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HI!
Sudip,
Yes, It's necessary to write the instrument name outside the Peel pouch on the opaque area (do not write on the transparent area).Information on the peel pouch will be name of the instrument, dimension of the instrument, alphabetical location, assigned number for specificity of the instrument as it can differenciate from other similar instruments and the the intials of the cssd technician. All of the above will enhance quality. The above information should be written with a permanent marker.
Best wishes
Devaiah
Technician's Exchange
Paper/Peel Pouches and Packages
by Rita Barnes, LPN, CRCST, ACE
Recently, I was approached by a different manufacturer than the present supplier of the paper/peel packages that our CS was currently using. It made me aware of some of the different factors to consider when choosing a p/p and that I needed to get some answers to make a decision.
There are many different formulations of plastics and companies who make them. Not all types of paper/plastic are acceptable for all types of sterilization. For example, Tyvek is useful only when the temperature is low such as in an ETO sterilizer When Tyvek is exposed to heat as in a steam autoclave, it can melt or burn. Nylon, on the other hand, can tolerate high temperatures such as dry heat but cannot tolerate steam and ETO cannot penetrate the film.
Peel-open pouches are very common and are excellent for small instruments and light-weight devices. They are acceptable for use in steam or ETO (check with the manufacturer). P/p’s are manufactured so one side is paper and the other is a transparent film. One major advantage is seeing the object through the plastic.
Rubber bands, staples, and paper clips should not be used to hold the packages together in a bundle. This practice can lead to pinholes and contamination.
The p/p package can be on a roll or precut. The package should be large enough to prevent rupture but small enough to keep the item from sliding around and causing a tear. Items should be put into the package so that the ring or handles are the first thing that is grabbed when the package is opened.
Labeling should be done only on the plastic side, never on the paper side, and never after the package has been sterilized as the wet ink can cause contamination by leaking through.
Double-pouching may be required if needed for sterile presentation. The inner pouch is to be sealed and placed into a larger pouch. Pouches should be paper-to-paper to allow the sterilant to penetrate through the paper
When loading the sterilizer, packages should stand up on edge in baskets and should be placed loosely.
I still had some questions and decided to ask them to the manufacturer of the paper/peel that we were presently using. Following are the questions with the answers that I got from them:
Q. What makes some film blue and other peel packages clear?
A. The film is a laminate of polyester and polypropylene, the adhesive between the two layers of plastic is tinted blue.
Q. Some p/p’s have a triple seal; what is the purpose of this?
A. The triple seal is used to minimize the possibility of "blow-outs."
Q. l have heard that we use British Standards. Why?
A. Most European countries have standards for pouches but the U.S. does not. The British Standards were the basis of ISO 9000 to which our processes conform.
Q. Does the U.S. have any standards at all?
A. No.
Q. When we peel the package to open, there is a correct direction to peel on the package; how is this done?
A. Many manufacturers starch the paper which holds down loose fibers and this enhances peelability. The starch, however, after being moistened by steam, then dries and tends to make the paper stiff and brittle. Peel the package open according to the arrows on the paper Be sure to look for loose fibers of paper that can fall onto or into the sterile field.
Q. How many instruments can go into a pouch? Is there a weight limit?
A. The limit for instruments in a pouch is best determined by the size and separation of items so steam can contact all surfaces. The weight would be limited by the strength of the seal.
Q. The package is made up of different plastics. What is the purpose of having different plastic materials in one package?
A. The polypropylene layer is adjacent to the paper and melts into it when heat sealed. The polyester layer has a higher melting point and is used for stability.
Q. Which are better-heat-seal or adhesive sealing?
A. Heat-seal and self-seal pouches are equally effective.
Q. Which are less expensive-heat-seal or self-seal?
A. Heat-seal are less expensive.
Q. What should we look for in paper, color, weight, etc.?
A. Paper should be made from bleached chemical wood pulp, free from dirt and unpleasant odor when dry or wet. Recycled paper may not be used. The paper should be treated with synthetic resin for strength and should not leave fluff or fiber in normal use. The paper should be white and not contain any toxic chemicals.
Q. Does the sealing method used affect shelf life?
A. A good seal insures unlimited shelf life.
Q. Are pinholes more visible with the blue color?
A. Pin holes may be more apparent with the blue color, however, the main advantage is it delineates the seal to the paper
Q. lf we double package, should the inside package be sealed or folded over?
A. If you double pack, it is preferred that the inner package be sealed to assure that the contents don’t drop out when removing it from the outer package.
Q. What is the purpose of "gusseted" pouches and are they more expensive?
A. Gusset pouches are used for high profile items and they are more expensive than flat pouches.
Q. lf the pouch goes on a tray, which side should be up? Can the paper lay down on the tray? We use the p/p to protect sharp tips.
A. The paper side should be up.
Q. I read that such things as tubing or asepto syringes should not be put into p/p. Is this true?
A. No!
Q. What is the history of p/p packages?
A. They have been in existence prior to FDA approval requirements.
Q. What class of medical device does FDA call p/p’s?
A. Class 1
Q. Can the p/p pouches ever be reused?
A. Peel pouches should never be reused.
Q. Can a package be used if drops of water are found inside or outside the package?
A. Water found inside or on a peel pouch could cause contamination as it would eventually leak through the paper.
Q. What does AAMI say about p/p’s?
A. AAMI states that pouches should be positioned on their side for sterilization.
Q. How are p/p’s made?
A. By heat sealing medical grade paper to polyester/polypropylene on three sides leaving an opening for the insertion of instruments, etc.
Q. Which are less expensive-flat rolls or ready-made pouches?
A. Rolls are less expensive to buy but sometimes more costly in use as people tend to make them longer than necessary.
Q. If the peel package is adhesive sealed, how do we open the package?
A. Pouches should be peeled apart. Sterile scissors should never be used as the outside of the pouch is considered contaminated.
Q. How many companies make peel package material?
A. At least 10 companies produce pouches in the U.S.
In summary, it appears that if used properly, the paper/peel pouches do have many advantages. As with other wrap or packaging that we use, we must evaluate our technique and our products in our own area. Considerations of the cost of a heat sealer and the number of packages that need processing in a day must also be included in our decision. Our heat sealer was getting older but we found it less expensive to have it refurbished at a cost of $75 compared to $900 for a new one.
Appreciation goes to Bill Abbott with Medical Action Industries, Inc. for his assistance and input into the writing of this article. Information was also taken from the Central Service Technical Manual, Fifth Edition.
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From:
(United Kingdom) Date: 22 April 2005, 12:54 [GMT]