In November 2010 the US Food and Drug Administration (FDA) issued a letter to stakeholders referring to certain needleless pre-filled glass syringes, following reports of compatibility issues when used with some needleless intravenous (IV) access systems. The problems related to the cardiac drugs adenosine (marketed by Teva, Sagent, Baxter, and Wockhardt) and amiodarone.
According to the guidance, “attempted connections between the needleless glass syringe and certain needles” caused events which “included syringe tips breaking upon injection, needles detaching during injection, and syringes breaking or jamming the IV lines or other patient use lines.”
The US FDA is inviting stakeholders and the general public to be part of the regulatory process by commenting on the guidance before writing the final version.
In this draft, the FDA has issued a number of non-binding recommendations in the design including: the use of bonded or staked needle for subcutaneous or intramuscular injections, a redesign of the glass syringe with internal dimensions to ensure connectivity and a design for dual connections between the glass syringe and connecting devices.
Furthermore, the FDA is suggesting a submittal of data from manufacturers of injectable drugs and biologics, as well as glass syringe makers, of data relating to premarket or investigational submission, including information to show:
- Demonstration of dimensional conformance to relevant FDA-recognized ISO standards in order to ensure compatibility with connecting devices
- Functionality of the syringe to show performance and proper connectivity
- The biocompatibility and sterilization
- The human factors testing and risk analysis of use errors
In-Pharmatechnologist.com contacted a number of manufacturers regarding the draft guidance but has yet to receive any responses.