Intravenous containers and solution packaging

As a general and pediatric surgeon for the past 34 y, I have had practical encounters with innumerable bottles and bags of intravenous fluids and medications. I have always taken the availability, durability, and sterility of these critical items for granted and have not given the technology behind them much thought. However, what we take for granted as readily available and reliable intravenous (IV) containers and administration sets are marvels of engineering complexity and manufacturing sophistication. Medical product design is a highly developed art and science. To bring an IV container to the bedside, several complex performance requirements must be met, multiple government standards and regulations must be satisfied, pricing and quality pressures must be resolved, and environmental impact must be respected. As far as I am aware, there are no articles about IV containers and solution packaging in the medical literature. I hope to correct this deficiency and to promote a better understanding and appreciation of a valuable part of our medical technology. Up until about 25 y ago, glass bottles were the only containers available for IV solutions. Although the availability, quality, and sterility of glass containers improved markedly from 1931 until the early 1950s,1 outbreaks of sepsis were reported from time to time, frequently related to the open system inherent in the glass container. As fluid left the glass container, it was replaced by room air through a tube vent, offering opportunities for contamination and for potential air emboli. In addition, glass is breakable, awkward to store, heavy, and expensive to clean and recycle. As the medical profession became more aware of the detrimental effects of particulate matter and leachables (chemicals leached from the glass and the rubber stoppers), alternatives to glass containers were researched and developed. Carl Walter was one of the first inventor-physicians to realize the potential application of the developing plastics industry and partnered with John Fenn to introduce plastic containers for blood and other IV solutions. These were first used during the Korean War. As a result, medics could carry many more units on their person and, under battlefield conditions, pass them like a football, which had been impossible with glass containers. The new plastic containers were made from polyvinyl chloride (PVC), the ingredients of which are mineral oil, rock salt, and natural gas, together with an appropriate plasticizer such as di-(2ethylhexyl) phthlate (DEHP). Flexible PVC containers for IV fluid went through several development and refinement phases in the 1960s and 1970s. The emphasis was on flexible, clear, unbreakable containers, with port access that could be dropped from 6 ft without bursting. Because the containers were collapsible, the fluid could be delivered without venting. The resulting closed system preserved sterility, significantly reduced the chance of air emboli, and was configured for minimal residual volume. PVC has low leachables and far less particulate matter than glass. It is compatible with a wide spectrum of drugs and other biologics. It accommodates aseptic filling and can be steam sterilized. It is hangable, piggy-back capable, and allows universal spike insertion and removal. Although these characteristics are frequently taken for granted, all were carefully designed and were tested and manufactured according to highly regulated processes, requiring adherence