Particles in Injections - What about the Patient?
» Fri Oct 08, 2010 3:06 pmIt is generally recognized that particles in injections may result in serious complications for patients. The potential serious adverse events resulting from the use of a sterile injectable product with particles by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis). Complications in connection with the subcutaneous route may includeforeign body granuloma, local injection site reactions, and increased immunogenicity (1)There are therefore official requirements for manufacturers to provide documentation tohealth authorities concerning particulate matter in injectable products (2)Many years ago I worked in the sterile department of a public hospital in Norway. Inconnection with quality control of injections one of my jobs was to count particles ininjections with an automatic counter and to identify them microscopically prior to release of each batch.Particles identified were for example glass, crystals, fibres from filters, or rubber particlesfrom the stoppers. The latter may have been released during the sterilisation process, heatingin autoclaves under high temperature and pressure.I was often present on the wards when patients were given injections after the rubber stopperson injection vials had been punctured prior to withdrawal of the doses.For interest, I sometimes counted and identified particles in injections both before and after puncturing the stoppers. There were, as expected, more rubber particles after puncturing andthe numbers were higher for thicker needles and several punctures.Recently I contacted Food and Drug Administration (FDA) and asked if there is a requirementfor manufacturers of injections including vaccines to produce documentation concerning particulate matter after puncture of rubber stoppers. The complete reply from FDA is posted below (3).It is surprising and disconcerning to learn from the answer received :³To the best of my knowledge, there is no specific requirement for the manufacturer to countand identify particles after vaccine stoppers are punctured´.If there was a requirement for this, it would undoubtedly result in more awareness from themanufacturers regarding the quality choice of rubber stoppers, an aspect which surely should be considered in connection with patients¶ health and safety.(1)http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm227225.htm (2)http://www.usp.org/pdf/EN/USPNF/PF35(5)_StimArticle-3.pdf (3) Reply from FDA. 10th October 2010: