Sterilization Of Medical Devices Wfhss-Books Pdf

Sterilization of Medical Devices WFHSS
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Level 2 Script of the wfhss education group Sterilization of Medical Devices. TABLE OF CONTENTS, 1 Definitions 3, 2 Introduction 5. 2 1 Characteristic parameters for calculating the effectiveness of a thermal sterilization. process background information 5, 2 1 1 D value 6, 2 1 2 z value 6. 2 2 Spores 7, 2 3 Proof of sterility 7, 2 4 Killing behaviour 8. 3 Sterilization processes 10, 3 1 General requirements for sterilization processes 10. 3 2 Sterilization with moist heat 11, 3 2 1 Processes for sterilization of liquids background 11.
3 2 2 Steam sterilization processes for reusable medical devices 12. 3 2 3 Steam sterilization of medical devices 13, 3 3 Low temperature sterilization processes 25. 3 3 1 Sterilization with ethylene oxide 26, 3 3 2 Sterilization with steam formaldehyde 30. 3 4 Hydrogen peroxide sterilization 33, 3 5 Sterilization with ionizing radiation 34. 4 References 35, Level 2 Script of the wfhss education group Sterilization of Medical Devices. Sterilization of Medical Devices, 1 Definitions, Based on the definitions of international standards the definition in brackets is the trial of a.
more understandable wording, Sterilization Validated process used to render a product free from viable microorganisms. killing or irreversible damage of all viable microorganisms. Sterile condition of a medical device that is free from viable microorganisms. with a probability of 1 1 000 000, D value Exposure time required under a defined set of conditions to cause a 1 logarithm or. 90 reduction in the population of a particular microorganism. the D value decimal reduction time is the time in minutes that is required to reduce a. population of a particular microorganism by one log level corresponding to an inactivation rate. z value Change in temperature in Kelvin K required to achieve a tenfold change in the rate. of microbial inactivation by a moist heat disinfection process. the z value gives the change in temperature in C needed to cause a 10 fold change in the D. value of an organism z denotes the relationship between temperature and microbial. inactivation and this is expressed in Kelvin K or C. SAL Sterility Assurance Level expressed as the probability of survival of a microorganism. after exposure to a sterilization process Usually an SAL of 1 1 000 000 10 6 is required. Spores Survival form of certain bacterial species spore forming bacteria. Steam Gaseous water, Steam under pressure Steam under a pressure that is higher than the atmospheric pressure. Saturated steam Water vapour in a state of equilibrium between condensation and. evaporation Steam with maximum water content, Superheated steam Water vapour whose temperature is higher than the boiling point of. water at the corresponding pressure, Autoclave Steam sterilizer but this term usually is not used for sterilizers for medical.
devices laboratory or waste autoclave, Level 2 Script of the wfhss education group Sterilization of Medical Devices. Equilibration time period which elapses between the attainment of the sterilization. temperature at the reference measurement point and the attainment of the sterilization. temperature at all points within the load, Sterilization module rectangular parallelepiped of dimensions 300 mm height 600 mm. length x 300 mm width Hence one StU has a volume of 54 litres. Standard test pack Laundry pack comprising cotton towels measuring 22 x 30 x 25 cm as. per EN 285, BD test Bowie Dick Test, Non condensable gas Air and other gas which will not condense under the conditions of. steam sterilization, Absolute temperature Temperature scale which is based on the absolute zero point. 0 00 K 273 15 C Usually a temperature difference is given in K. Sterile barrier system The minimum packaging configuration that provides a microbial. barrier and allows aseptic presentation of the product unit at the point of use. Batch Quantity of goods or material produced in a single manufacturing run. In this context the term batch denotes the entirety collectivity of sterile supplies assembled. in one sterilizer load which is exposed to the same conditions and for which the same. sterilization outcome can thus be expected, Validation Documented procedure for obtaining recording and interpreting the results.
required to establish that a process will consistently yield product complying with. predetermined specifications, In this context Validation serves to furnish documented proof of the ongoing effectiveness of. the reprocessing procedure under the operating conditions prevailing at the installation site. using the items encountered in routine operation in their respective packaging and with the. reference loads used i e produces clean disinfected or sterile devices. Routine control Tests to be carried out by the user to guarantee the ongoing effectiveness. and reproducibility of the reprocessing procedures. Level 2 Script of the wfhss education group Sterilization of Medical Devices. 2 Introduction, Medical devices that penetrate the skin or mucosa come into contact with wounds or are used. for blood blood products and other sterile medicinal products must be sterile when used. these are medical devices classified as critical by as per the regulations of the Robert Koch. Institute RKI, However that an object is free of viable microorganisms i e sterile is something that can. be claimed only with a certain degree of probability. European standard EN 556 based its definition of sterile medical devices on that of the. European Pharmacopoeia An item can be viewed as sterile if the theoretical value of not. finding more than one living microorganism in 1x106 1 million sterilized units on the end. product is assured, Accordingly the aim of sterilization is to achieve a Sterility Assurance Level SAL of 10 6. Sterilization is one step of the procedure used to process or reprocess medical devices The. other steps of reprocessing are cleaning and disinfection These decontamination measures. are aimed at reducing the microbial count to such an extent that before sterilization the. microbial load of heat resistant microorganisms with a D121 C value of 2 5 min see below. present on the supplies can be assumed to be zero To achieve a SAL of 10 6 the. sterilization process must be able to reduce the microbial count of heat resistant. microorganisms by 6 orders of magnitude 6 log levels see also Fig 3. 2 1 Characteristic parameters for calculating the effectiveness of a. thermal sterilization process background information. The effectiveness of a sterilization process can be calculated and evaluated on the basis of. certain parameters that have been experimentally identified. For an identified sterilization time T the associated holding time Z T can be calculated as. with D T 10 121 C T z D 121 C, n desired microbial reduction 6.
