Frequently Asked Questions

AS4187 is currently under review by Standards Australia. This is a very slow process. The format of AS4187 will change to be in line with the format of ISO standards BUT there is confusion as some think that Standards Australia will be adopting the ISO standard instead of AS4187. This is not true.

A Bowie Dick test, that is an air removal and steam penetration test, must be performed daily on sterilizers using mechanical means to remove air (e.g Prevacuum sterilizers). An appropriate Bowie Dick type test shall be selected according to the type of sterilizer as per AS4187:2003 Appendix A.

Facilities selecting an air removal and steam penetration test must ensure that it meets the criteria of a Bowie Dick type test.

NB: The Bowie Dick test is not applicable to downward displacement sterilizers as these have a longer cycle which can cause change to the indicator even if there is air present.

What do you do when the Bowie Dick test passes but there is moisture on the pack or in the sterilizer?

The Bowie Dick test has still passed but the reason for condensation requires further investigation. the condensation could be due to the chamber and door gasket being cold. Further information about failed tests can be obtained from the Sterilizing Maintenance Network of Advisors

Q. Why are Rapid Biological Indicators no longer available on SOA 7?

A. The company which previously supplied this product has ceased production. Guidance on which biological indicators should be used is available from:

• AS4187 Table 7.1 and AS4187 Section 8.6.3
• Easi-Sterilise Standard Operating Procedure-Quality 5.6
• Queensland Health Disinfection and Sterilization Guidelines-Section 4

Q. Why are immediate readout enzymatic indicators no longer available?

A. 3M Codes 2482, 2482F, 2482T and 2486F for flash and pre-vac sterilizers are no longer available and there is no replacement product. Therefore it is recommended that you review your practices to determine the actual need to use the product in the first instance and move to using 1hr, 3hr or 24hr biological indicators.

Flash sterilization is still an acceptable practice in emergency situations. The caveat being that flash sterilization is not permitted for cannulated instruments, complex instruments or tubing.

At this time there is no indication by Standards Australia that flash sterilizing will be excluded from use as part of the revised standard. Some Queensland hospitals have already moved towards a process called 'fast tracking'. This means that there is no flash sterlizing undertaken in the operating theatres but items are sent to CSD for rapid reprocessing.

Heavy duty/utility gloves (for the reprocessing of equipment) need to be provided for each individual to use over the course of one day only, then discarded. The gloves need to be cleaned and dried in between use (not left with gross soiling) following each reprocessing session in the one day. They should not be 'multi-person use' as hands become warm during use and the bacteria proliferate, hence the requirement for hand hygiene on removal.

Swabbing of instruments is not required. Heat is the best sterilant. It has been well validated, it is a reliable physical method and microorganisms are all susceptible to heat. If the quality assurance controls are passing then the item has been adequately processed and therefore can be regarded as 'sterile'.

Q. Is there a requirement for requalification if we have changed the sterilizer pump?

A. Not required if the make and model of the pump is the same. Requalification is required if the pump has been reconfigured or the calibration has been changed.

Laminate pouches must be processed as per AS/NZS 4187:2003 [Section 5.1.2.1] with the laminate side facing upwards. Non-compliance with this requirement has resulted in problems with process indicators and inconsistency of colour change. The silvery blue colour change of the Austmel process indicators has been caused by the pouches being placed in the sterilizer with the laminate face down. Where the indicator label has been sandwiched between the tray and the instruments contained in the pouch, condensate and poor steam pemetration between the tray and the laminate has caused the indicator not to fully change colour all over. Those parts of the indicator that were exposed to steam directly show good colour change.

Guidelines for the reprocessing of intracavitary probes is available from the Australasian Society for Ultrasound in Medicine

See Batch Labelling

Product complaints are only put in if the product being used is not functioning in the manner for which it was designed and purchased....not because a staff member dislikes the product.

Each facility must have an internal product complaint procedure in place. If there is a Clinical Products Manager in the organization then this person is responsible for managing all product complaints. The product complaint should primarily be dealt with in the first instance at the local level between the facility and the company.

Recurring product complaints should be managed by:

1. Meeting with the company to offer them the opportunity to rectify the product defect
2. Notify Health Services Purchasing & Logistics (HSPL) if the product is on Standing Offer Arrangement and submit Supplier Performance Form to HSPL.
3. For non-SOA items source the product from another supplier

Sterilizer maintenance records shall be maintained in a designated storage area for a period of time not less than that defined by state or local regulations or policy. Queensland Health Policy for the Retention and Disposal of Clinical Records provides direction for the retention of clinical records (which includes sterilizing service records).

Guidance on what documentation is required to be retained can be found in the Queensland Health Disinfection and Sterilization Guidelines.

Rust vs Staining

Stains can be removed wheras rust will leave permanent pitting damage on instruments. To determine if a brown/orange discolouration is a stain or rust, use the eraser test. Simply rub a pencil eraser over the discolouration. If the discolouration is removed and the surface metal underneath is smooth and clean, this is a stain. However, if the discolouration is removed with the pencil eraser and a pit mark appears under the discolouration, this is corrosion, which will continue to rust.

