Central Service - Issue 1/2000
- What's New in Standardisation: Steam Sterilizers for Laboratory Use
- Central Service for ÖGSV Members
- CE Mark
- Medical Devices Operator Ordinance
- Education & Work in the Field of Sterilization in Australia
- Austria: Directive on Processing of Endoscopes
P. M. Schneider:
Requirements for Parametric Release of Steam Sterilized Products
Parametric release of sterilized product provides a mechanism for release based solely on measurement of physical sterilization process parameters. However, parametric release is only one possible outcome following implementation of a quality system and validation of the sterilization process. Validation of the sterilization process encompasses all aspects of device processing or reprocessing that may effect the sterile condition. This includes validation of the sterilization equipment as well as validation and control of cleaning, packaging, loading and the actual sterilization process. While medical device manufacturers routinely validate the sterilization process and have appropriate quality systems in place, health care facilities in the United States have neither the resources to implement this process nor are their operations inherently conducive to process validation.
Validation of Irradiation Doses.
5 Years Experience with Method 1 of ISO Standard 11137
The European Standard EN 552 for validation and routine control of sterilization by irradiation (1) mentions under point A.4.1 (ff) that for the sterilization of medical devices which have to comply with the requirements of EN 556 (2) either the (historically well established) >= 25 kGy as sterilization dose or one of the methods which are based on the knowledge of the quantity of micro-organisms naturally occuring on the medical devices should be used.
These methods mentioned are described as Method 1 and 2 in the ISO standard 11137 (3) and Method 1 will be used more often than method 2 (1). The use of method 1 requires minimum doses for the sterilization of medical devices which are too high. This is due to the over-proportional influence of irradiation resistant micro-organisms (D10 values > 4 kGy), micro-organisms which practically do not occur in reality but which are used for the calculation of the final sterilization doses.
When these (only theoretically) occuring highly irradiation-resistant micro-organisms are left out of the calculation - and there is experimentally based evidence that they can be left out (4) - the necessary doses for the sterilization of medical devices may be reduced up to 25% under awareness of the requirements of EN 556 with positive consequences for the final manufacturing costs of medical devices.
Reuse of Single-Use Devices
Reuse of products meant to be used only once remains a controversial issue, not only in Europe but also in the United States where the Food and Drug Administration (FDA), after carrying out a thorough market study, intends to adapt the regulations regarding disposables (ref. Zentr Steril 1999; 7 (6): 359-361).
In Europe the Medical Device Directive (93/42/CEE) has as far as the manufacturer is concerned created the necessary clarity. However, the activities of the C.S.S.D. remain nebulous in those countries of the European Union where the government has not provided a regulatory framework in relation to reuse. In a number of countries reuse is strictly forbidden. In others the government's attitude is ambiguous by not promulgating clear guidelines as it fears the financial consequences of a total ban.
It is evident that an adequate answer in the form general guidelines of has to be provided by policy makers on the European level. The EFHSS can contribute by unanimously deciding on a minimum platform and by communicating it to the European decision makers. The proposition made by ASTER and VSZ to the Belgian authorities (see below) may serve as a basis for discussion. The proposition discusses only reuse within the same hospital where reprocessing is performed. "Reuse" in this context is defined as the use of a previously used product.
You are kindly requested to comment on the proposals via Central Service or the IDI Website (www.wfhss.com). Your reactions will then be incorporated into the final proposition.
Validation of Steam Sterilization Processes
Infections by Pseudomonas aeruginosa
Laundry Sterilization for another Hospital
Deposits on Sterilized Items