Rapicide (cidex) Opa 28 Sterilization Gallon New Ml02-0127 Exp 05/2016

US $2100

  • Bangor, Maine, United States
  • Jan 30th
RAPICIDE® OPA/28 High Level Disinfectant   1 Gallon container p/n ML02-0217 (compare to J&J ASP Cidex OPA) SUBJECT:    Use of Rapicide OPA/28 High Level Disinfectant  DATE:                       Policy No.          APPLICATION: SPD, OR, Endo/GI   DISTRIBUTION: RECOMMENDED: SPD / Sterile Processing Manager APPROVED BY:   Rapicide OPA/28 High-Level Disinfectant is a fast-acting, long lasting, highly compatible high-level disinfectant ensuring a safe and healthy environment for patients and staff.  This reusable ortho-phthalaldehyde disinfectant is designed for use on heat-sensitive, semi-critical medical devices that are unsuitable for sterilization.  This policy is meant to give guidelines for staff using Rapicide OPA/28 High Level Disinfectant and OPA/28 Test Strips.  Manufacturer’s Instructions For Use (IFU) should always be followed and kept in a place that is readily available for easy access by all staff.  Indications for Use: Rapicide OPA/28 may be used at or above the minimum recommended concentration (MRC) of 0.35% OPA as determined by Rapicide OPA/28 Test Strips in manual device reprocessing with an immersion time of at least 10 minutes at a minimum temperature of 20°C for a reuse period not to exceed 28 days. Rapicide OPA/28 may also be used in compatible, legally marketed automatic endoscope reprocessors at or above its MRC as determined by Rapicide OPA/28 Test Strips with an immersion time of at least 5 minutes at a minimum of 25°C for a reuse period not to exceed 28 days. Procedure: 1.     Always wear appropriate PPE when handling any High Level Disinfectant. Devices to be reprocessed must first be thoroughly cleaned according to device manufacturer’s recommendations for decontamination. The cleaning process should follow an established cleaning protocol consistent with professional society guidelines and/or a standard such as the ASTM F1518 “Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes used in the Examination of Hollow Viscera. 3.     Proper cleaning of device and removing excess moisture prior to immersing in Rapicide OPA/28 can assist in achieving the full reuse life of the chemistry.  Date and initial the Rapicide OPA/28 HLD bottle when first opened.  Expiration date of solution in the bottle in the original container is 75 days after bottle is first opened, or the expiration date on the bottle, whichever comes first. 4.     Read the directions for use on the bottle label and package insert, then pour Rapicide OPA/28 solution into a solution tray or appropriate container for manual disinfection 5.     Record the date that the solution was poured from the bottle, and the date that it can be reused, not to exceed 28 days. 6.     Use one Rapicide OPA/28 Test Strip to verify Rapicide OPA/28 solution is above minimum concentration level (MRC) before each use.  Dip one Rapicide OPA/28 Test Strip into the solution for 3 seconds. 7.     Read the test strip at 90 seconds and record the results of the test strip on the log sheet.  Test strip Certificate of Analysis may be downloaded at http://www.medivators.com/customer-support/certificates-analysis, by entering lot # on test strip bottle or case.  Quality control can also be performed at facility by following Test Strip instructions for use included with each case of test strips.  NOTE: Rapicide OPA/28 may be reused according to the directions for use up to 28 days provided that prior to each use the concentration of OPA in the solution is verified using Rapicide OPA/28 Test Strips to be above the MRC of 0.35%. The test strips must be used prior to each use. DO NOT rely solely on days in use. DO NOT use beyond the 28 day reuse period or the labeled expiration date even if the concentration is above the       1.     Read the directions for use on the bottle label and package insert, then pour Rapicide OPA/28 solution into a solution tray or appropriate container for manual disinfection 2.     Record the date that the solution was poured from the bottle, and the date that it can be reused, not to exceed 28 days. 3.     Use one Rapicide OPA/28 Test Strip to verify Rapicide OPA/28 solution is above minimum concentration level (MRC) before each use.  Dip one Rapicide OPA/28 Test Strip into the solution for 3 seconds. 4.     Read the test strip at 90 seconds and record the results of the test strip on the log sheet.  Test strip Certificate of Analysis may be downloaded at http://www.medivators.com/customer-support/certificates-analysis, by entering lot # on test strip bottle or case.  Quality control can also be performed at facility by following Test Strip instructions for use included with each case of test strips.   NOTE: Rapicide OPA/28 may be reused according to the directions for use up to 28 days provided that prior to each use the concentration of OPA in the solution is verified using Rapicide OPA/28 Test Strips to be above the MRC of 0.35%. The test strips must be used prior to each use. DO NOT rely solely on days in use. DO NOT use beyond the 28 day reuse period or the labeled expiration date even if the concentration is above the MRC. Maintain the solution at room temperature during the 28-day reuse period. Only Rapicide OPA/28 Test Strips should be used to verify MRC level has been met with Rapicide OPA/28 HLD.   References:    Association for the Advancement of Medical Instrumentation. (2013). Chemical sterilization and high level disinfection in health care facilities (ANSI/AAMI ST58:2005/(R) 2010). Arlington, VA: Author.       
Condition:
New: A brand-new, unused, unopened, undamaged item in its original packaging (where packaging is applicable). Packaging should be the same as what is found in a retail store, unless the item is handmade or was packaged by the manufacturer in non-retail packaging, such as an unprinted box or plastic bag. See the seller's listing for full details. ...
Brand Crosstex
Country/Region of Manufacture United States
Model Rapicide OPA 28
Compare to: J&J ASP Cidex OPA 20391
MPN 02-0217
Expires: May 2016 (5/16)

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