WO2014183805A1 - Procédé de décontamination d'instruments médicaux - Google Patents

Procédé de décontamination d'instruments médicaux Download PDF

Info

Publication number
WO2014183805A1
WO2014183805A1 PCT/EP2013/060313 EP2013060313W WO2014183805A1 WO 2014183805 A1 WO2014183805 A1 WO 2014183805A1 EP 2013060313 W EP2013060313 W EP 2013060313W WO 2014183805 A1 WO2014183805 A1 WO 2014183805A1
Authority
WO
WIPO (PCT)
Prior art keywords
phase
instrument
disinfectant
cleaning
decontamination
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2013/060313
Other languages
English (en)
Inventor
Robert John Hartley
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PARTNERS FOR ENDOSCOPY Ltd
Original Assignee
PARTNERS FOR ENDOSCOPY Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by PARTNERS FOR ENDOSCOPY Ltd filed Critical PARTNERS FOR ENDOSCOPY Ltd
Priority to PCT/EP2013/060313 priority Critical patent/WO2014183805A1/fr
Publication of WO2014183805A1 publication Critical patent/WO2014183805A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/16—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • A61B1/121—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use
    • A61B1/123—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use using washing machines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/24—Apparatus using programmed or automatic operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/15—Laboratory, medical or dentistry appliances, e.g. catheters or sharps

