Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home

1. Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home

2. 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

3. 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

4. MedSun 800-859-9821 medsun@s-3.com

5. Nursing Continuing Education One contact hour of nursing continuing education credit is available

6. Speakers Diana Rivi, MPH 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

7. 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

8. 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

9. 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.

10. 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.

11. HomeNet Focuses on identifying, understanding, and solving problems with medical devices used in the home setting

12. 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

13. Mary Weick-Brady, MSN, RN Associate Office Director for Home Care and International Initiatives OSB, CDRH FDA

14. 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”

15. 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)

16. Cost of Inpatient Care(Per Patient Month)Compared to Home Care • Examples show where devices play a major role (NAHC 2008)

17. 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 Medical Devices Migrating Into the Home – New Risks

18. Home Use Devices Must Be… • Useful • Usable • Iterative • Intentional • Intuitive • Integratable • Informative • Address the risks unique to the home

19. Examples of Emerging Technologies for the Home • Health informatics • Nanotechnology • Smart homes and interoperable technology • Telehealth • Wireless Technology

20. 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

21. 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 Types of Medical Devices and Examples of Home Healthcare Devices

22. 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

23. “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

24. “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

25. Think About the Device and its Environment 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

26. 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)

27. 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

28. 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

29. 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

30. 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

31. 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

32. Examples of Problems (continued) • Interactions with other devices • Electrical instrument deactivates pacemaker • Cell phone use interferes with monitoring equipment

33. Examples of Problems (continued) • Use Errors • Electric-powered wheelchair joystick is too close to speed button

34. 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

35. Human Factors (continued) • User Considerations • Abilities, expectations, familiarity with device • Training

36. 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

37. Other Considerations (continued) • Number of different brands

38. 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

39. 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: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm190658.htm

40. 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

41. 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

42. 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

43. 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

44. 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?

45. 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

46. 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

47. And Remember . . . We can’t address issues we don’t know about. Please communicate with your patients. Please report.

48. Questions and Answers

49. Questions and Answers “What is the best type of IV pump for home use?”

50. 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?”