2014 Reprocessing of Reusable Medical Devices in Health ......Reprocessing resources –equipment, personnel and accessories are sufficient for the workload. Control of documents and

Commissioned and Published by The New Zealand Sterile Sciences Association 2018

2014 Reprocessing of Reusable Medical Devices in Health Service Organisations

A S/ NZ S 4 187

SECTION 1

SCOPE AND GENERAL Clause Page(s) Description Compliance

Auditor Comments FA PA UA NA

Normative References 1.3 8-9 Normative references required for use with this standard are available.

Definitions 1.5 11-20 A list of definitions used in this standard is available for all staff to view and read.

FA = Fully attained PA = Unattained UA = Unattained NA = Not applicable



A S/ NZ S 4 187

SECTION 2

QUALITY MANAGEMENT Clause Page(s) Description Compliance


Policies and procedures 2.2.2 21 Documented policies and procedures in place for all reprocessing activities.

Records 2.2.3 22 Records of all reprocessing activities verify the processes that are carried out as documented.

Control of documents and records 2.2.4 22 All documents are stored in the designated area for the period of time defined by HSO Policy.

This period is aligned with NZ regulations.

All documents are available to staff and can be retrieved as required.

Management responsibility - general 2.3.1 23 The requirements of this standard are supported by the executive management group.

Service agreements are documented and reviewed at regular intervals.

Reprocessing resources – equipment, personnel and accessories are sufficient for the workload.

Control of documents and records 2.3.2 23 The required resources shall be provided by the HSO in order to:

a) Evidence is available to demonstrate the

implementation of AS/NZS4187 and the normative references.

b) A quality management programme is in place and

evidence of QI is available.

c) The requirements of customers are met.



d) There are sufficient staffing levels to maintain

continuous, efficient and safe operation.

SECTION 2



Control of documents and records continued

e) Conform with the necessary building, workspaces and associated utilities to achieve RMD reprocessing.

f) Reprocessing equipment purchased as appropriate for the intended purpose.

g) All buildings, process equipment, utilities and work

areas are maintained.

h) Supporting serviced are provided.

i) All staff carrying out reprocessing of RMDs have

completed an appropriate qualification in sterilising technology.

Reprocessing facility 2.3.3 23 The person responsible for the facility that reprocesses RMDs shall:

a) Have RMD reprocessing experience and qualifications.

b) Has the authority to implement the requirements of

this standard.

c) Ensure that the relevant policies and procedures are

documented and implemented reprocessing RMDs.

d) Has involvement in the day to day running of the

sterilising unit.

e) A formal orientation and education programme results

in competent staff.

Reprocessing facility continued f) RMD reprocessing personnel’s competencies are

reviewed regularly.

Equipment 2.3.4 24 a) HSO shall take into account the total time required for reprocessing RMDs as part of their operational planning and that there is sufficient supply of RMDs to meet the demand.


b) HSO shall ensure that there is sufficient reprocessing equipment available to meet the demand from customers.

2.3.5 24 For any reprocessing activities undertaken by an external contractor, HSO ensures that an agreement is in place outlining each parties responsibilities, including compliance with this standard.

SECTION 2



Product realisation 2.4 24

Purchasing 2.4.1 There are documented procedures for the purchasing of reprocessing equipment, RMDs and accessories:

a) The purchasing process includes risk based criteria for product selection and evaluation that includes health and safety workplace requirements.

b) The reprocessing facility manager being involved in the

process prior to the RMD purchase.

c) The purchasing process for RMD includes documented evaluation for compatibility to reprocessing systems available.

d) Purchasing criteria for reprocessing equipment requires compliance to safety and regulatory standards.

e) It is verified that the RMDs and RMD accessories are entered under Medsafe (NZ) and preferably ARTG (Australian Register of Therapeutic Goods.

f) Operational instructions are provided for use with

reprocessing equipment and RMD accessories.

Purchasing g) Validated reprocessing instructions complying to ISO 17664 are documented and available for RMD, trial and loaned RMDs.

h) Delivery acceptance criteria.

Identification and traceability of product 2.4.3 25


General 2.4.3.1 25 a) Procedures shall be available for the tracing and identification of all RMDs including those undergoing high level disinfection, loans and those on trial.

b) The traceability system of all RMDs shall enable the identification of a patient or patients whereby a non-conforming product has to be recalled.

Traceability records 2.4.3.2 25 a) For high level chemical disinfection of RMDs the processing records shall include:

SECTION 2



Traceability records continued i. The type of RMD being processed.

ii. The unique number identifying that particular item

such as a serial number.

iii. Unique identifier of the person doing the processing and the date that it occurred.

iv. Unique identifier of the person responsible for connecting the RMD to the AER or for manually immersing the RMD into the disinfectant.

v. The name or number of the specific automated

equipment that the RMD was processed in.

vi. Process cycle number and the date the RMD was

processed through the automated equipment.

vii. Other records that identify specific facts relating the to the specific cycle and the RMD being processed including the following:

A. Identification of the disinfectant used including type, batch number, manufacturers expiry date, date when opened / decanted, in-use expiry date and date for disposal.

B. Identification of the test strip, brand / type, batch number, manufacturers expiry date, date of opening test strips, in-use expiry date, date for


disposal, date of opening test strips, in-use expiry date, date for disposal, results upon opening of positive / negative controls, daily MRC or MRC check results, identification of person conducting positive and negative controls and identification of person conducting MRC check.

C. Record / printout of cycle process (paper or electronic), identification of self-disinfection cycles, water filter pressures, date of filter and chemical changes.

SECTION 2



Traceability records continued D. For manually immersing RMDs into disinfection, the temperature of the disinfectant, date and time of immersion, time removed from disinfectant, final rinse as per manufacturer’s instructions (both the chemical disinfectant the RMD).

viii. Attainment of process records are documented e.g. a

printout.

ix. Identification of the person who released the RMD

after processing.

26 b) Sterilising process records shall:

i. Process cycle number and the date of processing.

ii. Sterilisation identification number.

iii. RMD identification and quantity of each type of

RMD.

iv. Identification of the person who loaded the steriliser.

v. Other records:


A. Performance test results such as Leak Rate and

Bowie Dick tests.

B. Chemical and biological monitoring results.

C. Where appropriate, sterilising agent in use, batch number and expiry date.

vi. Process parameters attained are documented.

vii. Identification of the person who released the RMD

after processing.

Control of monitoring and measurement equipment

2.4.4 27

2.4.4.1 27 Monitoring and measuring equipment is calibrated at specified intervals traceable to national or international measurement standards; the HSO shall ensure that this happens.

SECTION 2



Control of monitoring and measurement equipment continued

External contractors using monitoring and measuring equipment shall ensue their equipment is calibrated at specified intervals to national or international measurement standards.

Calibration equipment shall be certified by the

certification body most suitable to do so.

Monitoring and measurement equipment shall:

a) Have calibration status identified.

b) Be adjusted or readjusted as necessary.

c) Be protected from adjustments that invalidated any

results.

d) Not be damaged through improper handling,

maintenance and storage.


Documentation 2.4.4.2 27 Calibration tests performed on each piece of monitoring and measuring equipment shall be documented including any adjustments made.

The certification number of the calibration device shall be included in the report.

