A safety watchdog group has raised a red flag over the at-home use of medical devices, but one provider said concerns should not derail the move of hospital-level care to the home.
As more individuals opt to receive care at home, devices like infusion pumps and ventilators are increasingly being used outside of the clinical settings for which they were designed. These trends are being driven by increased use of home healthcare, home dialysis and hospital home care. By 2030, the U.S. home medical equipment market is expected to grow to $21 billion, from $12 billion, according to a 2021 report by Nova Advisor, a healthcare research company.
Related: Rapid growth predicted for hospital-at-home market
This shift has prompted industry concerns about the safety of home medical device usage.
A Wednesday report by non-profit patient safety organization ECRI lists major technology hazards to look out for in 2024, and points to numerous instances where the use of medical devices in a home setting led to patient harm and death.
From medication errors related to infusion pumps to skin injuries caused by cardiac monitors, there are life-threatening risks associated with using complex, specialized equipment as an inexperienced layperson, said Dr. Marcus Schabacker, president and CEO of ECRI.
Clinics have standard practices and evidence-based processes that don’t apply in the home, Schabacker said. As such, providers need to think through how to help patients better understand their equipment.
“How do we advise patients to use the device safely,” Schabacker said. “How do we make them easier to operate and understand? And what kind of framework do we have so that if there is a technical or a medical problem, it can be addressed quickly and effectively?”
In its report, ECRI recommends providers educate patients on all medical technology being used in their homes, and only give out equipment compatible with the educational level, environment and cognitive and physical abilities of patients or caregivers.
Home health providers Amediysis and Trinity Health declined to discuss the report. Kidney care companies Fresenius and DaVita did not respond to questions Wednesday.
For device manufacturers, best practices would include conducting user testing, developing concise, simply worded instructions and using intuitive product design for home use.
To help patients handle equipment developed for expert use in a hospital, providers treating patients in their homes need to have infrastructure in place for troubleshooting, like a 24-hour call center, Schabacker said.
While at-home care is advantageous for some patients due to its capacity to be more personalized and comfortable, the sector still has a ways to go until it reaches zero preventable harm, he said.
“We want to make sure that the efforts we spent decades on in the hospital, to have quality assurance processes, are now getting transferred into the home,” Schabacker said.
Some quality assurance processes are being transferred into the home under the Centers for Medicare and Medicaid Services' Acute Care at Home waiver program. Launched in 2020, the program allows more than 300 hospitals to treat certain patients in their homes using medical equipment and remote patient monitoring, along with daily virtual and in-person clinical visits.
Compared with traditional home healthcare companies, hospital-at-home providers in the program have more stringent medical device safety protocols and less freedom in how they set up equipment and administer treatment, said Medically Home CEO Rami Karjian.
Medically Home, a company that provides technology and other acute care at-home services, has nurses or emergency medical technicians set up all equipment in the home. Clinicians are also on hand at least twice daily to deliver care to patients.
“For every IV that you have, there is going to be a clinician, nurse or a paramedic that is going to be in your home administering that IV,” Karjian said.
To reduce the potential for patient harm or medication errors, clinicians train patients and caregivers on the proper use of remote monitoring equipment, he said. Patients also have around-the-clock access to clinical staff for support in case a device malfunctions or fails.
Along with at-home device use concerns, ECRI said other health technology worries that should be fixed in 2024 include inadequate device cleaning instructions, insufficient artificial intelligence governance and erroneous drug compounding.
