory requirements Mobile apps not considered mobile medical apps No matter the platform, the bottom line is it must be safe and effective If it meets the definition of a device, it is a device (201(h)) 5
MEDICAL DEVICE SOFTWARE ENGINEERING AND CLINICAL VIEWS Engineering Calculate doses Display medical images Control treatment timing Collect user input Clinical Formulate treatment plans Recommend additional tests Diagnose presence of tumors Calculate insulin dose INTEROPERABILITY Ability of medical devices, clinical systems, or their components, to communicate in order to safely fulfill an intended purpose Innovative ways to interoperate DTV Cognitive Radio MedRadio (MICS) WiFi Wireless Technology GPS RFID WiMax WMTS Mobile Phones Mobile Radio WIRELESS ISSUES IN THE HOME Home RF Wireless environment is uncontrolled with many wireless emitters in/out of the home environment Little oversight or technical knowledge Rapidly changing wireless technology and environment Wireless is both a source and victim for electromagnetic interference (EMI) Wireless risks include: -data integrity, coexistence, EMC, accuracy, security, privacy FDA DIRECTIONS Guidance to manufacturers Labeling on an accessible site Address emergent issues 6
THEY ARE TRUSTING YOU ONE NEVER NOTICES WHAT HAS BEEN DONE; ONE CAN ONLY SEE WHAT REMAINS TO BE DONE Marie Curie, March 18, 1894 7