Non conformance HSO shall take action if the equipment if found not to conform to requirements; actions taken should be documented.

Measurement, analysis and improvement 2.5 27

Audits 2.5.1 27 Requirements of this standard shall be confirmed through the use of regular audits; findings shall be documented and corrective actions implemented.

Actions shall be reviewed to ensure they are addressing the identified deficiencies.

Nonconforming RMD 2.5.2 27 The HSO shall have a risk assessment policy for nonconforming RMDs.

Corrective action 2.5.3.1 27 Corrective action for nonconforming RMDs shall include:

a) Nonconformity identification including user complaints

or concerns.

SECTION 2



Corrective action continued b) Action plan formulated and actioned.

c) Action taken is documented.

d) Evaluation of action(s) to verify effectiveness.

e) Additional actions are taken if further corrections are

required.

Recall procedure 2.5.3.2 Procedures for recall shall:

a) Have examples of when a recall of nonconforming RMD

may be warranted.

b) Identify that recalls should happen in a timely manner.

c) Identify who is responsible for the recall.


d) Identify who should be notified of recall.

e) Identify who is responsible for recalling distributed

RMDs.

f) Identify who is going to report on the recall activities.

g) Include the information that is critical and included in

the recall notice.

h) Reconcile the quantities of recalled RMDs with the

distributed RMDs.

Recall report 2.5.3.3 28 HSO Policy shall determine recall report and include:

a) Circumstances of the need for the recall are identified.

b) Recalled RMD is identified and quantities are

reconciled with the distribution records.

c) Any patients impacted by recall are identified.

d) Root cause analysis of the recall is identified.

e) Corrective action is identified.

f) Consequences of the recall are identified.

g) Recommendations to prevent another recall are

identified.

SECTION 2



Preventative action 2.5.4 29 a) Potential causes of nonconforming RMDs should be identified.

b) Action plan to prevent nonconforming RMDs should be

implemented.

c) Action(s) taken to prevent nonconforming RMDs are

documented.

d) Preventative actions are evaluated for effectiveness.

e) Further preventative actions are identified and

implemented if required.




A S/ NZ S 4 187

SECTION 3

TITLE Clause Page(s) Description Compliance


Cleaning agents 3.2 31 Documented specification for each cleaning agent in use is available from the manufacturer / supplier.

Evidence is available from the RMD manufacturer where the cleaning agent in use is not recommended by the RMD manufacturer.

Cleaning agents shall:

a) Be intended for use on RMDs.

b) Be compatible for selected method of cleaning and the RMDs being cleaned.

c) Be used and diluted according to manufacturer’s instructions.

d) Be compatible with the quality of the available water.

e) Be biodegradable – preferably.

f) At the in-use dilution is non-toxic.

g) Be non-abrasive.

h) Be low foaming.

i) Be free rinsing.

j) Be in liquid form – preferably.

Disinfectants 3.3 31 Disinfecting agents shall meet the following criteria:



a) High level instrument grade disinfectant is used for the disinfection of a semi-critical RMD.

SECTION 3



Disinfectants continued b) Intermediate or low level instrument grade disinfectant is used for the disinfection of a non-critical RMD.

c) Other classes of chemical disinfectants such, as hospital grade disinfectant, are not used for reprocessing and RMD.

Sterilising agents 3.4 32 Specification for each sterilising agent shall be obtained from the manufacturer.

It should identify the sterilising agent, active ingredients, shelf life and any necessary storage requirements from the manufacturer.

The reuse of the sterilising agent shall be included if permitted.

Microbiocidal effectiveness 3.5 32 Comprehensive documentation is available that shows the microbiocidal effectiveness of disinfectants and sterilising agents used for re-processing RMDs in HSOs.

Information is available in published literature or technical monographs and provided by the suppliers of the disinfectants and sterilising agents.

Where claims of microbiocidal effectiveness are made, the manufacturer of the agent is required to provide evidence of this claim.

HSO shall demonstrate effectiveness of the sterilising agent and disinfectants when they are used outside of the supplier’s range of conditions.

Reference to the appropriate standard shall be as and when required.

Effects on RMD materials 3.6 32 Cleaning agents, disinfectants and sterilising agents shall be compatible with the RMDs being processes and the equipment the RMD is processed through.


Information supplied by the RMD and equipment manufacturer shall be reviewed for compatibility and the effects on material.

SECTION 3



Effects on RMD materials continued HSO shall discuss the possible effects of repeated exposure to cleaning agents, disinfectants or sterilising agents when they are not consistent with the processing instructions provided by the manufacturer or supplier.

The outcome of those discussions shall be documented.

Personnel and environmental safety

Safety Information 3.7.1 33 For each cleaning agent, disinfectant and sterilising agent, a Safety Data Sheet (SDS) shall be obtained.

Annual checks should occur to ensure that each SDS is the most up to date copy.

Sufficient information about the sage use, handling and storage of the hazardous chemical shall be supplied by the HSO to workers and emergency service workers.

Environmental impact 3.7.2 33 Local, national and regional regulatory requirements shall be assessed on the impact to the environment from the use of chemical agents, disinfectants and sterilising agents.

Control measures brought about to mitigate the impact on the environment shall be established and documented in accordance with national and regional requirements.

Health and safety procedures 3.7.3 33 Procedures for the storage, handling, decanting and disposal of chemicals shall be written taking into account the manufacturer’s instructions, SDS and regulatory requirements.


All containers used for containment of chemicals shall be labelled with reference to health and safety legislation.

Health and safety training 3.7.4 33 Personnel involved in the handling and use of cleaning agents, disinfectants and sterilising agents shall be trained in the safe handling, the use, storage and wearing of PPE.


A S/ NZ S 4 187

SECTION 4

PROCESS & EQUIPMENT CHARACTERISATION Clause Page(s) Description Compliance


General 4.1 34 HSO shall:

Obtain specifications from the manufacturer of the

equipment.

Establish that the necessary services and infrastructure

to safely operate the equipment are available.

Ensure that the selected reprocessing equipment processes are compatible within the RMDs to be processed.

Process characterisation 4.2 34 Detailed specifications for the processes delivered by the cleaning agents, disinfectants and sterilising equipment shall be obtained by the HSO.

Information provided by the equipment manufacturer

shall include:

a) Detailed description of the process cycle.

b) Process parameters and tolerances.



c) Means of monitoring and controlling process

variable.

d) Measures that enable a failure in cleaning, disinfecting or sterilising processes being recorded as ineffective and not being effective.

e) Any treatment to the product prior to exposure to

the equipment.

f) Description of product families that can be safely

and effectively processed.

SECTION 4



Process characterisation continued g) Known restrictions or limitations of RMDs being processed.

h) Post process cycle treatment (if applicable).

Equipment characterisation 4.3 35

4.3.1 35 HSO shall obtain detailed specifications from the equipment manufacturer for all equipment used to deliver cleaning, disinfecting and sterilising processes.

Information provided by the equipment manufacturer

shall include:

a) Equipment description, necessary ancillary items

and materials of construction.

b) Cleaning agent, disinfectant or sterilising agent specifications and description of how they are delivered to the equipment.

c) Description of instrumentation used for controlling, monitoring and recording of processes relating to cleaning, disinfecting and sterilising including the locations of sensors.


d) Fault identification recognised by the equipment including how a failure to achieve process parameters is not recorded as effective.

e) Safety features details.

f) Installation requirements including those for control

of emissions from environment.

g) Software description used for monitoring or controlling processes including the validation demonstrating it meets the design intention.

h) Software changes that can affect operation of

reprocessing equipment shall be validated.