Brown/Orange Stains-caused by high pH substance e.g chlorhexidine usage, improper soaps and detergents, cold sterilization solution, possibly baked-on blood, soaking in saline or using laundry soap.

Dark Brown/Black Stains-low pH acid stain, improper detergents and soaps or dired blood

Bluish Black Stains-ultrasonic processing of different metals e.g stainless steel with chrome, exposure to saline, blood or potassium chloride

Multicolour Stains-excessive heat by localized 'hot spot' in processing cycle

Light and Dark Spots-water spots from allowing instruments to air dry. Sodium, calcium and magnesium left on surface.

Bluish Gray Stains-cold sterilization solution being used outside manufacturer's guidelines

Black Stains-possible exposure to ammonia

Please refer to this factsheet: Use of Non-Sterile Implants including Screw banks and other Orthopaedic Implant Sets

• Consideration should be given to wire rack compactor systems as these increase efficiency and storage space.
• Shelving systems are to be designed and constructed to avoid inaccessible corners, with sealed seams, having non-porous surfaces which facilitate damp dusting and vacuum cleaning
• Shelving to be 250mm above the floor and 440mm from the ceiling

There is still some uncertainity about which single use only (SUO) products may be re-used. There are no single use only products authorised for re-use in Queensland Health facilities.

All concerns regarding steam supply should be referred to the Sterilizing Maintenance Network of Advisors

Ideally, sterile storage areas should be airconditioned with minimal air turbulence created by fans. the following points are regarded as minimum requirements whether or not storage areas are airconditioned:

• area to be dedicated for sterile stock storage
• area is to be free from dust, insects and vermin
• temperature range to be between 18 degrees celsius-22 degrees celsius with a relative humidity ranging from 35%-68%
• potential deterioration of materials and/or components of sterile

Ultrasonic cleaning is generally used as a supplement to manual or mechanical cleaning, or to clean delicate tubes or other hollow instruments. Gross contamination must be removed prior to immersion in the ultrasonic tank. Ultrasonic cleaners help minimise manual cleaning - they do not disinfect instruments.Refer to:

• Easi-Sterilise Standard Operating Procedure 1.10
• Oral Health Standard Operating Procedure 1.9
• Oral Health Standard Operating Procedure 5.3

Water testing (including pipe and RO) is performed at Forensic and Scientific Services at Coopers Plains. Further information is available on their website.

Most common issues releating to wet packs include wrapping techniques, sterilizer loading and steam quality. Read through:

• Section 4 of the Queensland Health Disinfection an Sterilization Guidelines
• Appendix 2A - Troubleshooting of Wet Packs Flow Chart
• Appendix 2B - Troubleshooting of Wet Packs

If after reading this information you are still unable to resolve the issues then contact the Sterilizing Maintenance Network of Advisors

Recently there has been confusion with regards to what needs to be wrapped, a batch label attached, documented on the sterilizing log sheet and then batch label placed in the individual dental patient's record.

Background

Towards the end of last year (2009) and earlier this year (2010) the Office for the Chief Dental Office and the Oral Health Steering Committee discussed packaging of all items that were placed in a sterilizer. A decision was made by the Oral Health Steering Committee that this was to occur. CHRISP's understanding of intent was that any instrument that was placed in the sterilizer would have a batch label applied and then when the instrument used on a patient the batch label would be placed in the patient's dental record. In April 2010 when CHRISP was given the responsibility of sterilizing in oral health we attended an Oral Health Steering Committee and sort clarification around this point. At that committee meeting whilst it was acknowledged that the decision had been made that all items placed in a sterilizer were to be packaged or wrapped and a batch label applied concerns were raised with regards to increase in human resources that was required to undertake this and also impact that this would have on patient throughput in some clinics. In addition, CHRISP also undertook site visits of some fixed and mobile clinics and discussed the decision that was made by the Oral Health Steering committee and it was evident that there were also issues with storage of items and the number of packaged/wrapped items placed in a bench top sterilizer was considerably less.

Current Recommendations

Due to the issues identified by a number of Oral Health Directors and Dental Assistants CHRISP endorses the following:

1. Practices in relation to packaging and wrapping of items should remain consistent with what has previously occurred unless the district has made a decision to move this way
2. All items that are packed or wrapped are to have a batch label applied
3. In line with the minimum mandatory requirements of AS4815 all items that are placed in the sterilizer are to be documented on the sterilizing log sheet
4. As instructed by the Office of the Chief Dental Office a batch label control pouch and a class 5 indicator control is to be placed in each sterilizing load and the results and batch label recorded on the sterilizing log sheet
5. With the exception of multi-packs of items such as mirrors and probes that are opened and used for a session (an in line with the minimum requirements of AS4815) any item that is packed/wrapped, when used on a patient, the batch label is to be placed in the patients dental record