October 2007

Q I am being asked to incorporate the processing of scopes into my sterile processing department. Should disinfection be done in the decontamination area or in the preparation and packing area? We have limited space. I am concerned about technique as well as the possibility of employee exposure to glutaraldehyde. My biomedical department said that ventilation hoods are not required but the labeling on the containers said that the chemicals should be used in a well ventilated area and that the soaking bins should be kept covered. How can I be sure the ventilation is adequate in my processing area?

A Let me preface my answer by stating you should obtain and follow the recommendations of your chemical manufacturer for the specific disinfectant agents you are using, as well as, relative state and federal EPA and OSHA regulations. Disinfection should be conducted in a clean environment – ideally it would be nice to have a segregated room for this practice to ensure the separation of soiled and cleaned equipment thus reducing the potential of cross contamination. Many institutions do not have the resources or space to facilitate such physical barriers (walls). If this is the case in your hospital it is important for you to establish a one way flow for processing of soiled goods, through the cleaning and disinfection processes. You can accomplish this by designating a specific work station or section of a work station for a particular function e.g. cleaning and disinfection. You can utilize signage or barrier lines to aid in the designation of work space use and flow. Workers must adhere to the proper dress codes and utilize PPE accordingly. This would require the changing of attire and PPE between the cleaning and decontamination process.

Q There seems to be an increasing number of medical devices and instruments that are requiring non conventional sterilization exposure times. Many require 10, 18 and even excess to 20 minutes of exposure time. I am concerned relative to the performance of various packaging materials such as wraps, peel pouches, paper bags and the like. Most of the literature provides documentation and validation for no more than 4 – 10 minutes of exposure. How can I be sure these products can withstand the extended exposure times without any compromise in their ability to maintain an adequate barrier to microbial penetration following sterilization? I just don’t feel comfortable using products without the appropriate validation.

A You are not alone. Many OR/CS professionals feel the same way and have voiced their concern to manufacturers, professional entities and governing agencies. Packaging materials are classified by FDA as class II medical devices and must be cleared by FDA for marketing. As you indicated most of these products were cleared and received their 510K’s prior to the onset of these extended cycles. So most were validated utilizing the more conventional sterilization exposure parameters of 4 – 10 minutes. As users we can’t be confident of a product’s performance and capabilities without specific validation and backup documentation which includes the product’s use under relative sterilization parameters. Thus far one professional entity, the Association of periOperative Registered Nurses (AORN), has published a statement which addresses this concern. In August 2007 the AORN Sterile Processing/Materials Management Specialty Assembly issued the following statement:

As of September 12, 2007, two manufacturers, Kimberly-Clark and Healthmark Industries, have responded to the AORN statement and have posted the documentation for the use of their packaging products, peel pouches, disposable wraps and paper bags in extended sterilization cycles on the AORN website, aorn.org Both manufacturers have validated their packaging products for extended cycles of 275°F for up to 30 minutes exposure.

Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His healthcare career spans over three decades as an administrator, educator, technologist and consultant.