Question received by Heather Demyan, Nurse Educator at The Ohio State U Medical Center.
"Is this device approved for hazardous medication administration?"
No, RxCrush is not approved by any organization other than our registration with the FDA as a Class 1 Medical Device. We also have CE Mark and are listed with EUMED, also as a Class 1 medical device.
RxCrush was designed to increase safety while manipulating hazardous medications. Using RxCrush pouches create a "contained" system that keeps medication dust and liquid under control through the process of crushing medications. Prudent precautions need to be used ie, PPE, controlled negative atmosphere room or hood etc., while handling Hazardous Medications. Also the instruction steps listed in the "How to Use" section of the web site need to be followed carefully to keep maximize the containment RxCrush was designed to provide.
However RxCrush is not a CSTD or controlled system transfer device and cannot contain aerosols from hazardous medications.
1 comment
Are the male and female adapters required for a “true” closed containment device so that this can be used outside of a negative pressure hood and remain compliant with USP <800>?