Medical Devices: Evidence and Research (Jun 2024)
Human Factors Validation of a Wearable, On-Body Infusor for Subcutaneous Administration of Furosemide
Abstract
Anthony D Andre,1 John F Mohr,2 Barbara W Cornelius,2 Matthew M Goodwin,2 Carson P Whitaker,1 Bhavini H Patel,2 Jessica A Huckleberry,3 Michael D Hassman2 1Interface Analysis Associates LLC, Saratoga, CA, USA; 2scPharmaceuticals, Inc, Burlington, MA, USA; 3Heart Group of the Eastern Shore, P.C, Fairhope, AL, USACorrespondence: Michael D Hassman, scPharmaceuticals, Inc, 25 Mall Road, Suite 203, Burlington, MA, 01803, USA, Tel +1 781 301 7373, Email [email protected]: Furoscix® (subcutaneous furosemide) is administered using a wearable On-Body Infusor (OBI) and is approved for the treatment of congestion associated with heart failure (HF). The purpose of this study was to assess the safe and effective use of the OBI and Instructions for Use (IFU) by patients with HF, caregivers, and healthcare practitioners (HCPs).Methods: Sixty participants (patients, n=30; caregivers, n=15; HCPs, n=15) were evaluated on completion of OBI use tasks and IFU knowledge tasks in a simulated use environment. Fifteen of the patients received OBI/IFU training before evaluation.Results: Overall, 893/900 (99.2%) use tasks and 2211/2220 (99.6%) knowledge tasks were completed successfully, without differences due to training. The most common (n=6) use error was failure to wipe skin or cartridge tip with an alcohol wipe. Errors were due to forgetfulness/misinterpretation rather than IFU clarity.Conclusion: The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.Keywords: heart failure, furosemide, subcutaneous furosemide, on-body infusor, human factors
