Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -13

Accepted - Volume 1

Comment Record
Commentor Mrs. Jean Henes Date/Time 2002-08-30 15:38:23
Organization Creighton Area Health Services
Category Health Professional

Comments for FDA General
1. General Comments I am concerned about the medications that we use that are in prefilled cartridges. These cartridges have to be placed in a reusable holder and then removed after the medication is given. Examples are Demerol and Morphine. The design of the holder is poor and we had one needlestick that occurred when the RN was removing the cartridge. She had not recapped the needle per our protocol. The products we use are Tubex and Carpuject. Recently we began ordering them without a needle attached but you still have to manipulate the cartridge out of the holder when done giving the injection. Other medications now come prefilled in a syringe barrel and all you have to do is attach the needle. When finished giving the injection you can dispose of the entire syringe. I have contacted both of the companies and they said they were aware of the problem but they were not in a position in the company to do anything about the problem. For other injectables we use syringes with retractable needles but I do not want to go to a multidose vial for pain medications because I think that would increase the likelyhood of a medication error. We are a 23 bed Critical Access Hospital and do not have a pharmacist on staff except 1-2 hours a day. Jean Henes, RN, BSN

EC -13