WFHSS and JSMI Conference 2012 - Session 2: Study on ......108 pouches with side gusset 4 We researched a thousand\⠀Ⰰ 尩 25 to 52cm\⠀挀攀渀琀椀洀攀琀攀爀尩 pouches
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Study on Sealing Quality and Reliability of Pouch Package Sterilized in Hospital Takako Kami, MS. RN. Hiroyoshi Kobayashi, MD. PhD. Division of Infection Prevention and Control Tokyo Healthcare University Postgraduate School
Study on Sealing Quality and Reliability of Pouch Package Sterilized in Hospital
Takako Kami, MS. RN. Hiroyoshi Kobayashi, MD. PhD. Division of Infection Prevention and Control
Tokyo Healthcare University Postgraduate School
Presenter
Presentation Notes
ご紹介ありがとうございます。この度第13回WFHSSにおきまして、このような機会を与えて頂きましたことに感謝致します。 Thank you for your introduction. Today, the 13th World Forum for Hospital Sterile Supply, It gives me great pleasure to speak to you today. 私はこれから、実際に病院で使われていた滅菌バッグを回収し、シーリングの状態を調査した内容をお話しします。 For my research, I collected pouches which had been sterilized and later open for use in hospitals. I investigated sealing conditions of the other side of the pouches which were not opened. Today I will talk about the findings.
Introduction
The ultimate goal of all packaging systems is to maintain sterile and aseptic conditions until the package contents are used for patients.
Pouch packages, containers, and wraps are used to maintain the aseptic condition. Sterility of all packages should be ensured before they are opened to use.
Results • No. of facilities cooperated: 13 • No. of pouches collected : 1,000 148 pouches that failed 25cm width:11poudhes (fail) 30-52cm width:137poudhes (fail) Of 148 pouches: 108 pouches with side gusset
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Presenter
Presentation Notes
We researched a thousand(1,000) 25 to 52cm(centimeter) pouches in 13 facilities. 13施設1000の滅菌バグを調査しました。 148枚が不合格。そのうち108枚がガゼットタイプでした。
Dye penetration test
Dye penetration test / Recommendation: 1 ×/ day Dye penetration test is performed in order to check Package barrier integrity.
No channel: pass Channel: fail
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Presenter
Presentation Notes
ブルーインクを用いて、使用済の滅菌バッグの残りのシール状況を調査、 通過したものを不合格として判定。 Blue ink was used to examine the condition of the remaining seals in the used sterilization pouches. The pouches were determined to have failed if the ink penetrated the seal width.
FAIL Blue ink penetration
the seal 6
PASS & FAIL
PASS
Presenter
Presentation Notes
このように、シールを通過したものは不合格。 These pouches failed because the ink penetrated the seal width.
PASS
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Presenter
Presentation Notes
この写真のように、ブルーインクがシール幅の半分近くまで侵入しているのもあったが、完全にブルーインクがシール幅を通過していない場合は、合格とした。 しかし、これは重大な問題と考える。 In some pouches, blue ink penetrated close to half the seal width. As shown in this photograph, if blue ink did not penetrate the entire seal width, the pouch was passed in the sealing test. However, it is still a major problem.
Creation of Leakage Narrow Channel by surgical sutures
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Surgical suture of different size 4-0, 1, 2,
The pouch is heat-sealed after fixing the sutures by adhesive tapes apart from sealing site
Test-sealing Fixing
Fixing
Presenter
Presentation Notes
チャネルを作ってみた。太さの違う手術用の糸を、滅菌バッグの上に3本並べ、シールされる場所から離れた下の方を予めテープで張り付け、糸が動かないように固定した後、糸の上から滅菌バッグをシールしてみた。 As shown, three types of suture were used with different diameters. They were placed on a sterilization pouch and arranged in rows. A tape was placed on each far below the sealing area to immobilize and pouch was sealed.
