Medical Device Compliance for Home Healthcare Settings

09 May 2023

Considerations for designing and manufacturing electronic medical devices

It wasn't too long ago that if you were sick and needed treatment, your options were limited to going to a clinic, physician's office, or hospital. But today, many patients don't need to leave the comfort of their homes to receive necessary care. That's because home healthcare is more accessible than ever. The market has grown immensely in recent years due to a number of factors, like an aging population, rising healthcare costs, the prevalence of telemedicine, and advances in technology. As a result, the demand for electronic home healthcare technology has skyrocketed.

What is considered a home healthcare device?

What exactly is a home use healthcare device? The U.S. Food and Drug Administration (FDA) defines a home use medical device as: a medical device intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes.

• A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
• A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

Devices in home healthcare settings are commonly used to monitor vitals like blood pressure or oxygen saturation rate, but can also be used by people to manage chronic illnesses, such as diabetes, to administer critical medication. Some popular medical devices used in home settings include blood pressure cuffs, pulse oximeters, glucose monitors, and nebulizers.

Considerations when Manufacturing Home Healthcare Devices

When we think about designing and manufacturing electronic medical devices that will be used in a home setting vs. a healthcare setting, it's important to note that:

• Home care medical device is in principle not different than a professional medical device
• FDA guidance(s) apply, and registration is required
• Special attention needs to be applied – user/patient home; user/patient are not professional
• Usability and interface design are important considerations, especially for older adults, and technology designs need to be tested with these populations
• Special safety standard compliance is required

As with any medical device, it is also critical to assess and test at every stage from design through production. The process helps to ensure you can identify and mitigate any issues as you move from one step to another so there are no surprises when you are too far into the development process. The steps include:

• Conducting a risk assessment
• Reviewing relevant standards and regulations
• Developing a test plan
• Performing verification testing
• Validating the device
• Reviewing test results
• Preparing for certification

Conclusion

I've outlined just some of the issues and factors to consider when manufacturing medical devices for use in a home healthcare setting. But with so many different types of products included in the home healthcare medical device category, there are specific considerations to ensure proper use, privacy, security, safety, and compatibility of these devices. For a more in-depth look at the compliance requirements, download our white paper, "The Evolution of the Home Healthcare Market and Medical Device Compliance."