Controlling and monitoring software 4.3.2 35 Software shall be validated when it is used to control and / or monitor cleaning, disinfecting and sterilising processes.

SECTION 4



Controlling and monitoring software continued

Any changes to software that affects or can affect the operation of reprocessing equipment shall be validated.

Standards for reprocessing equipment 4.3.3 35 Equipment used to reprocess RMDs shall comply with

relevant standards:

a) Washer Disinfectors – ISO 15883.

b) Ultrasonic Cleaners – AS2773.1 or AS2773.2.

c) Drying Cabinets – AS2514.

d) Heat Sealers – ISO 11607-2 and ISO / DTS 16675-3.

e) Steam Sterilisers Large – EN285.

f) Steam Sterilisers Small – EN13060.

g) Dry Heat Sterilisers – ISO 20857.

h) Ethylene Oxide Sterilisers – EN1422.

i) Steam / Formaldehyde Sterilisers – EN14180.


j) Peracetic Acid Sterilisers – ISO14937.

k) Hydrogen Peroxide Gas / Plasma Sterilisers – ISO 14937.

l) Aeration Cabinets – ISO 25424 (steam formaldehyde) or

ISO 11135 (EO).

m) Endoscope Storage Cabinets – EN16442.

n) Biological Indicator Incubators – ISO 11138-1 or ISO

14161.



A S/ NZ S 4 187

SECTION 5

PRODUCT DEFINITION Clause Page(s) Description Compliance


General 5.1 37

5.1.1 37 RMD and processing equipment manufacturer’s

instructions for cleaning and disinfection are available.

There is evidence that the HSO has followed these

instructions.

Classification for reprocessing 5.1.2 Categorising and RMD is done according to Spaulding

Classification System.

RMDs are categorised according to intended use and

level of required reprocessing to render safe for reuse:

a) Critical.

b) Semi-critical.

c) Non-critical.

i. Using a validated moist heat sterilising process or a validated low temperature sterilising process, critical RMDs will be sterilised between uses on individual patients.

ii. Semi-critical RMDs shall be:

A. Using a validated moist heat sterilising process or a validated low temperature sterilising process, semi-critical RMDs will be sterilised between uses on individual patients or



B. A validated thermal disinfection process shall be used if a semi-critical RMD used on an individual patient is not able to be sterilised.

SECTION 5



Classification of reprocessing continued C. Semi-critical RMDs used on an individual patient and not suitable for processing through a thermal disinfecting process shall be processed through a high level chemical process.

iii. HSO shall define when a non-critical RMD shall be processed through a validated cleaning process and where necessary, a validated disinfecting process.

Policies and procedures 5.1.3 38 Policies and procedures shall be developed by the HSO for the reprocessing of RMDs, including the following:

a) Introduction of a new RMD, loan RMD or a returned RMD from repair. To be processed by a validated cleaning process at a minimum.

b) The processing of RMDs at a minimum to a validated cleaning and high level disinfection that require off site repair and maintenance.

c) The processing of loan or trial RMD to a validated cleaning and high level disinfection process prior to its release.

39 d) The full processing of RMDs that have been opened but

not used.

e) Critical medical devices shall be reprocessed to the highest level between patient uses. This includes devices whereby a sheath / sleeve / protective barrier is used.

f) Single use items past their expiry date and unused shall only be reprocess if permitted by the medical device manufacturer. Manufacturer’s instructions for the processing of the item shall be followed without fault.


Product families 5.2 39 RMDs can be classified into product families to assist with

the processing methods. Documentation should include:

a) Description of RMD, materials of constructions and

configuration.

SECTION 5



Product families continued b) Intended use of RMD.

c) Design and design characterisations of the RMD.

d) RMDs physical characteristics, mass, surface area and

thermal conductivity.

e) Method of packaging for the RMD and the SBS are to be

used.

Limiting values

53 40 The variables are specified identifying the limiting values that can affect each process (temperature, pressure, humidity and time etc).

The RMD and equipment manufacturers are consulted in identifying the limiting values that can affect the performance of their products.

Corrective action for each variable is identified and

documented.

Pre-disinfection and pre-sterilisation cleanliness of RMDs

5.4 40 The HSO shall ensure that the cleanliness of the RMD and its packaging (where applicable), presented for disinfection or sterilisation is controlled and shall not compromise the effectiveness of the process.

Not sure what this relates to??

Packaging system 5.5 40

General 5.5.1 40 Sterile barrier systems in use for terminally sterilised RMDs conforms with ISO 11607-1 and ISO 11607-2.

Compatibility 5.5.2 40 The sterile barrier systems used are compatible with the sterilising process used.


The sterile barrier systems used allow for air removal and penetration of the sterilising agent and removal of water vapour.

Protective packaging 5.5.3 40 The sterile barrier systems and its contents are protected by the protective packaging until point of use.

If applied prior to sterilisation, the protective packaging is compatible with the sterilising process.

Reprocessing Environment 5.6

SECTION 5



General 5.6.1 40 The physical environment and necessary equipment is provided by the SO to ensure safe and effective reprocessing of all RMDs, including loan and trial RMDs.

This includes environmental controls in areas that impact on RMD bioburden (temperature, humidity, traffic flow, ventilation and air flow).

Facility design 5.6.2 41 Clean and dirty activities are segregated through the design, construction and maintenance of the reprocessing facility.

The environment minimises the risk of cross contamination of a cleaned, disinfected and sterilised RMD.

There is a unidirectional work flow – dirty to clean.

Facility finishes 5.6.3 41 All windows in a reprocessing facility are not opened.

Windows, ledges and inaccessible areas for cleaning are minimised.

All walls, ceilings and other surfaces are flush, smooth, non-shedding, water resistant and able to withstand frequent cleaning.

Wall and floor junctions are all covered and flush.


Floors are covered in a non-slip, sealed material.

Fixtures and finishing 5.6.4 41 Work surfaces, fixtures, furniture and fittings are constructed from robust, non-shedding materials.

Work surfaces, fixtures, furniture and fittings are easy to clean and able to be maintained in a good condition.

Shelving is designed and installed to enable safe handling practices.

Shelving has smooth surfaces and does not damage product, packaging materials and other materials.

Fittings are flush with wall surfaces and ceilings.

SECTION 5



RMD cleaning sinks 5.6.5 41 For pre-treatment, manual cleaning and rinsing, dedicated sinks shall be provided.

They are of a size and depth to enable RMDs to be completely immersed.

Ergonomically designed workstations allow staff to fully immerse and retrieve RMDs without potential injury.

RMD cleaning sinks continued There is sufficient workspace available on the workstations that enable a unidirectional workflow and minimise cross contamination.

Cleaning sinks are not used for any other purpose other than for what they are designed for.

Lumens requiring water and / or air flushing are provided.

Water 5.6.6 41 Water of the required quality is available (as per Section 7).

Workstations 5.6.7 41 The reprocessing facility has sufficient ergonomically designed workstations and electrical computer terminal points.


Workstations are equipped for the preparation and packaging of RMDs.