D 121 C 2 5 min and, z 8 K for the temperature range to 128 C. The characteristic variables used here are primarily the microbial and process specific D. values and z values, Level 2 Script of the wfhss education group Sterilization of Medical Devices. 2 1 1 D value, D value the D value decimal reduction time is the time in minutes that is needed to reduce a. population of a particular microorganism by one log level at a given temperature. corresponding to an inactivation rate of 90, The D value can be obtained from an experimentally identified survival curve or from an. For example spores of Geobacillus stearothermophilus at 121 C have a D value of around 1 5. 2 5 min and at 115 C the D value is approx 18 min, 2 1 2 z value.
The z value gives the change in temperature in C needed to cause a 10 fold change in the D. value of an organism z denotes the relationship between temperature and microbial. inactivation and this is expressed in K degree Kelvin as absolute temperature unit. These values are based on calculation of sterilization parameters for processes using. standardized sterilization parameters, D values in D values in min. Microorganism spore z value, min at 115 C at 121 C. suspension in water K, D115 C D121 C, Geobacillus, 15 24 1 5 4 0 6 7. stearothermophilus, Bacillus atrophaeus 2 2 0 4 0 7 8 13. Bacillus megaterium 0 025 0 04 7, Clostridium sporogenes 2 8 3 6 0 8 1 4 13.
Tab 1 D values and z values for some spore forming bacteria as per Wallh u er 1988. Following the formula above the D value for G stearothermophilus at 134 C is only a few. Other characteristic variables used for sterilization processes such as the F value and degree. of lethality will not be discussed in detail here, Lethality The sterilizing effect which is also called lethality or death rate indicates the effect. of a heat treatment expressed as the number of decimal reductions in the number of. microorganisms, F Value The F value for the process is the number of minutes required to kill a known. population of microorganisms in a given item under specified conditions. Level 2 Script of the wfhss education group Sterilization of Medical Devices. 2 2 Spores, A number of groups of bacteria spore forming bacteria are able to form highly resistant. capsules spores when facing environmental conditions that are unfavourable to them During. sporulation the cell plasma membrane largely melts away and the remaining spores can. persist for years or even decades while surviving unharmed external influences such as heat. cold draught or exposure to disinfectants see Specialist Course Level I Script. These heat resistant spores include bacteria that have major implications in surgery such as. those causing gas gangrene or gas oedema Clostridium perfringens C histolyticum C. novyi as well as the causative organism of tetanus Clostridium tetani This is actually the. reason why surgical instruments have to be sterilized while thermal disinfection suffices for. other bacteria such as Staphylococcus aureus which often cause postoperative wound. infections, 2 3 Proof of sterility, Proof that a medical device is sterile cannot be provided by the end product For a sterility test. based e g on immersion of the device in a nutrient solution in purely statistical terms more. than one million of specimens would have to be investigated to demonstrate a SAL of 10 6. Apart from the fact that a high level of secondary contamination would be likely it would not be. possible to detect all microorganisms or to use the devices after examination. Therefore for many years now bioindicators have been used to verify the effectiveness of. sterilization This meant that germ carriers harbouring G stearothermophilus spores of a. defined resistance and population microbial count were exposed to the process and an. investigation then conducted to see whether all spores had been killed. In many facilities the use of bioindicators already has been replaced by physical tests for. steam sterilization in the healthcare setting with the entire pressure and temperature course. of a cycle being recorded by means of thermocouples and pressure sensors Based on the. theoretical temperature it can be elucidated whether saturated steam conditions are assured. at all sites within the sterile supplies Verification of the test results by means of bioindicators. as was prescribed until recently and continues to be stipulated in some cases by the. authorities can now be omitted in the case of sterilizers that are subjected to annual. thermoelectric testing or of validated processes based on EN ISO 17665. In many countries validation of sterilization processes is a legal requirement Hence the. sterilization process must be validated i e to demonstrate that the requirements are being. reproducibly met for each step of the process, Level 2 Script of the wfhss education group Sterilization of Medical Devices.
2 4 Killing behaviour, Please refer to Specialist Course Level I Script for information on the growth. reproduction of microorganisms, The various types of processes that can be used for sterilization differ essentially in terms of. their principle of action, In steam sterilization microorganisms are quickly killed through denaturation destruction of. their proteins Conversely superheated steam needs a longer time and a much higher. temperature to effect killing since under such conditions microorganisms are killed through. oxidation processes Sterilization in superheated steam is comparable with hot air sterilization. 180 C 30 minutes Superheated steam has a negative impact on the sterilization process. since this steam does not or does not adequately condense and only steam that is able to. condense will be able to transfer the requisite energy in the form of the heat released during. condensation to the sterile supplies, The sterilisation process must demonstrate evidence that the Sterility Assurance Level SAL. the probability of a microorganism being present is equal to or less than 1 10 6 has been. achieved for the respective sterilizer load The specified sterilization conditions must be based. a proven temperature time relationship or, experience of the bioburden microbial load on the respective medical devices and.
of the resistance profiles of such microorganisms, In the healthcare setting only processes that meet the first condition are used. Above the maximum temperature range at which microorganisms can survive these are not. as one would expect abruptly killed after a certain exposure time rather a reduction in the. Level 2 Script of the wfhss education group Sterilization of Medical Devices Page 5 35 2 Introduction Medical devices that penetrate the skin or mucosa come into contact with wounds or are used for blood blood products and other sterile medicinal products must be sterile when used

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