Doctors and nurses scramble through the emergency room calm and collective. However, it’s no secret their minds are racing as they care for, and save the lives of, patients each and every day. It’s also no secret that patients put their trust in medical professionals to diagnose and treat illnesses. You’ve probably never stopped to consider how doctors and nurses tell the difference between certain medical devices. For instance, did you know the difference between a 22 gauge needle and a 20 gauge needle cannot be distinguished by the naked eye? The diameter of a 22 gauge needle is .0275 inches, while a 20 gauge needle has a diameter of 0.0375. Do you know how medical professionals tell the difference between medical devices? Color-coding, of course!
The first paragraph may have blown your mind a little bit, so your wheels may be turning. Have you ever really stopped to consider color-coding in the vast world of medical devices? As we previously stated, color-coding helps doctors differentiate medical devices. However, there are also other reasons for color-coding. For example, colored contacts are used to change the color of a person’s eyes. Regardless of the use of a medical device, it is critical for manufacturers to ensure these devices are safe, and how they achieve coloration is also important to the health of patients.
Federal law gives the Food and Drug Administration (FDA) regulatory power over virtually all color additives used in food, drugs, cosmetics and medical devices that come in contact with people’s bodies. While manufacturers and marketers may have one set of reasons for the colors they choose for devices and medications (a particular shade of teal polls high as feeling more trustworthy, for example). The FDA’s focus is ensuring the colorants used in items are as safe as possible and unlikely to cause adverse reactions.
According to Medical Plastics News, Foster Corporation, a provider of custom polymers for medical devices, introduced a new line of color concentrations formulated with FDA-approved pigments. Since these pigments have been previously evaluated for use in medical devices, the amount of time it takes for a new device to be approved may be shortened. According to the FDA, warning letters pertaining to color additives are common, so it is important to ensure your device complies with regulations.
At PSI, we can test for additives, like colorants, in a variety of ways. High-Performance Liquid Chromatography (HPLC) can be used to separate mixtures composed of small molecules and polymers, and identify individual components. Through Ultraviolet-Visible Spectroscopy (UV-Vis), we can determine the concentration of pigments.
Do you have questions about color additives? We invite you to contact our team of experts to discuss your testing needs.