Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -14

Accepted - Volume 1

Comment Record
Commentor Dr. Sean Clarke Date/Time 2002-09-12 11:38:03
Organization Center for Health Outcomes and Policy Research
Category Academic

Comments for FDA General
Questions
1. General Comments Our research group has been investigating needlestick injuries in nurses for almost 15 years, from the early 1990's (before safety-engineered devices were widely available), to as recently as 1999. We recently published a paper in the American Journal of Infection Control (Clarke et al., Am J Infect Control 2002; 30: 207-216) based on 1998 data collected independently of any industry support. Our results suggest that some forms of equipment (for instance, safety-engineered equipment for phlebotomy) are associated with lowered risks (in the range of a 30% reduction) of needlestick injuries. While our data are drawn from a non-randomized cross-sectional study of a limited number (22) of institutions and involve retrospective reports of injuries, and the statements in your call for comments regarding the limitations of existing data (especially to quantify risks of specific equipment brands and models) are absolutely correct, there is nevertheless a good deal of evidence (albeit not always of the highest methodological quality) to suggest that some types of equipment are safer than others. Given the human and financial costs of needlestick injuries, rigorous study of these questions to obtain evidence of the required grade is clearly indicated, especially if in the course of deliberations it is determined that a ban on specific equipment types is not indicated based on the current state of the science. If I can provide further information about our work, please do not hesitate to contact me.




EC -14