Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -9

Accepted - Volume 1

Comment Record
Commentor Ms. Sandi Hartka Date/Time 2002-07-19 10:57:49
Organization Terumo Medical Corp
Category Company

Comments for FDA General
Questions
1. General Comments Comments re Docket No. 01P-0120 Medical Devices; Needle-Bearing Devices; Request for Comments and Information From: Terumo Medical Corporation A. Banning per 21 USC 360f Banning the non-safety devices (e.g. IV catheters, blood collection devices) is inappropriate because: 1. There has been no presentation of significant statistical evidence that confirms the number of needlesticks for particular types of non-safety devices is significant compared with the number of needlesticks occurring with an equal number of uses of the same type of safety devices. Without this information we cannot demonstrate the risk outweighs the benefit. 2. Use of safety devices does not preclude needlestick injury. It is expected to minimize needlestick injury, however, the intended use/indication for use does not include “prevents” needlestick injury unless it is a needleless system. Additionally, the intended use of these devices brings them into contact with blood and body fluids, which inherently poses a potential risk to the healthcare worker. Based on these circumstances it has not been determined that the risk outweighs the benefits. 3. Healthcare professionals are trained to use these devices safely and effectively. In addition, they are taught the inherent risks of use and the necessary precautions to take to minimize inadvertent injury. Many of the needlestick incidents that occur can be attributed to improper user technique and failure to follow/observe other OSHA guidelines for Blood Bourne Pathogen protection. Assigning risk only to non-safety devices cannot be done until these other safety risks are considered in conjunction with the risk to benefit analysis of safety vs. non-safety devices. 4. At this time, there is concern that mandating the use of only safety devices may not be possible due to the inability to meet the necessary levels of production to meet the current usage quantities that are required to provide adequate healthcare to patients. In addition, the use of safety devices will increase healthcare costs without supporting evidence that the benefit of using them outweighs the risks. cont. C. Labeling The proposed additional labeling for non-safety devices is not necessary because: 1. Healthcare professionals are trained to use these devices safely and effectively without additional labeling. 2. Healthcare professionals are cognizant of the risks associated with use of these devices through their training and education. Additional labeling does not provide any added benefit to these professionals.




EC -9