Stainless Steel Needles: Quantifying Cobalt Risk To Comply With EU Medical Device Regulation

By Dr. Laura Berardi, Regulatory and Scientific Affairs Specialist – Drug Containment Solutions, Glass Department, Stevanato Group

Syringes and autoinjectors play an important role in improving patient care and well-being, but even the slightest misstep in crafting their components can lead to unintended consequences. From discomfort to potentially life-threatening issues, it's crucial that each part functions flawlessly in harmony with the whole. This study dives deep into this critical aspect of medical device safety, ensuring the noble goal of healing remains paramount.

Cobalt has been reclassified as a Category 1B carcinogen, which has implications for the pharmaceutical sector as it can be present in medical devices such as needles. The European Medical Device Regulation (MDR) requires appropriate labeling and justification for the use of substances classified as carcinogenic, mutagenic, or toxic to reproduction. However, the MDR does not provide clear parameters for determining the levels of these substances. Stevanato Group conducted a study to assess the toxicological risk of cobalt in needles and syringes.

The study involved analyzing the chemical compounds present in assembled syringe products and individual needle components. The results showed that iron was the compound recorded at the highest level in the extraction analysis, while other compounds such as silicon and TOC were also detected. Cobalt was not detected in any needle samples.

These findings provide certainty that levels of substances such as cobalt are within compliant levels, allowing for compliance with the MDR. Learn how a manufacturing partner who is committed to supporting pharmaceutical partners and ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.