WO2010134826A1

WO2010134826A1 - Methods and apparatus for providing traceability and for validating sterilisation equipment and processes

Info

Publication number: WO2010134826A1
Application number: PCT/NZ2010/000020
Authority: WO
Inventors: Christo Andre De Klerk; Terry Dean Kemp
Original assignee: Mercer Technologies Limited
Priority date: 2009-02-13
Filing date: 2010-02-12
Publication date: 2010-11-25

Abstract

In a first method a sterilisation identification code is correlated with items to be sterilised by reading an identification code associated with a sterilisation bag and writing the identification code to an electronic identification tag associated with the sterilisation load. In a second method a sterilisation bag is validated by applying an identification feature to a sterilisation bag, reading the identification feature before a sterilisation process and checking the identification feature against a database of valid identification features. If the code is valid the bag is processed and if not processing is inhibited. In a third method the effective sterilisation of a sterilisation load is validated by recording sterilisation information for a sterilisation process in association with a unique identification code of a processed sterilisation bag. Processing apparatus and a sterilisation services system are also disclosed.

Description

METHODS AND APPARATUS FOR PROVIDING TRACEABILITY AND FOR VALIDATING STERILISATION EQUIPMENT AND PROCESSES

FIELD OF THE INVENTION

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. In one embodiment 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.

BACKGROUND OF THE INVENTION

The applicants prior application published as WO2007/055595 discloses a sterilisation method and apparatus in which items to be sterilised may be sterilised within a plastic bag whilst the exterior of the sterilisation bag is maintained at atmospheric pressure. The disclosure of this application is hereby incorporated by reference.

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.

The chance of spreading diseases must be kept as low as possible, hospital acquired infection is clearly the last thing either a patient or the hospital wants. The most common and proven method used for sterilisation is 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.

The practices around sterilisation are under continuous scrutiny, much debate and research especially over the past decade has resulted in numerous standards being introduced internationally. The one major area of debate has been around patient safety with direct reference to the sterility of instruments at point of use in the operating theatre. Once sterile, the sterility of an instrument is dependent on the sterile barrier system and safe handling of the instrument between the steriliser/autoclave and point of use.

Never before has sterile processing facilities been under more pressure to reprocess surgical instruments more quickly, efficiently and safely - and to prove that they have done so. Throughput logistics of a steriliser dictates more than one pack or load per sterilisation process (cycle). Typically a steriliser will be measured in sterile units

(StU's) and all standard procedures and processes are subjected to these parameters. In fact all sterilisation processes must be validated especially with respect to the load characteristics.

Traditional sterilisation practice is built on a basis of batch and queue. Unfortunately the many variables with respect to load specifics, configuration, sterile barrier application, sterile operator actions plus the handling and transport logistics presents ever changing challenges to standardised operating procedures. In fact it has been determined that; "Cause of most outbreaks from contaminated medical-surgical devices not following standard processes for sterilisation and disinfection." Source: US Centers for Disease Control and Prevention (CDC).

With the rapid development of information technology hardware and software, the technology is now available to individually code most medical devices and this will contribute substantially to the correct identification and tracking of individual devices. Unfortunately technology surrounding sterilisation has lagged behind and sterilisation of individual devices or single instrument trays is not normally standard operating practice, therefore no sterilisation assurance program at individual tray or device level is possible.

Standard operating processes followed for the sterilisation of multiple loads (trays) per sterilisation process is affected by many factors applicable to load dynamics, steriliser function and human actions. Unfortunately human action is normally blamed for failures associated to sterilisation practices but it must be noted that each sterilisation process is a unique event.

A deficiency in any of the variables necessary for effective sterilisation can result in a non-sterile device(s) when the absolute outcome must be a sterilised/sterile device. For this reason sterilisation of multiple loads of devices per sterilisation process is not the optimum process 'to do the right thing'. Standards recommend that each sterilisation process should be validated (identical load configuration and placement which is not normally practical in a busy sterile services department/facility). No two load configurations are identical, typically trays/packs are loaded in different locations in a steriliser chamber and contribute towards poor loading techniques, packs are poorly packed or too large or dense/heavy for the cycle parameters and the result may be poor air removal from the packs, poor steam penetration and the entire load may inadvertently not be processed/sterilised.

A recent online survey found that the biggest cause of error in the instrument processing system can be attributed to people problems - 65% human error. At the

World Congress of Sterilisation (2008) - a presentation by Gina Pugliese, RN, MS highlighted the following:

• To err is human - we all make mistakes

• Learn from error and "near miss" and use to improve the process • Focus on system not the worker

• Determine how a system redesign could reduce risk and make the changes • Create an environment to make it easy to do it right and difficult to make a mistake

The goal therefore must be to change the process to make it easy to do the right thing and hard to do the wrong thing.

How to create a culture of safety that focuses on system redesign - to prevent errors and improve patient safety must be the objective. 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.