It is difficult to find a channel macroscopically
9 Marks for suture channels
Presenter
Presentation Notes
糸を取り除いた部分は、触るとへこみが有り、ここに糸が有ったということが分かる。 サイズ２号の跡は、滅菌バッグのへこみを肉眼で見確認することが出来る。 これらは、シーラーのベルト部分に異物が付着している様子を作った。 The pouch was sealed from above the sutures. The photograph shows the areas after the sutures were removed. It was possible to feel depressions in the areas where the sutures were removed. The depression on the sterilization pouch was visible to the naked eye for size 2. The sutures simulated foreign matters attached to the sealer belt.
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Seal Leak Test
Presenter
Presentation Notes
しかし、ブルーインクを垂らしてみても、其々の糸が置いてあった部分はインクは通過しない。２号の糸ほどの太い異物があっても、インクの通過はみられず、シール幅の半分程度までで止まっています。 ただ、この状態で、滅菌器の中に入れた場合は、その部分からシールが破裂し、無菌状態は破綻するのではないかと予想できるし、破裂しなかったとしても、無菌状態で保管され、使われるとは思えません。 There was no complete ink penetration even in an area where size 2 had been placed. It simulated a foreign matter as large as that suture. Ink only penetrated half the seal width. However, if a pouch had been placed in the sterilizer in this condition, the seal would likely have been broken from this area. Thus, an aseptic condition would not have been maintained. Even if the seal were not broken, it is unlikely that an aseptic condition would have been maintained during storage until the use of the content.
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The diameter of braided silk 2 Is regulated to be between 0.500 and 0.599mm
by US Pharmacopeia, 24th edition
Presenter
Presentation Notes
トンネル（チャネル）部分をしっかり把握するため、ブルーインクをシールの両サイドから垂らしてみました。 ４－０、はインクの垂れはまったくなく、 １号糸は少しだけインクがシール部分に侵入している様子が分かります。 2号糸になりますと半分近く、インクが侵入していますが、これほど大きな異物が付着しても、熱が伝わるシーラーもあることも分かりました。 Blue ink was applied to both sides of the seal to thoroughly examine the channel areas. There was no ink penetration for the 4-0. There was a small amount of ink penetration in the seal area for size 1 . There was ink penetration of nearly half the seal width for size 2. Even when a foreign matter as large as size 2 was attached to the sealer belt, there was still heat transfer from the sealer.
Channel visible due to ink penetration
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Presenter
Presentation Notes
チャネルが出来ていなくても、滅菌中に圧力の変化でシール部分が破裂する可能性があることから、無菌状態が破綻する可能性が有ると予想できますが、今回の調査は、滅菌後のバッグを回収していることもあり、この写真のように、明らかにシール幅をブルーインクが通過したものだけを不合格と判定した。 The seal might break due to changes in pressure during sterilization even if a channel does not form. Therefore, an aseptic condition might not be maintained. In this study, we collected pouches after sterilization. The pouches were determined to have failed only if blue ink completely penetrated the seam width as shown in the photograph.
A big Hole ！
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Presenter
Presentation Notes
ブルーインクが通過したバッグをいくつか見て頂きます。 ご覧のように、チャネルと言えないような、大きな穴が開いているバッグも沢山ありました。滅菌の質は保てていなかったと考えます。 Some pouches with ink penetration will be shown here and in the next few slides. There were many pouches with holes too large to be called “channels.” One such example is shown here. The quality of sterilization was likely not maintained.
Pouches with gussets
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Presenter
Presentation Notes
今回の調査で分かったことですが、滅菌バッグの種類に、写真のような『マチ付きタイプ（ „pouches with side gusset“）』というのがあります。 このタイプの不合格率はとても多かった。 調査した1,000枚のうち、不合格は、148枚。そのうち、マチ付きタイプ滅菌バッグ（ pouches with side gusset）の枚数は、108枚もありました。 Through this study, we discovered that there are sterilization pouches called “pouches with gusset.” This photograph shows a pouch with gusset. The failure rate of this type of pouch was unusually high. There were 148 failed pouches out of 1,000 total pouches. Of these 148 failed pouches, 108 were pouches with side gusset.
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Pouches with gussets
Presenter
Presentation Notes
こちらの滅菌バッグも、マチ付きタイプ（ pouches with side gusset）です。フィルムの重なり部分とサイド側にもインクが通過しチャネルが出来ています。 This sterilization pouch is also the side gusset type. Ink penetration and channels were seen in areas with overlapping film and on the sides.
