From May 2014 – CS Solutions.

Double pouching for sterile presentation? ATP use in CS?

by Ray Taurasi

Q The OR requires that Sterile Processing double peel pouches all items sent to them. They claim this is essential to allow for sterile presentation to the sterile field. I cannot find anything in AAMI or AORN recommendations stating this is necessary. I find it strange that they have no issues with commercially prepared items they use from manufacturers that are all single packaged. Why should there be different packaging standards for items sterilized in-house versus commercially sterilized items?

A There are no AAMI or AORN recommendations that state you must double peel pouch items for use in the Operating Room. Both AORN and AAMI state that you should follow the manufacturer’s IFUs for any packaging materials. Their recommendations also advise that if a hospital chooses to double peel pouch they must be sure that the manufacturer has validated their pouches for double pouching. Most peel pouches have not been validated for double pouching. I know of no peel pouch manufacturer that requires double peel pouching for the use of their products. As part of FDA clearance, packaging manufacturers must provide validation that their product is capable of allowing sterilant permeation to achieve sterilization of the package contents. They must also provide validation of the product’s ability to maintain sterility until the point of use. Some operating rooms want certain items double pouched for sterile presentation. This might include multiple small items or instruments that might present a challenge in aseptic presentation and thus may need to be held together or contained while being passed off to the sterile field. I find that many hospitals are unnecessarily double pouching all items as a force of habit while others claim it is necessary to prevent tears and punctures and to maintain sterile integrity. If you are double pouching due to tears and punctures you may want to investigate your packaging techniques. Tearing is often associated with the following issues:

1. Packaging oversized or heavy objects in a peel pouch
2. Using the inappropriate size pouch for the item(s) being packaged
3. Failing to use packaging aids such as tip protectors on sharp tip instruments or devices with protrusions
4. Using light weight poor quality peel pouches for “perceived savings”

If you find you are double pouching all items to ensure sterility maintenance and using a less expensive and lower quality pouch – you might want to explore other peel pouches that are available and that provide a multi-layer of heavier polymer (plastic) and a heavier paper weight for added protection and superior performance. While the individual pouch cost might be slightly higher, use of such could, in the long run, cut your peel pouch inventory usage in half and result in real significant savings by reserving the practice of double pouching strictly to those items requiring such for aseptic presentation.

Q We are evaluating ATP monitoring systems to use for testing our surgical instruments and other medical devices to verify cleaning efficacy. I am confused as to what the passing number should be for an ATP detection test? Of the devices we have looked at they each have different pass/fail levels. I consulted with our infection control officer and he said that while ATP testing is used in our Housekeeping and Food Service departments, he doesn’t feel that ATP is a good test for monitoring surgical instruments. I know many of my colleagues in other hospitals are using ATP testing in their CS departments to monitor cleaning efficacy of surgical instruments. I am a bit confused by the mixed information I am receiving on the use of ATP. What are your thoughts on this?

A Adenosine tri-phosphate (ATP) is a chemical that is produced in every living cell. So its presence on a surface tells us that there is something on that surface that is, or was recently, alive. An area or surface to be tested is swabbed, the swab is placed into a holder containing a chemical solution that prevents ATP degradation and is then placed into an illuminometer, which determines the detection of ATP residual in relative light units (RLU) which is emitted from the swab. Acceptable RLU values vary from system-to-system and currently there is not a standard pass/fail unit of measurement across the various manufacturers’ ATP testing systems. One manufacturer might say that a pass would be an RLU below 25 while another might claim a pass would be anything below 250 RLUs.

ATP testing has been around for many years. It originated in, and is still used to effectively monitor equipment and surfaces in the food and environmental industries. In these industries highly invasive medical devices are not used or tested and the measure of “clean” does not have the same impact. ATP is not present in viruses nor is it present in components such as protein, carbohydrate, hemoglobin, lipids, and the like, which are the precise soils we are confronted with in CS when cleaning invasive medical devices and surgical instruments. ATP degrades over a period of time and once it does degrade it cannot be detected. This means it is possible to get a pass reading in ATP detection yet still have visible organic soil remaining on an object . In the photo below, a sample of dried blood on a stainless steel plate was taken utilizing an ATP device. You will note visible blood is on the swab yet the ATP reader detected a zero RLU reading, meaning there was no ATP present despite the presence of blood. We obviously would not want to use a medical device in surgery with residual soil remaining on it. It would be more appropriate to use actual organic soil detection testing devices on invasive medical devices and surgical instruments which are cable of detecting organic soil such as protein, carbohydrate, hemoglobin, lipids and the like.

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.