Regulations, standards, rules, and dictates. They're an unavoidable part of the medical device industry and for good reason: the industry involves substances and products that affect our bodies. In the U.S. the Food and Drug Administration (FDA) ascertains that medical devices are safe to use and do what their manufacturers' say they will.
Many medical devices include plastic tubing for fluid or gas transfer. When it comes to that tubing, the FDA's oversight can involve everything from the individual ingredients that make up a plastic or rubber compound, to manufacturing processes, to the tubing's reaction with things with which it may come in contact...like patients.
Of critical interest is tubing materials. Ideally all ingredients should be lot traceable, and they may also need to meet regulations involving United States Pharmacopoeia (USP) Class VI, Underwriters Laboratories (U.L.), the National Sanitation Foundation (NSF) or other organizations. Documentation such as Material Safety Data Sheets and records regarding the origins of the tubing's ingredients may need to be kept on file.
Another important aspect relating to the tubing's ingredients is leachables. These are substances used during manufacture that may come out of, or leach from, the tubing and contaminate the gas or fluid flow. This may not be significant if the flow is a byproduct or waste product, but oftentimes that is not the case.
One such leachable substance is Di(2-ethylhexyl) phthalate, better known as DEHP. It's a chemical agent added to resin to increase workability during processing and to impart flexibility in the finished product. DEHP and other plasticizers such as BBP, DBP, DnHP, and DIDP are included on lists of carcinogens from both the federal government and the state of California. Their use in medical devices has caused concern, and products containing these chemicals over a certain concentration must display a warning label. Some PVC tubing products contain DEHP while others, such as NewAge Industries' Nylobrade® reinforced PVC hose, do not.
Other considerations when it comes to medical device tubing include changes to ingredients or processes and the actual production of the tubing. Should the raw ingredients be scheduled to change, you should receive advance notice, as you'll need time to determine how or whether the proposed changes will affect your device and its operation.
Some common tubing materials used in medical device applications are silicone, PVC, and fluoropolymer. Your application will determine which is the best choice. And although your particular device may not require tubing that's manufactured in a clean room, it still needs to be made with precision and uniformity. Documented work instructions and/or good manufacturing practices should be followed, and quality control procedures must be in place to ensure consistent tubing products for your medical devices.
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