Workstations are of adequate size to accommodate packaging materials.

Workstations, where applicable, are height adjustable.

Safe movement of staff and equipment is possible between workstations.

Lighting 5.6.8 42 Adequate lighting is present that enable a thorough visual check of RMDs.

Where required, task lighting and magnification is available.

All ceiling lights are flush fitting to the ceiling.

Storage 5.6.9 42 Bulk items are stored externally to the cleaning and packaging areas.

SECTION 5



Chemicals are stored safely in accordance with applicable workplace health and safety requirements and regulations.

The unloading steriliser area is provided to enable cooling and aeration of sterilised RMDs.

Processed RMDs released for use are stored in a dedicated area.

Facility cleaning 5.6.10 42 The reprocessing facility is cleaned regularly.

There is a documented procedure and schedule for the cleaning of the reprocessing facility.

The reprocessing facility is maintained in a hygienic condition.

Cleaning equipment used is separate and dedicated to both dirty and clean areas.


Entry to facility 5.6.11 42 Entry to the reprocessing facility is restricted to authorised personnel only.

Hand hygiene 5.6.12 42 Sufficient hand hygiene facilities are available and accessible in the reprocessing unit.

Personal protective equipment (PPE) is easily accessible in each area of the reprocessing facility.

HSO approved alcohol based hand rubs (ABHR) and liquid soaps are in use in the reprocessing facility.

Training is provided for the use of ABHR and liquid soaps.

When performing reprocessing activities, hand cream is not used.

Hand hygiene residue is not transferred to RMDs or packaging material.

Waste disposal 5.6.13 42 Waste disposal complies with local regulatory requirements.

Ventilation 5.6.14 42 Cleaning and sterile storage areas ventilation are in accordance with AS 1668.2.


A S/ NZ S 4 187

SECTION 6

PROCESS DEFINITION Clause Page(s) Description Compliance


General / introduction 6.1.1 43 The detailed specification for the RMD does not compromise the safety, quality or the performance of that RMD.

The reprocessing of a RMD is established and specified and includes all cleaning disinfecting, packaging and sterilisation information.



The chemical and biological indicators to be used during the validation process are specified by the HSO.

All chemical and biological indicators comply with the relevant ISO/EN standards.

The manufacturer’s instructions for reprocessing their RMDs are included in the HSO’s reprocessing procedures.

The manufacturer’s instructions should meet the requirements of ISO 17664.

Any deviation from manufacturer’s instructions should be documented and validated.

Immediate use sterilisation 6.1.2 43 The process for immediate use sterilisation is defined and validated as art of the HSO’s sterilising protocols.

An RMD processed using immediate use sterilisation where an SBS is not used shall be used immediately by the end user.

The processing of RMDs using immediate use sterilisation does not happen because of insufficient supplies of RMDs or as a cost saving mechanism.

SECTION 6



Immediate use sterilisation continued The transfer method of immediate use sterilised RMDs does not lead to contamination of the RMDs.

An immediate use sterilised RMD is not held for future use or for another procedure.

Cleaning process definition

General 6.2.1 44 Specifications for the cleaning process are defined.

All RMDs are cleaned after patient use.


RMDs and their cleaning process are compatible and performed using the manufacturer’s validated cleaning instructions.

RMDs not able to be safely and effectively cleaned, are not processed.

Transportation and pre-treatment

Transportation 6.2.2.1 44 Transportation of used RMDs to the reprocessing facility is outlined in written procedures.

Personnel and the environment are protected from contamination and harm by the transportation methods.

Pre-treatment 6.2.2.2 44 Procedures are developed at the point of use for the pre-treatment of used RMDs.

Methods used shall:

a) Include the removal of gross soil.

b) Not damage the RMD.

c) Not compromise the cleaning, disinfecting and sterilising processes that occur subsequently.

d) Avoid the drying of contaminants on used RMDs.

e) A specified period of time hs been identified between the use of an RMD and when it is subsequently reprocessed.

SECTION 6



Cleaning 6.2.3 44 The cleaning procedure shall include the following:

a) RMDs are disassembled prior to pre-treatment or cleaning.

b) Methods used do not damage but effectively clean the RMD.


c) RMD manufacturer’s instructions are used.

d) RMDs are allocated to specific cleaning pathways including manual cleaning, manual or ultrasonic pre-treatment or cleaning in a Washer Disinfector without pre-treatment.

45 e) Manual cleaning of an RMD is only used when required by the RMD manufacturer.

f) Manual cleaning of an RMD is used as pre-treatment.

g) Visible soiling is removed prior to processing through an ultrasonic cleaner.

h) Items processed through an ultrasonic cleaner are subsequently processed through a further manual or mechanical cleaning process.

i) All RMDs processed through a mechanical washer are loaded whereby all parts and surfaces are exposed to the cleaning process.

j) Damage is prevented through careful loading techniques.

k) Drying methods do not compromise the cleanliness of a RMD.

l) Low-linting cloths and / or instrument grade medical air are used when a drying cabinet is not available.

m) Use of instrument grade medical air is used following health and safety procedures and documented.

n) Cleaning of washer disinfectors, loading racks, trolleys, ultrasonic cleaners and any other accessories are all documented and written in accordance with manufacturer’s instructions.

SECTION 6



Cleaning continued o) All brushes and other manual cleaning accessories are thermally disinfected and / or sterilised daily.


Disinfecting process definition 6.3 45

General 6.3.1 45 A specific process has been defined as low, intermediate or high level disinfection to be used for the killing of micro-organisms on a cleaned RMD.

Categorising RMD for disinfection 6.3.2 45 RMDs requiring disinfection have been categorised according to Spaulding Classification as semi or not critical.

Non-critical RMD 6.3.3 45 Non-critical RMDs are subjected to low or intermediate level disinfection according to HSO Policy or RMD manufacturer’s instructions.

Non-critical RMDs are subjected to low or intermediate level disinfection using either thermal disinfection or an instrument grade disinfectant.

A documented procedure is available.

Chemical disinfectant manufacturer’s instructions are followed in relation to exposure time, temperature, pH and water quality for dilution of disinfectant.

Non-heat labile semi-critical 6.3.4 46 Semi-critical RMDs unable to withstand moist heat or low temperature sterilisation undergoes thermal or chemical disinfection. A procedure is documented.

Washer disinfector used for thermal disinfection complies with ISO.

Common holding times for thermal disinfection using moist heat complies with Table

.

Heat labile semi-critical RMD 6.3.5 46 Heat labile semi-critical RMDs undergo high level disinfection; the use of washer disinfectors to achieve this complies with ISO 15883-4.

A procedure has been documented.

A contingency plan exists in case the equipment malfunctions or breaks down.

SECTION 6




Heat labile semi-critical RMD continued Use of a high level instrument grade disinfectant is documented and includes handling, storage and the use of the disinfectant.

The manufacturer’s instructions for the use of the high level instrument grade disinfectant are followed to ensure the specified level of disinfection is achieved.

RMDs are rinsed in water of suitable quality and quantity to reduce risk of exposure to residue disinfectant.

RMD and disinfectant manufacturer’s instructions are followed.

RMDs used in sterile cavities, in known immune-compromised patients or for invasive procedures are rinsed with sterile water or water filtered through a 0.22 (add symbol) sterilising grade filter.

