First Author: A.Antoszyk USA
Co Author(s): C. Baker J. Calzada H. Cummings N. Deboo C. Quezada Ruiz Z. Haskova
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The recently FDA-approved sterile ranibizumab PFS eliminates injection preparation steps, which in previous studies reduced procedure time compared with the standard vial, leading to improved office efficiency. The purpose of these studies was to evaluate the usability of the ranibizumab PFS by assessing whether US healthcare professionals could successfully prepare and perform intravitreal injections (IVI) using the ranibizumab PFS without prior training, and with only the Instructions for Use and US Prescribing Information available.
Simulated-use usability study: retina specialists (n=15) and ophthalmic medical personnel (n=15) prepared the PFS and performed injections into a model eye. Actual-use usability study: (ClinicalTrials.gov identifier: NCT02698566), 3 assistants and 3 retina specialists prepared the PFS and performed intravitreal injections, respectively, in study eyes of patients with retinal diseases (n=35).
Twelve tasks specific to the unpacking, preparation, and proper administration of the PFS for IVI were evaluated by two study assessors. Task performances were evaluated for use errors, close calls, and operational difficulties. Post-injection subjective user evaluations were given to assess ease of use.
All participants successfully performed all essential and safety-critical tasks without use errors in both the simulated-use and actual-use human factors usability studies. The majority of ranibizumab PFS users rated the tasks required to use the ranibizumab PFS as “Easy” or “Very Easy.” A single adverse event (AE) was observed, with 1 patient experiencing a mild subconjunctival haemorrhage that resolved by end of study. This AE was deemed related to the injection procedure and not to the PFS itself.
Both the simulated-use and actual-use usability studies yielded consistent data, showing that healthcare professionals are able to use the ranibizumab PFS by successfully performing all critical tasks involved in preparing and delivering an IVI while maintaining aseptic conditions and without prior training. Considering the number of patients that require IVI for retinal diseases, the ease-of-use, time savings achieved, and reduced risk of contamination associated with use of the ranibizumab PFS may represent a significant benefit for both health care providers and patients in real world clinical settings.