Can we label sterilization packages with a Sharpie brand marker?

Question

Our staff used to label all of our cardiovascular sets and supplies with a red Sharpie brand permanent marker and we would use a black Sharpie for all other items. This provided a quick and easy method to visually identify these special critical items. The labeling was restricted to the autoclave tape on the outside of wrapped packages and the film side of peel pouches. We have a new OR educator who claims we cannot use the red colored markers, because it violates AAMI standards. I have looked through the AAMI documents and could not find any such statement. Before I discontinue the use of the red markers for labeling I thought I would consult with you, is the red Sharpie okay to use for labeling packages to be sterilized?

Answer

To my knowledge there is no such AAMI document. Regardless of the ink color, it is important that you only use marking pens that have been validated for use in sterilization conditions and the sterilization process you are utilizing. Most Sharpies have not been validated for industrial usage or for use in the sterilization conditions. There are a couple of Sharpie markers that do conform to the ASTM standard D4236 which means the product has been evaluated by a toxicologist for acute and chronic toxicity and the Safety Data Sheet (SDS) identifies ingredients as presenting any chronic health hazard, along with safe use instructions. The pens that bear the AP seal with the notation “conforms to ASTM D4236” (see right) are the markers that may be used for labeling your packages. The onus however remains with the user to check the manufacturer’s documentation to determine under what temperatures and conditions the inks can be used and to be mindful to consult the SDS. The user must also ascertain the compatibility with the intended sterilization process and the potential for any chemical reactivity. In my opinion it would make more sense to utilize medical grade markers that have been designed and validated for the use of labeling medical packages for sterilization. The inks should be of a medical grade, present no cytotoxicity, be non-leaching, and be permanent. The manufacturer should provide instructions for use and validation documentation for the conditions and methods of sterilization that the markers are compatible with. I only know of one medical packaging manufacturer and source for such marking pens which are available in four colors: red, black, blue and green (see above).

From Healthcare Purchasing News

Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His healthcare career spans over three decades as an Administrator, Educator, Technologist and Consultant. He is a member of AORN, AHA, SGNA, AAMI and a past president of IAHCSMM and has served on and contributed to many national committees with a myriad of professional organizations, manufacturers, corporations and prestigious healthcare networks. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences. In addition to this column he has authored several articles and has been a featured speaker on the international scene.