Safe Home Healthcare: Addressing Risks in Home Medical Device Use

Healthcare at home has become an increasingly popular alternative to hospital-based treatment, offering patients the comfort and convenience of receiving care in familiar surroundings. However, while the home care model presents clear benefits, it also brings about unique challenges—especially when patients or their family members are tasked with operating complex medical devices. These devices, such as ventilators, hemodialysis machines, and infusion pumps, have traditionally been used in acute care settings, where healthcare professionals provide continuous oversight. With such devices increasingly being used in the home, the need for appropriate selection, management, and use of those technologies is becoming more critical.

One of the most significant concerns associated with home healthcare is the potential for preventable harm due to improper use or malfunction of medical devices. As highlighted in ECRI’s annual Top 10 list of healthcare hazards, improper setup and management of these technologies, particularly by lay users, can result in delayed or inaccurate care, with serious consequences for patient health. This year, ECRI has expanded the discussion of this issue to explore in greater detail the risks associated with home use of complex medical devices.

The Risks of Home-Based Medical Devices

In a hospital setting, medical devices are typically operated and monitored by trained healthcare professionals, ensuring the safety and effectiveness of the treatments they deliver. In contrast, at-home patients or their caregivers are often responsible for operating and maintaining these devices without the necessary training or expertise. As a result, there is a significant risk of errors that can lead to severe patient harm.

ECRI has investigated several patient harm incidents linked to improper setup or lack of familiarity with medical devices in the home setting. These include:

• Medication error leading to hospitalization: An infusion pump was programmed incorrectly, delivering the wrong dose of medication.
• Fatality: A ventilator alarm failed to sound, leading to a lack of intervention when the patient’s breathing became compromised.
• Fatality: Venous needle dislodgement during dialysis led to a fatal outcome.

These incidents highlight how important it is for healthcare providers and home caregivers to ensure that medical devices are properly configured and that users understand how to operate them effectively. The following are common factors that increase the risk of harm when medical devices are used at home:

• Lack of device oversight: Errors and malfunctions may go unnoticed or unreported, particularly when the device is not continuously monitored.
• Misinterpretation of device data: Home caregivers may misinterpret device readings, leading to incorrect decisions about patient care.
• False sense of security: Patients and caregivers may develop an unrealistic belief in the reliability of the device, even when it is malfunctioning.
• Malfunction or misuse of devices: Patients or caregivers may be unfamiliar with how to troubleshoot device issues, resulting in delays in care or patient injury.
• Connectivity issues: Medical devices that require internet or Wi-Fi connectivity may fail to transmit vital data to healthcare providers if the home setting lacks reliable internet service.
• Improper storage of accessories: Medical supplies and accessories, such as tubing or sensors, may become damaged if not stored correctly, leading to further complications.

These challenges are becoming more pressing as the demand for home healthcare continues to grow. The Centers for Medicare & Medicaid Services (CMS) has authorized hospitals to offer acute care at home to more than 360 hospitals across the United States, a number that is expected to rise. In response to this growing trend, the FDA launched its Home as a Health Care Hub initiative in April 2024, underscoring the importance of addressing these risks and ensuring that home healthcare is safe and effective.

ECRI’s Recommendations for Safe Home Healthcare

To reduce the risks associated with home healthcare and the use of complex medical devices, ECRI offers several key recommendations for healthcare providers, health technology management (HTM) professionals, and other stakeholders. These recommendations focus on ensuring that devices are appropriately chosen, properly used, and regularly monitored in the home setting.

1. Form a Multistakeholder Team to Assess Patient and Caregiver Readiness: Before prescribing any medical device for home use, it’s essential to assess the patient’s and caregiver’s ability to operate the technology safely. A multistakeholder team—including representatives from risk management, nursing, HTM, IT, and medical teams—should establish a process for assessing the patient and caregivers before prescribing any medical device, as well as regularly thereafter and any time they experience a clinical event.
2. Perform Home Assessments to Identify Infrastructure Needs: When possible, healthcare providers should assess the home environment to identify potential issues that could impact device operation, such as space limitations, electrical requirements, or cleaning and disinfection concerns. These assessments can help ensure that the home is equipped to support the medical device and that there are no environmental factors that might impede its function.
3. Educate Patients and Caregivers on Proper Device Use: Clear and thorough training is essential for ensuring that patients and their caregivers know how to operate medical devices correctly. Healthcare providers should offer hands-on training and repeated demonstrations, ensuring that patients can use the devices independently. Instructional materials should be provided, and a point of contact should be available to answer any questions about device operation or troubleshooting.
4. Consider Usability When Choosing Devices for Home Use: Devices used at home should be designed with the lay user in mind. When selecting a device, healthcare providers should consider factors such as the device’s ease of use, legibility of displays, and clarity of instructions. The device should also be comfortable for patients to use and designed to minimize user fatigue.
5. Ensure Proper Functioning and Maintenance of Equipment: Before deploying medical devices in the home, healthcare providers should ensure that the equipment is in good working condition and has undergone preventive maintenance.
6. Confirm Device Setup and Provide Comprehensive Instructions: When delivering a device to a home care setting, healthcare providers should ensure that it is set up to minimize the burden on patients or caregivers. This includes providing all necessary consumables, accessories, and clear instructions for use. Providers should also ensure that patients and caregivers understand where to acquire replacements and how to troubleshoot any issues.
7. Maintain Accurate Records and Stay Informed of Device Recalls: Healthcare providers should maintain up-to-date records of all devices allocated to home patients, including contact information and device-specific details. Providers should also ensure that they are promptly informed of any recalls or alerts related to the devices in use.
8. Encourage Reporting of Issues with Home Healthcare Devices: It’s essential for healthcare providers to encourage patients and caregivers to report any issues with medical devices. Providers should keep internal logs of these incidents to inform future device selections, training efforts, and the development of best practices for home healthcare.

Conclusion

While the shift toward home healthcare offers many benefits, it also presents unique risks—particularly when it comes to the use of complex medical devices. By following ECRI’s recommendations and adopting a proactive, multistakeholder approach, healthcare providers can help ensure that devices are used safely and effectively in the home setting. Through education, thoughtful device selection, and ongoing monitoring, we can mitigate the risks and help ensure that patients receive the high-quality care they need in the comfort of their own homes.

Learn more about potential sources of danger we believe warrant the greatest attention for the coming year and offers practical recommendations for reducing risk and preventing harm.