It is clear to those skilled in the art of sterilisation of an item(s) in a consistent, reproducible and recordable manner that this goal is made virtually impossible due to the multiple variables faced by sterilisation practitioners daily, predominantly as a result of current technology and processes available to sterilisation practitioners. In addition two seemingly conflicting concerns exist - providing quality patient outcomes and reducing operating budgets.

In fact numerous patient associations have been calling on healthcare providers to adopt modern electronic data capture systems to allow individual medical devices to be tracked as they move around hospitals and external sterile services facilities.

In the opinion of the inventors there are solutions that can simultaneously offer improved patient outcomes, improved efficiency and lower costs - the solution lies within the foundation of quality control through effective process flow and control.

Process flow can either support or hinder outcomes and sterilisation services have not yet realised all the benefits from implementing process improvement practices.

Rising standards and growing expectations on patient safety demands that best practices be employed. Process improvement is best served by implementing production methods and technologies that can offer standardised, reproducible and quality outcomes utilising processes and technologies that make it difficult to make mistakes.

It is an object of the invention to provide improved 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 or to at least provide the public with a useful choice.

SUMMARY OF THE INVENTION

According to a first embodiment there is provided 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.

According to a further embodiment there is provided 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.

According to a further embodiment there is provided 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.

If a failure is recorded during a sterilisation step then further processing for the failed unique identification code may be inhibited. 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.

According to a further embodiment there is provided 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.

According to a still further embodiment there is provided 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.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described by way of example with reference to the accompanying drawings in which:

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; and

Figure 7 shows a sterilisation services apparatus.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION

In response to the challenges encountered by those skilled in the art, from the following description it will be evident that the requirements below are desirable:

Enabling sterilisation

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.

Compatible with the sterilisation process The process in combination with a sterile services apparatus and package

(sterilisation bag) will ensure compatibility of the sterilisation process parameters in adherence to international standards.

Ensure product integrity and patient safety The sterilisation process flow will not affect the quality of the article(s) or contribute towards endangering the patient or process on which the sterile article(s) will be used, subject to the article(s) to be processed being rated for the sterilisation parameters. Maintaining Sterility

After successful completion of the sterilisation process flow the load will remain sterile during handling, transportation and storage until use, whilst process flow is adhered to and package seal integrity is intact.

Packaging authentication

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.

Tracking and traceability

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.

In the preferred form of the invention the process (Figurei) will also provide or facilitate the following:-

An intelligent Pack Station (Figure 2) with four (4) clearly defined zones.

Zonei (Figure 3)

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.

Zone 2 (Figure 3) (Optionally) wrap the load/tray and lid containing the load with a porous wrap.

Zone 3 (Figure 3)

Take package (plastic bag) from feed magazine. Slide bag over the bag spreader jig to open the load-end. Slide tray into the opened bag. (Optionally authenticate bag at this point) Zone 4 (Figure 3)

Present open load-end of plastic bag to the authentication / sealing device. The plastic bag is fitted with a tamperproof label incorporating the authentication media and a controlled serialised unique identification mark (UIM) and the label is checked for the covert nano-code or similar authentication. On authentication fail - reject of the plastic bag the plastic bag/load must be returned to Zone 3 for repacking.

On pass - 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). On 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.

Read the current UIM (from previous load) from the tray RFID tag and finalise the record in the DC/S. Associate the new UIM (from the current bag label) with the tray RFID tag.

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 (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.

On pass - initiate start of sterilisation process. UIM is stored as process 'Batch ID'.

End of Cycle...

If sterilisation cycle has failed for whatever reason then bag is not sealed. The SSA will provide a visual display of process fail. UIM record is updated as a failed load at DC/S. Return package to Zone 3 for repackaging.

On pass - Seal bag in partial vacuum within the SSA.

(Optionally) print cycle parameters and data on SSA local panel printer. Store cycle record against UIM in SSA database. Transfer copy of cycle record to DC/S UIM record.

Open door and visually inspect seal and vacuum integrity.

In further embodiments the process provides the following:

Transport. (Figure 3 & 1)

Remove the vacuum-sealed package from the processing carrier and transfer to the transport carrier. Transport to Sterile Store. On exit from the CSSD area RFID tag UIM within the terminally sterilised load/package is automatically read. The DC/S record is checked and the package location status is updated. If an invalid UIM is detected an alarm is indicated. On entry into the Sterile Store area the RFID tag UIM is automatically read. The DC/S record is checked and the package location status is updated. Details are pushed to the Hospital Inventory Management System. If an invalid UIM is detected an alarm is indicated. Dispatch (Figure 1)

On selection of package from Theatre Picking List the package is taken from the Sterile Store. On exit from the store the RFID tag UIM is automatically read and the DC/S UIM record location and status is updated. If the package has expired an alarm is indicated.

Theatre (Figure 1 )

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.

