CS Q & A With Bob Marrs

 

Bob Marrs, Director of Aesculap Consulting Services and Field OperationsBob Marrs has 24 years of  Perioperative experience, which includes various roles from Certified Surgical Technologist to CSD Technician, Case Cart Coordinator, Sterile Processing Supervisor, Manager and Director. He maintains certifications as a CRCST, CIS, CHL and is a certified instructor through IAHCSMM. For 6 years during his career, Bob served as the President of the Texas State Association of Central Service Professionals and as an IAHCSMM Executive Board member. He also served as the Chair and Co-Chair of the IAHCSMM membership committee and is currently a member of the Orthopedic Council Committee.


Question:  I just completed reading an article that addresses rigid sterilization containers v. Sterile Wraps. It's interesting that this study found that a whopping 87% of the container interiors - both used and unused - tested positive for bacteria. Thought it was interesting to see that they are recommending the wrap.  What are your thoughts?
Answer:  This article has stirred much debate within the CSD community. I would like to offer some insight to the questions raised with this study. 

 

The vendor/manufacturer of "blue wrap" paid for and sponsored a sterility maintenance study at Applied Research Associates (ARA), comparing blue wrap and rigid containers. I would like to have seen this testing performed by an independent third party at an FDA approved testing facility. They literally had a vested interest to ensure that the study had a favorable outcome for "blue wrap".

The sterile packaging comparison was not a representative comparison of packaging material. Many of the sterile containers were used for years and not properly maintained and as it was stated in the article, some did not meet the manufacturer's specification and should not have been in service. This is of vital importance! As you know, a container is a Class II Medical device. As with all other Class II devices, it is imperative to follow the manufacturers' IFUs for preventative maintenance, disassembly, cleaning, disinfection, assembly, sterilization, transport and use. These devices should be repaired with Original Equipment Manufacturer (OEM) parts.

In this study the wrapped sets that were evaluated, employed new blue wrap and were never put into service such as being transported and stored on a shelf after sterilization. I would have liked to see real world testing of these products. Anyone who has worked in periOperative services, to include the OR and CSD, has seen and experienced first hand the issues surrounding "blue wrap". I do not think that I need to elaborate here.

I would like to discuss briefly the Testing Facility and Methods utilized in this study. ARA, the test facility, has no or limited medical device FDA validation test experience.

Given that some new containers did not achieve positive results, which is contrary to the FDA reviewed validation studies, the entire test method could be in question.
The test method used 8 air exchanges and a 90 minute air flush in the aerosol chamber - This test method is not based on ISO, AAMI or FDA guidelines.
None of the container manufacturers were contacted to assist in the test protocol or to review test results.

I would like to present some facts regarding container systems:

FACT: For over 35 years, the  Container Systems have undergone successful validation testing to support numerous FDA 510(k) clearances for Steam, EtO, ASP STERRAD Sterilization and STERIS VPRO Sterilization.

FACT: As part of the FDA 510(k) clearance process for Container Systems, container manufacturers have successfully performed aerosol validation studies, on new and used containers, at an ISO 17025 accredited laboratory that uses FDA cleared equipment.

FACT: Container System aerosol validation studies for these companies were reviewed and cleared by the FDA.

FACT: Properly maintained containers typically offer a 10+ year service life.

Companies that manufacture containers will offer a number of tools to support users in reprocessing and inspecting the Sterile Container Systems.

At the end of the day, as I stated earlier, a container and "blue wrap" are considered Class II Medical Devices and should be properly used according to the Manufacturers' IFUs. This is the only way to ensure that these devices are safe for use with our patients.

After all, we all do what we do every day for the patient who is under the drapes! We are all in the business of "Patient Safety". We should strive everyday to achieve "Best Practice" at our facilities.


Question:  This subject came up recently at our facility. We all know that different companies have IFUs that tell the user how to handle and reprocess their devices. But what if you want to use their device in a safe way that has not been validated? I think every institution has the right and ability to verify a process but maybe not the knowledge on how to do so.
Answer:  This question hits on two topics, Validation and Verification. Validation is something that can only be performed by manufacturers of medical devices with the assistance of sterilization testing labs (such as SPS Medical now HighPower testing labs). These testing labs are subject to inspection by the FDA and have more stringent standards for compliance. Verification, more specifically "user verification", is the verification of an FDA validated process. 

 

A hospital will perform verification of validated processes in their specific environment. For example, when you receive a new set of loaner instruments you would verify that these instruments can be sterilized in your facility utilizing the manufacturers' IFUs and your specific policies, procedures and sterilization protocols.