Definitions

  • the present invention relates to a method for the decontamination of medical instruments, and in particular a method for the decontamination of endoscopes.
  • Endoscopes are complex reusable medical instruments consisting of a long, thin, flexible (or rigid) tube used to visual internal examination of a patient. Endoscopes are routinely exposed to mucus and other gastrointestinal secretions, blood, saliva, faeces, bile, and sometimes pus, and therefore require unique consideration with respect to
  • Rigid endoscopes are commonly sterilised using an autoclave which subjects the endoscpes to high pressure saturated steam at 121 °C for around 15-20 minutes.
  • flexible endoscopes are heat labile and cannot be autoclaved.
  • the current process of decontamination for flexible endoscopes comprises two basic stages: a) manual cleaning, which includes brushing with single-use wire brushes, and
  • AER Automated Endoscope Reprocessor
  • AER machines should be used for all endoscope decontamination following manual pre-cleaning.
  • AER machines are recommended both because they reliably expose all external and internal components of the endoscope to thorough disinfection and rinsing, and because they help prevent atmospheric pollution by the disinfectant, and manual disinfection is no longer considered acceptable.
  • AER Automatic Endoscope Reprocessors
  • the rinse water is bacteria free. This requires expensive reverse osmosis or filtration systems to produce the bacteria free water which are both costly to purchase and maintain. Even with such systems the ability to consistently achieve bacteria free rinse water is problematical and it is necessary for the final rinse water to be sampled from the automatic reprocessor and tested for its microbiological quality at least weekly. In addition, the rinse phase takes some 6 or more minutes to achieve complete flushing of any residues, therefore significantly increasing the sterilization cycle time and limiting the number of endoscopes which can be processed within a given time period.
  • an automated method for the decontamination of medical instruments comprising placing the instrument within a cleaning chamber of an automated decontamination device; commencing a cleaning phase for the removal of contaminated material from the device; subsequent to the cleaning phase commencing a disinfectant phase comprising the application of a disinfectant to the instrument; and following the disinfectant phase commencing a drying phase in which the hypochlorous acid is allowed to dry on the surface of the instrument.
  • the disinfectant is preferably a hypochlorous acid. It has been found that when permitted to dry on the surface of an endoscope or other medical instrument that hypochlorous acid is safe for ingestion by a human and therefore subsequent rinsing of the hypochlorous acid is unnecessary. By applying a drying phase following the disinfectant phase, removing the final rinse phase altogether, and allowing the hypochlorous acid to dry on the endoscope, the time consuming and expensive processes required to produce bacteria free rinse water, and the time associated with the rinse cycle are obviated.
  • the automated decontamination device comprises a controller configured to cause the commencement of the cleaning, disinfectant and drying phases. The controller ensures that each phase is operated for the optimum period and may also control temperature and flow rate of the fluids concerned with each stage.
  • the decontamination process is terminated following the drying phase and the instrument is not rinsed following the disinfectant process either prior to or following the drying phase.
  • the instrument is not rinsed following the disinfectant process either prior to or following the drying phase.
  • the drying phase preferably comprises generating a forced airflow and applying said airflow to the instrument to increase drying efficiency.
  • the method may further include the step of rinsing the endoscope following the cleaning phase and prior to the disinfectant phase. This ensures that the detergent from the cleaning phase is removed so as to prevent spoiling of the hypochlorous acid.
  • the method may further including the step of drying the instrument following rinsing and prior to the disinfectant phase to ensure that the disinfectant is not diluted by any retained cleaning solution.
  • the method may be a method of decontaminating a flexible endoscope.
  • the disinfectant is preferably a disinfectant combination, which comprises; a first supply of a water-soluble hypochlorite; and a second supply of at least one saturated, water- soluble, physiologically acceptable carboxylic acid, wherein the carboxylic acid is in solution in an alcoholic solvent which comprises ethanol, the alcoholic solvent optionally also containing water.
  • the hypochlorite is preferably in aqueous solution.
  • the carboxylic acid may be a mono-, di-or tn-functional, saturated alkanoic acid optionally having one or more substituents which are substantially inert in the presence of a chlorine donor.
  • the acid is a solid when in pure isolated form at 20[deg.]C, and is an alkane dioic acid with up to 7 carbon atoms in a saturated chain, or a hydroxyl substituted alkanoic acid.
  • the alcoholic solvent for the carboxylic acid may comprise 40 to 60% by weight of ethanol, substantially all the balance being water.
  • the first supply may be in the form of a sealed or closed pack containing the hypochlorite in aqueous solution at an alkaline pH. 7.
  • the second supply may be in the form of a further sealed or closed pack containing the carboxylic acid in solution in said alcoholic solvent.
  • an automated decontamination apparatus for the decontamination of medical instruments such as endoscopes, the device comprising a housing defining a cleaning chamber for receiving an instrument for decontamination; cleaning means configured to apply a cleaning fluid to the instrument when located within the cleaning chamber; disinfecting means configured to apply a disinfectant to the instrument; and a controller for controlling the cleaning means and disinfectant means, the controller being configured to initiate a cleaning phase in which the cleaning means is operated to clean an instrument, to subsequently initiate a disinfecting phase in which the disinfecting means is operated to apply a disinfectant to the instrument, and to initiate a drying phase subsequent to the disinfecting phase in which the disinfectant is permitted to dry on the instrument.
  • the disinfecting phase preferably comprises utilising the disinfecting means to apply a hypochlorous acid to the instrument.
  • the apparatus preferably comprises rinse means for rinsing the medical instrument, the controller being configured to activate said rinsing means following the cleaning phase and prior to the disinfectant phase.
  • Figure 1 is a schematic representation of a method of
  • An automated endoscopic reprocessor comprises a housing defining a cleaning chamber for receiving endoscopes for reprocessing and a door for proving access to and sealing the chamber.
  • a plurality of trays is located within the housing defining load carriers for receiving the endoscopes.
  • the trays preferably comprise a wire frame structure arranged to optimise access to the endoscopes by cleaning fluids.
  • a plurality of nozzles is located within the cleaning chamber, each nozzle being arranged to be connected to the tubes or channels of the endoscopes when the endoscopes are located within the load carriers.
  • the plurality of nozzles are configured to channel air and/or cleaning fluids to the endoscope tubes.
