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Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home
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Agenda FDA/MedSun/HomeNet overview Trends in homecare Role of FDA
FDA definition of a medical device and adverse event Examples of medical device adverse events The role of the home healthcare providers in understanding, recognizing and reporting medical device adverse events Q&A
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Objectives At the end of this session you will be able to:
Describe four common types of medical device problems Explain why reporting problems with medical devices is important Explain how the home environment impacts the use of medical devices Describe the role of the home healthcare professional in promoting patient safety with medical devices
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MedSun 800-859-9821 medsun@s-3.com
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Nursing Continuing Education
One contact hour of nursing continuing education credit is available
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Speakers Diana Rivi, MPH Mary Weick-Brady, MSN, RN
Public Health Analyst Office of Surveillance and Biometrics (OSB) Center for Devices and Radiological Health (CDRH) Food and Drug Administration (FDA) Mary Weick-Brady, MSN, RN Associate Office Director for Home Care and International Initiatives OSB, CDRH FDA
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Organization of FDA FDA is comprised of several Offices and Centers
Office of the Commissioner (OC) Office of Regulatory Affairs (ORA) Center for Devices and Radiological Health (CDRH) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) National Center for Toxicological Research (NCTR) 7 7
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Organization of FDA (continued)
Three FDA Centers deal with medical products: Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) MedSun HomeNet
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Center for Devices and Radiological Health
CDRH promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.
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MedSun An adverse event reporting program
Over 350 health facilities participate The primary goal of MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
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HomeNet Focuses on identifying, understanding, and solving problems with medical devices used in the home setting
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Impact of Healthcare Trends on Homecare
Setting hospital to home Caregivers clinicians to family caregivers and to patients Medical Technology devices have become more complex, smaller, and portable Patient increase in knowledge about healthcare options more empowered and active in the decisions related to care
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Mary Weick-Brady, MSN, RN
Associate Office Director for Home Care and International Initiatives OSB, CDRH FDA
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CDRH Operational Definition of Home Use Medical Devices (developed by the Home Care Committee July 2008) “a home use device is a medical device intended for users in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for use, and may require training by a licensed health care provider in order to be used safely and effectively”
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Home Care Facts 20,000 home care organizations (13,000 Medicare certified) 7.6 million individuals in home care $50 billion per year Growing 20% per year 75% receive skilled nursing 69% > 65 years old 44 million are caregivers of someone >18 2/3 are women By 2030, 71.5 million over 65 1/5 US adults report a disability (47.5 million) (National Association for Homecare 2004)
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Cost of Inpatient Care (Per Patient Month) Compared to Home Care
Examples show 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 (NAHC 2008)
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Medical Devices Migrating Into the Home – New Risks
Environment Children EMI Location Noise Pets and vermin Power outages and sources Public emergencies Safety Sanitation Space Temperature, air quality, humidity Water Use Compatibility with lifestyle and usefulness Instructions for use are poor or nonexistent for lay users Interface and ease of use Off label use Ruggedness of the device for many conditions Selling Rx devices on the Internet User’s educational level User’s emotional stability User’s physical capabilities
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Home Use Devices Must Be…
Useful Usable Iterative Intentional Intuitive Integratable Informative Address the risks unique to the home
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Examples of Emerging Technologies for the Home
Health informatics Nanotechnology Smart homes and interoperable technology Telehealth Wireless Technology
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FDA’s Role Develop guidance and further regulation as needed (legislative proposal) Standardize labeling for home use devices Monitor claims and labeling Establish reasonable assurance of the safety and effectiveness of these device technologies Continue with research Collaborate with the FCC, CMS, and other government agencies Collaborate on and use international standards for new technologies Address the sale of prescription devices on the internet Monitor adverse events and take appropriate action Perform postmarket studies or post approval studies Assure effective recalls for devices in the home environment Educate the public about safe use of their medical device
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Types of Medical Devices and Examples of Home Healthcare Devices
Capital Equipment Medical beds, bedrails, scales, wheelchairs, walkers, IV poles, infusion pumps, enteral feeding pumps, lifts, shower chairs, blood pressure equipment, home hemodialysis, negative pressure wound therapy Instruments glucose meters, pulse oximeters, insulin pumps Monitoring Systems cardiac, telemetry, patient call systems Reagents fecal occult blood test Disposables & Accessories ventilator breathing circuits, filters oxygen therapy related devices needles, syringes, IV catheters, IV tubing, foley catheters, feeding tubes, gloves Implantables defibrillators, hip/knee implants, drug-eluting stents Computerized Medical Systems hardware software versions
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What is an Adverse Event?