A hospital does not have the ability to validate a product for a specific process. While we will all agree that we believe that a product could be safe to use in a particular process, hospitals are not in the testing and validation business. You can, however, request that the manufacturer perform testing and validation and provide you with evidence of this testing. If a hospital decides to utilize a device in a non-validated process, then they have become, for all intent and purposes, a testing and validation lab and will be subject to the same scrutiny from the FDA. This can be a very slippery slope and lead a facility down a road that they are not equipped to substantiate or afford.

Here is an FDA document regarding the Reprocessing of Medical Devices In Healthcare Settings - Validation Methods & Labeling. This is to provide information on what a Medical Device Manufacturer must comply with to attain a 510(k) approval.


Question:  Recently, we've been drying our flexible endoscope in the decontamination area. Now the JHACO commission told us to dry these scopes in the clean side area where we process all the clean instruments. Is this the right way to dry and process the scope after it's done cleaning and processed in the scope machine (medivators)?
Answer:  With the recent issues surrounding the cleaning and high level disinfection (HLD) of duodenoscopes, the Joint Commission has been very focused on the cleaning, high level disinfection, storage and use of these devices, and rightly so. The Joint Commission surveyors are spending more time ensuring that healthcare facilities are following the manufacturers' guidelines and observing that staff are following proper procedure when reprocessing them. The Society of Gastroenterology Nurses and Associates, Inc. (SGNA) released updated guidelines for the care and handling of these scopes.

While the guidelines do not speak specifically to drying on the clean side, this would be the assumption as the decontamination area is the dirtiest area in CSD. If you keep scopes and/or other items in decontamination after they have been cleaned, you can assume that they will be re-contaminated. Forced air is typically found on the decontamination side of CSD so this portion of the drying process will most likely take place here. SGNA is very specific as to the storage and drying of the scopes using drying cabinets. They also refer you to the manufacturers' IFUs.

"Endoscopes must be stored in an area that is clean, well-ventilated and dust-free in order to keep the endoscopes dry and free of microbial contamination. An endoscope that is not dry must be reprocessed before use. Endoscopes should also hang freely so that they are not damaged by physical impact. Endoscopes should be stored in accordance with the endoscope and storage cabinet manufacturers' IFU".

Always ensure that you follow the written guidelines and manufacturers' instructions for use when reprocessing these devices.


Question:  Hello Mr. Marrs. What would you say is the most popular tracking system in the nation? I am familiar with Censitrac. Just curious what most hospitals prefer.
Answer:  I always try to stay vendor neutral when talking to customers about various products. There are numerous companies that provide CSD tracking solutions. I recommend that you create a standard questionnaire so you can ask each vendor the same questions. Rate each vendor based on your facility needs. This will help you narrow your search down to one or two vendors. Ask each vendor for customer references so that you may speak to the users to gain important feedback. I also recommend site visits to facilities that use your top few systems. Once you have done this, you can then prepare a capital request for your administration. As always, look for systems that will meet your needs. Cost will also be an important factor to consider. At the end of the day, the more compelling story that you can deliver to your administrators, the better.


Question:  I have a question regarding scopes. Every Day we use a Campo Trophy Scope, like four times a day. I noticed now that the scope is starting to appear like an old one. There are black spots all over (in the body area) but I know if it’s a stain or a residue from water. When I first received it, it was not like that and now its almost three months but it already looks like an old one. I’m using Plasma Sterilization for the Scope. Any suggestions?
Answer:  Thank you for your question. This is difficult to answer without seeing the scope in person. here are a number of processes that could be causing this issue with black spots. Water/Steam quality could impact the spotting on the scope. Chemical residues from the disinfection process could also cause this. Also, the metal could be reacting to the sterilization process if you are not using steam, i.e. Sterrad. I would recommend contacting the manufacturer of this scope to see if any other customers are having this issue. I would also recommend a complete review of your cleaning, disinfection and sterilization processes to ensure that you are following the manufacturer’ IFU’s exactly as described.


Question:  My facility went from single peel packing to double packing because of holes. We were folding peel packed item, to be placed into the larger size. Our infection control department stopped the staff from doing this, saying it was sterile. I have worked in Sterile Processing for 36 years and worked in four different hospitals. The hospitals that double peel packed always folded. So my question is: Which way is correct?
Answer:  I will refer you first to your manufacturer’s instructions for use. Some manufacturers of peel pouches do not recommend double pouching. Please review your manufacturer’s instructions for use to ensure that double pouching is appropriate. Most facilities utilize double pouching to make aseptic presentation easier in the operating room. Now that I have that out of the way, based on AAMI ST79:8.3.4 Paper-plastic pouches states, if an item is to be double packaged, you should use sequentially sized pouches, the inner pouch should fit into the outer pouch without folding it. The pouches should be positioned so that plastic faces plastic and paper faces paper. Utilizing the proper sized pouches allows for adequate air removal, steam penetration and drying.


