Development of a multilayer film for the first US Food and Drug Administration cleared aseptically-produced intravenous solution bags with a short history of key medical device milestones

Abstract

Flexible intravenous solution containers (IV bags) were introduced to the marketplace in the early 1970s. These new containers were designed to replace glass IV bottles and were quickly adopted widely for delivering medical solutions to patients throughout the world. The 40 years during which commercially available IV solutions in glass bottles were used, the healthcare industry grew dramatically with better patient outcomes while also reducing operational costs. These early developments then led to the rapid expansion of new medical devices that have been further developed to improve healthcare and reduce overall costs of the products and devices. It is not an exaggeration to suggest that the medical device industry was founded on the development of the flexible poly (vinyl chloride) (PVC) plastic IV tubing and bag. After the IV bag product lines grew to serve many markets, a new unmet need was discovered for an aseptically produced premixed drug container. This article will review how a new film was developed and used to produce the required aseptically made IV premixed drug product. It was, after the Food and Drug Administration (FDA) gave “clearance to market”, a ground-breaking product, never before thought possible for the highly FDA-regulated and controlled industry.