An event whereby a medical device has, or may have, caused or contributed to a death or serious injury. Includes events resulting from: Device failure Device malfunction Improper or inadequate device design Manufacturing problems Labeling problems Training issues Use error
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“Medical errors most often result from a complex interplay of multiple factors. Only rarely are they due to the carelessness or misconduct of single individuals.” Lucian L. Leape, M.D. A leading patient safety expert from Harvard University
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“Swiss Cheese” Model of System Failure that Can Lead to Injury
Device Maintenance Device Problem Reporting Problem Not Pursued FAILURE 1 Older infusion pump with no labeling or instruction for use; susceptible to maintenance-related breakdown; first free-flow event occurs Departmental Communication FAILURE 2 Problem is not shared by the patient with home care provider FAILURE 3 Pump is not removed from home; recurring problem not pursued FAILURE 4 Free-flow event not reported to staff FREE-FLOW: PATIENT OVER- MEDICATED
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Think About the Device and its Environment
Electric Power, Heat, Humidity, Temperature, Stability Light, Other Devices or Electronics in home (EMI) Pets, Kids, Noise level Staff Patient/ Caregiver Medication Port & Filter Pressure Valves Heated Humidifier Exhalation Filter Tracheal Tube Accessories & Disposables
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Top Reported Adverse Device Events in MAUDE June 2008 – August 2009
(total number of events = 1059 where location states “home”) Insulin infusion pumps Implantable cardioverter defibrillator Automatic implantable cardioverter defibrillator with cardiac resynchronization Ventricular (assist) bypass Mechanical walker Implantable pacemaker pulse generator Piston syringe Intravascular administration set Continuous ventilator (facility use)
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What Types of Medical Device Issues Should I Look for?
Defects Software problems Failure to work as intended/malfunction Instructions/labeling/packaging issues Interactions with other devices, or other electronic equipment in the home Use errors Human Factors issues Combinations of the above
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Examples of Problems (continued)
Defects IV pump bracket found with large crack and sharp edges Ventilator started smoking Gloves found discolored and with holes Crutches collapse
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Examples of Problems (continued)
Software problems Vital signs monitor did not transmit information to central station Software glitches with new software installation Virus infects device operating software Day-light savings software considerations
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Examples of Problems (continued)
Failure to work as intended/ malfunction IV pumps not infusing as programmed Safety mechanism on IV catheters/syringes failing Medical bed would not maintain position Shower chair collapse Walker leg malfunction Broken connector clip on patient lift
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Examples of Problems (continued)
Instructions/Labeling/Packaging issues Instructions for use (includes graphics/icons/charts) Unclear Misleading Incomplete Difficult to see, i.e. too small, colors Absent Complex, i.e. written for healthcare provider and not for patient or family caregiver Packaging Damaged package Missing components Sterility issues Device size is incorrect
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Examples of Problems (continued)
Interactions with other devices Electrical instrument deactivates pacemaker Cell phone use interferes with monitoring equipment
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Examples of Problems (continued)
Use Errors Electric-powered wheelchair joystick is too close to speed button
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Human Factors (continued)
Human Factors – the science of how humans interact with technology; focuses on the device-user interface, incorporates the following: Device Design Environment of Use User Characteristics 34
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Human Factors (continued)
User Considerations Abilities, expectations, familiarity with device Training 35
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Human Factors (continued)
Issues with patient or family caregiver training and education Training is not appropriate to audience Unclear Misleading Incomplete Training is not provided Training only addresses device set up but does not include information about: Device maintenance Troubleshooting Device replacement parts
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Other Considerations (continued)
Number of different brands 37
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MedSun Adverse Event Example
MedSun report – liquid oxygen stationary home unit Event description included Details about problems with the oxygen contents indicator Observations about manufacturing changes to the materials used to make the fittings Biomedical engineer testing Actions taken as a result of report FDA follow up with manufacturer Manufacturer changed device design to remedy problem
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MAUDE Adverse Event Example
MAUDE report - Negative Pressure Wound Therapy System Event Description Actions taken as a result of report FDA Nurse Analysts trending of similar device events Convened team to investigate Preliminary Public Health Notification issued November 2009 Online available: ices/PublicHealthNotifications/ucm htm
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Your Role in Homecare Medical Device Patient Safety
Recognize, report, and understand device problems Identify actual and potential problems, adverse events, close calls with medical devices used in the home Ask your patients questions about their device Report the problem through your organizations’ chain of command Include details in your report, i.e. where did this event occur, what happened, device identifiers Notify the manufacturer
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What Do We Mean by “Potential for Harm?”
