[Recommendation for validation and routine monitoring of sterilization processes with ethylene oxide for medical devices]. / Zalecenia dotyczace walidacji i rutynowej kontroli procesów sterylizacji tlenkiem etylenu.

The European Medical Device Directives specifically address sterilization issues in a number of instances. The European Standards for sterilization of medical devices, especially EN 550, EN 554, EN 556 regulate the manufacture, installation and operation of sterilizers as well as the validation of sterilization processes, on using ethylene oxide (EN 550) or moist heat (EN 554) for sterilization. This recommendation is intended as a source of information for conducting validation according to EN 550 and concomitantly for ensuring that the medical devices reprocessed (cleaned, disinfected, packed, sterilized, stored) in the hospital setting or in other healthcare establishments are endowed with the same level of safety with respect to sterility as that of industrially produced and marketed sterile medical devices.

[Standardization. Sterilization standards and their impact on hospital services]. / Normalizacja. Normy dotyczace sterylizacji i ich wplyw na praktyje szpitalna.

The European commission produced series of Directives which were aimed at harmonizing the European market whilst maintaining high standards to protect the citizens. Within each directive drafted Essential Requirements which had to be satisfied in order to market throughout Europe. The Medical Device Directive (93/42/EEC) covers the vast majority of medical devices including active non-implantable and non-active implantable medical devices. Demonstration of compliance to harmonized European Standards (EN) was proof of compliance with Essential Requirements of the Directives. The European Standards Body (CEN) created a series of European Standards which would enable to demonstrate compliance with Essential Requirements. The CEN organisation has a pyramidal structure. Standards are produced in the CEN Technical Committees (TC's) composed of representatives from each country's own standards organization. The Technical Committee in turned created a series of Working Groups (WG), who's job it was to actually generate the text of the standards. Two of standards committees are working to generate standards which relate to sterilizers and sterilization: TC102--the standards emanating from this committee are product related, TC 204--the standards relate to sterilization practice. In Poland, the standarisation activity is provide by Polish Committee of Standardisation. From 5th June 1997 operate Problem Commission number 272 for sterilization affairs. The job of the commission consist on translation of European'offs Standards and transform them to Polish Standards. After accede Poland to European Union, Polish hospitals will have to adjust to European Standards.

[Validation of sterilization processes]. / Walidacja procesów sterylizacji.

Sterilization is a special process, where the results of processes (efficacy of sterilization) cannot be verified by subsquent inspection and testing of the product (the items sterilized). For this reason sterilization process must be validated. Validation of sterilization processes is required by Medical Devices Directive 93/42 EEC and GMP. Also the sterilization processes in the hospitals shall be validated. The validation of sterilization of processes as described in European Standards: EN 550--for ethylene oxide EN 554--for moist heat.

[Sterile packaging]. / Opakowania sterylizacyjne.

After decontamination, cleaning, maintenance and functional testing, sterilized items must be packed suitably. The package must protect sterilized items against microbial contamination during removal from the sterilising chamber, and during storage or transport until use. The sterilized material must be packaged in suitable packaging material in accordance with the sterilising method. Sterilization packaging must conform to standards. There are not Polish standards for sterile packaging of medical devices. The article give general guidelines about: properties of sterile packaging, various national standards and European Standard, the packaging materials, general compatibility with the sterilization process which is intended to be used, general compatibility with the package forming process, and shelf life considerations.

[Evaluation of medical supplies sterilization at health care institutions in Poland]. / Ocena sterylizacji sprzetu medycznego w placówkach sluzby zdrowia w Polsce.

The assessment of the condition of sterilization of medical supplies in health care settings in Poland was done. The following issues were taken into consideration: preparation of medical supplies for sterilization, methods of sterilization, including used apparatus, and the control systems for monitoring the quality of sterilization process. It was shown that the system of sterilization of medical supplies in Poland is not satisfactory. There is the need for improvement actions, especially including: the change for dry-heat sterilizers to autoclaves; the organization of the centers for sterilization services; the installation of washer-disinfectors, and the wide introduction of monitoring of the quality of sterilization processes with the use of chemical indicators and the periodic control with biological indicators.

[The effect of growth media on recovery of test microorganisms after exposure to saturated steam under pressure]. / Wplyw podlozy wzrostowych na odzysk drobnoustrojów testowych poddanych dzialaniu pary wodnej w nadcisnieniu.

The aim of this study was to find out which growth media give the best condition for the development of test bacteria after exposure to saturated steam under pressure. The test organisms were strains of Bacillus subtilis NCTC 3610 and Bacillus stearothermophilus NCTC 8923. The test prepared from spore suspension were exposed to saturated steam under pressure 0.2 atn-B.subtilis, and 0.7 atn-B. stearothermophilus with various length of exposure /sublethal conditions/. After the exposure the tests were placed in growth media. The obtained results show that the compositions of the medium in which spore-forming bacteria are grown after the exposure under sublethal conditions to saturated steam under pressure affects the recovery of the test organism. The media with glucose, tryptose and L-alanine provided the best conditions for growth.

[The influence of load size on the result of ethylene oxide gas sterilization]. / Wplyw wielkosci zaladunku na efektywnosc sterylizacji gazowej tlenkiem etylenu.

The purpose of the study was establishing whether the size of the load--that is the degree of filling of sterilizer chamber with medical instruments--could have an effect on the time needed for eradication of all microorganisms subjected to the action of ethylene oxide. The test organism used was the strain of Bacillus subtilis var. niger ATTC 9372. Tests were prepared with about 3.6 x 10(6) spores per one test. The tested samples were exposed to ethylene oxide at concentration of 750 mg/l, at 50-80 degrees C, at 40% humidity during 30, 60, 120, 180, 240 and 300 minutes in three variants: in empty sterilizer chamber im chamber loaded with plastic objects (polyethylene and polypropylene)--600 g weight in chamber with similar load weighing 1200 g. The obtained results showed that the degree of filling of sterilizer chamber influenced the efficiency of gas sterilization with ethylene oxide. The effectiveness of each sterilization process with ethylene oxide should be controlled using biological indicators.

[The stability of biological indicators used for monitoring ethylene oxide gas sterilization]. / Okreslenie wplywu okresu przechowywania biologicznych wskazników kontrolnych na ich przydatnosc do monitorowania procesów sterylizacji gazowej tlenkiem etylenu.

It was found the correlation between the storage time of biological indicators and their usefulness for monitoring of gas sterilization with ethylene oxide (EO). Bacillus subtilis var niger ATTC 9372 was used as a test organism. Two kinds of investigations were done: observation of bacterial growing or lack of growing after 1 hour exposition of storage tests in EO (EO concentration- 750 mg/l, temperature +/- 50 degrees C, (humidity-40%) and examination of drop in number of spores on strip tests after storage time. The results show that sterilization efficacy may be monitored using such spore strip tests up to six months of storage.

[Actual state of medical supply sterilization in Poland]. / Aktualny stan sterylizacji sprzetu medycznego w Polsce.

The analysis of condition of sterilization of medical supplies in Poland was done. It consider the problem of preparation of medical supplies to sterilization, methods of sterilization and control monitoring system in this matter. The results of this analysis suggest proposition for improving of activities in this field.