Sterilising with PeelVue+ Sterilisation Pouches Guidelines and Validation Instructions. Dental Office QMS Support

Transcription

1 Sterilising with PeelVue+ Sterilisation Pouches Guidelines and Validation Instructions Dental Office QMS Support

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3 Contents Page 1 Introduction 4 2 Preparation 5 3 Defining the right pouch size 6 4 Loading and closing the pouch 8 5 Sterilisation process 10 6 Storing and opening the pouch 11 7 Shelf life and product disposal 12 8 Additional information 13 9 Documentation 14 DUX BV, Utrecht, All forms of duplication or publication require written approval. DUX Dental Zonnebaan 14 l NL-3542 EC Utrecht The Netherlands Tel l Fax info@dux-dental.com l

4 1 Introduction Every dental surgery must have a Quality Management System (QMS) in place, an integral element of which is surgery hygiene. A central aspect is compliance with the sterilisation requirements for medical devices. PeelVue + sterilisation pouches comply with all relevant guidelines for sterile instrument packaging 1, can be validated, and are therefore suitable for all sterilisation requirements in your surgery. This guide shows you how PeelVue + sterilisation pouches can be used and validated according to the sterilisation requirements in practice and thus supports you with the daily implementation of your Quality Management System. Packaging Process Validation The packaging process to be carried out by the dental surgery in accordance with DIN EN ISO includes the following points: Installation qualification (IQ): Checking whether the device is installed correctly and whether critical parameters (sealing temperature, sealing pressure, sealing time) are defined and monitored. Operational qualification (OQ): Checking whether critical parameters are fulfilled in practice. Performance qualification (PQ): Regular control as to whether the packaging process is mastered and thus whether the sterile barrier systems produced are optimally closed. Special aspects when using PeelVue + sterilisation pouches Because the Installation Qualification (IQ) and Operational Qualification (OQ) were already ensured during the production of the self-adhesive PeelVue + sterilisation pouches, only Performance Qualification (PQ) remains in the area of responsibility of your surgery. To ensure mastery of the packaging process and an optimally closed sterile barrier system, please follow the individual steps in this guide. 1 PeelVue + Sterilisation Pouches comply with: Directive 93/42/EEC; DIN EN 868-5; ISO and 2. 4

5 2 Preparation Before working with PeelVue + sterilisation pouches, please familiarise yourself with the separate components of the pouch o 10 mm wide seal 19 mm wide self-adhesive closure flap Built-in, chemical external processing indicator Built-in, patented chemical internal processing indicator Closure validation (patent pending) o Perforation line Pictograms with closure instructions Air vents Colour coding Non-adhesive corners for easy opening 11 Internal/Effective dimensions 12 Article number and external dimensions (inch) 5

6 3 Defining the right pouch size When selecting the right size of the sterilisation pouch, please consider the various internal dimensions of the available PeelVue + pouches. Observe the ratio between the size of the product(s) to be sterilised and the internal capacity of the PeelVue + sterilisation pouch. The thicker the product(s) to be sterilised (e.g. cassettes), the less width is available in the pouch. Select the right pouch size for the product(s) to be sterilised and make sure the sterilisation pouch is loaded to only three-quarters of its volume. If in doubt, select the next largest PeelVue + sterilisation pouch. TIP: With the special PeelVue + Internal Size Grid", you can define the right pouch size quickly and easily; the photo example shows PeelVue + with the colour coding gold. The grid is available from DUX Dental free of charge. The colour coding of the individual sterilisation pouches allows easy and rapid selection of the available PeelVue + pouch sizes and facilitates (re-) ordering. 6

7 3 Defining the right pouch size x 135 mm 70 x 80 mm x 230 mm 50 x 170 mm x 230 mm 65 x 170 mm x 100 mm 35 x 50 mm x 165 mm 115 x 110 mm x 380 mm 195 x 290 mm x 305 mm 60 x 210 mm x 305 mm 85 x 210 mm x 305 mm 185 x 210 mm x 305 mm 110 x 210 mm x 405 mm 245 x 325 mm * The specified external dimensions can vary slightly for production reasons x 510 mm 310 x 425 mm 7

