WO2010134826A1 - Procédés et appareils destinés à assurer la traçabilité et à valider un équipement et des opérations de stérilisation - Google Patents

Procédés et appareils destinés à assurer la traçabilité et à valider un équipement et des opérations de stérilisation Download PDF

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Publication number
WO2010134826A1
WO2010134826A1 PCT/NZ2010/000020 NZ2010000020W WO2010134826A1 WO 2010134826 A1 WO2010134826 A1 WO 2010134826A1 NZ 2010000020 W NZ2010000020 W NZ 2010000020W WO 2010134826 A1 WO2010134826 A1 WO 2010134826A1
Authority
WO
WIPO (PCT)
Prior art keywords
sterilisation
bag
identification code
load
identification
Prior art date
Application number
PCT/NZ2010/000020
Other languages
English (en)
Inventor
Christo Andre De Klerk
Terry Dean Kemp
Original Assignee
Mercer Technologies Limited
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 Mercer Technologies Limited filed Critical Mercer Technologies Limited
Publication of WO2010134826A1 publication Critical patent/WO2010134826A1/fr

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Classifications

    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q30/00—Commerce
    • G06Q30/06—Buying, selling or leasing transactions
    • G06Q30/0601—Electronic shopping [e-shopping]
    • G06Q30/0603—Catalogue ordering
    • 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour

