Home medical devices pose risks for Medicare beneficiaries and their caregivers

But these devices—known as durable medical equipment in Medicare Part B parlance and ranging from infusion pumps to nebulizers to CPAP machines to home dialysis machines—also come with five potential problems for users and caregivers:

• Home medical devices can be potentially unsafe due to their design or misuse.
• They often come with little or no support for the person using the device when the Medicare beneficiary or caregiver lacks the knowledge and expertise to operate them effectively.
• They can be problematic in certain home environments.
• When they’re recalled, users don’t always know about it.
• Medicare doesn’t cover their entire cost.

Medicare Part B pays for 80% of the cost of durable medical equipment (after the Part B deductible, which is $240 in 2024) if a health provider determines it’s medically necessary and prescribes it. You must purchase or rent the device through a Medicare-enrolled supplier; if you have a Medicare Advantage plan from a private insurer, you must get the device from a company on its list of suppliers.

The aging population, technology improvements and Covid have contributed to the explosion in home medical devices, says Rene Quashie, vice president, digital health at the Consumer Technology Association.

But Scott Lucas, vice president for device safety at the ECRI nonprofit safety organization, says the devices are typically designed, and intended, for acute-care hospital use.

“Now we put them in the home and the expectation is for the patient or the caregiver to understand how to use those devices, interpret alarms, figure out settings, understand recall notices and effectively respond to those recalls,” Lucas says.

Home medical devices: “a pressing safety hazard”

All these factors, Lucas says, create a system ECRI feels is hazardous.

In fact, ECRI named medical devices at home “the most pressing health technology safety hazard for 2024,” based on its lab testing, investigations, assessments of hospital practices and research reviews.

In ECRI’s report, analysts found what they called “numerous examples of patient harm” from home-use devices.

They noted that medication errors can arise while changing infusion pumps, skin injuries can happen when a cardiac monitor’s electrodes aren’t applied correctly and fatalities can occur if a home ventilator alarm doesn’t activate or goes unheard or a home-dialysis machine’s needle gets dislodged.

The Food and Drug Administration (FDA) Center for Devices and Radiological Health, which regulates home medical devices, has been receiving an increasing number of “adverse event reports” about them.

Says Lucas: “It’s really time for the right stakeholders to come to the table and say, ‘Look, we’ve got to redesign, or at least think forward, to prevent some of the hazards that we know are likely to happen.’”

The need for support and training

Quashie believes the trend in medical device usage at home means “we need to be mindful and thoughtful of how much responsibility we place on consumers and make sure we build infrastructural support and training for them so they use these tools effectively.”

In some cases, that support and training is lacking or nonexistent from the hospital or medical facility prescribing it and the manufacturer.

I saw that recently when a close relative was discharged from a rehab facility with no instructions or help to attach and use an IV at home aimed at preventing an infection. Our family was told to find a visiting nurse but due to the nursing shortage, we had difficulty finding one. After many calls and much aggravation, we ultimately got a nurse—on a FaceTime video.

“Many types of home healthcare equipment are often still too complex for safe and accurate use by most patients and caregivers,” a recent UL report on home medical devices says. “Due to their lack of experience, patients and caregivers may be unaware of the routine maintenance procedures required to ensure the accurate operation of a device over time.”

Instructions, experts say, are sometimes written for health professionals in medicalese because the products are designed for hospital use, not home use.

“If you look at the instructions for an infusion pump, they’re really quite extensive,” says Lucas. “Those instructions should be written at a sixth-grade literacy level.”

Quashie believes the ability to call a manufacturer’s call center if you’re having trouble with a home medical device “is incredibly important.”

Support and training can be especially helpful to people who have low incomes and lack the digital literacy to operate home medical devices.

Cindy Cota, Vice President of Community Health Innovation at Volunteers of America (a health, housing and human services provider), recently wrote the FDA urging the agency consider the challenges of implementing home care technology for older adults with lower incomes.

Low digital and health literacy skills and lack of caregiver support, she wrote, “can hinder an older adult’s ability to access technology equipment and services initially as well as understand how to operate devices successfully.”

And, Cota told me, “for adults who have lower incomes, we’re also talking about ‘Do they need someone alongside them to walk them through the steps needed to effectively use the home medical device?’”

