On August 1, 2007, a new needle safety mandate — TRBA 250 — took effect in Germany. The TRBA 250 regulates protection from needle stick injuries and is significantly more stringent than its previous version.

A "must" regulation, this recent mandate stipulates, among other things, the use of "one-handed needle safety solutions." A handful of drug products on the German market today comply with this new regulation in several therapeutic fields such as LMWH, EPO and vaccines. But many don't.

Safety Syringes, Inc. (SSI) has successfully helped many of our pharmaceutical customers meet TRBA 250 compliance with our innovative line of products, ongoing support and valuable compliance information. We realize that many members of the pharmaceutical industry are still working toward achieving compliance with TRBA 250, even though the deadline has passed. It's not too late. We can help. For these companies, SSI extends our products and expertise to expedite compliance.

Meeting TRBA 250 compliance not only allows you to elevate safety standards, but also solidify your competitive position by allowing you to protect and even capture new market share. To assist our customers in meeting compliance and remaining competitive, SSI will continue to expand our product platform and manufacturing capacity, maintaining and even improving our on-time delivery record.

By responding to customer challenges and opportunities such as TRBA 250, SSI continues to be recognized as a worldwide leader in safety systems for prefilled syringe presentations, including our UltraSafe Passive® Drug Delivery System. We thank our pharmaceutical customers for their support and trust, and look forward to helping you strengthen your leadership position by reaching compliance.

What you need to know about TRBA 250 compliance.

Effective as of August 1, 2007, TRBA 250 is a "must" regulation that applies to both hospitals and physicians' offices. TRBA 250 mandates certain performance requirements for needle safety devices, including:

• One-handed activation
• No change in technique
• No re-use

Exceptions to this sharps injury prevention regulation are risky and difficult to realize. SSI can help you avoid this risk while meeting the challenge of TRBA 250 compliance with innovative products, expert support and valuable information.

Your Safety Mobilization Team

Experts from SSI are available to help you devise the best and most profitable solutions for meeting compliance. Team members are ready to assist you now.

info@safetysyringes.com

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Legal Brief / Opinions / Articles

To help you better understand and reach compliance, SSI offers this convenient online library of information. Click on the links to view, download and print articles, briefs and opinions.