Reprocessing Guide
3 Pages
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Page 1
According to FDA
Hygienic Reprocessing HEINE EasyClean LED Laryngoscope Handles General warning and safety information: WARNING! This symbol draws attention to a potentially dangerous situation. Non-observance can result in moderate to major injuries. NOTE! This symbol indicates valuable advice. Notes are important, but not related to hazardous situations.
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Limitations on reprocessing
Instructions on hygienic reprocessing must be adhered to, based on national standards, laws and guidelines. The described reprocessing measures do not replace the specific rules applicable for your institution/ department. After each use, carry out hygienic reprocessing. If you use reprocessing programs with temperatures above 60 °C (e. g. automated cleaning and disinfection or steam sterilization), you need to remove the batteries and the casing (if available) first OR refer to the battery manufacturer´s instructions. Equipment, where there is a suspicion that they have been in contact with Creutzfeld-Jakob disease (CJD) pathogens or variants thereof must not be reprocessed under any circumstances. Please consider the instructions of the manufacturer for the applied reprocessing media. HEINE Optotechnik GmbH & Co. KG only approves the agents and procedures listed in this instruction. The reprocessing is to be carried out by persons with adequate hygienic expertise. If the valve on the bottom insert opened during reprocessing, or if the bottom insert has not been completely closed, the handle inside shall dry with opened bottom insert, the valve shall be closed (pressed in) and the reprocessing shall be repeated. The described reprocessing procedures are represented alongside the corresponding material compatibilities. Reprocessing must be carried out in accordance with an approved processing procedure. HEINE Optotechnik GmbH & Co. KG cannot guarantee the sterility and disinfection of these procedures. This has to be validated by the user e. g. Hospital or the manufacturers of the reprocessing equipment. Before using it again, ensure that the handle is completely dry after reprocessing. Ensure that the bottom insert is completely closed during reprocessing to avoid liquid entry. As long as the product meets the requirements of ISO 7376. Periodically check the integrity of the device and that the illumination is sufficient.
According to FDA
Choice of the reprocessing procedure The hygienic classification (Spaulding classification) of the laryngoscope handles, as well as the decision for one of the offered reprocessing procedures, is the responsibility of the user or the qualified person(s) responsible for reprocessing. Internal regulations of your hospital/ institution, national directives, recommendations, standards and laws need to be considered. For highly infectious cases (previous or following patients) (e. g. in case of a proven existence of a dangerous infectious disease (symptomatic or asymptomatic), the reprocessing guidelines in this document are superseded by processes of your institution / practice-internal regulations, national directives, recommendations, standards and laws.
If you, the user or the qualified person responsible for reprocessing,
have classified the handle as “non-critical” (Spaulding classification) o i.e. the handle contacted only intact skin and did not penetrate it or it did not directly contact the patient o and is not visibly contaminated with microorganisms and organic soil (e. g. blood, body fluids)
then intermediate level wipe disinfection can be performed (see chapter A). Otherwise, high-level disinfection (i.e. manual cleaning with immersion-disinfection or automated cleaning and disinfection) and/or sterilization shall be performed (see chapter B-G). Choose one of the following reprocessing methods: Cleaning and disinfection Automated cleaning and disinfection
Chapter A
Chapter B
Manual cleaning (brushing)
Chapter C
Low Temperature STERRAD / VHP (Steris)
Chapter F
Chapter D
Steam
Chapter E
Chapter G
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High-level manual disinfection (immersion)
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Sterilization
No sterilization
Intermediatelevel wipe disinfection
According to FDA
Chapter A: Intermediate-level wipes disinfection
2. 3.
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Containment and transportation Reprocess as soon as possible following use. Preparation Disassemble the blade from the handle and reprocess separately. Manual cleaning and disinfection Pay attention that all surfaces are completely moistened for the complete exposure time specified by the disinfectant manufacturer. If necessary, increase the number of wiping procedures and or the number of wipes. Equipment Intermediate level disinfection wipes: alcohol and/or quarternary ammonium compounds (e. g. Super Sani-Cloth by PDI) having an EPA-registered claim for activity against Mycobacterium tuberculosis and Hepatitis B. Implementation Using the disinfectant wipe, start from the top of the handle and wipe down 3 times while turning the handle. This procedure is to be repeated 3 times, each with a new disinfectant wipe. Pay particular attention to recesses, ridges, difficult to access areas of the snap-in mechanism, below the hinge and the bottom insert. For removing the disinfectant and drying afterwards, follow the instructions provided by the disinfectant manufacturer. Inspection and function testing Check the handle for any visible contaminants or abrasions. Reprocess again if necessary. Dispose if the contaminants cannot be removed. Perform functional testing after reprocessing. Storage Store it in such a way that it is protected from recontamination, dust and moisture.
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