Procedure(s) are written for RMDs that are unable to be fully immersed during cleaning and a disinfection process that includes minimising the risk of cross contamination.

Packaging process definition 6.4 47

General 6.4.1 47 A specification for the packaging of an RMD is available.

The SBS and protective packaging in use does not impede the effectiveness of the sterilisation process used.

The SBS and protective packaging in use maintains the sterility of the RMD until point of use.

Packaged RMDs processed through a steam sterilisation process includes a drying phase.

Single use SBS products are exposed to a single sterilisation process only.

Packaging procedures 6.4.2 47 Procedures have been developed and implemented for the following procedures:

a) The inspection, assembly and testing of RMDs prior to being packaged.

SECTION 6



Comments FA PA UA NA

Packaging procedures continued b) The procedure includes information from the manufacturer for the testing, maintenance, lubrication and calibration of RMDs.

c) Specific instructions for the assembly of RMDs into set or trays include containment devices such as instrument pins or stringers.

d) SBS and packaging materials are selected and used according to manufacturer’s instructions:

i. SBS and packaging materials used for packaging RMDs comply with ISO 11607-1 and EN868 Series.

ii. Reusable fabrics used for packaging RMDs comply with AS 3798-8.

iii. Only those tray liners, tip protectors and other materials specifically designed for use with packaged RMDs are in use.

iv. Packaging materials used enable aseptic presentation of the processed RMDs.

v. Sealing and closure methods used ensures the integrity and sterilised RMDs until point of use.

vi. Pre-formed SBS have specified and documented sealing process parameters and tolerances identified.

vii. String, non-adhesive tape, staples, pins and elastic bands are not used for sealing packaged RMDs.

viii. Tamper evident sealing is used.

ix. RMDs are labelled prior to the sterilisation process.

x. Contents are identified in the label, batch control information is provided.

xi. Labelling materials and method of application does not compromise the sterilisation process.

xii. Labels in use remain attached securely to the processed RMD until point of use.

Sterilising process definition 6.5 47


SECTION 6



General 6.5.1 47 A specification for the sterilisation of RMDs to the required Sterility Assurance Level (SAL) is available.

The SAL achieved for terminally sterilising RMDs is 10-6.

48 The manufacturers of RMDs have supplied the sterilising process definition.

General continued Sterilisation instructions have been provided to the HSO by the RMD manufacturer.

The HSO have confirmed capability to sterilise RMDs as per manufacturer’s instructions.

Steriliser manufacturer has provided instruction to the HSO on how to use their steriliser.

HSO is responsible for process definition and process validation when undertaking processes outside of the manufacturer’s recommendation for steriliser cycles.

Sterilisation procedures 6.5.2 48 HSO has developed and implemented procedures taking into consideration the RMD and steriliser manufacturer’s instructions. They will include:

a) Selection of sterilisation process and method for the RMD taking into account the RMD manufacturer’s instructions.

b) Steriliser manufacturer’s specifications for loading the steriliser are achieved.

c) Steriliser manufacturer’s instructions for the use of, routine monitoring and control of the sterilisation process are followed.

d) The area sterilised items are unloaded in is controlled.

e) Processed RMDs are not adversely affected due to the environmental conditions in the unloading area.

f) Processed RMDs are left to cool sufficiently if process by moist heat or dry heat.


g) RMDs processed by Ethylene Oxide are not unloaded from the steriliser chamber until the in-house aeration phase is completed.

SECTION 6



Sterilisation procedures continued h) Load release criteria implemented comply with Clauses 9.1, 9.2 and 9.3.

Moist heat sterilisation 6.5.3 48 Common parameters outlined in Table 6.2 are achieved when using moist heat sterilisation.

Moist heat sterilisation continued 49 The temperature measured at the reference measurement point and the saturated steam temperature calculated from the measured chamber pressure is in accordance with the phase boundary line in Figure 6.1.

Steam dryness value is 0.95 equivalents to 95% dry saturated steam is achieved at a minimum.

Ethylene Oxide Sterilisation 6.5.4 50 Oxide process definition complies with Clause 8 as follows:

a) ISO 11135 when RMDs are processed using a conventional, industrial ethylene oxide process.

b) ISO 14937 when RMDs are processed using a flexible sterilisation chamber.

c) Process conditions for ethylene oxide sterilising comply with Table 6.3.

d) Gas mixture is specified when used mixed with ethylene oxide.

e) Gas leaks are detectable when the gas supply is not self-contained within the steriliser chamber.

f) An established means of reducing ethylene oxide residual levels is established so that processed RMDs comply with ISO 10993-7.

Dry heat 6.5.5 50 Process definitions comply with ISO 20857.


Common parameters outlined in Table 6.4 are complied with for dry heat sterilisation processes used in HSOs.

Low temperature sterilisation systems 6.5.6 51 Manufacturers of low temperature sterilisation processes have validated the efficacy of the sterilisation process.

SECTION 6



Low temperature sterilisation systems continued

Manufacturers of low temperature sterilisation processes have provided comprehensive instructions for the use of their system.



A S/ NZ S 4 187

SECTION 7

VALIDATION Clause Page(s) Description Compliance


General 7.1.1 52 Installation Qualification (IQ) has been undertaken to demonstrate that all reprocessing equipment and ancillary items have been supplied and installed as per manufacturer’s instructions.

Operational Qualification (OQ) has been undertaken on all reprocessing equipment that has demonstrated the capability of all cleaning, disinfection and sterilisation processes as per the manufacturer’s instructions.

The HSO has shown that the PQ for cleaning, disinfection and sterilisation processes operates consistently and in accordance with predetermined criteria.

The instrumentation used in IQ, OQ and PQ has been calibrated and results documented and recorded.

In the case of office based practices in remote places, the service provided has complied with OQ and PQ validation requirements.

RMDs used by the HSO and loading configurations have been used by the Service Provider as specified by the HSO.

On completion of PQ, the HSO has verified the performance of the steriliser, which includes, but is not limited to:

i. The Service Provider’s tests report has been reviewed.



ii. List of steriliser tests conducted.

SECTION 7



General continued iii. Reference loads used including the use of biological and chemical indicators.

Table 7.1 7.1 53

7.1.2 53 IQ and OQ has been undertaken for each piece of equipment in the unit.

PQ has been carried out for each process delivered by each piece of equipment.

54 For each process, a validation protocol has been developed that includes identification of the equipment and any ancillary equipment used.

A validation report is completed for the cleaning, disinfecting and sterilisation processes.

Installation Qualification (IQ) 7.2 54

General 7.2.1 54 IQ has been completed for all the processing equipment and ancillary equipment by the equipment manufacturer or supplier. This includes the services and environment required for this equipment.

The manufacturer’s installation specifications have been complied with.

Equipment installation qualification 7.2.2 54 All reprocessing equipment has had IQ performed upon installation in compliance with applicable national / international standards and the manufacturer’s instructions.

The HSO has consulted with the equipment manufacturer prior to installation of new or relocated reprocessing equipment.

a) The location for installation has been specified.


b) Environmental conditions are in accordance with the manufacturer’s recommendations.

c) Required services (water, steam and air), have been provided in accordance with manufacturer’s specifications.

