PubMed · 15181796
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2004. Developing high quality training.. https://pubmed.ncbi.nlm.nih.gov/15181796/
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Sterile services departments are in such a poor state that new centres are needed. A super-centre, shared between local trusts, is to be tried in Bradford and Leeds. Stocks and movement of instruments will need close monitoring under a centralised system.
OBJECTIVES: To develop a microbial test method to ascertain the passage of airborne bacteria through the medical device packaging system after sterilization, and to apply this test method to flexible packages under mechanical pressure changes. METHODS: Petri dishes filled with nutrient agar were integrated into the packaging unit prior to sterilization. We examined paper packaging consisting of 1 (single-paper packaging [P]), 2 (double-paper packaging [PP] and textile and paper double packaging [TP]), and 3 (double packaging with transport packaging [TPP]) layers. After sterilization, the test packages were pressed five times per minute for 1 or 3 hours by a mechanical device weighing 1 kg. This exposure took place in rooms with an average airborne bacterial count of 35 (room 1) or 440 (room 2) CFU/m3. The packaging was opened following culture at 37 degrees C for 48 hours to determine the number of colonies formed. RESULTS: The proportion of contaminated packages rose with the duration of mechanical stress and increased airborne bacteria concentration. Thus, mechanical pressure change for 3 hours resulted in the contamination of 60% (P), 15% (PP), 0% (TP), and 0% (TPP) of the packages in room 1, whereas 100% (P), 65% (PP), 73% (TP), and 0% (TPP) of the packages in room 2 were contaminated. CONCLUSIONS: This test method allows sterile packaging systems to be tested for contamination under practical conditions without extensive laboratory preparation. Contamination as a result of laboratory errors can be ruled out almost certainly.
OBJECTIVES: We assessed long-term trends in ethylene oxide (EtO) worker exposures for the purposes of exposure surveillance and evaluation of the impacts of the Occupational Safety and Health Administration (OSHA) 1984 and 1988 EtO standards. METHODS: We obtained exposure data from a large commercial vendor and processor of EtO passive dosimeters. Personal samples (87,582 workshift [8-hr] and 46,097 short-term [15-min] samples) from 2265 US hospitals were analyzed for time trends from 1984 through 2001 and compared with OSHA enforcement data. RESULTS: Exposures declined steadily for the first several years after the OSHA standards were set. Workshift exposures continued to taper off and have remained low and constant through 2001. However, since 1996, the probability of exceeding the short-term excursion limit has increased. This trend coincides with a decline in enforcement of the EtO standard. CONCLUSIONS: Results indicate the need for renewed intervention efforts to preserve gains made following the passage and implementation of the 1984 and 1988 EtO standards.