Manufacturers of medical device must inform us of all the important information on the safe and effective use of each of their products. This information must be placed on the label in order to inform the user of any precautions. Manufacturers use internationally recognized graphic symbols, pictograms or icons to communicate that information to its users because most medical products are sold internationally.
There are many documents available that categorize the requirements and definitions for the use of international symbols used in medical device labeling. One of the most comprehensive books I have found is ANSI/AAMI/ISO 15223-1:2012 (Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements).
Many of the symbols are very easy to understand, such as the rectangle with the word STERILE inside the box with the initial EO to the right. We know that icon means the product was sterilized by ethylene oxide.
If the box to the right contains the letter “R” it was sterilized by irradiation or if there is a picture of a thermometer, it was sterilized using steam or dry heat.
If a package label has a picture of a triangle containing the words NON STERILE. These products should not be used on a sterile field. In addition, facilities should not sterilize items containing this symbol unless the manufacturer has provided validated instructions on how to sterilize the item.
If you see a number 2 in a circle with a diagonal line going through it, this means the items is single use only and should not be reused.
Did you know the picture of a book with a small letter “i” in it means to consult the instructions for use? This symbol is often used when there is important safety information that must be reviewed before the product is used.
We often see what looks to me like a building with three roofs and a chimney. This picture is usually accompanied by a set of numbers. Those numbers represents the date the product was manufactured.
A fairly new symbol in use is a picture of a box having a jagged edge sitting in a circle with a horizontal line through it. If you see this icon it means do not use if package is damaged.
There are hundreds of labeling symbols used internationally and we must all be aware of their meanings.
Can you decipher the label below?————————– Rose Seavey MBA, BS, RN, CNOR, CRCST, CSPDT President/CEO Seavey Healthcare Consulting, LLC