  • the AER comprises means for directing and agitating cleaning fluids to the endoscopes located on the load carriers within the chamber. These may be fixed or rotating nozzles, hoses of any other suitable means for mechanically directing fluid to the endoscopes in use.
  • the AER further includes a controller for controlling and coordinating the cleaning and disinfecting processes occurring within the cleaning chamber. Following use in a medical procedure, an endoscope is first subjected to an initial manual cleaning stage to remove the bulk of external contaminants. Following the initial manual cleaning stage the endoscope is placed on a load carrier within the cleaning chamber. The chamber is closed and sealed and the operator then activates the cleaning cycle.
  • operation of the cleaning cycle comprises a single activation stage such as operation of a single button or switch, with no further input being required from the operator.
  • a cleaning solution which is preferably an enzymatic cleaning solution is externally directed to the endoscopes by the cleaning means.
  • the nozzles connected to the endoscope channels direct the cleaning solution internally to the endoscope to flush out and clean these channels.
  • the cleaning phase is operated for approximately 5 minutes after which time it is discontinued by the controller.
  • a short rinse phase is then preferably activated by the controller to rinse the enzymatic solution from the endoscope using filtered water.
  • bacteria free water is not required for this intermediate rinse phase as any bacteria which may be present is destroyed by the following disinfectant phase. As such, the expensive and time consuming processes associated with such bacteria free rinsing are avoided by the present invention.
  • an intermediate drying phase is introduced in which the external water is permitted to drip dry to prevent dilution of the subsequently applied disinfectant.
  • air is blown through the tubes of the endoscope by the nozzles to facilitate drying of these channels.
  • the controller activates the final disinfectant stage.
  • the cleaning means are used to direct a flow of disinfectant fluid at the endoscope.
  • the disinfectant used is a hypochlorous acid.
  • Hypochlorous acid is a mixture of active elements derived from salt by electrolysis through a proprietary electrochemical cell. Electrolysed saline produces a rapidly active biocide in the form of hypochlorous acid that is effective against vegetative bacteria, mycobacteria, spores, yeasts and viruses.
  • the hypochlorous acid is applied to the endoscopes by the cleaning means both externally and internally to the tubes by the nozzles. These may be the same cleaning means as used for applying the enzymatic solution or separate fluid delivery means.
  • the applicant has surprisingly found that hypochlorous acid may be retained on the surface of an endoscope and that the remaining residue is non-toxic and may be safely ingested by a human.
  • hypochlorous acid retained as a residue on an instrument such an endoscope remains active and continues to kill bacteria. Therefore, the applicant has found that not can a hypochlorous acid residue be safely retained on the surface of endoscope, but such retention should be encouraged as it provides an actively anti-bacterial surface coating to the endoscope which continues to maintain the sterility of the endoscope following reprocessing.
  • the preferred hypochlorous acid is a hypochlorous acid marketed by the applicant as TrioSafe, and as described in UK Patent Number GB2477597.
  • the controller of the present invention is configured to commence a drying phase following the disinfectant phase in which the hypochlorous acid is allowed to dry on the surface of the endoscope.
  • the endoscope In the drying phase the endoscope is retained within the cleaning chamber and permitted to dry.
  • Commencement of the drying phase may comprise the cessation of the disinfectant stage alone and the absence of a further rinse phase.
  • Initiation of the drying phase may also comprise the controller initiating a timer to regulate the drying period and notify the operator when the drying period is complete. This may comprise a visual or audible signal and/or the automated unlocking of the access door to permit removal.
  • the cleaning chamber includes means to force airflow to accelerate and increase the efficacy of drying process.
  • Air may be blown onto the external surface and/or through the channels of the endoscope tubes. Following drying the disinfectant process is terminated by the controller. The reprocessor is controlled such that no further rinsing takes place to ensure that the hypochlorous acid is permitted to dry on the surface of the endoscope is to ensure that it is retained on the surface of the endoscope following drying and during subsequent storage.
  • the drying stage is complete when the hypochlorous acid in contact with the endoscope has substantially transitioned from the liquid phase with a solid phase residue remaining as a coating on the endoscope. It will however be appreciated that while the residue is preferred the drying phase may comprise only the removal of the liquid phase
  • hypochlorous acid or other suitable disinfectant from the endoscope through evaporation with no residue remaining as such a process still obviates the requirement for rinsing.
  • the cycle is complete and the endoscope is removed from the cleaning chamber without a final rinse stage.
  • Permitting the hypochlorous acid to dry on the endoscope and the absence of a final rinse stage distinguishes the process of the present invention from the systems of the prior art and provides previously unobserved technical advantages.
  • the hypochlorous acid is permitted to dry on the surface (internal and external) of the endoscope such that the surface is substantially coated with a residue layer of dried hypochlorous acid.
  • the AER unit In a pass-through AER the AER unit is located with a loading access within a non-sterile room and a corresponding unloaded access opening into to a sterile clean room such that the disinfected endoscopes are removed in sterile environment in which they are then stored.
  • the cleaning chamber comprises two access doors, with the contaminated endoscopes being loaded in the non-sterile room through a first access door and removed in the clean rom through the second door.
  • the AER may be a single entry unit which the endoscopes are inserted and removed from the unit through the same access.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne un procédé automatisé de décontamination d'instruments médicaux tels que les endoscopes, dans lequel l'instrument est tout d'abord placé dans une chambre de nettoyage d'un dispositif de décontamination automatisé. Une phase de nettoyage démarre alors pour l'élimination du matériel contaminé du dispositif. Après la phase de nettoyage, une phase de désinfection démarre, ladite phase comprenant l'application d'un désinfectant à l'instrument, qui peut être l'acide hypochloreux. Après la phase de désinfection, une phase de séchage démarre immédiatement sans étape de rinçage. Dans la phase de séchage, l'acide hypochloreux est laissé à sécher à la surface de l'instrument de sorte qu'au moins les parties de l'instrument destinées à un contact interne avec un patient soient substantiellement revêtues d'une couche séchée d'acide hypochloreux qui est conservée pendant le stockage et jusqu'à l'utilisation de l'instrument.
PCT/EP2013/060313 2013-05-17 2013-05-17 Procédé de décontamination d'instruments médicaux Ceased WO2014183805A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2013/060313 WO2014183805A1 (fr) 2013-05-17 2013-05-17 Procédé de décontamination d'instruments médicaux