Question:  If a STERRAD@ load (example cameras) cancels, is it necessary to unwrap, replace test strip, and rewrap before restarting the load?
Answer:  The short answer is yes. I will refer you to the manufacturer’s recommendations on this question. Ultimately the blue wrap, tapes and integrators are all singe use devices. Meaning they can not be processed more than one time as this could impact the sterility of your device. The tape and integrators are designed to show you that the package has been exposed to the sterilization process. If you do not unwrap and rewrap these packages, you do not know that they have been exposed to the sterilization agent via color change.


Question:  What can be used to clean the connection ends of Power Surgical Instruments. What about the effects of sterilization and the chemical reaction of such cleaning fluids? Has any specific brand been validated for PSI’s.
Answer:  For this question, I will refer you to the manufacturer’s instructions for use. The IFU’s will provide specific details surrounding the cleaning disinfection, assembly, sterilization, storage and use of these devices. When the company submits a 510(k) study to the FDA, they have performed all testing and sterilization validation concerning their product. They will be very specific as to the appropriate chemicals and sterilization methods used to utilize with their specific product.


Question:  I am hearing different things about how OR’s need to send their dirty instrument trays to Sterile Processing. My question is:
“Do is instruments need to be restrung after the surgical procedure is completed prior to sending them to Sterile Processing?”
“Why have we been advised in the OR to NOT string dirty instruments prior to sending to Sterile Processing?”

Answer:  I will refer to “Best Practices” when answering this question. The Association of periOperative Nurses (AORN) speaks specifically to this in the point of use section.

  • Multi-part instruments should be opened, disassembled, and arranged in an orderly fashion within their original set configuration to ensure return as a complete set after processing.
  • Hinged instruments should be opened using stringers, racks, or instrument pegs designed to contain instruments.
  • Protect delicate instruments from damage by placing light instruments on top of heavier instruments or segregate into separate containers. Microsurgical instruments should always by segregated into separate containers.
  • If any delay in decontamination is expected, instruments should be moistened with an enzymatic pre-soak solution to keep blood and any debris from drying.

 


Question:  This is regarding wet trays vs wet loads. I recently read something about a single wet tray not constituting a wet load. I recently had a wet tray that we feel had excess moisture due to it being a plastic tray with a finger mat. We did recall the load as per our policy. No other trays were wet and we have had no other instances from that sterilizer. The sterilizer parameters were fine and the BI passed. In this case, one of the trays was placed on the back table, and because it was recalled, we had to tear down the room. I want to re-write our policy to allow for some critical thinking. I cannot find the source where I read that a single tray does not constitute a wet load and I am looking for something to back me up.
Answer:  You are correct and I believe that you did the right thing in lieu of the standards. I have always taught my staff that “when in doubt, throw it out”. While it created extra work, it’s always good practice to err on the safe side. 

There is a difference. A wet set is just that, a set that contains moisture internally or externally after a sterilization cycle. Based on AAMI ST79 Annex – P A wet load is when you have visible moisture either internally or externally on two more packages, the load should be considered wet.

The moisture may be in the form of visible dampness, droplets, or puddles of water on or within a pack. If wet packs are observed in the processing area they should not be released. if wet packs are observed in the user area (e.g., in the OR) they should not be used. Any wet packs should be reprocessed following measures taken to help ensure excess moisture/condensation does not occur.

I recommend that you update your recall policy to articulate a load recall it two or more sets present with moisture.


Question:  I would like you to clarify this question that has been brought to my attention.
When processing Gas Plasma (tyvek) pouches, where is the correct location to attach the “Censitrac/SPM printed label,” on the front of the paper side or the back on the clear side?
Answer:  When processing any peel pouch please ensure that you follow the manufacturer’s IFU’s. Also AAMI ST79.8.3.2 states, “Package labels (e.g., process indicators, labels for product identification and lot number, expiration statement labels) should be capable of remaining securely affixed to packages throughout the course of their handling from sterilization to use”. Any labeling should take place on the plastic side of the pouch. The primary reason for utilizing the plastic side of the pouch is to prevent damage to the paper side (i.e. writing on the package). Also, the plastic side is impervious and placing labels on the paper side could impede the sterilant from penetrating appropriately.


Question:  We are not allowed to use any brushes inside the “clean room”, but how are we able to inspect inside or make sure that instruments with cannulas, especially Frazier Suctions, are clean inside before sterilizing?
Answer:  You are correct, there should not be any brushes inside the clean/assembly side of CSD. Any time a surveyor sees brushes, they travel down the road of “why are you cleaning instruments on the clean side”? Ultimately, it is the responsibility of the technician working in decontamination to ensure that your devices with lumens are clean. there are companies that offer devices that can help you visualize the inside of lumened devices. If you would like to contact me, I can send you information about these devices.