SECTION 7



Equipment installation qualification continued

d) Detailed equipment specifications and operational instructions have been provided by the manufacturer.

Heat sealing equipment has been supplied calibrated by the equipment manufacturer.

A certificate of calibration has been supplied by the equipment manufacturer.

Services qualification 7.2.3 54

Water quality 7.2.3.1 54 The water supplied to the reprocessing facility is of suitable quality for its intended purpose (see Table 7.2).

The supplier of local water and the HSO consult when changes likely to affect the quality of potable water occur.

Tests have been conducted prior to the installation of equipment to demonstrate the quality of water supplied.

Water supplied is supplied in accordance with the manufacturer’s specifications and results have been documented.

Water that is softened, filtered, demineralised, reverse osmosis or distilled is provided in accordance with equipment manufacturer’s requirements.

Steam quality 7.2.3.2 55 Tests have been conducted prior to the installation of equipment to demonstrate the water supplied to the steam generator comply with EN285 (see Table B1).


Results have been recorded for the testing of the water supplied to the steam generator.

The steam supplied by a dedicated steam generator whereby the feedwater is chemically untreated complies with EN285 (see Table B1).

Steam purity tests have been conducted during IQ and OQ in accordance with EN285 (see Table 10.1).

SECTION 7



Steam quality continued Results for the steam purity tests do not exceed the limits specified in EN285 (see Table E2).

Steam quality tests have been conducted during IQ and OQ in accordance with EN285.

Steam dryness value tests are conducted in accordance with EN285 and are not less than 0.95.

56 Steam dryness value tests are conducted during IQ.

Steam dryness value tests are used to determine the root cause of a nonconforming process.

Operational Qualifications (OQ) 7.3 56 PQ is performed by the equipment manufacturer in accordance with national or international standards.

a) PQ has been carried out for each process delivered by each piece of equipment.

b) When a service is changed.

c) When existing equipment is modified and delivers a new process.

d) When a new RMDs or loading configurations are introduced.

e) When equipment is put back into service after repair.

Performance Qualification (PQ) 7.4 56


General 7.4.1 HSO performs PQ.

PQ is performed by suitably trained in-house personnel or by an external contractor who is suitably experienced and qualified.

PQ is undertaken in accordance with the applicable national and international standards.

PQ is performed by the HSO:

a) Immediately after IQ and OQ for a new or relocated piece of equipment.

SECTION 7



General continued b) When the repairs or service carried out may impact on the quality of the processed RMD (see Clause 10.5)

c) If the existing equipment is modified in order to deliver a new process.

d) Using RMDs that represent the most difficult RMDs that are processed by the HSO.

e) When there have been changes or modifications to packaging or loading configurations; where new or modified RMDs are introduced that change already qualified product families.

Risk based assessment is carried out when anew RMD is introduced and it is not equivalent to existing product families.

PQ is carried out annually by the HSO.

Cleaning processes 7.4.2 57 There is no objective means of assessing the performance of cleaning RMDs in place and it is validated.

Washer disinfectors 7.4.3 57 Thermal and disinfection processes using washer-disinfectors have PQ carried out as per the ISO 15883 series of standards.


Packaging process 7.4.4 57

General 7.4.4.1 57 PQ of packaging processes are conducted in accordance with ISO 11607-2.

Packaging processes to be validated are:

a) Process of sealing using pouches, bags and reels.

b) Sterilisation wraps – folding and closing.

c) Reusable containers – filling and closing.

7.4.4.2 57 PQ is carried out on the heat sealing process.

Results are documented.

7.4.4.3 57 PQ is carried out on the wrapping process.

Results are documented.

SECTION 7



General continued 7.4.4.4 57 PQ is verified by the manufacturer of the containers and show that sterilising conditions are attained and maintained within the container and its contents.

Sterilising process 7.4.5 57 An overkill approach for PQ is used by the HSO.

Required sterilising conditions are attained and demonstrated.

The PQ conducted demonstrates the attainment of 10-6 SAL for terminally sterilised RMDs.

PQ loads used are a representation of the loads that are routinely sterilised and is based on the most challenging load to sterilise.

Total mass of the load is specified and documented.

RMDs used for PQ are packaged identically to those routinely packaged.

The presentation and orientation of the RMD in relation to the process is specified and documented.


58 PQ process encompasses both Physical Performance Qualification (PPQ) and Microbiological Performance Qualification (MPQ).

a) PPQ verifies attainment of specific critical physical parameters reached in the sterilising process within the load.

b) MPQ demonstrates through the use of biological indicators the microbiological lethality in the load.

MPQ identifies that the biological indicators placed in the load where required sterilising conditions where the most difficult to achieve.

PPQ and MPQ are performed concurrently during the PQ process.

Biological indicators used during PQ:

a) Comply with relevant part of the ISO 11138 standard applicable to the sterilisation method used.

SECTION 7



Sterilisation process continued b) Are specified by the manufacturer as being resistant to the sterilising agent chosen.

c) Are more resistant to the sterilising agent chosen than any bioburden that remains on the RMD after cleaning or disinfection.

d) Are placed in the positions within the load and packaged RMDs known to be difficult to achieve sterilisation.

e) Meet the BI manufacturer’s validated microbiological method for recovering spores exposed during the sterilisation process.

58 Process Challenge Devices (PCDs) used for PQ in ethylene oxide sterilisers comply with ISO 11135.


PCDs used for other sterilising methods are equivalent or more challenging than the most difficult sterilising conditions.

Internal chemical indicators used during PQ:

A. Comply with the relevant parts of ISO 11140.

B. Placed in the positions known to be the most difficult to achieve sterilisation.

C. Must not adversely affect RMDs.

D. Not used as the sole means for establishing the sterilisation process.

PQ is conducted in accordance with the relevant standard:

a) For sterilising systems where no other standard applies – ISO 14937.

b) For steam sterilising – ISO 17665-1.

c) For ethylene oxide sterilisation – ISO 11135.

d) For dry heat sterilisation – ISO 20857.

e) For steam formaldehyde sterilisation – ISO 25424.

SECTION 7



Sterilisation process continued Three consecutive and successful exposures to the load process are conducted within the defined tolerances.

Exposures that do not meet the defined tolerances are reviewed with corrective actions identified and completed.

59 Failed exposures attributed to factors not relevant to the effectiveness of the process being validated are documented as not being related to the process performance.


Moist heat sterilising PQ processes have the penetration time added to the sterilisation holding time.

Data from the PQ process is generated including physical, chemical and microbiological results.

Levels of any process residues are demonstrated as being below specified regulatory limits where applicable and following exposure to the sterilisation.

RMDs are demonstrated as meeting safety, quality and performance requirements after being subjected to the upper tolerances of process parameters of the defined process.

Review and approval of validation 7.5 59

General 7.5.1 59 Validation reports are documented in accordance with the validation protocol for each process.

The validation report includes information and data generated during IQ and OQ studies for equipment.

The validation report includes information and data generated during PQ for each specified process.

IQ and OQ data includes:

a) Conformation and verification that the calibration of test equipment has been checked and where necessary, adjusted.

b) Confirmation that reprocessing equipment delivers reproducible results within the defined process.

SECTION 7



General continued c) The process parameters and their tolerances.

d) For steam sterilisers, the value set of an air detector test or the results of biological indicators used alone or in conjunction with PCDs.

