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EP2746375B1 - Spray pour instruments - Google Patents

Spray pour instruments Download PDF

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Publication number
EP2746375B1
EP2746375B1 EP12198630.1A EP12198630A EP2746375B1 EP 2746375 B1 EP2746375 B1 EP 2746375B1 EP 12198630 A EP12198630 A EP 12198630A EP 2746375 B1 EP2746375 B1 EP 2746375B1
Authority
EP
European Patent Office
Prior art keywords
instruments
use according
apparatuses
corrosion
weight
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.)
Revoked
Application number
EP12198630.1A
Other languages
German (de)
English (en)
Other versions
EP2746375A1 (fr
Inventor
Karina Wesemann
Jürgen Staffeidt
Ina Haacke
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.)
Chemische Fabrik Dr Weigert GmbH and Co
Original Assignee
Chemische Fabrik Dr Weigert GmbH and Co
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47559179&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP2746375(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Chemische Fabrik Dr Weigert GmbH and Co filed Critical Chemische Fabrik Dr Weigert GmbH and Co
Priority to ES12198630T priority Critical patent/ES2894603T3/es
Priority to PL12198630T priority patent/PL2746375T3/pl
Priority to EP12198630.1A priority patent/EP2746375B1/fr
Priority to HUE12198630A priority patent/HUE056796T2/hu
Publication of EP2746375A1 publication Critical patent/EP2746375A1/fr
Application granted granted Critical
Publication of EP2746375B1 publication Critical patent/EP2746375B1/fr
Revoked legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
    • C11D1/02—Anionic compounds
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
    • C11D1/88—Ampholytes; Electroneutral compounds
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
    • C11D1/88—Ampholytes; Electroneutral compounds
    • C11D1/94—Mixtures with anionic, cationic or non-ionic compounds
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/02—Inorganic compounds ; Elemental compounds
    • C11D3/04—Water-soluble compounds
    • C11D3/06—Phosphates, including polyphosphates
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/48—Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D2111/00—Cleaning compositions characterised by the objects to be cleaned; Cleaning compositions characterised by non-standard cleaning or washing processes
    • C11D2111/10—Objects to be cleaned
    • C11D2111/14—Hard surfaces
    • C11D2111/16—Metals