Definitions

  • the present invention relates to methods and apparatus for providing traceability of sterilised items and recordal of the sterilisation process employed as well as methods and apparatus for validating sterilisation equipment and processes.
  • an identification feature associated with a sterilisation bag may require authentication for the bag to be processed in sterilisation equipment.
  • a unique code may be associated with each sterilisation load to enable traceability of the load, the sterilisation process and its location.
  • Sterilisation is an absolute necessity for various industries typically health care, laboratory, pharmaceutical and food processing industries. In a healthcare facility it is necessary that all equipment and materials used for treating patients are absolutely safe for use, the chance of spreading diseases should be kept as small as possible. As is well known, articles used in the operating room, such as surgical instruments, must be sterilised before and after each use.
  • sterilisation by pressurised high temperature steam in a pressure chamber or vessel for a prescribed period of time. Pressurised high temperature steam within a stainless steel pressure chamber is the preferred method for sterilisation of laboratory equipment and in the industrial manufacturing and healthcare sectors.
  • Gina Pugliese further recommends that we "Need to standardise the process” - Simplify, Automate, Reduce Reliance on Vigilance. Redesign with “forcing functions” making it impossible to do it wrong.
  • Process flow can either support or hinder outcomes and sterilisation services have not yet realised all the benefits from implementing process improvement practices.
  • a method of correlating a sterilisation identification code with a load to be sterilised including the steps of: a. reading an identification code associated with a sterilisation bag; and b. associating the identification code to an electronic identification tag associated with the load.
  • the identification tag may be an RFID tag incorporated with the item(s) to be sterilised within the sealed sterilisation bag or be applied to the bag in the form of a tamper resistant label, or both.
  • the identification code may be associated with the electronic identification tag in a database or by writing the identification code to the electronic identification tag.
  • a method of validating a sterilisation bag including the steps of: a. applying an identification feature to a sterilisation bag; b. reading the identification feature before a sterilisation process; c. checking the identification feature against a database of valid identification features; and i. if valid, processing the contents of the bag; or ii. if invalid, inhibiting processing of the contents of the bag.
  • the authentication feature may be read prior to a bag sealing operation with sealing prevented if the authentication feature is invalid or absent.
  • the identification feature may identify the type of sterilisation bag and/or be a unique code uniquely identifying the bag.
  • a method of validating the effective sterilisation of a sterilisation load including the steps of: a. enclosing the sterilisation load in a sterilisation bag having a unique identification code; and b. reading the unique identification code during a sterilisation process; and c. recording sterilisation information for the sterilisation process and storing it in association with the unique identification code.
  • the unique identification code may be read and written to an identification tag, such as a RFID tag, associated with the sterilisation load.
  • a sterilisation services apparatus may read the unique identification code before a sterilisation step and inhibit it from performing the sterilisation step if the unique identification code has a failure associated with it.
  • a processing apparatus including a reader for reading an identification code associated with a sterilisation load, and a controller for controlling the operation of the apparatus wherein before performing a process the controller must read an identification code associated with a sterilisation load and confirm that information associated with the identification code permits processing of the sterilisation load.
  • the processing apparatus may include a communication device for obtaining information associated with the identification code stored remotely from the apparatus.
  • the processing apparatus may be a bag sealing apparatus or a sterilisation services apparatus.
  • a sterilisation services system including: a. a bag sealing apparatus; b. a sterilisation services apparatus; and c. a database, wherein the bag sealing apparatus and sterilisation services apparatus communicate with the database to communicate sterilisation information.
  • the system may include readers positioned to read identification codes associated with sterilisation loads and communicate read information to the database to enable the location of sterilisation loads to be monitored and an input device in communication with the database enabling details of the items of a sterilisation load to be associated with an identification code.
  • Figure 1 shows a flow diagram of the processing of a sterilisation load
  • Figure 2 shows a flow diagram of a pack station sequence
  • Figure 3 shows a flow diagram of a sterilisation process
  • Figure 4 shows a flow diagram for operation of sterilisation services apparatus
  • Figure 5 shows a bag sealing apparatus
  • Figure 6 shows a sterilisation services apparatus
  • Figure 7 shows a sterilisation services apparatus.
  • the process flow will enable sterilisation through predetermined, controlled and reproducible steps, replacing the dependency on the difficult to implicate standard operating procedures associated with batched based sterilisation and questionable breathable sterile barrier system technologies.
  • the process flow requires authentication of the packaging prior to sterilisation of article(s) to ensure an authenticated and validated package and reproducible sterilisation outcome.
  • the process flow shall incorporate package and load tracking by means of a label incorporating a unique identification marking to ensure a reproducible and controlled process flow with tracking and traceability of individual loads.
  • Load is received from 'Pick and Pack' area. Enter details of load and contents into the Data Capture/Storage (DC/S) system via barcode reader / keyboard or similar.
  • DC/S Data Capture/Storage
  • Zone 2 ( Figure 3) (Optionally) wrap the load/tray and lid containing the load with a porous wrap.
  • Zone 4 ( Figure 3)
  • the authentication / sealer device seals the open load-end of the package/plastic bag.
  • the seal parameters checked against predetermined criteria (Optionally - the seal is checked for integrity via a camera or pressure test).
  • seal check fail - reject the package is returned to Zone 3 for re-packing.
  • On pass - read the UIM (2D data matrix) on label and create a new record in the DC/S. Save the seal check data to the UIM record.
  • Transport ( Figure 3) Transport the packaged load to the sterilisation services apparatus (SSA) or alternatively place the packaged load into a transport carrier and transport to the SSA device.
  • SSA sterilisation services apparatus
  • SSA Figure 3 & 4 Open the door of the SSA. Slide out the process carrier from within the SSA compensator. Place packaged load into process carrier and fit the process snorkel into the open neck of the package. Adjust over the clamp / seal bar. Slide the process carrier into the SSA and check correct snorkel fitment. Close door. Start Process. The SSA will read the UIM and confirm validity from the DC/S. On fail - reject of the package, open door and invalidate UIM record on DC/S. Return package to Zone 3 for repackaging.
  • the RFID tag UIM On entry into the operating theatre the RFID tag UIM is automatically read and the DC/S UIM record location and status is updated. The details are pushed to the Hospital Patient Billing System.
  • the package is aseptically opened in theatre at point of use and the plastic bag and wrap disposed of.
  • the used items are returned to the tray and transported back to the decontamination area of the sterile services department (SSD).
  • SSD sterile services department
  • the tray RFID tag UIM is automatically read.
  • the DC/S package location status is updated.
  • the RFID tag UIM On entry into the decontamination area of the SSD the RFID tag UIM is automatically read and the DC/S UIM record location and status is updated. Further location updates may be performed by the washer decontaminator machines.
  • the process flow shall not be limited to the preferred embodiment and may take the form of a non-networked stand-alone system and may take the form of functioning over multiple SSA's respectively in either/or a single or multiple sites.
  • FIG. 5 shows a sterilisation bag sealing apparatus 1 with a sterilisation bag 2 loaded.
  • a perforated cage 3 containing items to be sterilised has previously been inserted into an open end 4 of sterilisation bag 2 and the ends of bag 2 adjacent end 4 have been placed between sealing bars 5 and 6 of the sealing apparatus.
  • a reader 7 reads an identification feature 8 associated with the bag.
  • An identification feature may be in the form of a covert marking such as an invisible marking or a physical feature of the material used etc. Such covert markings may be used to validate the bag or may represent a unique identification code.
  • a unique identification code may also be applied in the form of a tamper proof bar code 10 or other similar unique marking technique.
  • Controller 9 may store information to enable local validation of an identification feature or it may communicate with a remote database (see Figure 7) to validate an identification feature (particularly a unique identification code). Heat-sealing of the bag 2 by sealing bars 5 and 6 may only be allowed if any identification feature (unique identification code or covert marking etc.) is validated. If an identification code is validated it may be written to an electronic identification device 10, such as an RFID device, by RFID writer 11. Alternatively the unique identification code may be associated with an identification code of electronic identification device 10 in a database (such as database 39 in figure 7).
  • a sterilisation services apparatus 13 is shown.
  • a sterilisation bag containing items to be sterilised is placed within a tray 15 inside chamber 14 and door 16 may then be closed.
  • a snorkel 17 supplying sterilant to bag 2 is inserted into opening 12 of bag 2.
  • An RFID reader/writer 18 interrogates RFID tag 10 when a user initiates a sterilisation cycle.
  • the unique identification code read by RFID reader/writer 18 is supplied to controller 19 which may validate the identification using an internal database or communicate via network 20 to a remote database 21 to validate the identification code. Only if the code is validated may a sterilisation process commence.
  • Sensors 22 and 23 may measure temperature and pressure or other process parameters which may be recorded for a sterilisation process and be stored in remote database 21. Additionally process information may be written to RFID tag 10 by RFID reader/writer 18.
  • the RFID tag 10 may be a disposable RFID tag and may be provided in combination with a chemical indicator.
  • the chemical indicator may change colour to indicate that a required sterilisation process has been performed and its state may be visually observed through the walls of transparent bag 2.
  • FIG. 7 a sterilisation system including the bag sealing unit 1 and sterilisation services apparatus 13 shown in Figures 5 and 6 is shown.
  • the system is located within interconnected rooms consisting of decontamination room 24, packing room 25, sterilisation room 26, storage room 27 and operating room 28.
  • RFID readers 29 to 34 are provided at doorways to read packages 2 as they pass through each doorway and provide the identification code read from RFID tag 10 to computer 35.
  • Sealing unit 1 and sterilisation services unit 13 likewise communicate with computer 35 (although wired connections are shown wireless connections may be employed).
  • Computer 35 may communicate via network 38 with database 39 that stores valid identification code numbers for sterilisation bags.
  • a returned cage 3 and items to be sterilised pass by reader 29 and the RFID tag associated with each cage 3 is read and its unique identification code is passed to computer 35 and on to database 39. Decontamination and cleaning of items and cages is then performed in decontamination room 24. A cage and items to be sterilised may be transferred from room 24 to room 25 for packing. Again the unique identification code is read by reader 30 and the code passed to database 39. Desired items may be packed in a cage in room 25 and placed within a bag-sealing unit as shown in Figure 5. Validation of the bag is as previously described with bag sealing unit 1 communicating with computer 35 and database 39 to validate the bag and provide processing information relating to the sealing operation to database 39.
  • the bag If the bag is invalidated this information is passed to database 39 and the bag cannot be further processed. In this case the bag will need to be removed and processing must recommence.
  • the package 2 may be transferred from room 25 to room 26 for sterilisation. Again the unique identification code is read by reader 31 and the code passed to database 39.
  • Sterilisation services apparatus 13 operates as previously described to validate a sterilisation bag, the sterilisation process and record sterilisation parameters. This information is communicated to database 39 via computer 35. If at any stage the identification code is invalidated the sterilisation process cannot be continued. Upon successful sterilisation the package 2 may be transferred from room 26 to room 27 for storage. Again the unique identification code is read by reader 32 and the code passed to database 39. When required the package 2 is transferred to theatre 28.
  • the unique identification code is read by reader 33 and the code passed to database 39.
  • the package may then be opened and the items used.
  • the unique identification code is read by reader 34 as the cage containing the items is returned to room 24 to recommence the process and the code passed to database 39.
  • the proposed process is focussed on the customer and creating a specific value stream with quality and reduced lead-time in the optimised flow.
  • the process flow is an operational road map with predetermined sets of steps, each serves as the quality control and pass/reject check point in the process.
  • the invention relates to a validation friendly method and standardised operating process flow to facilitate sterilisation through predetermined steps offering traceability at load level, replacing the dependency on the difficult to implicate standard operating procedures associated with batched based sterilisation and questionable breathable (porous) sterile barrier system technologies.
  • the process provides smart process control, intelligent process tracking with accurate traceability offering substantial benefits over existing batch and paper based systems totally dependent on old technologies and manual human actions.
  • Processing and controlling the sterilisation parameters of an individual load/tray now offer the industry the means to implement an accurate sterilisation assurance program per tray built on the foundation of an intelligent sealed impervious sterile package (absolute sterile barrier system) and subject to the individual instruments being marked traceability can be extended with certainty down to instrument level.

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  • Health & Medical Sciences (AREA)
  • Business, Economics & Management (AREA)
  • Accounting & Taxation (AREA)
  • Finance (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Marketing (AREA)
  • Theoretical Computer Science (AREA)
  • Engineering & Computer Science (AREA)
  • General Physics & Mathematics (AREA)
  • General Business, Economics & Management (AREA)
  • Physics & Mathematics (AREA)
  • Strategic Management (AREA)
  • Economics (AREA)
  • Development Economics (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

Dans un premier procédé, un code d'identification de stérilisation est mis en corrélation avec des éléments à stériliser en lisant un code d'identification associé à un sac de stérilisation et en écrivant le code d'identification sur une étiquette électronique d'identification associée à la charge de stérilisation. Dans un deuxième procédé, un sac de stérilisation est validé en appliquant un élément d'identification sur un sac de stérilisation, en lisant l'élément d'identification avant une opération de stérilisation et en vérifiant l'élément d'identification dans une base de données d'éléments d'identification valides. Si le code est valide, le sac est traité; sinon, le traitement n'est pas autorisé. Dans un troisième procédé, la stérilisation effective d'une charge de stérilisation est validée en enregistrant des informations de stérilisation d'une opération de stérilisation en association avec un code d'identification unique d'un sac de stérilisation traité. L'invention concerne également des appareils de traitement et un système de services de stérilisation.
PCT/NZ2010/000020 2009-02-13 2010-02-12 Procédés et appareils destinés à assurer la traçabilité et à valider un équipement et des opérations de stérilisation WO2010134826A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
NZ57491209 2009-02-13
NZ574912 2009-02-13
NZ574911 2009-02-13
NZ57491109 2009-02-13

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WO2010134826A1 true WO2010134826A1 (fr) 2010-11-25

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2518239A (en) * 2013-09-17 2015-03-18 Tristel Plc Decontamination System
WO2016026866A1 (fr) * 2014-08-18 2016-02-25 CLINARIS Process Management GmbH Système de surveillance et de validation de la préparation hygiénique de supports de patient mobiles
US20160210548A1 (en) * 2015-01-21 2016-07-21 Covidien Lp Wirelessly detectable objects for use in medical procedures and methods of making same
US10595958B2 (en) 2008-10-28 2020-03-24 Covidien Lp Wirelessly detectable objects for use in medical procedures and methods of making same
DE102018125180A1 (de) * 2018-10-11 2020-04-16 Aesculap Ag Sterilisationsverpackung für Sterilgut mit Sensorvorrichtung und Sterilisationsverfahren mit aktiver Sterilisationsprozessanpassung
US10660726B2 (en) 2015-01-21 2020-05-26 Covidien Lp Sterilizable wirelessly detectable objects for use in medical procedures and methods of making same
US10722323B2 (en) 2009-11-23 2020-07-28 Covidien Lp Method and apparatus to account for transponder tagged objects used during medical procedures
US10874560B2 (en) 2015-01-21 2020-12-29 Covidien Lp Detectable sponges for use in medical procedures and methods of making, packaging, and accounting for same
US11213773B2 (en) 2017-03-06 2022-01-04 Cummins Filtration Ip, Inc. Genuine filter recognition with filter monitoring system

