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NHIA Submits Comments to FDA on At-Home Use Medical Technologies

August 30, 2023

NHIA responded to an FDA request for comment on “Increasing Patient Access to At-Home Use Medical Technologies,” applauding the agency for recognizing the importance of facilitating access to care in the home. The association made several recommendations, including: 

  • Encourage development of technologies that enable clinicians to remotely view, program, and download data from infusion pumps by holding listening sessions with clinicians and consumers to better understand desired capabilities.
  • Focus on the needs of patients since devices used at home must be designed for use by the patient, rather than the clinician.
  • Consider an accelerated approval pathway for catheter lock combination solutions (i.e., antimicrobial, anticoagulant) for the prevention of catheter-related bloodstream infections in high-risk populations requiring long-term central venous access. 
  • Ensure clinical trials consider alternative settings when developing novel medication therapies and devices. For drug approvals, this could mean considering medication stability at room temperature, minimizing aseptic preparation steps that occur outside a pharmacy, and ranges for infusion times so clinicians can adapt infusion to the method of administration. 
  • Fix Medicare coverage of 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 that often restricts options for pharmacists and nurses designing a patient-specific treatment plan for drugs infused in the home and limits site of care options. 
  • Consider the care setting when collecting data to evaluate quality. For example, NHIA’s standardized definitions for pump-related events occurring in the home setting. 
 

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