Executive Summary: Home Health Specialists Discussion
MedSun: Newsletter #14, May 2007

A focus group with home health specialists was conducted by conference call on May 21, 2007, in preparation for development of the HomeNet subnetwork in the Food and Drug Administration’s (FDA) Medical Product Safety Network (MedSun) Project. The individuals who participated were associated with MedSun health care facilities. Attendees from the home health community included a quality improvement specialist, a durable medical equipment (DME) company representative, risk management/infection control staff, a rural home care provider, a registered nurse who works in quality improvement, a hospital-based biomedical engineer, and a hospice case manager for a home health/hospice agency.

The group discussed problems observed with medical devices and their use in the home environment. The participants also discussed the types of medical devices used in their home health programs, as well as differences in the age and quality of devices between those that may be brought to the home environment and those used in other health care settings. Their responses indicated that some providers are vigilant about device distribution, training of patients and caregivers, and responsibility for maintenance. Although some agencies work with DME companies to use the same equipment that is available in hospitals, others do not. In these cases, patients may not be able to bring a medical device they used at home into the hospital environment because of issues related to the device’s age, maintenance, and the staff’s unfamiliarity with it. The participants also noted that patients may be sent home with devices, such as a holter monitor or a particular infusion pump, that are not routinely managed in the home.

The group also discussed issues with labeling and use instruction. Among the barriers to device use the participants identified were the age of the population; inability of the patient or caregiver to speak or read English; the unmet need for instructing individuals who are illiterate or have low literacy; and family members, neighbors, and staff (both professional and nonprofessional) who are not familiar with the devices. The participants seemed to agree that there was generally a great lack of adequate labeling and instructions for devices. They noted concerns about the small font size on the labeling and inadequate instruction on how to turn a device on or off, recognize problems with alarms, respond to alarms, and troubleshoot to quickly rectify problems. In addition, they identified the need to train emergency responders on the use home equipment.

Reporting problems with medical devices was generally managed by the completion of an occurrence report that would be forwarded to Safety and Risk Management for processing. It was also learned that the Joint Commission will be evaluating competency training of patients in operation of devices and that DME companies must be accredited in 2008 in order to participate in competitive bidding. Further, individual States may mandate proof that instructions were understood, including device operation (by return demonstration) and environmental safety issues (e.g., exit strategy in the event of fire). Also mentioned was a bill under consideration by Congress that would confer ownership of a device to the patient after 36 months of use. This would sever any relationship with a home care agency or DME, which could have a significant impact on reporting problems with the device or maintenance programs.

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