8 4 Loading and closing the pouch PeelVue + sterilisation pouches already feature an external and patented internal processing indicator (ISO compliant), and therefore it is not necessary to affix a separate processing indicator when processing loose instruments. Pre-fold the closure flap backwards along the perforation line. This allows for easier closure later. Visually check whether the flap folded backwards falls in the space between the two triangles. If not, reposition the closure flap as far as necessary for it to fall between the two triangles. Now fill the pouch. Make sure that sharp objects do not puncture the pouch, as sterilisation cannot be guaranteed if the pouch is damaged. TIP: Sterilisable instrument protective caps protect sharp and pointed instruments and ensure safe handling without injuries. 8

9 4 Loading and closing the pouch Remove the release liner. The pouch is closed by pressing the adhesive flap onto the transparent film - triangles (closure validation) mark the exact position. The adhesive closure flap must be stuck down between the two triangles on both sides. Run both thumbs several times and firmly from the centre to the edges. The pouch is correctly sealed when the closure strip adheres without any folds between both closure validation symbols. 9

10 5 Sterilisation process Loading the Auto/Chemiclave When loading the auto/chemiclave, stack the pouches vertically or on their sides. When stacked horizontally, ensure that the pouches do not touch each other, so that the surfaces of the sterilisation pouches are completely exposed to the steam or other sterilising agent. The pouches must not come into contact with the chamber walls. For the sterilisation procedure, follow the auto/chemiclave manufacturer s directions. Consult the appropriate operating instructions as necessary. TIP: Let the sterilisation pouches dry and cool off in the chamber of the auto/ Chemiclave before removing them. After the sterilisation process, the colour of the internal and external process indicator must have changed from light blue into dark grey. Discolouration of the indicators shows whether the time, temperature and steam processing conditions were met. 10

11 6 Storing and opening the pouch Store sterilised instruments in the sealed pouch in a dry, closed room. Ensure adequate circulation of air during storage. The pouch is opened on the side with the processing indicators. Open the pouch by taking hold of the transparent film at the corners and peeling it off the paper side. Lift the film in the middle and pull it completely off the paper. TIP: The paper side can function as a sterile tray liner. 11

12 7 Shelf life and product disposal A loss of sterility is usually deemed to be event-dependent rather than time-dependent (storage duration). This means that the material inside the PeelVue + packaging remains sterile and germ-free until the sterile barrier is broken. This can be caused for example by tears, punctures, humidity or by opening the pouch. According to ISO a maximal storage period of 6 months is recommended if protected storage is to be guaranteed. PeelVue + sterilisation pouches do not meet the definition of a hazardous waste, and can be discarded in normal waste (40 CFR ; tested using the TCLP, EPA Publication SW-846). Please observe the local waste disposal regulations. 12

13 8 Additional information Monitoring of Performance Qualification (PQ) The evidence to be furnished within the framework of the regular Performance Qualification (PQ) that the packaging process is mastered and delivers optimally closed sterile barrier systems can among other things be brought using visual control and/or with a seal integrity test (ink test), pursuant to DIN EN ISO , test method ASTM F This test makes tears, cutting, channels or open sealing seams immediately visible and ensures that the sterile barrier system is optimally closed. Close the pouch (as described in Chapter 4). Open the pouch on the side with the processing indicators. Now add the colouring agent to the pouch with the help of a pipette. Check the tightness of the closing flap of the pouch for a maximum of 5 seconds for any channelling*. An optimally closed pouch shows neither leaks nor channelling within 5 seconds. Note: The colouring solution that is used in the ink test ASTM F1929 is very fluid and has a wicking effect**. The paper pouch will absorb the solution which spreads fast along the paper fibres that are coloured directly. After 5 seconds, significant wicking occurs and this can also be wrongly interpreted in the test. Hence a test longer than 5 seconds is not recommended. * Channelling: a small, continuous, open passage across the width of the seam through which microorganisms can pass. ** Wicking: The distribution/absorption of a liquid onto and/or in the surface of a fibrous material. 13

14 9 Documentation Now you have learned how PeelVue + sterilisation pouches should be used in the dental surgery. Always refer to these guidelines if you are unsure of particular steps in loading, closing or other handling of the PeelVue + sterilisation pouch. For quality insurance purposes, please confirm and record that all responsible staff have read and understood the instructions for the use of PeelVue + sterilisation pouches. You can use this page for documentation. Name Date/Signature Name Date/Signature Name Date/Signature Name Date/Signature Name Date/Signature Name Date/Signature 14

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