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US4514965A (en) * 1979-11-19 1985-05-07 Mitsubishi Rayon Company, Limited Apparatus for continuously packing medical appliances for sterilization
US6237604B1 (en) * 1999-09-07 2001-05-29 Scimed Life Systems, Inc. Systems and methods for preventing automatic identification of re-used single use devices
GB2381751A (en) * 2001-11-08 2003-05-14 Aaron Goodall Safety surgical sterilisation tool and system
US20030187586A1 (en) * 2002-03-29 2003-10-02 Katzenmaier Kevin R. Electronic management of sterilization process information
US20070094303A1 (en) * 2003-11-05 2007-04-26 Arthur Zwingenberger System for management of processed instruments
US20080024310A1 (en) * 2004-03-16 2008-01-31 Newage Industries, Inc. Tracking system for gamma radiation sterilized bags and disposable items
US20080030345A1 (en) * 2007-05-24 2008-02-07 Smith & Nephew, Inc. System and method for tracking surgical assets
US20080219899A1 (en) * 2005-09-15 2008-09-11 Germitec Medical Instrument Disinfecting System

Patent Citations (8)

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Publication number Priority date Publication date Assignee Title
US4514965A (en) * 1979-11-19 1985-05-07 Mitsubishi Rayon Company, Limited Apparatus for continuously packing medical appliances for sterilization
US6237604B1 (en) * 1999-09-07 2001-05-29 Scimed Life Systems, Inc. Systems and methods for preventing automatic identification of re-used single use devices
GB2381751A (en) * 2001-11-08 2003-05-14 Aaron Goodall Safety surgical sterilisation tool and system
US20030187586A1 (en) * 2002-03-29 2003-10-02 Katzenmaier Kevin R. Electronic management of sterilization process information
US20070094303A1 (en) * 2003-11-05 2007-04-26 Arthur Zwingenberger System for management of processed instruments
US20080024310A1 (en) * 2004-03-16 2008-01-31 Newage Industries, Inc. Tracking system for gamma radiation sterilized bags and disposable items
US20080219899A1 (en) * 2005-09-15 2008-09-11 Germitec Medical Instrument Disinfecting System
US20080030345A1 (en) * 2007-05-24 2008-02-07 Smith & Nephew, Inc. System and method for tracking surgical assets

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10595958B2 (en) 2008-10-28 2020-03-24 Covidien Lp Wirelessly detectable objects for use in medical procedures and methods of making same
US10722323B2 (en) 2009-11-23 2020-07-28 Covidien Lp Method and apparatus to account for transponder tagged objects used during medical procedures
GB2518239A (en) * 2013-09-17 2015-03-18 Tristel Plc Decontamination System
CN105473167A (zh) * 2013-09-17 2016-04-06 垂丝泰尔公开有限公司 用于净化医学设备项目净化以及跟踪净化过程的系统
US9433474B2 (en) 2013-09-17 2016-09-06 Tristel Plc System for decontaminating medical equipment items and tracking decontamination process
WO2016026866A1 (fr) * 2014-08-18 2016-02-25 CLINARIS Process Management GmbH Système de surveillance et de validation de la préparation hygiénique de supports de patient mobiles
US20160210548A1 (en) * 2015-01-21 2016-07-21 Covidien Lp Wirelessly detectable objects for use in medical procedures and methods of making same
US10660726B2 (en) 2015-01-21 2020-05-26 Covidien Lp Sterilizable wirelessly detectable objects for use in medical procedures and methods of making same
US10874560B2 (en) 2015-01-21 2020-12-29 Covidien Lp Detectable sponges for use in medical procedures and methods of making, packaging, and accounting for same
US11065081B2 (en) 2015-01-21 2021-07-20 Covidien Lp Sterilizable wirelessly detectable objects for use in medical procedures and methods of making same
US11213773B2 (en) 2017-03-06 2022-01-04 Cummins Filtration Ip, Inc. Genuine filter recognition with filter monitoring system
DE102018125180A1 (de) * 2018-10-11 2020-04-16 Aesculap Ag Sterilisationsverpackung für Sterilgut mit Sensorvorrichtung und Sterilisationsverfahren mit aktiver Sterilisationsprozessanpassung

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