Definitions

  • the invention relates to the use of a foam spray for the pretreatment of contaminated medical or surgical instruments and apparatus, as well as a method for reprocessing medical and / or surgical instruments and apparatus.
  • Surgical instruments go through a so-called instrument cycle. After use in the operating room, they are placed in a container by the surgeon or operating room staff and sent for processing.
  • the so-called pre-disinfection is known as a wet disposal method in which the instruments are placed in a large immersion container filled with disinfectant solution. These dipping tanks often contain 50 l of disinfectant solution. Such a pre-disinfection is often used in France, for example.
  • the disposed instruments are brought to a central instrument preparation facility.
  • instrument reprocessing in hospitals is largely carried out centrally, since according to the state of the art and relevant recommendations on hospital hygiene, decentralized reprocessing is not recommended.
  • the central processing must have a so-called unclean side and a clean side; for access to the clean side, for example, locks are provided through which the clean side can be entered. This can only be economically represented in a central processing.
  • the disposed instruments are sent for machine cleaning and disinfection. After cleaning and disinfecting, they are removed on the clean side and usually packaged in common surgical sets that contain, for example, the necessary instruments for a specific operation. These sets are then steam sterilized (134 ° C) in a further step and stored for use.
  • the foam sprays known in the prior art (see for example the Patent US6235692B1 ) all have enzymes to initiate or support protein degradation and in this way prevent blood residues from drying on.
  • the pH value is usually in the neutral range.
  • US 6 562 296 B1 discloses a method of cleaning surgical instruments with an enzyme-free cleaner, the contains at least 10% by weight of an alkanolamine and has a pH of 6-10.
  • US 2005/0079097 A1 discloses a method for destabilizing prions. Medical instruments are treated with a composition that contains surfactants and has a pH of at least 11.5.
  • the invention is based on the object of providing the use of a foam spray and a method of the type mentioned at the outset that prevents residues from drying on before the central preparation of the instruments and ensures that the instruments retain their value over the long term.
  • foam spray containing surfactants to inhibit chloride-induced corrosion in the pretreatment of contaminated medical or surgical instruments and apparatus, before transferring the instruments and / or apparatus to a central instrument reprocessing station, characterized in that the foam spray is enzyme free and has a pH of 9 or more.
  • Medical and / or surgical instruments and apparatus are all devices used in the medical and hospital sector, as well as parts thereof, which can be reprocessed after their use.
  • the agent used according to the invention is formulated to be sprayable. This means that it is kept ready for use in a form that allows a user to spray it directly as an aerosol onto the surfaces of the instruments.
  • An aerosol container is a container from which the agent can be sprayed as an aerosol, for example by means of a spray head.
  • the invention has recognized that the foam sprays known in the prior art are disadvantageous in several respects. In particular, they do not guarantee protection of metallic surfaces (in particular surfaces made of stainless steel and anodized aluminum) against corrosion, in particular pitting corrosion induced by chloride ions.
  • the foam spray used according to the invention has a comparatively high pH value; it has been shown that this ensures effective protection, in particular against corrosion induced by chloride ions.
  • the use of the enzymes considered necessary in the prior art for foam sprays is dispensed with.
  • the presence of proteolytically active enzymes requires a relatively low pH value in the neutral range, since the enzymes can develop their effect only in this pH range.
  • effective protection of the surfaces against undesired drying of dirt residues and on the other hand against corrosion is guaranteed.
  • the pH of the foam spray is preferably at least 10, preferred upper limits are pH values of 13 or 12. A pH value in the range 10-12 is therefore particularly preferred.
  • the pH value is determined in a solution of 1% by weight of the agent in water.
  • the surfactants are preferably amphoteric and / or anionic surfactants.
  • the anionic surfactants used are preferably foam-forming. This makes it easier to spray the agent as a foam.
  • suitable anionic surfactants are acyl glutamates, alkyl sulfates and ether sulfates. Amphopropionates, amphoacetates and betaines are, for example, suitable as amphoteric surfactants.
  • the surfactant content is preferably between 0.2 and 5% by weight, more preferably 0.5 and 1.5% by weight.
  • the foam spray can contain, for example, alkaline phosphates, particularly preferably polyphosphates, which at the same time can take on an important function as dispersing aids for the uniform wetting of the surface of the instruments.
  • alkaline phosphates particularly preferably polyphosphates
  • Alkali tripolyphosphates such as potassium tripolyphosphate are particularly preferred.
  • the content of alkaline dispersants is preferably 5 to 40% by weight, more preferably 15 to 30% by weight.
  • the invention makes it possible, on the one hand, to keep contaminated instruments on the surface moist for periods of several hours and, on the other hand, not to corrode, or at most to a very small extent.
  • the period of time between step a) and the beginning of step c) is preferably 24 hours or less, preferably 12 hours or less, more preferably 6 hours or less.
  • a complete cleaning, disinfection and subsequent sterilization of the instruments and devices is carried out in the central instrument reprocessing station.
  • the result of this reprocessing are instruments that are ready for reuse, e.g. packaged Surgical sets.
  • the sterilization can also take place separately from the complete cleaning and disinfection in the central instrument reprocessing station.
  • the cleaned and disinfected instruments can be packaged and then possibly spatially (and optionally temporally) separated from the preparation of the central instrument preparation station sterilized, e.g. steam sterilized.
  • the agent prepared in this way (hereinafter referred to as MAS) is made available in an aerosol container ready to be sprayed.
  • test specimens were then wiped with a paper towel soaked with methanol. To delimit a partial area of the test specimen, 1 measuring cell with a diameter of 13 mm is glued to each test specimen.
  • the solutions are applied in measuring cells. After 6, 24 and 72 hours of storage at 20 ° C., the measuring cells are removed and the test specimens are rinsed with lukewarm water for 30 seconds using a low flow pressure.
  • a second visual inspection and a second microscopic inspection also showed no traces of corrosion.
  • Example 2 Since no corrosion whatsoever was found in Example 2, additional tests according to DIN 51360 (determination of the corrosion protection properties of water-mixed cooling lubricants) were carried out. This standard is designed in such a way that, based on testing on gray cast iron chips that are comparatively susceptible to corrosion, corrosion to a certain extent is always obtained.
  • This example describes a complete instrument cycle including a method according to the invention.
  • Surgical instruments used in the operating room are, after use, placed in a tray located in the operating room and sprayed with a foam spray from Example 1.
  • the sterilized instrument sets are brought to the sterile store and kept there for the next use.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Claims (11)

