High-Level Disinfection Description: 

High-Level Disinfection (HLD) refers to the treatment of medical devices and dental instruments to inhibit most viable microorganisms, except some spores and prions when present in a significant load. HLD refers to the reprocessing of semi-critical medical devices and dental instruments that are heat-sensitive or incompatible with traditional sterilization methods. Semi-critical devices are devices that contact intact mucous membranes or non-intact skin, and typically do not penetrate tissues or otherwise enter normally sterile areas of the body.

Again the preferred method for critical and semi-critical is heat sterilization, however, if an item is not heat tolerant and there is not a single-use option then HLD is an acceptable method. HLD involves devices undergoing a timed liquid chemical process in which items are treated with a high-level disinfectant and processed with a rinse cycle of water to remove chemical residue. Aespetic transfer and storage should always be considered after rinsing.

HLD: Gluteraldehyde VS. Otrho-phthalaldehyde (OPA)?

Glutaraldehyde has been widely used for a long time in healthcare facilities as a HLD for reusable medical devices. Most solutions are acidic and must be activated to become sporicidal. Ortho-phthaladehyde (OPA) has demonstrated superior mycobactericidal activity compared to Glutaraldehyde and requires no mixing or activation. OPA has been shown to last longer before reaching its MRC and the concentration of the active ingredient does not decrease with age alone.

To protect yourself from exposure to glutaraldehydes and/or OPA's use local exhaust ventilation and use a fume hood where possible. Avoid contact with the skin by using nitrile or rubber gloves (latex does not provide adequate protection). Wear goggles and face shields when handling.

Note: Until recently, there have been only two OPA manufacturers with FDA-cleared 14- day solutions that provide a 12-minute manual soak time. Crosstex now proudly offers an OPA with FDA clearance that has a 28-day reuse life and 10-minute manual soak time, called Rapicide® OPA/28. For detailed product information and work tools (wall posters, solution log sheets) on Rapicide OPA/28 HLD and Rapicide OPA/28 Test Strips, Crosstex invites you to visit: www.OPA28.com

HLD Procedures to Follow (Rapicide® OPA/28):

1. Always wear appropriate Personal Protective Equipment (PPE) when handling any High-Level Disinfectant.
2. Date and initial the Rapicide OPA/28 HLD bottle when first opened. Expiration date of solution in the bottle is 75 days after bottle is first opened, as long as the 75 days does not extend past the expiration date on the container.
3. 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
4. Record the date that the solution was poured from the original container, and the date that it can be reused, not to exceed 28 days.
5. Use Rapicide OPA/28 Test Strip to verify Rapicide OPA/28 solution is above minimum concentration level (MRC) before each use. Dip Rapicide OPA/28 Test Strip into the solution for 3 seconds.
6. Read the test strip at 90 seconds and record the results of the test strip. Test strip Certificate of Analysis may be downloaded by entering lot # on test strip bottle. Quality control can also be performed at facility by following Test Strip instructions for use included with each case of test strips.
7. 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.