MedSun Adverse Event Reports Related to Home Healthcare Devices
MedSun: Newsletter #17, September 2007

Jill Marion, Biomedical Engineer, MedSun Project Manager

Introduction
Changes in healthcare have stimulated a significant progression from the hospital environment to the home environment.1 In fact, according to results of the 2000 National Home and Hospice Care Survey “approximately 1,355,300 patients were receiving home healthcare services from 7,200 agencies.”2 In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home healthcare annually.3

As patients have moved to the use of home healthcare services for recuperation or long-term care, the medical devices necessary for their care have followed them. As a consequence, complex medical devices are more frequently being used in the home, many times under unintended conditions. This in turn has implications for the safe and effective operation of these devices, especially those with sophisticated requirements for proper operation or maintenance.1

Focus on Home Healthcare Device Surveillance
The Food and Drug Administration (FDA) defines home healthcare devices as those used in the home environment by persons who are ill or disabled and who need, or whose care providers need, education or other related healthcare services in order to use or maintain the devices safely and effectively. The FDA is focusing surveillance efforts on two types of devices: devices whose settings are not intuitive (e.g., thermometers, heating pads); and devices that may require additional education, training, and instructions for use in order to ensure the safety and effectiveness of the device, as well as improved patient outcomes (e.g., infusion pumps, ventilators). 1

By means of HomeNet, the newest subnetwork of the Medical Product Safety Network (MedSun), FDA is interested in learning more about device-related problems in the home. HomeNet is a targeted effort focused on identifying, understanding, and solving problems with medical devices used in the home environment. 4

MedSun Reported Adverse Events
To understand the scope of currently reported adverse events involving devices used in the home environment, FDA reviewed MedSun reports submitted between January 1, 2002, and April 27, 2007, which indicated the event reported had occurred in the home. The results of the MedSun search are as follows:

Results by Patient Age (in years):
Age: x=18; Percentage of Reports: 23%
Age: 18Age: x=55; Percentage of Reports: 37%
No age listed; Percentage of Reports: 11%

Results by Patient Sex:
Female; Percentage of Reports: 43%
Male; Percentage of Reports: 44%
Sex not listed; Percentage of Reports: 13%

Top 10 Home Healthcare Devices Reported:
1. Infusion Pump - 30%
2. IV Tubing - 11%
3. Venous Access Device - 11%
4. Feeding Tube - 8%
5. Surgical Hardware - 8%
6. Semi-electric Hospital Bed - 8%
7. Ambulatory Infusion Pump - 8%
8. Oxygen Concentrator - 8%
9. Wheelchair, powered - 4%
10. Ventilator - 4%

The search results include adverse events that resulted from using home healthcare devices; it is important to note, however, that the search also elicited reports that identified adverse events resulting from devices that do not fit the FDA’s definition of a home healthcare device. In these reported incidents, the problem usually began while the patient was in the home (e.g., breast implant rupture, implantable cardioverter defibrillator lead breaking), but did not necessarily involve a device meant for home treatment purposes. While the FDA is interested in both types of reports, HomeNet will focus solely on reports involving the use of home healthcare devices.

Examples of these devices include:
•Infusion pumps
•Ventilators
•Pulse oximeters
•Glucose testing supplies
•Defibrillators
•Enteral feeding systems
•Thermometers
•Heating pads
•Nebulizers
•Wheelchairs
•Apnea monitors
•Durable medical equipment

Case Examples
Case 1: A patient was sent home after surgery with a pain pump to manage postoperative pain. The pump is designed so the patient can remove it by following tips from the surgeon. The patient found resistance while trying to remove the pump catheter. The patient called the manufacturer and was told to call the physician. The patient called the physician’s office and was instructed by the office nurse to pull harder. The patient did as instructed and the pump catheter broke off in the patient’s shoulder. A radiopaque line on the catheter was visible by X-ray, and the retained catheter was surgically removed.

Case 2: A patient was discharged to home on total parenteral nutrition (TPN). The patient was given an infusion pump to administer TPN 16 hours a day. The patient went to a clinic when the central line clotted. Examination of the pump showed it was not administering the TPN to the patient. The patient was admitted to the hospital for hydration and stabilization.

Case 3: A patient was ambulating with a wheeled walker when the left front leg of the walker snapped within the lowest support brace. Neither the support brace nor the clamp securing it to the left front leg was affected. The patient fell, striking her head, and required sutures to close the wound and a CT [computerized tomography] of the head to rule out bleeding.

Conclusion
With the creation of HomeNet, MedSun will strive to enhance patient safety by improving the recognition, reporting, and understanding of device-related events; by utilizing the HomeNet community as an interactive venue in which to validate and understand device-related adverse event signals identified by FDA and HomeNet participants; and by validating reports of device problems in “real time” so that timely interventions to resolve or mitigate problems may ensue.

References:
1. Weick-Brady, M., Lazerow, R. (2006). Medical Devices promoting a safe migration into the home. Home Healthcare Nurses: The Journal for the Home Care and Hospice Professional, 24: 5, 298-304.
2. National Center for Health Statistics. (2004). Home health care patients: Data from the 2000 National Home and Hospice Care Survey. Retrieved August 9, 2007, from http://www.cdc.gov/NCHS/pressroom/04facts/patients.htm.
3. National Association for Home Care & Hospice. (2004). Basic statistics about home care. Retrieved August 9, 2007, from http://www.nahc.org/home.html.
4. Kaufman, D. (2007). HomeNet Information Factsheet. Food and Drug Administration MedSun News.


Additional Information:

Home health care patients: Data from the 2000 National Home and Hospice Care Survey
http://www.cdc.gov/NCHS/pressroom/04facts/patients.htm

Basic statistics about home care
http://www.nahc.org/home.html


MedSun Newsletters are available at www.fda.gov/cdrh/medsun