Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -7

Accepted - Volume 1

Comment Record
Commentor Ms. Beth Slingluff Date/Time 2002-06-28 16:09:23
Organization Carondelet Health Network
Category Health Professional

Comments for FDA General
Questions
1. General Comments As manager of occupational health services at two urban hospitals and leader of our hospital teams to reduce needlestick injuries, I am aware of the significant risk to health care workers in using needle-bearing devices. However I would strongly request that the FDA not take the step of banning any devices for two reasons. First, the manufacturers of needleless and safety devices have thus far been unable to keep up with demand. For example, Abbott, the only manufacturer of needleless meperidine systems, is unable to meet demand and so we, like many other hospitals, are having to re-tool despite our desire to use this product. Until manufacturers can meet our demands nationwide, banning any device is simply unworkable as we need to meet day to day patient care requirements. Secondly, as some safety devices come on the market, it is apparent that they are not able to be used with some of our other existing systems. Again as an example, we recently purchased some safety device 5cc syringes (because the manufacturer could not meet demand for non-safety devices) only to discover that the saftey syringe was incompatible with other devices in anesthesia and other areas of the hospitals. We continue to move ahead with introducing safety devices but must always trial devices and train staff to use them. Each new device requires that we adequately investigate and then introduce the device for maximum success with minimal risk. FDA does not need to ban devices for us to continue our efforts and a ban would only hamper efforts for gradual conversion to safety devices.




EC -7