After the surgical process the used items are returned to the tray and transported back to the decontamination area of the sterile services department (SSD). On exit from theatre the tray RFID tag UIM is automatically read. The DC/S package location status is updated.

Decontamination (Figure 1 )

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.

Referring now to figures 5 to 7 apparatus for performing the invention will be described. Figure 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. When a sealing operation is initiated a reader 7 reads an identification feature 8 associated with the bag. There may be one or more identification features. 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).

In this way items to be sterilised may only be sealed within a valid sterilisation bag and the unique identification code assigned to the bag may be written to an electronic identification device to facilitate further tracking utilising the electronically readable electronic identification device 10. The opening 12 at the other end of bag 2 is narrow and so cage 3 cannot be removed without opening the bag.

Referring now to Figure 6 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.

Referring now to Figure 7 a sterilisation system including the bag sealing unit 1 and sterilisation services apparatus 13 shown in Figures 5 and 6 is shown. In this embodiment 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. The arrangement is purely exemplary and it will be appreciated that the layout will vary depending upon the environment the system is employed in. 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.

In use 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. 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. Upon successful sealing 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.

Again 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.

It will be seen that a process is provided with checks to ensure that only a properly processed package may ultimately be used. The integrity of the package prevents tampering or contamination without detection (if breached the bag will not adhere to the cage). The novel process flow along and technologies employed greatly reduce the risk of error. Authentication, unique identification serialisation and RFID technology, used in a redundant/complementary strategy incorporating an impervious sealable packaging (plastic bag) device as the means of sterilisation.

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.

More particularly 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 flow through the predetermined steps and gates has a "doing it right" best practices approach offering a methodology whereby the progress can be controlled, measured and tracked because what gets measured gets done right.

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.

The controlled (pass/reject) automated methodology and standardised operating process per load/pack to facilitate sterilisation and the broader RFID based traceability of the individual loads complete logistics life cycle (SSD to Theatre and back) offers a substantial improvement over current practices.

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.

The invention as described herein is open to modification as will be appreciated by those skilled in the art. For example, rather than performing as a process flow for sterilisation the process flow could be used for retort or food cooking but not limited to only these applications.

Other modifications and improvements to the invention will be apparent to the skilled person and will fall within the scope of the invention as it is intended.

While the present invention has been illustrated by the description of the embodiments thereof, and while the embodiments have been described in detail, it is not the intention of the Applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details, representative apparatus and method, and illustrative examples shown and described.

Claims

WHAT WE CLAIM IS:-

1. 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 with an electronic identification tag associated with the load.

2. A method as claimed in claim 1 wherein the electronic identification tag is incorporated with the load within the sealed sterilisation bag.

3. A method as claimed in claim 1 or claim 2 wherein the identification code is written to the electronic identification tag.

4. A method as claimed in any one of the preceding claims wherein the electronic identification code is applied to the bag in the form of a tamper resistant label.

5. 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.

6. A method as claimed in claim 5 wherein the authentication feature is read prior to a bag sealing operation and sealing is prevented if the authentication feature is invalid or absent.

7. A method as claimed in claim 5 or claim 6 wherein the identification feature identifies the type of sterilisation bag.

8. A method as claimed in claim 5 or claim 6 wherein the identification feature is a unique code uniquely identifying the bag.

9. 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.

10. A method as claimed in claim 9 wherein if a failure is recorded during a sterilisation step then further processing for the failed unique identification code is inhibited.

11. A method as claimed in any one of claims 9 to 10 wherein the unique identification code is read and associated with or written to an electronic identification tag associated with the sterilisation load.

12. A method as claimed in claim 11 wherein the electronic identification tag is an RFID tag.

13. A method as claimed in claim 11 or claim 12 wherein a sterilisation apparatus reads the electronic identification tag before a sterilisation step and is inhibited from performing the sterilisation step if the unique identification code has a failure associated with it.

14. 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.

15. Processing apparatus as claimed in claim 14 including a communication device for obtaining information associated with the identification code stored remotely from the apparatus.

16. Processing apparatus as claimed in claim 14 or claim 15 wherein the apparatus is a bag sealing apparatus.

17. Processing apparatus as claimed in claim 14 or claim 15 wherein the apparatus is a sterilisation services apparatus.

18. A sterilisation services system including:

a. a bag sealing apparatus as claimed in claim 16;

b. a sterilisation services apparatus as claimed in claim 17; and

c. a database, wherein the bag sealing apparatus and sterilisation services apparatus communicate with the database to communicate sterilisation information.

19. A system as claimed in claim 18 including 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.

20. A system as claimed in claim 18 or claim 19 including an input device in communication with the database enabling details of the items of a sterilisation load to be associated with an identification code.

21. A method as claimed in claim 12 wherein the electronic identification tag includes a chemical indicator.

22. A method as claimed in any one of claims 1 to 4 wherein the electronic identification tag is an RFID tag.