STERILE PROCESSING INSIGHTS by Stephen Kovach


SUBMIT YOUR QUESTIONS: editor@hpnonline.com


General peel pouch questions Q


While the present ANSI/AAMI ST79 does not give a specifi c distance, criti- cal 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.


A


• 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.


Q A


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 steriliza- tion 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 prod- ucts properly, you must have training. I will use the example from one of the


“What size and type the medical device is and what form of steriliza- tion does this device need?”


There are various types and size of peel pouches on the market today.


“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?


many manufacturers of peel pouches. I fi nd support in their F 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 gen-


eral guideline, it is recommended fi lling a pouch up to a maximum of 3/4 of its packing volume to allow the package to conform to air evacuation processing dur- ing 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 contrac- tion 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 medi- cal devices and staff need to use critical thinking, and what CPD really stands for (“Creative People Downstairs”), in apply- ing how to use proper peel pouching tech- nique 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 depart- ment 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. HPN


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 pack- aging for sterilization and sterilizer loading. Healthmark.info. https://www.hmark.com/wp-content/uploads/2022/03/Guid- ance_Peel_Packs_Sterilization_packaging_and_autoclav.pdf.


3. Sterile Processing University, LLC. (2020, December). The Basic of Sterile Processing Textbook (7th ed.). 246. (N. Cho- bin, 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.


Photo credit: wip-studio | stock.adobe.com 42 November 2022 • HEALTHCARE PURCHASING NEWS • hpnonline.com


Stephen M Kovach, BS, CFER, started in the medical fi eld in  as a steriliation orderly and as ored in many positions itin te ealtcare ndstry e presently is linical dcator merits at ealtmar ndstries


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