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Q I am an infection control manager and recently attended an infection control conference. One of the speakers talked about various utility requirements for the sterile processing area and had emphasized the need to have medical grade air readily available. I don’t quite understand exactly what medical grade air is or its application in sterile processing. Does this apply to the environmental air that is circulated through the department or is it oxygen for emergency carts?
A Medical grade air, sometimes mistakenly referred to as instrument air (medical gases are respired, instrument air is not), is basically a medical gas that must meet the requirements set forth by the National Fire Protection Association, NFPA 99: Health Care Facilities Code. This air must be compliant with American National Standards Institute and International Society of Automation ANSI/ISA S-7.0.01. That is the quality standard for instrument air, which is filtered to 0.01 micron, free of liquids, and hydrocarbon vapors and dry to a dew point of -40°F (4.444°C). There are medical devices such as those with lumens that require drying and instrument air is blown through the channels; instrument air may also be used for testing the performance of some medical devices. (See Figure 1.)
Q I am the perioperative educator and quality assurance specialist for our offsite ambulatory care and surgery centers. During a recent accreditation inspection the surveyor issued a citation because cleaned instruments were being returned to the main hospital dry and in a closed tote container. The surveyor referenced an infection control standard that said instrumentation should be kept moist during transportation for final processing. I questioned the citation and told her our policy was for the satellite centers to manually clean all instruments, in accordance with IFUs, and then place them in a covered bin for return to the main hospital where they are packaged and sterilized. The surveyor held firm on the citation and further recommended that we assess our entire process for the handling and transportation of instrumentation between the satellite locations and the main hospital campus. I really feel that the citation is unwarranted and believe our method of handling “clean” instrumentation is appropriate. Am I wrong? What am I missing here?
A Without knowing the standard, source and reference for the citation I cannot really fully address or respond to your issues and concerns. In general, I can see no rationale for or need to keep clean instruments moist during transportation. There are several recommendations, guidelines and standards relative to the transportation and handling of soiled, clean and sterile medical devices. The accrediting bodies and their surveyors are very watchful and concerned regarding proper handling and transportation of medical devices in accordance with standards of practice. It seems to me that the surveyor may not have fully understood your protocol or likely saw practices that were questionable or conflicting. You should be able to obtain the reference standard for which you were cited as non-compliant in order to respond with a corrective action plan.
When assessing your current protocol you should include the following:
- Does your process allow for complete segregation of clean, sterile and soiled items from one another?
- Are all items properly contained in covered, rigid, puncture-proof containers?
- Are all containers clearly labeled and identifiable as clean, sterile, soiled and/or biohazardous?
- Are the conditions of the soiled and clean processing rooms in compliance with standards?
- Are the manual cleaning procedures strictly enforced and in compliance with the device manufacturer’s IFUs?
- Are all the personnel responsible for processing /cleaning the instruments at the various satellite centers trained and competent to perform these functions?
- Are personnel following the proper use of personal protective equipment (PPE)?
- Are the processing protocols consistent throughout the organization?
- Are the transportation vehicles in compliance with various DPH, DOT regulations?
- Are policies and procedures readily accessible to personnel at all locations?
- Are quality assurance protocols for cleaning verification and documentation in place?
Q I am the lead Central Sterile Processing (CSP) technician and report to the OR nurse manager. We only have one magnifier in our department which I know is not sufficient. I would like to have one at every work station and we really need a borescope to inspect our shaves and small instruments with channels. Every time I bring this up to my manager she says the one we have should be enough and that there is no requirement to have one at every station. She says that the budget is tight and that there is no way we can spend several thousand dollars on magnifiers. What can I do to convince her that we do need more inspection devices?
A You are absolutely correct – one magnifier is not enough to conduct the inspections of your instruments and other medical devices properly. There are many different types of visual inspection tools that should be used in CS to thoroughly inspect devices. (See Figure 2.) One type of visual inspection device cannot meet all of your needs. Most instrument manufacturers’ IFUs include a visual inspection step. Inspection is of course necessary to ensure that visual soils are removed but instruments also need to be inspected to be certain they are not damaged. Many instruments have small parts, recessed crevices, channels and other areas that cannot been seen by the naked eye or reached without the use of a borescope.
Just about all of the professional organizations that have guidelines or standards including AAMI, AORN, SGNA, emphasize the need for visual inspection. I would suggest that you review these documents for support as well as the IFUs of your instrument manufacturers, especially orthopedic devices such as arthroscopic shavers. To help get you get started here is an excerpt from ANSI / AAMI ST79 Section –7.5.5: “After completing the cleaning process, personnel should visually inspect each item carefully to detect any visible soil. Inspection using magnification might identify residues more readily than the unaided eye.”
I recommend that you gather all of the information necessary to support your need for additional visual inspection tools and share it with your manager, along with a request for the devices you need.