Validation report 7.5.2 59 The validation report include:


a) Equipment specification and any changes or modifications to instruments or controls.

60 b) Equipment identification including serial number, manufacturer name and address, type of equipment and model number.

c) Safety specifications compliance document (marine inspection).

d) Pressure vessel certificate.

e) Maintenance report and a planned maintenance schedule including checks and tests.

f) Installation and operating instructions

g) Medical device regulation documentation, if applicable.

h) Documentation on any faults and how they were resolved.

i) For each type of product family / load the load configurations, heat penetration studies for packaging products for each product family / load type.

j) Cycle parameters for each type of cycle; copy of process specification.

k) Identify personnel involved in the validation process including their qualifications.

l) Requalification, periodic testing and routine testing schedule.

m) Training manuals for operating personnel.

n) Equipment currently in use, maintenance results and routine performance tests data.

SECTION 7



Approval of validation reports 7.5.3 60 Validation reports are reviewed and approved by designated person.

Results of review are documented and approved.


Copy of validation reports are kept in the reprocessing facility.



A S/ NZ S 4 187

SECTION 8

ROUTINE MONITORING AND CONTROL Clause Page(s) Description Compliance


General 8.1 61 Routine monitoring and control demonstrates specified validated cleaning, disinfection, packaging and sterilising processes are delivered.

Data is recorded for each cleaning, disinfection, packaging and sterilising process and demonstrates defined tolerances for process specification has been met.

Each operating cycle is retained.

Routine and control of cleaning process 8.2 61

General 8.2.1 61 Table 8.1 – routine monitoring and control for the cleaning process meets the following requirements:

o Washer disinfectors.

o Ultrasonics.

o Drying cabinets.

o Endoscope storage cabinets with an air flow.

o Manual cleaning.

o Manual chemical disinfection.

Manual cleaning 8.2.2 61 Visual inspection is carried out on completion of any manual cleaning process.

Washer disinfectors employing thermal disinfection

8.2.3 62 At the completion of each washer disinfector cycle the process records are checked.



SECTION 8



Washer disinfectors employing thermal disinfection continued

Cycle variables are verified against the process records for each stage of the process.

a) Cleaning and drying equipment function correctly.

b) Dosage of cleaning agent(s).

c) Time and temperature combination maintained by disinfector is not less than that specified.

d) Exposure time.

Ultrasonics 8.2.4 62 The ultrasonic cleaner is tested daily in accordance with AS 2773 or AS 2773.1.

Cleaning efficacy inspection 8.2.5 62 Visual inspection utilising magnification is used to determine cleaning efficacy at the completion of the cleaning process.

Drying cabinets 8.2.6 62 Temperature of all dryers are checked and recorded daily.

Routine monitoring and control of manual chemical disinfection with high level instrument grade disinfectant

8.3 62 For each instrument grade High Level Disinfectant (HLD), the monitoring activities are documented as follows:

a) HDL temperature.

b) Contact time.

c) Volume of rinse water.

d) The MRC of the instrument grade HLD is monitored prior to each use or at least daily and results documented.

e) The HLD and the chemical indicators used are compatible.

f) If required, positive and negative controls for the MRC indicators are used to establish that they detect MRC below acceptable limits.


Routine monitoring and control of washer disinfectors employing chemical disinfection for thermolabile endoscope

8.4 63 Process records and process indicators (if required), are checked after each completed cycle to verify process was successfully achieved.

The chemical disinfecting process is monitored and controlled in accordance with Table 8.1.

SECTION 8



Routine monitoring and control of washer disinfectors employing chemical disinfection for thermolabile endoscope continued

If required by the manufacturer, process indicators are

used to verify MRC of the chemical disinfectant.

Process variables are verified and / or monitored:

a) Disinfecting equipment is functioning correctly.

b) If required, chemical disinfecting agent concentration during disinfection phase.

c) Contact / time is correct.

d) Any other parameters required by the manufacturer of the washer disinfector or disinfecting agent used.

Microbiological surveillance of flexible endoscope with channels

8.5 63 Flexible endoscopes with channels undergo microbiological surveillance.

Gastrointestinal endoscopes are tested quarterly (GENCA Guidelines).

Flexible endoscopes with channels used in sterile body cavities are tested monthly (unless sterilised).

Flexible endoscopes with channels are tested according to HSO Policy if they undergo terminal sterilisation.

On loan or returned from repair flexible endoscopes with channels are microbiologically tested on receipt within 72 hours.

Routine monitoring and control of packaging process

8.6 63 Packaging procedures are carried out in accordance with the process definition (Section 6).


Each packaged item is monitored so that it meets the required specification (visual inspection when loading a steriliser carriage).

64 On loan or returned from repair flexible endoscopes with channels are microbiologically tested on receipt with 72 hours.

Impulse and rotary heat sealers without a process record, have the temperature checked and recorded on a daily basis.

SECTION 8



Routine monitoring and control of packaging process continued

A visual check of the sealing temperature is made prior to each episode of sealing.

Where the process variables are monitored for heat sealers for each episode of sealing, the correct process variables are confirmed at completion of sealing.

Daily, one or more samples of sealed PSBS have the seal integrity checked before and after sterilisation. A visual check of the entire seal integrity is carried out.

Rigid reusable sterilisation containers (RRSC) are visually inspected prior to each use.

The container and lid of each RRSC is inspected for dents or cracks.

The seal / gasket of each RRSC is still intact and not compromised along its entire length.

The closing mechanisms lock firmly in place.

The filter has been replaced or is within the acceptable number or reusable cycles.

Routine monitoring and control of sterilising process

8.7 64

General 8.7.1 64 Sterilising equipment is checked each day prior to use that it is functioning as intended.


Process records are checked on completion of each cycle to verify process.

Low temperature sterilising systems 8.7.2 64 Manufacturer’s instructions for performance tests are conducted as required.

Dry heat 8.7.3 64 Manufacturer’s instructions for performance tests are conducted as required.

Moist heat 8.7.4 64 Daily and / or weekly performance tests are conducted as required.

Steam sterilisers that utilise a vacuum air removal process in the pre-sterilisation stage have daily air removal and steam penetration tests completed.

SECTION 8



Moist heat continued Bowie and Dick type tests used comply with ISO 11140-3, ISO 11140-4, or ISO 1114-5 as appropriate.

For small steam sterilisers, air removal and steam penetration tests comply with EN 867-5 or ISO 11140-6 as appropriate.

65 Sterilisers that utilise a vacuum during the sterilisation cycle and have an air detector fitted have a weekly leak rate / vacuum test and an air detector function test.

Steam sterilisers without air detectors have a daily leak rate / vacuum test performed prior to the Bowie and Dick test.

Table 8.2: Requirements for routine monitoring and control of sterilising equipment

65 Table 8.2: Requirements for the routine monitoring and control of sterilising equipment is met.

Biological indicators 8.7.5 66 Biological indicators used for routine monitoring, MPQ and controlling sterilisation processes comply with ISO 11138.

Biological indictors used;

i. As part of MPQ.


ii. Every validated ethylene oxide sterilisation load.

iii. For use in dry heat and low temperature sterilisers, the manufacturer’s instructions are followed.

iv. For validated moist heat sterilisation processes as determined by HSO.

