NHIA Submits Comments to FDA Regarding At-Home Use Medical Technologies
- By Laurie Watanabe
- Sep 05, 2023
The National Home Infusion Association (NHIA) has submitted comments in response to a U.S. Food & Drug Administration (FDA) request on “Increasing Patient Access to At-Home Use Medical Technologies.”
In an Aug. 30 announcement, the NHIA said it was “applauding” the FDA for understanding “the importance of facilitating access to care in the home.”
Addressing her comments to FDA Commissioner Robert M. Califf, M.D., NHIA CEO/President Connie Sullivan, B.S. Pharm, said the NHIA appreciated recognition “of facilitating access to care in the home and for issuing this Request for Comment to promote expanded access to home use technologies.”
Sullivan added, “For more than 40 years, home infusion therapy (HIT) pharmacists and nurses have
collaborated to provide and administer intravenous (IV) and subcutaneous infused medications to
patients in their homes safely and effectively. Home infusion therapy keeps high-risk patients
with serious infections, heart failure, immune diseases, cancer, and other conditions out of
institutional settings and allows them to receive treatment at home. This proven model of care is
overwhelmingly preferred by patients, while also being cost-effective relative to institutional
Among the NHIA’s recommendations are to develop technologies that enable clinicians to remotely view, program, and download data from infusion pumps; to focus on how devices will be used by patients at home, rather than by clinicians; consider “an accelerated approval pathway for catheter lock combination solutions” that could prevent catheter-related bloodstream infections; to ensure that clinical trials include considerations for, as an example, drugs being administered in the home rather than in a clinical setting; change Medicare coverage for home infusion “so that infusion medications can be administered via disposable (non-durable) devices that are simpler for patients to use, compared to infusion pumps”; avoid drug labeling “that is prescriptive regarding method of administration or who administers the drug,” because such language can be restrictive to pharmacists and nurses working with patients who take drugs infused at home; and “consider the care setting when collecting data to evaluate quality.”
Read Sullivan’s full letter to the FDA here.
Laurie Watanabe is the editor of Mobility Management. She can be reached at firstname.lastname@example.org.