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2013/060313 WO2014183805A1 (fr) 2013-05-17 2013-05-17 Procédé de décontamination d'instruments médicaux

Publications (1)

Publication Number Publication Date
WO2014183805A1 true WO2014183805A1 (fr) 2014-11-20

Family

ID=48485160

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2013/060313 Ceased WO2014183805A1 (fr) 2013-05-17 2013-05-17 Procédé de décontamination d'instruments médicaux

Country Status (1)

Country Link
WO (1) WO2014183805A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020245658A3 (fr) * 2019-06-06 2021-01-21 Asp Global Manufacturing Gmbh Système et procédé de séchage de canaux d'instrument médical pendant le nettoyage

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5840251A (en) * 1995-10-31 1998-11-24 Nitto Medical Corporation Device and method for cleaning, disinfecting and drying an endoscope
EP0923951A2 (fr) * 1997-12-17 1999-06-23 Ethicon, Inc. Conteneur pour le nettoyage ou la stérilisation d'articles ayant une lumière
US20070059202A1 (en) * 2005-02-25 2007-03-15 Tichy Daryl J Disinfectant systems and methods
EP1815782A2 (fr) * 2006-02-02 2007-08-08 Olympus Medical Systems Corp. Dispositif et procédé pour la déshydratation de canaux d'endoscope
WO2011010166A2 (fr) * 2009-07-23 2011-01-27 Applied Chemistry Limited Système de décontamination de l'eau
GB2477597A (en) 2010-02-03 2011-08-10 Mauve Technology Ltd Disinfectant materials and methods
GB2500866A (en) * 2012-02-08 2013-10-09 Partners For Endoscopy Ltd Method for decontamination of medical instruments

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5840251A (en) * 1995-10-31 1998-11-24 Nitto Medical Corporation Device and method for cleaning, disinfecting and drying an endoscope
EP0923951A2 (fr) * 1997-12-17 1999-06-23 Ethicon, Inc. Conteneur pour le nettoyage ou la stérilisation d'articles ayant une lumière
US20070059202A1 (en) * 2005-02-25 2007-03-15 Tichy Daryl J Disinfectant systems and methods
EP1815782A2 (fr) * 2006-02-02 2007-08-08 Olympus Medical Systems Corp. Dispositif et procédé pour la déshydratation de canaux d'endoscope
WO2011010166A2 (fr) * 2009-07-23 2011-01-27 Applied Chemistry Limited Système de décontamination de l'eau
GB2477597A (en) 2010-02-03 2011-08-10 Mauve Technology Ltd Disinfectant materials and methods
GB2500866A (en) * 2012-02-08 2013-10-09 Partners For Endoscopy Ltd Method for decontamination of medical instruments

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020245658A3 (fr) * 2019-06-06 2021-01-21 Asp Global Manufacturing Gmbh Système et procédé de séchage de canaux d'instrument médical pendant le nettoyage

Similar Documents

Publication Publication Date Title
JP4012062B2 (ja) 使用済み医療器具類の洗浄・滅菌処理方法
US11000607B2 (en) Methods and systems for the sterilization of endoscopes
CN101389358B (zh) 用于处理同种异体移植产品的装置和方法
CN1585817A (zh) 用气态氧化剂对朊病毒感染材料污染的表面进行去污
AU2003230976B2 (en) Supplemental ozone treatment methods for difficult cleaning and sterilizing applications
EP2922579A1 (fr) Procédé de stérilisation comportant un fluide de stérilisation et microbulles de cavitation générées par ultrasons
WO2007103617A2 (fr) Appareil et procédé de stérilisation
US6610251B1 (en) Method of sterilizing medical instruments
JP4469577B2 (ja) 治療器具の洗浄消毒方法
JP2010530251A (ja) 再使用可能な医療品を機械的処理するための方法
GB2500866A (en) Method for decontamination of medical instruments
JP2006141505A (ja) 医療器具洗浄消毒装置および医療器具の洗浄消毒方法
JP2011147768A (ja) 過酢酸および過酸化水素からなる組成物の水溶液を用いる医療用、外科用および歯科用器具を手により滅菌する方法
WO2014183805A1 (fr) Procédé de décontamination d'instruments médicaux
WO2012029906A1 (fr) Procédé de lavage de dispositif médical et appareil de lavage de dispositif médical
EP1257301B1 (fr) Desinfection de dispositif medical
JP2002186583A (ja) 内視鏡洗浄消毒方法、その内視鏡洗浄消毒装置及び内視鏡洗浄消毒に用いる消毒液
JP3460977B2 (ja) ゴム部材を有する医療機器の消毒、滅菌方法と装置
US20260000799A1 (en) Low-temperature sterilization device and method thereof
KR102297143B1 (ko) 차염발생 내시경 소독장치 및 그 구동방법
JPH01305956A (ja) 殺菌洗浄方法
US20060233661A1 (en) Methods for disinfection and tracking of soiled items
US20060275172A1 (en) Item reprocessing and sterile packaging apparatus
TW200302113A (en) Cleaning and sterilizing treatment of used medical appliance
Mishra LEGISLATION IN STERILIZATION

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13724796

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13724796

Country of ref document: EP

Kind code of ref document: A1