Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -10

Accepted - Volume 1

Comment Record
Commentor Mr. James Reed Date/Time 2002-07-23 11:40:06
Organization Medamicus Inc.
Category Company

Comments for FDA General
Questions
1. General Comments Having conducted extensive user preference research on sharps protected devices in recent months, it is clear that end user compliance with the Needlestick Safety and Prevention Act varies widely from facility to facility. In fact, many healthcare providers (particularly physicians) indicate that they will only use safety products if and when they are forced to do so. It is also clear that OSHA and JCAHO do not have the enforcement resources required to ensure widespread compliance with current legislation. Infection control personnel and department managers are often not motivated or empowered to generate real change within organizations. Therefore, rather than attempt to attack this compliance issue from the 'demand' or user side of the equation, it may be more productive to attack it from the 'supply' side. Simply put, if non-safe products are unavailable, use of sharps protected products will quickly become ubiquitous. Consensus among my contacts in industry is that complete compliance with safety legislation could be many years away unless the Federal government is able to find a more effective way to enforce its mandate. Until a complete ban on non-safe devices is implemented, the financial and human costs of sharps injuries will continue to mount.




EC -10