Experts strongly recommend scrutinizing a device’s instructions for use, care and cleaning before operating it—or getting help from a family member or friend to do this for you.

Problematic in certain home environments

Home medical devices may not be appropriate for, or even work in, certain homes.

The FDA’s Center for Devices and Radiological Health says on the FDA site: “Complex medical devices are used more frequently in the home, many times under unsuitable conditions. This in turn has implications for the safe and effective operation of these devices.”

As the UL report notes: “In the event of a power outage or natural disaster, few patients and caregivers would be equipped to handle a medical emergency prompted by the interruption of these vital services.”

Also, UL says, outdated or ungrounded electrical wiring systems may not prevent users of home healthcare equipment from electrical shock and insufficient ventilation can adversely impact the performance of some devices.

Not to mention pets or people in your home inadvertently disconnecting the devices. “We’ve seen [paw] prints from animals with four legs on top of ventilators in the home,” says Lucas.

One challenge is that the devices are generally prescribed by doctors who have never been in the homes of the people who’ll use them. So, they don’t know if the home environment is appropriate, says Lucas.

When recalls aren’t known by device users and caregivers

Some home medical devices get recalled for potential safety hazards (my brand of continuous glucose monitor, for one), but their owners don’t always know about it.

Politico reported that the number of the most serious medical device recalls, as classified by the FDA, rose by nearly 50% last year, to 102. In July 2024, Philips sent an urgent recall due to alarm problems in several models of its sleep-apnea ventilators. The FDA noted the problems could result in respiratory failure or death, noting there had been 894 malfunctions, 10 injuries and seven deaths.

To be notified about a home medical device recall, you need to fill out the product’s registration form. Many Medicare beneficiaries and their caregivers don’t, however, so they never receive emails or letters about the potential hazards.

ECRI called gaps with recalls of home-use medical devices “the nation’s most pressing health technology safety issue for 2023.” The researchers wrote: “Accurate and understandable information about medical device recalls often does not reach patients using those devices in the home.”

Even when people do get notified, ECRI says, the recall language can be “jargon-heavy and perplexing.”

The Government Accountability Office is now investigating the FDA’s oversight of medical device recalls. This follows a ProPublica/Pittsburgh Post-Gazette investigative series revealing the agency got hundreds of complaints about Philips’ breathing machines before announcing a 2021 recall.

An industry source familiar with medical device policy making told me that “companies make every effort” to ensure the products’ users and their physicians are aware of recalls and that the manufacturers are ready and willing to work with the FDA to improve the recalls process.

The experts’ advice: Before getting a home medical device, check the FDA’s website to see if it has had a recall or safety alert. Then, once you have the device, fill out its registration card and send it in so you’ll be notified if there is a safety issue. If your product gets recalled, have a conversation with your doctor.

Covering the cost of the devices

Although Medicare covers 80% of the cost of the device, it doesn’t necessarily cover the product’s related costs.

For instance, home medical devices often require a broadband internet connection to send the user’s doctor their readings and results, but that cost isn’t covered by Medicare. High-speed internet isn’t even possible in some rural locations.

Certain home medical devices are expensive, too. That means some people can’t afford the 20% co-pay for them.

Medicare does pay for a home safety assessment, but it might not pay for someone to help you use a home medical device.

A health provider or community worker offering the service must arrange with Medicare for reimbursement. “It’s a process,” says Cota.

How the FDA is trying to help

A new FDA program called Home as a Health Care Hub aims at addressing some of the challenges people face with home medical devices.

This initiative is bringing together health care providers, device manufacturers, consumer tech pros, patient groups and an architecture firm to make homes and their residents more medically holistic.

The FDA held its initial Home as a Health Care Hub virtual meeting recently.  

“I was encouraged by it because we had the provider community, the technology community and the patient and caregiver community all together in the same place, exchanging information and views,” says Quashie, who is on its steering committee.

Home as a Health Care Hub is starting with a focus on improving treatment of diabetes. The goal: creating virtual reality prototypes of a person-centric home for this by the end of 2024.

Making home medical devices more home-friendly and user-friendly will likely take time.

“It’s going to be a work in progress over the next several decades perhaps to really get this right,” says Lucas. “But I think it’s important to start now.”

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