Dear Chary,
Can the Bowie & Dick test be used in gravity displacement sterilisers? Yes, it can.
Why? Because there are no reasons why it shouldn't!
The Bowie & Dick test is a steam penetration test for porous loads (textile packs). Although it was originally designed to be used in high vac sterilisers, it is used now in fractional vacuum sterilisers, which are quit different from high vac sterilisers. If you do the Bowie & Dick test in your steriliser and it passes the test it gives you an indication that the steriliser is suitable for the sterilisation of textile packs. One thing is very important with every test you do with chemical indicators; you must ensure that the indicator is not exposed to the sterilisation conditions for too long or that the sterilisation temperature is too high. For example, if the indicator is designed to change colour in saturated steam of 134°C in 3 minutes, you make sure that the exposure of the indicator to steam of at least 134°C is not longer than 3 minutes and that the temperature is not much higher than 134°C (see EN867-3 for the allowed tolerances). Very often the indicator of the Bowie & Dick test is over exposed and small penetration faults are disguised. This is unfortunately also very true for vacuum sterilisers. The sterilisation conditions (time and temperature) in the test pack must be verified by measurement.
We, at the National Institute for Public Health in the Netherlands, did some research on gravity displacement sterilisers as they are in use in the third world countries; basically large pressure cookers. We found that these sterilisers with the correct procedure are well capable of sterilising textile packs and give a good performance of the Bowie & Dick test and fulfil the requirements for load dryness in EN285. Without the use of a vacuum pump. The report can be downloaded from the RIVM website:
http://www.rivm.nl/bibliotheek/rapporten/318902011.html
From the reactions on your question I am confirmed in my earlier impressions that there is a lot of confusion about the Bowie & Dick test. For the revision of EN285 I wrote a proposal for an informative annex to EN285, explaining the position of the Bowie & Dick test in the totality of performance tests for steam sterilisers. Please accept it as my personal view on the matter.
"Informative annex on the tests using the standard test pack. The small load thermometric is used as the basic test for large steam sterilisers. It is typically performed during process development and subsequent type testing as well as during the operational qualification. The materials and dimensions of the test pack are chosen to be identical to the 'standard' Bowie and Dick test (see clause 19), which has been in use for decades as a routine sterilizer test in many countries throughout Europe. The factors influencing the penetration of steam into this test pack have been the subject of many investigations over the years. Literature on the subject is abundantly available.
Readers of this standard are however warned against overrating of the value of any tests in which the standard test pack is used.
* The standard test pack bears no intentional relationship to the loads that are routinely sterilised in the particular steriliser. Nevertheless it is obvious that, because the test pack is composed of steam permeable, water absorbent porous material, it is closer related to porous loads (linen, drapes, gauze, bandages etc.) than to solid or hollow stainless steel surgical instruments. The value of the tests in which the standard test pack is used for steam sterilisers that are not intended to be used with porous loads (typical instrument steriliser) is therefore limited.
* The standard test pack does not present a particular great challenge to the air removal system. Against common believe vacuum assisted air removal is not necessary to obtain satisfactory steam penetration in the standard test pack (and full porous loads for that matter) [B. Muis et al, RIVM 318902011].
* The standard test pack is not necessarily the worst case load. The materials and dimension of the test pack are not chosen on the basis that this will present the worst case load for any particular steam steriliser. The materials and dimensions of the testpack are not chosen on scientific grounds, but merely on the historical availability of these materials in hospitals. Data are available to show that in small steriliser chambers (1 to 4 stu) a smaller test pack may actual present a greater challenge to the process than the standard test pack [Meurer et al, Central Service Vol. 8, 2000].
In small chambers (from 1 stu to 4 stu) the steam penetration is influenced by the position of the steam inlet and drain relative to the test pack. Depending on the actual configuration steam might be partially injected into the test pack. Other influences that are of relative great importance in smaller steriliser chambers are the velocity of steam entering the steriliser chamber, the velocity and quantity of fluids being drained from the steriliser chamber and rate of pressure change [reference Hurrell, Kingston?]. Whereas these factors may give a positive contribution to the steam penetration in the test pack, this is not necessarily the case with routine steriliser loads.
Studies have been performed in which the steam penetration into the standard test pack and steam penetration into hollow devices is compared, to show that hollow devices may present a far greater challenge than the standard test pack [Gömann et al. Central Service Vol 3, 2001].
A steam steriliser capable of a successful thermometric small load test is not a 'good for all steriliser'. Such a steriliser is not necessarily capable of sterilising porous materials of different composition (mixed cotton-polyester/ micro-fibres/ laminated fibres), larger or smaller pack sizes, packs wrapped in materials conforming to EN868-2/sub., stainless steel surgical instruments, hollow devices or lumen. The capability of the particular steam steriliser to sterilise the actual loads (specific medical devices, packaging, loading configurations, amounts, etc) when connected to the facilities that are available in the given situation shall be established by performance qualification to international standard (ISO 17665)."
Adrie de Bruijn
National Institute of Public Health and the Environment (RIVM)
PO Box 1
3720 BA Bilthoven
The Netherlands
|