Proposed regulatory change in view of the silicone quantification test in hypodermic syringes

With the increasing advance in diagnostic and therapeutic technologies, more and more health products are available in the market, and consequently, actions directed to their control and monitoring are necessary. Single-use hypodermic syringes (SuHS) are medical devices widely used in a variety of health services and are commonly used in medication administration. They are usually made of high quality plastic and internally lubricated with medical grade polydimethylsiloxane (silicone oil). The current legislation establishes the limit of 0.25 mg/cm² of lubricant per syringe, and the aspect evaluation, by visual inspection, as a method of analysis. Thus, this study aims to evaluate the applicability of the aspect evaluation assay on the presumption of excess lubricant in SuHS commercialized in Brazil, by comparing results obtained in the aspect and extraction/quantification assays (standardized method). Nineteen batches of SuHS were analyzed, totaling 168 units. All samples failed in the aspect evaluation for presenting excess silicone inside. The extraction/quantification assay of the same samples showed that only 2 samples had a mean lubricant content above the standard, ie 87.5% of the failures in the lubricant aspect evaluation would not occur in the extraction/quantification assay. This result highlights the need for regulatory changes regarding the subjective form of lubrication analysis (visual inspection) in SuHS currently used, and suggests the extraction/quantification test as a more accurate and reliable alternative, minimizing the possibility of errors in analysis of metrological certification.