APRIL 5, 2023 – The U.S. Army Medical Center of Excellence Medical Test and Evaluation Activity (MTEAC) conducted a customer test an auto-injector single use, self-containing needle-based injection system for the Joint Program Executive Office – Chemical, Biological, Radiological, Nuclear Defense – Medical (JPEO–CBRND–Medical).
The test was conducted at Camp Bullis, Texas during the last week of March 2023. Eleven 68W Combat Medic and one 68Y Eye Specialist Soldiers participated in the test.
The Advanced Anticonvulsant System, Rafa Midazolam Auto-Injector (Rafa AI) is a single use, self-containing needle-based injection system prefilled with 10 milligrams of Midazolam. The drug is delivered as an intramuscular injection with a 22-gauge needle. The Rafa AI was specifically redesigned for this customer test with a gray safety pin to prevent accidental injury.
The midazolam autoinjector received U.S. Food and Drug Administration approval August 2022. The midazolam autoinjector is indicated for the treatment of status epilepticus, or prolonged seizures, in adults.
The purpose of the test was to conduct a human factors assessment of the effectiveness of the Rafa AI with a redesigned safety pin. The data collected from this CT to determine the effectiveness and usability of the Rafa AI in a chemical, biological, radiological, and nuclear (CBRN) operational environment.
Ms. April Schnortz, MTEAC Test Officer, said “We are conducting this test due to the modification to the safety cap of the Rafa Midazolam Auto-Injector. The test is to verify that the redesign makes it easier to use the device. The Soldiers participated in simulated CBRN buddy-aid and self-aid scenarios and demonstrated the use of the device.”
Leadership will use the data collected from this test to determine the effectiveness and usability of the RAFA AI in a chemical, biological, radiological, and nuclear (CBRN) operational environment. The redesign of the Rafa AI will further aid in the handling and use of the auto-injector while wearing Mission Oriented Protective Posture (MOPP) gloves.
“The test was a success, and the next step is to provide the product manager the results of the test to determine if there needs to be any additional changes before fielding to our Soldiers.” stated Schnortz
MTEAC and JPEO–CBRND–Medical are working hand in hand to verify and ensure that the modifications to the Rafa Midazolam Auto-Injector is an improvement on effectiveness and suitability when utilized by the warfighter. The results of the test will be forwarded to JPEO–CBRND–Medical for analyzation.
If approved, the redesigned autoinjector will enter production and begin fielding to the Joint Services.
To learn more about MTEAC visit their webpage at https://medcoe.army.mil/usamteac
By April L. Schnortz, PMP, Test Officer
Materiel Test and Evaluation Activity