Safety Alert for Sterrad Hydrogen Peroxide System, Anvisa registration nº 10132590628, models Sterrad 50, Sterrad 100, Sterrad 100S, Sterrad 200 and Sterrad NX.

Safety alert

923

2008-06-12

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

The outlet oil mist filter and / or filter assemblies on the vacuum pump of the above sterilization systems may fail prematurely and emit a mist of mineral oil and traces of other compounds, which will be transported through the air. advanced sterilization products received reports from users who experienced the following symptoms after inhalation of oil mist: burning, watery, watery eyes, dry throat, headache, nausea, and wheezing. advanced sterilization products states that reported symptoms have been resolved quickly, and generally without the need for medical evaluation or treatment. people with breathing problems, such as asthma, may be at greater risk if exposed to the oil mist. advanced sterilization products states that test results from mist and other compounds indicated levels that were below the occupational safety and health administration permitted exposure limit recommended by the national institute for occupational safety and health, usa, time and limit of short term exposure; however, accumulation of mineral oil and other airborne compounds may exceed these limits if the system operates additional cycles after the first oil emission, especially in an area with poor ventilation. the manufacturer claims that filter failure does not compromise the sterility of the reprocessed devices in a complete cycle and according to the instructions in the user guide. the manufacturer initiated a field correction by issuing an urgent device correction letter, dated april 24, 2008.

Verify that you received from the Advanced Sterilization Products the Urgent Device Correction letter dated April 24, 2008. Identify any affected product in your inventory. The sterilization system should be installed and used only in a well-ventilated area (> or = 10 air / hour changes) as instructed in the "Installation Requirements and Product Specification" document. Users with respiratory problems, such as asthma, should take special precautions against exposure. If mist, mist or smoke is present in the room where an affected system is present, Advanced Sterilization Products recommends the following: (1) Cancel the cycle if the sterilizer is operating. Do not use the instruments of an incomplete cycle. (2) Exit the room and avoid entering again until the mist has dissipated. (3) Discontinue use of the sterilization system until repaired. Contact Johnson & Johnson at 0800 709 6411. The manufacturer states that no adjustments to the oil mist or planned maintenance (MP) filter are required at this time for the Model 50 or Model 100NX systems. The company will perform the following on-site services, free of charge, between April 28 and October 2008: (1) For Model 100S systems: The MP schedule will be adjusted in the software to change the service interval to 6 months or 750 cycles , what happens first. (2) For Model 200 systems: the filter and gasket assembly will be replaced. (3) For Model NX systems: The filter assembly will be replaced, and the MP schedule will be adjusted in the software to change the service interval to 6 months or 650 cycles, whichever occurs first. Execute all MPs according to the schedule. Notify the relevant staff about this issue.