Q
“Why do you and other companies suggest in your in-services to use one- to 1- ½ inches of spacing within a peel pouch? I have been told it has to be at least two inches. What is the correct spacing?
A
While the present ANSI/AAMI ST79 does not give a specific distance, critical thinking is important when placing any device in a peel pouch. This revolves around selection of the pouch for the device to be sterilized. You need to ask the following questions.
Q
“What size and type the medical device is and what form of sterilization does this device need?”
A
There are various types and size of peel pouches on the market today.
• Pouch Types:
• Paper /plastic (steam and EtO)
• Tyvek (low-temperature sterilization).
• Sizes /Kinds:
• Heat sealable
• Self-seal
• Roll stock (may be cut to size)
• Gusseted (mostly for large items).
Choosing the correct size and application of the pouch is important. When placing a medical device inside a peel pouch, we need to make sure it is not:
· Too tight: the seal may not hold.
· Too loose: the item will move too much, which could also stress the seals to the point of rupturing.
Thus, when placing the medical device inside the peel pouch, it will need to allow for adequate air removal, penetration of the sterilant, and drying.
You must remember the peel pouch expands and contracts with any sterilization process, so spacing inside the peel pouch is vital to have delivering a sterile device inside that peel pouch.
As with any product, manufacturers give instructions for use (IFU) and other supporting documents. To use their products properly, you must have training. I will use the example from one of the many manufacturers of peel pouches. I find support in their IFU for the general statement concerning distance; thus, in their IFU/other documents, they suggest to, “Leave enough space beyond the seal for the opener to easily grasp (usually ½-inch to two [2] inches).”1 “As a general guideline, it is recommended filling a pouch up to a maximum of 3/4 of its packing volume to allow the package to conform to air evacuation processing during sterilization….”2
Various technical training manuals for medical device reprocessing technicians make these statements concerning distance within a peel pouch.
“A paper-plastic pouch of appropriate size should be chosen. … The pouch must be large enough to allow at least one inch (2.5 cm) of space between the item and the edges of the pouch.”3
“To allow space for packaging contraction and proper circulation, leave about one inch (¼” per side of package) of space between the items in the pouch and the sealed edges.”4
I understand that many departments do not have a complete selection of pouches to adequately place devices inside pouches. Because departments do not order enough peel pouches and the proper sizes, staff must adjust and use the products they have. Ideally, staff would have many sizes, but that is not the case.
Based on my years of experience, I have taken the approach that each department is different. There are many different medical devices and staff need to use critical thinking, and what CPD really stands for (“Creative People Downstairs”), in applying how to use proper peel pouching technique with what they have available. Thus, giving guidance of one- to 1- ½ inches is not out of line per the information supplied by the manufacturer(s) and my experience and research.
I hope this helps answer your question
My suggestion, regardless of who you buy your pouches from, is to apply critical thinking skills—starting with reviewing the companies you use for peel pouches, their IFUs, and other documents. Next, look at reference manuals (e.g., professional societies) and articles to make a Standard Operating Procedure (SOP) for the department you work at. This way, you base it on the products you have available to supply a sterile medical device.
Oh, and do not forget to have proper training with a repeat demonstration in how to pick a) the proper peel pouch, b) place the medical device inside, c) seal and label it, d) load it in the sterilizer, and e) store and retrieve it properly to deliver it to your customer.
References:
1. Smith, M. (2019, December 3). Instructions for Use: Steriking® Heat Seal Pouches [Rev. B]. Healthmark.info. Retrieved June 24, 2022, from https://www.hmark.com/wp-content/uploads/2022/02/Steriking-Heat-Seal-Pouches-IFU-2022-05-02.pdf.
2. WIPAK OY/STERIKING®. (2009, May). Guidance on packaging for sterilization and sterilizer loading. Healthmark.info. https://www.hmark.com/wp-content/uploads/2022/03/Guidance_Peel_Packs_Sterilization_packaging_and_autoclav.pdf.
3. Sterile Processing University, LLC. (2020, December). The Basic of Sterile Processing Textbook (7th ed.). 246. (N. Chobin, Ed.). Sterile Processing University, LLC. (Original work published 2019).
4. IAHCSMM. (2016). Central Service technical Manual (8th ed.). 268. The International Association of Healthcare Central Service Materiel Management.
Stephen M Kovach, BS, CFER, started in the medical field in 1975 as a sterilization orderly and has worked in many positions within the Healthcare Industry. He presently is Clinical Educator Emeritus at Healthmark Industries.
