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KSR Publishing, Inc.
Copyright © 2016

         Clinical intelligence for supply chain leadership



December 2013

CS Solutions



Questions can be sent to:jakridge@hpnonline.com
called in to Jeannie Akridge at HPN:(941) 927-9345 ext.202 or mailed to:
HPN CS Questions, 2477 Stickney Point Road, Suite 315B, Sarasota, FL 34231
Names and hospital identification will be withheld upon request.

Ray Taurasi

Distilled water vs. saline soak; tears in wrapped sets; keeping instruments open for cleaning

by Ray Taurasi

Q Although I am not sure why, I have always been told that surgical instruments should not be left soaking in saline. During surgery, our OR staff places all used instruments in a ring stand soak basin which contains irrigating saline. When the case is over they place all the instruments in saline soak basins for transport to SPD for reprocessing. I have been trying to get them to stop this practice and use distilled water instead. The OR staff is resistant to this change and the OR supervisor says there is no need to change as she doesn’t want to add another basin to the surgical field. Am I wrong in my thinking? If not can you provide some support information to me that might be helpful in facilitating change?

A What you have been told is correct, surgical instruments should not be soaked in saline. Saline contains chloride ions which can be very damaging to surgical instruments. These chloride ions are highly caustic and can cause pitting and deterioration to instruments. (See figures 1 and 2.) For support you most likely will not have to look any further than your instrument manufacturers IFU on the care and handling of their surgical instruments. Most clearly state that prolonged soaking especially in saline solutions should be avoided. Professional organizations such as, AAMI, AORN, and IAHCSMM also advise against soaking surgical instruments in saline in their recommended practice documents and educational technical training manuals.

Figure 1
Figure 2

Q I am the nurse manager for Sterile Processing Services for a large acute care hospital. We sometimes find tiny tears that penetrate one layer of the instrument set wrapper. Some of the OR and SPD staff feel that it is ok to use the set as long as the tear hasn’t penetrated all layers of the wrapper. Others believe that if any tears are found the sets must be considered contaminated and not used. Those in favor of using the sets argue that it is similar to using the inner package of a peel pouch that is double pouched. I frankly am undecided; I can see the rationale of both arguments. What are your thoughts?

A I believe that if any compromise in sterile packaging integrity is found that the set must be considered unsafe for use, broken down and completely reprocessed. You cannot compare the peel pouch scenario to flat wrap. Packaging materials are class 2 medical devices and for FDA clearance they must demonstrate specific bacterial barriers, sterilization compatibility and the ability to maintain sterility until the point of use. Your IFU for the flat wrap gives specific directions for wrapping and use of their product in accordance with product validations. The appropriate use ensures that the packaging material will provide the required barrier to microbial penetration. That means that all layers must be intact. For FDA clearance, peel pouches have demonstrated that their material composition provides the specified and validated microbial barrier with single pouch packaging. If there was a tear or hole in a peel pouch you would consider the contents contaminated. In cases where you might double pouch with the intent to dispense the inner pouch onto a sterile field or pass off to the scrub nurse — if the outer pouch is compromised or has a tear the inner pouch must be considered unsterile and should not be passed off to the scrub nurse or placed on a sterile field.

Figure 3
Figure 4

Q I understand that hinged, ring handled and movable part instruments are supposed to be left opened during the cleaning process, however for many devices like rongeurs this just isn’t feasable or possible when using automated washers. Manufacturer IFUs state the devices should be open but they provide no directions as to how this can be done. So if we don’t follow the IFUs, we are libel if the instruments aren’t clean. Since there is no way to keep these instruments open in a washer we are spending far too much time on manual precleaning measures and often this leads to inadaequate cleaning, or the instruments just going through the washer unopen. Do you have any suggestions?

A When instruments are closed, they are closed to cleaning. Water and detergent cannot reach all the surfaces of the instrument. It is these more complex instruments that are more likely to harbor organic matter, which can lead to cross contamination and possible infection. Device manufacturers, AAMI, AORN, and others strongly recommend that instruments be kept in an open position when being cleaned. Open instruments will allow for the maximum exposure to cleaning agents and the mechanical actions that dislodge and remove soil. There are various instrument spreaders available which are designed to keep such instrumentation open during the automated cleaning process. (See figures 3 and 4.)

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. He is a member of AORN, AHA, SGNA, AAMI and a past president of IAHCSMM and has served on and contributed to many national committees with a myriad of professional organizations, manufacturers, corporations and prestigious healthcare networks. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences. In addition to this column he has authored several articles and has been a featured speaker on the international scene.