December 2007

Q I have heard that peel pouches should not be used inside wrapped or containerized instrument sets. I don’t understand the rationale for this. We have been placing peel pouches in sets for years and have never encountered any problems. I have conducted my own testing using both chemical and biological indicators and all tests have proved satisfactory. I have never seen anything in writing stating this is an inappropriate use of pouches and frankly it is the best way to contain and protect small delicate accessory pieces that are required in sets. Could you please comment?

AYou can find documentation which advises against the use of paper / paper peel pouches within wrapped or containment devices in the AAMI document ST79, 8.3.4, page 60. The document clearly states that paper/plastic pouches are not appropriate for use in wrapped sets or containment devices. The ASHCSP (The American Society for Healthcare Central Service Professionals) recommended practices also state that peel pouches should not be used in this manner. The rationale is well grounded, as all directions for use and recommendation for the effective sterilization of products packaged in peel pouches state that peel pouches be placed standing on edge with the plastic side of one pouch next to the paper side of the next pouch. Peel pouches must be loosely spaced to allow adequate permeation of the sterilant. The sterilant can not permeate the plastic and must pass freely through the paper. Peel pouches can not be placed appropriately within a container or wrapped package in such a manner and may result in presenting a barrier to sterilant penetration and intimate contact to all surfaces and items contained in the pouch. The inappropriate placement and use of plastic peel pouches with instrument sets may also cause wetness, preventing adequate drying. If any moisture is found within a sterilized set it must be considered contaminated and not be used.

The fact that you may have conducted some testing that did not show evidence of sterilization failure does not support your inappropriate use of peel pouches contrary to recommended practices. Sterilization is at best a probability which is based on sound proven and effective technical practice. The chemical and biological indicators do not validate or ensure the sterility of all contents with a sterilized package. What they do tell you is that if you have applied sound consistent protocols in all aspects of the reprocessing and sterilization process which is in accordance with recommended practices than you can be confident that the required sterilization conditions within your package have been achieved.

Figure 1 - Medical grade paper bags

Sterility testing and assurance goes beyond the scope of the simple testing you conducted. Your testing process, and sample base range are not adequate to support your use of peel pouches against manufacturer instructions and the AAMI and ASHCSP recommendations noted previously. You are basically playing Russian roulette and taking a chance on patient safety. I must advise you to change your practice before you realize any adverse affects. There are more economical and approved packaging alternatives to contain and protect small delicate pieces which must be included in wrapped or containment devices. One such alternative is the use of medical grade paper bags which are validated and cleared for such use including extended sterilization cycles. (See Figure 1.)

Q Could you provide advice relative to labeling on peel pouches? What is the best way to identify the contents in a peel pouch? Is it ever acceptable to write on the package?

AOne must be very careful when writing on any packaging materials. There is always the potential that the writing instrument (pen, pencil or, marker) may penetrate and damage the package integrity. Also inks can possibly leach through a package and be deposited on the instruments or other medical devices within the package. Most inks are not medical grade and may be toxic. Residuals found on medical devices could in turn be deposited in a patient and result in adverse outcome affecting the patient.

If it is necessary to write on a peel pouch to identify the contents it is important that you never write on the paper side. Writing should only be done on the plastic side utilizing a soft tip permanent marker containing a non toxic ink. The plastic is not permeable and therefore will minimize the potential for leaching. Another alternative would be to use approved sterilizable adhesive labels which you may write on or purchase preprinted.

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, ASHCSP, 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.