  1. Utilisation d'un spray de mousse
    a1) qui contient des tensioactifs,
    d) pour l'inhibition de la corrosion induite par le chlorure
    a) lors du prétraitement d'instruments et d'appareils médicaux ou chirurgicaux contaminés,
    b) avant le transfert des instruments et/ou des appareils à une station centrale de traitement d'instruments,
    caractérisée en ce que le spray de mousse
    a2) est exempt d'enzymes et
    a3) présente un pH de 9 ou plus.
  2. Utilisation selon la revendication 1, caractérisée en ce qu'il présente un pH d'au moins 10.
  3. Utilisation selon la revendication 1 ou 2, caractérisée en ce qu'il présente un pH d'au plus 13, de préférence d'au plus 12.
  4. Utilisation selon l'une quelconque des revendications 1 à 3, caractérisée en ce qu'il contient des tensioactifs amphotères et/ou anioniques.
  5. Utilisation selon la revendication 4, caractérisée en ce qu'il contient un tensioactif moussant anionique.
  6. Utilisation selon l'une quelconque des revendications 1 à 5, caractérisée en ce que la teneur en tensioactifs est de 0,2 à 5% en poids, de préférence de 0,5 à 1,5% en poids.
  7. Utilisation selon l'une quelconque des revendications 1 à 6, caractérisée en ce qu'il contient un dispersant alcalin.
  8. Utilisation selon la revendication 7, caractérisée en ce que le dispersant alcalin est un polyphosphate.
  9. Utilisation selon la revendication 7 ou 8, caractérisée en ce qu'il contient 5 à 40% en poids, de préférence 15 à 30% en poids de dispersant alcalin.
  10. Procédé pour le traitement d'instruments et d'appareils médicaux et/ou chirurgicaux, présentant les étapes :
    a) aspersion des instruments et/ou des appareils qui ont été utilisés à l'aide d'un spray de mousse qui
    a1) contient des tensioactifs,
    a2) est exempt d'enzymes et
    a3) présente un pH de 9 ou plus ;
    b) transfert des instruments et/ou des appareils à une station centrale de traitement d'instruments ;
    c) réalisation d'un nettoyage, de désinfection et d'une stérilisation complets des instruments et/ou des appareils dans la station centrale de traitement d'instruments pour la restauration d'un état prêt à l'emploi des instruments et/ou des appareils.
  11. Procédé selon la revendication 10, caractérisé en ce que la durée entre l'étape a) et le début de l'étape c) est de 24 h ou moins, de préférence de 12 h ou moins, plus préférablement de 6 h ou moins.
EP12198630.1A 2012-12-20 2012-12-20 Spray pour instruments Revoked EP2746375B1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
ES12198630T ES2894603T3 (es) 2012-12-20 2012-12-20 Aerosol para instrumentos
PL12198630T PL2746375T3 (pl) 2012-12-20 2012-12-20 Sprej do przyrządów
EP12198630.1A EP2746375B1 (fr) 2012-12-20 2012-12-20 Spray pour instruments
HUE12198630A HUE056796T2 (hu) 2012-12-20 2012-12-20 Spray eszközökhöz

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP12198630.1A EP2746375B1 (fr) 2012-12-20 2012-12-20 Spray pour instruments

Publications (2)

Publication Number Publication Date
EP2746375A1 EP2746375A1 (fr) 2014-06-25
EP2746375B1 true EP2746375B1 (fr) 2021-07-28

Family

ID=47559179

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12198630.1A Revoked EP2746375B1 (fr) 2012-12-20 2012-12-20 Spray pour instruments

Country Status (4)

Country Link
EP (1) EP2746375B1 (fr)
ES (1) ES2894603T3 (fr)
HU (1) HUE056796T2 (fr)
PL (1) PL2746375T3 (fr)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0028674B1 (fr) 1979-10-12 1983-06-15 Hoechst Aktiengesellschaft Utilisation d'esters acides d'acide phosphorique ou leurs sels comme inhibiteurs de corrosion de métaux
WO1998004666A1 (fr) 1996-07-29 1998-02-05 The Clorox Company Agent de nettoyage en aerosol pour moquette
US6235692B1 (en) 1998-08-26 2001-05-22 Cottrell International, Llc Foaming enzyme spray cleaning composition and method of delivery
US6387858B1 (en) 2000-03-31 2002-05-14 Steris Inc. Safe transport gel for treating medical instruments
US6562296B1 (en) 1997-10-08 2003-05-13 Chemische Fabrik Dr. Weigert Gmbh & Co. Kg Process for cleaning surgical instruments
US20050079097A1 (en) 2002-01-28 2005-04-14 Petra Tiarks Cleaning and disinfection of surgical and medical instruments and appliances
EP1839681A1 (fr) 2006-03-31 2007-10-03 Ethicon, Inc. Traitement par mousse de peroxyde d'hydrogène
EP1935366A1 (fr) 2006-12-22 2008-06-25 Ethicon, Inc Récipient de suivi d'instrument et procédé
US20090197790A1 (en) 2008-02-05 2009-08-06 Amcol International Corporation Drip resistant cleaning compositions
US20120316097A1 (en) 2010-02-23 2012-12-13 Lion Corporation Detergent for metal

