INDUSTRY Bidfnow Is the Steam o.k.? The Air Detector Knows the Answer ‘A the international arena sterilisation of medical devices is being continually regulated by new standards , of existing standards are being revised as needed This is particularly true in the case of the standards relating to steam stetisation. In- temational standard ISO 17665 "Steri- ization of Health Care Products", whichis presently available as a draft version, will ‘soon replace European standard EN 554 regulating “Validation and routine moni= toring for sterilisation with moist heat" ‘The second edition of European standard 285 "Steriisation ~ Steam steriisers — Large sterlsers” will soon be published. ‘Standard prEN 13060, which is completely now and applies to the same area but in this case to small stetlisers up to 60 litres, was recently put 2 vote, Publication of this standard is soon expected. All three draft standards make reference toa device known as “air detector" which hitherto hhas elicited little attention in Germany or in other counties, Butjust what isan air detector? Before we answer this question, we must first ofall consider the quality of steam 2s. a sterlant. In this paper steam of @ good ‘quality is understood to moan a form of steam that contains no, or only minute ‘quantities of, air or of other non-con- 30081LETTERS Snow the requisite concentration range, this is surely an acceptable method if one as- ‘sumes thatthe BD laundry package serves 2 a reference for a worst-case scenario. ‘Measurements conducted by the Ad Hoc Group of the TC 102 WG 2 + 3 Stan ardisation Committee, which revised Eu ropean standard 285, have demonstrat- €ed that the BD testis not suitable for all lumened instruments or MIS instruments. Ieis under discussion to incorporate the hollow device process challenge device (PCD) Hollow A as specified in EN 867-5 4s an additional type test into standard EN 286. Whereas the BD test needs ap- prox. 100 - 200 ml NCGs to exceed the 2 temperature range, volumes of less than 1 mi NCG are already critical for an MIS instrument, since this volume cove ers large surfaces within an MIS instru- ‘ment, which then cannot be propery ster- lised. This means that the inert gas con- centrations that are hazardous for MIS in- struments are more than 100-fold small fer that than those applicable to the BD laundry package, representing solid and porous instruments. Cen the air detector measure NCG concentrations that are smaller by even two orders of magnitude? Non-condensable gases are composed of air and primarily CO,, The CO, is gen erated by decomposition of hydrogen car- bonete salts when water is heated, pro- vided that the salts have not been previ ‘ously removed by means of an appropri ate water treatment procedure. Asis well known, there is outgasing of CO, and sir (on heating the feedwater. However, CO; dissolves once again on coming into con tact with water and gives fise to carbon dioxide (aerated water) at low tempera- tures. In the air detector steam condens- ces and, in the presence of NOGs, a two- phase mixture is formed, composed of ‘water and gas bubbles. The gas bubbles are used to measure NCGs. Whereas the air dissolves in the condensate only very slowly, alatge portion of the gaseous CO; immediately dissolves in water. The greater the pH value, the faster wil this dissolve. Hence a large proportion of the CO, dis- ‘appears, thus eluding detection. Can you ive any information on the order of mag- nitude of the detectable CO; proportion? We would be grateful if you could please respond to these queries. Knowing the possibilities and limitations of an air de- tector is surely in the interest of all users ‘of such a system. + [~enaimat sevice —TVatume 2 3000 Author's Reply ‘oer Eittor| | Elem 10 Bee comer | Witte sees ihe 26 stator Dr Kaiser makes reference to the timepoint at which inet gases occur t0 the measurement sensitivity of hollow de~ vices and to detection of CO, indeed, these points merit discussion when fo- ‘using on steam sterilisation. However, the use of the air detector tends to be ‘based on a pragmatic approach: the air detector simulates a medical device which, due tots geometry and cooling properties, hampers steam penetration. To reinforce this effect, the air detector is placed at the most critical site within the steriiser ‘which harbours the highest partion of non- condensable gases. tis checked, and re- set, for proper functioning at the time of validation. At tis juncture it ust be bone in mind that routine validation of the ster- llsation process at annual intervals has become an established practice in hospi- tals in the meantime. When carrying out testing within the framework of valida- tion, thermoelectric measurements are performed in the medical devices ~ as in the air detector. Here observance of the delta 2K criterion plays a pivotal role be- cause the temperature difference mea- ‘sured is a good meesure of steam pene- 348 tration, which is of paramount importance. Since at the time of adjustment (calibra: tion), the air detector correlates with this, ‘measure on using the 8D test packege (checked) (see European standard EN 285) andit simulates a aifficut-to-steriise ‘medical device, its “Go or no 90” signal is decisive in respect of steam penetration. This is all the more true in view of the fact that this test is not conducted once annually or daily but for each and every sterilisation load. For routine operation the air detector is a robust test system that conforms to EN 285.However, the Ad Hoc Group of the TC 102, WG 2+ 3 Stan- daidisation Committee, of EN 285, has acknowledged that the BD test is not nec- essarily representative of hollow device systems. This fact will probably lead to a tightening of EN 285 in that a special ho!- low device test system willbe introduced (Hollow A), However, this does net at all impinge of the use of the air detector. Standardisation institutes and industry have a joint task: technology and stan- ‘dards must be tallored to each other. With- ‘out anticioting future events, itis con celvable that the air detector will be equippedin the form of a Hollow A device as outlined in EN 8675, This would assure ‘a direct correlation between the air de- tector and MIS hollow devices, endowed with corresponding sensitivity. But we ‘must first of all avait further develop- ‘ments and amendments to EN 285 which has just been revised. +