ISO 14161 is referenced when selecting, using and interpreting biological indicator results.

Chemical indicators 8.7.6 66 Chemical indicators used for process development, routine monitoring, PQ and controlling sterilisation processes comply with ISO 11140-1.

Chemical indicators used:

i. If routinely used, as part of PQ.

ii. On the exterior of each packaged RMD.

SECTION 8



Chemical indicators continued iii. When used in low temperature sterilisers where a liquid chemical sterilising agent is used, the manufacturer’s instructions are followed.

iv. As required by HSO Policy.

v. When semi-critical RMDs are sterilised unwrapped, a chemical indicator is used in each load.

vi. If used inside a packaged RMD, the chemical indicator is placed in the most difficult location determined during validation.

ISO 15882 is referenced when selecting, using and interpreting chemical indicator results.

Process challenge devices (PCD) 8.7.7 66 If used, PCDs are equivalent or more challenging to the sterilising process when placed in the position of a packaged RMD at the point most difficult to achieve sterilisation.

ISO 15882 is referenced when selecting, using and interpreting PCD results.


ISO 11135 is followed when using PCDs to monitor ethylene oxide sterilisation processes.

67 ISO 11140-6 or EN867-5 are complied with when using PCDs as an air removal and steam penetration test in small steam sterilisers.



A S/ NZ S 4 187

SECTION 9

RELEASE OF RMDS FOLLOWING REPROCESSING Clause Page(s) Description Compliance


General 9.1 68 Each individual phase of the reprocessing process is verified prior to the release of RMDs to the next phase (see figures 9.1 and 9.2).

Cycle records are checked for each phase prior to the RMD being released to the next phase.

Results of test soil cleaning indicators, biological indicators, chemical indicators and PCDs are checked as per HSO Policy and as part of product release.

Where the use of biological indicators is mandatory, the results are known prior to produce release.

RMD release criteria 9.2 70 Specified procedures are available that enable the review of records and the release of RMDs from the cleaning, disinfecting, packaging and sterilising process.

Acceptance criteria are defined in these procedures for each process and show conformance to the relative specifications.

(See comment) 71 Compliance with release criteria as outlined in Table 9.1 is complied with for each phase of reprocessing.

Do we need to itemise each type of process.

RMD release 9.3 72 All acceptance criteria for the release of RMDs are met.

RMDs are not released until compliance with acceptance criteria is met.

RMDs are designated as nonconforming when release criteria are not met.



Nonconforming RMDs are quarantined and managed in accordance with Clause 2.5.

SECTION 9

RELEASE OF RMDS FOLLOWING REPROCESSING Clause Page(s) Description Compliance


Records of RMD release 9.4 72 Clause 2.4.3 is complied with for tracing released RMDs.

HSO is working towards implementing an electronic

tracking / process recording system.

Handling, transport and storage of released reprocessed RMDs

9.5 72 Critical / semi-critical RMDs are handled, transported and stored in a manner that prevents the risk of contamination.

RMD sterility is maintained, including items purchased sterile by the HSO.

A suitable storage environment is available.

Staff are educated on the correct handling, transport

and storage of sterile items.

Transport systems used protect the package integrity

until point of use.



A S/ NZ S 4 187

SECTION 10

MAINTAINING PROCESS EFFECTIVENESS Clause Page(s) Description Compliance


General 10.1 73 The effectiveness of cleaning, disinfecting, packaging and sterilising processes is periodically assessed.

Each process is delivered according to documented specifications.

HSO has agreements in place with service providers who are suitably trained and qualified.

Service providers undertake planned preventative maintenance, recalibration and reassessment of process effectiveness.

Service providers undertake annual requalification of all reprocessing equipment.

Calibration 10.2 73 Calibration of all instrumentation used for monitoring cleaning, disinfecting, packages and sterilising processes is carried out regularly (see Clause 2.4.4).

Maintenance of equipment 10.3 73

General 10.3.1 73 All equipment is part of a planned preventative maintenance programme and is undertaken in accordance with manufacturer’s instructions.

Preventative maintenance is carried out by a

competent person or the manufacturer.

The maintenance activity and timeframes are specified.

An electrical safety check is carried out annually.



Where applicable, air filters are checked and changed

as required by the equipment manufacturer’s IFU’s.

Records of all maintenance carried out are retained and

readily available.

SECTION 10



Return to use 10.3.2 73 RMDs are not processed in any equipment undergoing maintenance until all activities have been completed and documented.

At a minimum, Table 10.1 is complied with.

Maximum period of delay permitted for scheduled maintenance is specified by the HSO.

Maintenance records 10.3.3 73 Maintenance records identify the equipment and history of routine and unscheduled maintenance and repairs. Records include the following information at a minimum:

a) Reason for repair or maintenance.

b) Date of repair or maintenance.

c) Equipment model and serial number.

d) Location of equipment.

e) Description of repair or maintenance.

f) Identification of replaced parts.

74 g) Name of the person or company who carried out the repair or maintenance.

h) Name of person releasing equipment back fit for use.

The preventative maintenance schedule, procedures and documented records meet the requirements of Section 2 of this standard.


Table 10.1 75 Recommend frequency of preventative maintenance, recalibration, testing of sterilisers and associated equipment is carried out.

Table 10.2 76 Recommend frequency of preventative maintenance, recalibration, testing of cleaning, disinfecting and packaging equipment is carried out.

Table 10.3 77 Recommended frequency of preventative maintenance, recalibration, testing of automated endoscope reprocessers is carried out.

SECTION 10



Identifying faults 10.3.4 77 Faulty equipment is identified and action is taken to correct the fault.

Faulty equipment that may impact on the quality and safety of a RMD or the safety of staff is removed from use.

Cleaning of equipment 10.3.5 77 HSO has an established protocol for the cleaning of equipment that includes the recommendations of the manufacturer.

The frequency of cleaning and the methods used are outlined and documented.

All cleaning of equipment is documented and records kept.

Requalification 10.4 78

General 10.4.1 78 Requalification is performed annually when a change is made to a RMD, its packaging or to the cleaning, disinfection, packaging or sterilising processes or major repairs or changes made to the reprocessing equipment.

A designated competent person is responsible for determining the necessity and extent of the requalification of reprocessing equipment.

Procedures for requalification 10.4.2 78 Specified procedures for requalification are available.

Requalification occurs in line with these procedures.


Requalification records are retained.

Review and acceptance of requalification 10.4.3 78 Data from requalification is reviewed against known defined acceptance criteria.

Records are retained including corrective action(s) taken when defined acceptance criteria is not met during requalification.

Assessment of change 10.5 78 An assessment is carried out when any change to reprocessing equipment or to a process occurs that may impact on the quality of a reprocessed RMD.

SECTION 10



Assessment of change continued If a change has had an effect on the process, a repeat of part or all of IQ, QQ or PQ is performed.

Rationale for this decision and the outcome of

assessment is documented.

The cleaning, disinfection, packaging or sterilising process is assessed when a RMD, its packaging or presentation of the RMD is changed.

PQ and process definition are performed when

assessed as necessary.

Assessment outcomes and decisions reached and their

rationale are documented.

Documents

2014 Reprocessing of Reusable Medical Devices in Health ......Reprocessing resources –equipment, personnel and accessories are sufficient for the workload. Control of documents and