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0028674B1 (fr) 1979-10-12 1983-06-15 Hoechst Aktiengesellschaft Utilisation d'esters acides d'acide phosphorique ou leurs sels comme inhibiteurs de corrosion de métaux
WO1998004666A1 (fr) 1996-07-29 1998-02-05 The Clorox Company Agent de nettoyage en aerosol pour moquette
US6562296B1 (en) 1997-10-08 2003-05-13 Chemische Fabrik Dr. Weigert Gmbh & Co. Kg Process for cleaning surgical instruments
US6235692B1 (en) 1998-08-26 2001-05-22 Cottrell International, Llc Foaming enzyme spray cleaning composition and method of delivery
US6387858B1 (en) 2000-03-31 2002-05-14 Steris Inc. Safe transport gel for treating medical instruments
US20050079097A1 (en) 2002-01-28 2005-04-14 Petra Tiarks Cleaning and disinfection of surgical and medical instruments and appliances
EP1839681A1 (fr) 2006-03-31 2007-10-03 Ethicon, Inc. Traitement par mousse de peroxyde d'hydrogène
EP1935366A1 (fr) 2006-12-22 2008-06-25 Ethicon, Inc Récipient de suivi d'instrument et procédé
US20090197790A1 (en) 2008-02-05 2009-08-06 Amcol International Corporation Drip resistant cleaning compositions
US20120316097A1 (en) 2010-02-23 2012-12-13 Lion Corporation Detergent for metal

Non-Patent Citations (9)

* Cited by examiner, † Cited by third party
Title
"Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten", BUNDESGESUNDHEITSBLATT, vol. 55, 2012, pages 1244 - 1310, XP055759057
"Comprehensive guide to steam sterilization and sterility assurance in health care facilities", AMERICAN NATIONAL STANDARD - ANSI/AAMI ST79:2017, 1 January 2017 (2017-01-01), pages 1 - 185, XP055919052
ANONYMOUS: "Instrumente werterhaltend aufbereiten. Instrumente werterhaltend aufbereiten, 10. Ausgabe", ARBEITSKREIS INSTRUMENTENAUFBEREITUNG - BROSCHÜRE, 1 January 2012 (2012-01-01), XP093133166, Retrieved from the Internet <URL:https://www.aestheticliner.de/wp-content/uploads/2023/08/aesthetic-liner-services-instrumenten-aufbereitung-werterhaltend-aki-broschuere.pdf> [retrieved on 20240220]
DR WEIGERT: "neodisher MA Détergent poudre alcalin moyen Pour une utilisation en laveur désinfecteur", 1 February 2005 (2005-02-01), XP055758977, Retrieved from the Internet <URL:https://www.drweigert.com/com/uploads/tx_product_manager/downloads/product/dataSheet/neodisher-MA_MB_fr_PN4107_2005-02-01.pdf> [retrieved on 20201210] *
DR. WEIGERT: "neodisher ® MA - Détergent poudre alcalin moyen Pour une utilisation en laveur désinfecteur", 1 February 2005 (2005-02-01), XP055758977, Retrieved from the Internet <URL:https://www.drweigert.com/com/uploads/tx_product_manager/downloads/product/dataSheet/neodisher-MA_MB_fr_PN4107_2005-02-01.pdf>
FALBE ET AL.: "Roempp Chemie Lexikon, 9. Auflage", 1 January 1989, pages: 65, 66, 4014, 4252 - 4255, XP055919081
NSS HEALTH FACILITIES SCOTLAND: "Decontamination of medical devices (surgical instruments) ", GUIDANCE FOR SERVICE USERS - GUID 5017, SUPPLEMENT TO SHTM 01-01 DECONTAMINATION OF MEDICAL DEVICES IN A CENTRAL DECONTAMINATION UNIT, 1 September 2018 (2018-09-01), pages 1 - 18, XP055919055, Retrieved from the Internet <URL:https://www.nss.nhs.scot/media/1556/shtm-01-01-guid-5017-v10-sep-2018.pdf>
SWISSMEDIC: "Gute Praxis zur Aufbereitung von Medizinprodukten - Für Gesundheitseinrichtungen, die Medizinprodukte aufbereiten", 1 November 2016 (2016-11-01), XP055919046, Retrieved from the Internet <URL:https://oegsv.com/wp/wp-content/uploads/Gute-Praxis-zur-Aufbereitung-von-Medizinprodukten-2016-D.pdf>
SWISSMEDIC: "Gute Praxis zur Aufbereitung von Medizinprodukten in Arzt-und Zahnarztpraxen sowie bei weiteren Anwendern von Dampf-Klein-Sterilisatoren", ANLEITUNG KIGAP, VERSION 1.0D, 1 April 2010 (2010-04-01), pages 1 - 38, XP055919041, Retrieved from the Internet <URL:https://www.kantonsapotheker.ch/fileadmin/docs/public/kav/2_Leitlinien___Positionspapiere/KIGAP.pdf>

Also Published As

Publication number Publication date
EP2746375A1 (fr) 2014-06-25
ES2894603T3 (es) 2022-02-15
PL2746375T3 (pl) 2022-02-14
HUE056796T2 (hu) 2022-03-28

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