User Preference Study Of Reconstitution Systems For Factor VIII Products

Patients with hemophilia A are treated with infusions of factor VIII (FVIII) to treat or prevent bleeding episodes. Before administration, freeze-dried FVIII powder must be reconstituted as a liquid solution. Several needleless reconstitution systems are available to improve the ease and safety of FVIII infusions. The purpose of this study was to identify common errors/failures in handling, as well as preferred attributes, across the available FVIII needleless reconstitution systems.

In an international, cross-sectional, blinded study, needleless reconstitution systems were evaluated via one-on-one interviews with hemophilia patients and caregivers, hemophilia nurses, and emergency room (ER)/surgical nurses. During the interviews, participants indicated which systems they had used in the past and completed questionnaires rating the importance of various reconstitution system attributes. They then performed 3 mock reconstitutions using up to 3 of the available reconstitution systems being studied. For the mock reconstitutions, participants did not handle systems currently used or used for ≥6 months within the previous 2 years. Each system was handled 3 times: first use was unaided (without instructions); second use was after instructions and a demonstration video had been provided; third use was unaided. Researchers observed the participants while they handled the systems and noted difficulties encountered. Handling failure was defined as handling with errors or issues leading to failure or handling with uncompleted steps that prevented subsequent handling steps. Participants subsequently rated each system separately on various attributes and provided a comparative assessment of the systems on 7 domains (ease of use, contamination safety, safety from injuries, speed of preparation, easy to travel with, waste produced, and ease of learning).

A total of 408 participants were recruited (107 patients, 106 caregivers, 79 hemophilia nurses, 116 ER/surgical nurses). During the first (unaided) handling, ER/surgical nurses were more likely than the other participant groups to experience handling failure with the reconstitution systems. After participants were provided instructions on correct use, the likelihood of incorrect handling decreased among all participant groups but remained highest for ER/surgical nurses. Some handling failures seen during the first use persisted through the third use (ie, after instructions had been provided). The 2 reconstitution system attributes considered most important by study participants were convenience of use and potential for accidental contamination.

A learning effect was apparent for all FVIII needleless reconstitution systems tested. To decrease handling errors, users should be provided with comprehensive training materials before first use. Development of new, more intuitive systems may reduce the likelihood of errors during FVIII reconstitution, especially among groups such as ER/surgical nurses who infrequently handle reconstitution devices.

Khair:Bayer: Received funding for lecturing at educational symposia Other. Giersdorf:Bayer, Baxter, and CSL Behring: Membership on an entity’s Board of Directors or advisory committees. Kalweit:Bayer HealthCare Pharmaceuticals: Employment. Riske:Bayer HealthCare: serves on committee Other.