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Pouches with gussets
Presenter
Presentation Notes
フィルムが重なっていると熱が伝わりにくいため、マチ付部分の構造上チャネルがフィルム間や、サイドにできてしまうのだと考えられます。 両サイドのシール部分との境目にもチャネルが多いのが目立ちました。 また、中に入れるdeviceの大きさによっては、テンションがマチ付部分(gusset)にかかり、チャネルを大きくしてしまう事も考えられます。 It is difficult for heat to transfer when there is overlapping film. Thus, side gusset areas are likely structurally susceptible to channel formation between films and on the sides. There were also many channels on the border of the seal area on both sides. Heat transfer was likely difficult in those areas. In addition, there can be tension in the side gusset areas depending on the size of the device that is placed in the pouch. This tension can cause the channels to enlarge.
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Pouches with gussets (all failed) Many Leak Channels by Incomplete Sealing
Presenter
Presentation Notes
これらもやはりマチ付きタイプです。 シール強度やシール温度の条件が均一に伝われば良いのですが、シーラー側の問題ではないと考えます。これでは、滅菌の質が担保されません。 These pouches are also the side gusset type. In an ideal situation, the seal strength and seal temperature are uniform . It seems unlikely to be a sealer problem. In this condition, the quality of sterilization cannot be ensured.
Multiple Leak Channels
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Presenter
Presentation Notes
チャネルはフィルムの重なり部分だけではなかった。こちらはシーラーに問題があるかもしれません。やはり、シーリングの状態を毎日チェックする。また定期的なシーラーの点検は重要であることが理解できます。 The conditions of the seal must be examined and assessed not only in areas with overlapping film but also in other areas. It is also important to periodically inspect the sealer.
Soiled Pouches
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Folded Pouches
Presenter
Presentation Notes
The left photograph shows dirty pouches, with foreign matters inside. An investigation is needed for these types of pouches to find out if it is due to insufficient washing, rust, or water/steam that is the sterilant. The right photograph shows folded pouches. When double packaging is used, the inner pouch is sometimes folded to facilitate its placement into the outer pouch. This folding could compromise the sterility assurance level. If the steam penetration area is smaller, the contact time will be also shorter between the steam and the package content. It is important to eliminate this type of practice 左のように、汚れているものもありました。洗浄不足なのか？錆？水の問題？追求することが必要と思います。 右の写真は、折りたたまれています。二重包装の場合に、外側滅菌バッグに入れやすいよう、内側の滅菌バッグが折りたたまれることがありますが、この事象は滅菌保証を阻害すると考えます。 折らずに二重包装することを習慣にするべきだと思います。
Plastic films were completely peeled
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36cm
Presenter
Presentation Notes
とても大きな袋が使われていることにも驚きました。 It was surprising that such large pouches were being used.
Large pouches 40cm W, Ca 80cm L
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80 cm
40 cm
Presenter
Presentation Notes
写真の滅菌バッグは、幅が約40ｃｍ、長さは約80cmあります。 どうやってシールしたのでしょうか？？ シールが上手くできたとは考えにくいです。 シール出来たとしても、どのようにして無菌のまま、デバイスを取りだし、渡したのでしょうか。 Deviceにあった包装形態を選択することは滅菌の質の保証するには不可欠な条件だと思います。 The sterilization pouches in the photograph are 40 cm in width and 80 cm in height. How were such large pouches sealed? It is difficult to think that they were sealed properly. Even if they were sealed, how were the contents removed and handled in an aseptic condition. For sterilization of devices, selection of proper forms of packaging is considered essential to ensure the quality of sterilization.