Events that are caught before anything harmful occurred packaging defect product not sterile Important observations of a chronic problem with a device cannot hear device alarms device not easy to use Problems which lead staff to develop “work-a-rounds” taping devices together, or substituting parts because of problems with a certain part “Out-of-the-box” problems that are identified before use on a patient cracked tubing noted during setup
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Why Reporting Medical Device Problems Is Important In Your Home Care Agency
Prevent future problems and protect your patients, families, staff Achieve performance improvement goals Assist Risk Management with claims or litigation Provide information to manufacturers and/or U.S. Food and Drug Administration Impact the public health for the nation’s patients, family caregivers and/or health care providers Effect changes in policies and procedures
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When Do I Report? When you think a device has or may have caused or contributed to any of the following outcomes (for a patient, caregiver, staff member): Death Serious injury Minor injury Close calls or other potential for harm
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What Do I Report? If there was an injury, what happened to the persons affected? Respiratory arrest Where was the patient at the time of the event? Home, car, work, school, etc. What happened while the patient or caregiver was using the device? What, if any, were the problems with the device(s) involved? IV tubing found to have holes due to pets in the home What is the intended use of the device or why was the patient prescribed this device to use in their home? Diabetic patient What, if any, were the follow-up medical procedures required because of the event? Antibiotics administered What are the names of the manufacturers of the devices involved? What are the relevant manufacturer device identification numbers? Serial, model, lot, catalog, and any other specific information What did you do to solve the problem?
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How Do I Report? Use your organization’s reporting system…
Know policy and procedures Complete documentation/forms Report to MedSun Representative who will submit a report online
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Your Role Identify actual and potential problems, adverse events, close calls with home healthcare medical devices Talk to your patients. Ask them questions about their device: Are they confident using their device? Is the device easy to use? Are the instructions clear? Report the problem or adverse event to your supervisor, according to policy and procedure Make sure your report includes details: Where was the patient when the event occurred? What happened? Device type? Manufacturer and brand? Other device identifiers, model #, serial #, catalog # Remove the device and save the packaging, if applicable
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And Remember . . . We can’t address issues we don’t know about.
Please communicate with your patients. Please report.
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Questions and Answers
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Questions and Answers “What is the best type of IV pump for home use?”
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Questions and Answers “A patient recently asked me about whether it was ‘o.k.’ to buy a wheelchair on the Internet. What should I tell him about purchasing a medical device on the Internet?”
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Questions and Answers For more FDA-related consumer information about buying a medical device online
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Questions and Answers “I care for a patient who lives in a rural area and is being discharged from the hospital on home hemodialysis. She will be two hours from the nearest dialysis clinic. What medical device associated risks should I consider?”
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Questions and Answers An FDA Checklist for Home Healthcare Medical Devices
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MedSun 800-859-9821 medsun@s-3.com
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Disclaimer For information about limitations on the use of the Microsoft ® images contained in this presentation, go to For information about limitations on the use of other images contained in this presentation, contact MedSun at
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