Human Factors Validation of a Wearable, On-Body Infusor for Subcutaneous Administration of Furosemide.

Purpose: 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.

Human factors studies of a prefilled syringe with stable liquid glucagon in a simulated severe hypoglycemia rescue situation.

Background: Two human factors studies evaluated whether a stable liquid formulation of glucagon in a prefilled syringe (G-PFS) could be safely and effectively administered and evaluated the effectiveness of the product label guide and instructions-for-use (IFU). Research design and methods: In a formative study, 11 participants received orientation with the G-PFS instructional materials and performed a single unaided rescue attempt. In the validation study, 75 adult and adolescent participants received training or familiarized themselves with the G-PFS IFU, Label Guide, and device. All participants returned 1 week later to perform a single unaided rescue attempt of a simulated person with diabetes suffering from an emergency severe hypoglycemic event. Results: The formative study resulted in a 100% success rate across all rescue dose attempts. The validation study resulted in 74/75 (99%) of participants successfully using the G-PFS to administer the full glucagon rescue dose, and validated that intended users could learn from, comprehend, and recall the G-PFS instructions to successfully use the product. Conclusion: The G-PFS provides a familiar, easy-to-use alternative to currently marketed lyophilized glucagon kits for treating severe hypoglycemia. The G-PFS IFU and Label Guide enable even untrained users to successfully administer a full rescue dose of stable liquid glucagon.

Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation.

Background: A room-temperature stable, soluble liquid glucagon formulation loaded into a prefilled, single-use, two-step autoinjector is under development for severe hypoglycemia rescue. We report a human factors validation program evaluating the glucagon autoinjector (GAI) (Gvoke HypoPen™; Xeris Pharmaceuticals, Inc., Chicago, IL) versus marketed glucagon emergency kits (GEKs) for managing severe hypoglycemia. Methods: A simulated-use human factors usability study was conducted with the GAI versus marketed GEKs in 16 participants, including adult caregivers and first responders, experienced with glucagon administration. A summative human factors validation study of the GAI was conducted with 75 volunteers. Participants were (1) trained on the device and procedure or (2) given time to individually read the instructions and familiarize themselves with the device. Participants returned a week later to perform an unaided rescue attempt that simulated rescue of patients with diabetes suffering a hypoglycemia emergency. Participant actions were recorded for critical rescue tasks and use errors. Results: In the usability study, 88% (14) successfully administered a rescue injection using the GAI versus 31% (5) using GEKs (P < 0.05). Mean total rescue time of use was 47.9 s with the GAI versus 109.0 s with GEKs (P < 0.05). In the validation study, 98.7% successfully administered the rescue injection using the GAI. Overall, there were no patterns of differences between trained versus untrained participants, between caregivers versus first responders or between adults versus adolescents. Conclusion: The GAI and instructional materials can be correctly, safely, and effectively used by intended user, which support continued development of the GAI as an alternative to GEKs.

Subcutaneous sumatriptan delivery devices: comparative ease of use and preference among migraineurs.

BACKGROUND: Several sumatriptan subcutaneous autoinjector devices for acute treatment of migraine patients are available, each device differs with respect to design and features. Determining device preference and ease of use is important because patients experiencing a migraine attack are often functionally impaired. OBJECTIVE: The objective of this human factors study was to compare migraine patients' device use performance and preferences for three sumatriptan subcutaneous autoinjectors: a disposable two-step device (Zembrace® SymTouch®), a disposable three-step device (Sumavel® DosePro®), and a multistep reloadable device (Imitrex® STATdose®), using simulated injections. METHODS: Each study subject performed two unaided simulated injections with each of three different drug delivery devices, which were presented in counterbalanced order. The participants were then asked to rate the three devices on various subjective measures. The primary end point was overall device preference using a visual analog scale. RESULTS: A total of 54 subjects participated and each subject performed two simulated injections with each of the three devices. Most subjects preferred the two-step device (88.9%) to the three-step (13.0%) and the reloadable (1.9%). The two-step device had higher mean overall preference ratings (F (2, 159)=56.6, P<0.01) and higher ratings for ease of use, intuitiveness, convenience, portability, and control. The two-step device had a first injection full-dose delivery success rate of 44.4%, higher than both the reloadable (24.1%) and the three-step (3.7%) devices. The number of errors with the two-step device (n=3) was ~90% lower than the three-step (n=49) and reloadable (n=44) devices. CONCLUSION: In this human factors study, 54 migraineurs used simulated injections to compare three sumatriptan subcutaneous delivery devices. Zembrace SymTouch, a two-step device, was most preferred compared with Sumavel DosePro and Imitrex STATdose. It also ranked highest for ease of use and various other measures. In this study, migraine patients preferred the autoinjector that they rated as simpler and more intuitive.

Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients.

BACKGROUND: Migraine pain relief is reported by more than 50% of patients who receive low dose (3 mg) of sumatriptan. Currently, there is no two-step autoinjector of low-dose sumatriptan available on the market for acute migraine treatment. To fulfill this need, a fully assembled, single-dose, subcutaneous autoinjector (sumatriptan 3 mg; product-code DFN-11) was developed. The device allows for injection with a simple two-step, push-to-inject process and provides feedback of the injection activation, progress, and completion. OBJECTIVE: To determine if DFN-11 autoinjector can be used correctly and safely by migraine patients. METHODS AND PARTICIPANTS: A human factors validation study was conducted with 45 migraine patients (30 oral-only medications users; 15 injectable sumatriptan users) who performed one unaided simulated injection. Two days prior, half the oral participants were briefly trained. All others were only given the device to inspect and written instructions to review. No injections were performed during the initial session. All participants received written instructions at the injection session. RESULTS: All participants (45/45; 100%) performed the injection without any errors. Objective measures included device removal from packaging, cap removal, expiration date check, inspection of fluid in window, identification of allowable injection site, proper device positioning, dose confirmation, and device disposal. All participants (45/45; 100%) reported no difficulty administering the injection and no concerns about using the autoinjector during a severe migraine onset. CONCLUSION: The results showed that the DFN-11 autoinjector can be used with safe handling without patterns of confusion, failures, high-risk errors, wet injections, or patient safety risks. The DFN-11 autoinjector was validated to be used correctly and safely by migraine patients, whether they were injection experienced, unexperienced, trained, or self-trained.

Automated external defibrillator use by untrained bystanders: can the public-use model work?

OBJECTIVE: For automated external defibrillators (AEDs) to be practical for broad public use, responders must be able to use them safely and effectively. This study's objective was to determine whether untrained laypersons could accurately follow the visual and voice prompt instructions of an AED. METHODS: Each of four different AED models (AED1, AED2, AED3, and AED4) was randomly assigned to a different group of 16 untrained volunteers in a simulated cardiac arrest. Four usability indicators were observed: 1) number of volunteers able to apply the pads to the manikin skin, 2) appropriate pad positioning, 3) time from room entry to shock delivery, and 4) safety in terms of touching the patient during shock delivery. RESULTS: Some of the 64 volunteers who participated in the study failed to open the pad packaging or remove the lining, or placed the pads on top of clothing. Fifty-percent of AED2 pads and 44% of AED3 pads were not placed directly on the manikin skin compared with 100% of AED1 and AED4 pads. Adjacent pad displacements that potentially could affect defibrillation efficacy were observed in 6% of AED1, 11% of AED2, 0% of AED3, and 56% of AED4 usages. Time to deliver a shock was within 3.5 minutes for all AEDs, although the median times for AED1 and AED4 were the shortest at 1.6 and 1.7 minutes, respectively. No significant volunteer contact with the manikin occurred during shock delivery. CONCLUSIONS: This study demonstrated that the AED user interface significantly influences the ability of untrained caregivers to appropriately place pads and quickly deliver a shock. Avoiding grossly inappropriate pad placement and failure to place AED pads directly on skin may be correctable with improvements in the AED instruction user interface.