In used large pouches plastic film is completely peeled
22 Plastic films
Presenter
Presentation Notes
The common feature in these large pouches is that they were opened with the plastic films completely peeled away. It is impossible to open such a pouch while holding it with both hands. It need to be placed on a table when the film is pulled away to open the pouch. In this situation, since the film often curls inward, it is highly likely that a device gets contaminated from the curled film. In addition, if a sterilization pouches becomes inflated during sterilization, the enlarged bag can come in contact with the rack or ceiling of the sterilizer. Subsequently, the pouch can get torn or the seal can be broken. Considering these events, it is necessary to adopt a better way of packaging large devices such as using wraps instead. We need to avoid a situation where compromised sterility due to inappropriate packaging goes unnoticed at a time of use of a device.大きな袋に共通していることは、 フィルム側をすべてめくって開封しているということです。 両手に持ったまま、開封するのは無理です。 テーブルに置き、フィルム面のみめくり開封したと予想します。フィルムは内側に巻くことが多い為、フィルムでdeviceが汚染される可能性は高いと考えます。 また、滅菌中の滅菌バッグのふくらみを想定しますと、膨らんだ滅菌バッグが棚等にあたり、破れる、シールが裂ける等の事象が起きることもあると思います。 これらのことを考慮すると、大きなdeviceは包装の形態をラップに変えるなどの工夫が必須と考えられます。 包装が適切ではなかったために、無菌を維持できず、それに気づかすにdeviceを使用することになりかねない。
Was it possible to remove the instrument from the large pouch aseptically ?
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52 cm
80 cm
Presenter
Presentation Notes
不潔にすることなくデバイスを取りだせたのでしょうか？ Was it possible to remove the instrument from the large pouches aseptically ?
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Conclusion
• Ca 1000 pouches already opened were gathered from thirteen facilities.
• Opposite side of sealing was tested by dye penetration method.
• 148 were revealed the exist of leaks. • Among them 108 were side gusset.
Presenter
Presentation Notes
I'd like to conclude by making the following points. We examined 1000 opened pouches collected from thirteen facilities. Seal leak tests were conducted with blue ink on the parts that were still sealed. Leak channels were observed in 148 pouches; of these, 108 were pouches with side gussets. The width of the examined pouches was between 25 cm and 52 cm. It can be said that leak channels were mostly found in pouches that were 30–52 cm in width. 11,000枚の滅菌ご使用済の滅菌バッグを13施設から回収し調査した。 滅菌バッグの幅25－52cmの袋が対象。シールリークテストの結果148枚が不合格、そのうち108枚がマチ付き（ガゼット）タイプだった。 幅の大きい袋に不合格が多かった。
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• On the double folded part of pouch side, the heat of sealer does not penetrate evenly. This is the reason why leak channels are often observed in the double folded side-sealing.
• Large pouches are apt to result in incomplete
sealing because it is too large to handling adequately at heat sealing and the gusset may makes easily folds of the sealing part. So the large pouch should be carefully reevaluated to select for use.
Presenter
Presentation Notes
Pouches with gussets have three layers of film in some parts, where it is thought that heat does not penetrate well. Many leak channels were observed in these parts. Creases form easily when sealing large pouches, which poses a difficult technical problem. Relatively large packs are sometimes used in Japan; in these cases, a wrapping method is sometimes appropriate in consideration of contamination risk when opening the pack. マチ付きバッグは、シーラーの熱がフィルムの重なり部分に十分伝わらないため、サイド部にchannelが多く見られたと考えられる。 大きい滅菌バッグは、シーラーに手が届きにくい、シール部がしわになりやすい、開封が難しいなどが予想でき、包装形態の見直しが必要と感じた。
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• Periodical maintenance of the sealer, and routine leak test of sealing should be required for the sterility maintenance.
• Education of the personnel engaged in central services is important factor for the package barrier integrity.
• When sterilizing pouch is selected, adequate size and shape should be considered.
• Handling and preservation of the pouches after sterilization should be also considered carefully.
Presenter
Presentation Notes
Routine sealer maintenance and seal leak tests should be conducted in order to maintain the sterility of the sterilized packages. We felt that it is necessary to select appropriate wrapping forms, know the correct way to handle sterilized pouches, and establish an education system to improve selection and knowledge. 定期的なシーラーの点検、シールリークテストの実施は滅菌バッグの無菌性を維持するために重要であり、ルーチンに実施することが望ましいと考える。 包装形態の適切な選択、滅菌バッグの正しい取り扱いの現状を知り、これらを改善する為の教育システム構築が必要と感じた。
We thank the healthcare personnel for their kind cooperation to provide us the clinically used sterilization pouches.