Question:  How long should a sterile load stay inside the chamber of the Autoclave, once it’s been sterilized and the door is opened?
Answer:  This is a question for the manufacturer of your sterilizers. Of course, I will recommend that you check the manufacturer’s instructions for use (IFU’s) before you contact the manufacturer. This information should be found within these documents. There are numerous factors that can impact the dry time/door cracking that is necessary to adequately dry your sets: Temperature and humidity levels, weight and density of your instrument sets, load configuration, altitude, seasonal changes, types of packaging material, just to name a few. The manufacturer of your sterilizers will have a recommended time to crack the door of your sterilizer but ultimately it may be something that you have to experiment with at your facility.


Question:  Do all wash items need to be germicidal disinfected before handing out to clean side of prep pack?
Answer:  This is another great question and one I will have to defer to the manufacturer of your medical devices in question. The cleaning and/or anti-microbial process that is appropriate for certain devices will be described in the manufacturer’s IFU’s.


Question:  I was told at an SPD conference how check for a secure seal on hard cases. The process is to put a dollar bill or water in the case, secure the lid and tip the case. If water leaks, the seal is bad and if you can pull the dollar out, the seal is bad. My question is—How do we know when to replace seals or lids so we have a secure lid?
Answer:  This is a great question and one that I have heard numerous times. Again, I will refer to the manufacturer’s IFU’s for this answer. Containers are a Class II medical device and should be treated accordingly. The manufacturers of these devices have performed countless validation tests on these devices to ensure that they maintain their integrity. This validation testing has been performed in an FDA approved sterilization testing lab. As a user, it is vitally important to ensure that these devices are maintained according to the manufacturers’ IFUs with regards to disassembly, cleaning, disinfection, assembly, sterilization, storage and use. AAMI ST79 also has very specific instructions concerning the use of rigid container systems. With regards to the aforementioned checks utilizing the “dollar bill” and “water” test, I would ask the presenter to provide me with scientific testing and validation results from an FDA approved sterilization testing facility. It is the responsibility of the user to follow the manufacturers’ IFUs to ensure that these devices work the way that they were intended. As long as you follow the FDA 510(k) approved instructions for use, I , the manufacturer and the FDA believe that you are perfectly safe in using your containers.


Question:  Is it compliant to have adhesive tape, for labeling, on the outside of the sterile container?
Answer:  I will refer to the manufacturer’s IFU to answer this question. Can you find in the IFUs that it is ok to place tape or adhesive on your containers? In my travels I often find layers of old adhesive on containers in other words, it has rarely been properly maintained. This results in sticky dirty debris on the outside of containers. There is no way to effectively clean this built-up adhesive. We know that if a device is not clean, it can not be sterile.


Question:  Is there anything in the ANSI/AAMI ST79 that states how wide ringed instruments’ jaws have to be open in a tray or peel pack?
Answer:  Unfortunately, AAMI ST79 is not specific to how many inches an instrument needs to be open during the cleaning and sterilization process. I will ask you to refer to the manufacturer’s IFUs for the cleaning and sterilization of surgical instruments. For cleaning, AAMI ST79.7.5.6 states “all jointed instruments should be open to make sure all surfaces are cleaned”. For sterilization, AAMI ST79.8.4.4 states, “all jointed instruments should be in the open or unlocked position with ratchets not engaged. Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the open position”.


Question:  Are there any integrity issues with “water stains” being on instrumentation?
Answer:  This is a great question. The short answer is no. Water spots do not cause integrity issues on instruments. Water spots and stains are ugly and can look bad but do not harm your instruments or render them useless. On the other hand, it is very important that CSD Technicians be able to discern between water spots and different types of corrosion. If you are experiencing significant water spotting/staining, I recommend that you have a company or consultant group visit your facility to test your water and steam to ensure that it is not harming your very valuable instrument fleet. Both water and steam have significant impact on the life of your surgical instruments. You have some very good resources available that discuss water.

  • AAMI ST79, TIR 34:2007 (Technical Information Report) has specific requirements concerning “Water for the reprocessing of medical devices.”
  • The Red Book – Instrument Reprocessing, Reprocessing of Instruments to Retain Value. Working Group Instrument Reprocessing Vol. 10, 2012. This is an excellent resource that can be downloaded at no charge at www.a-k-i.org. You might hear this document referred to as the European AAMI document. The document provides pictures and descriptions of various staining and corrosion that you will find on your instruments.
  • IAHCSMM and CBSPD have excellent resources as well 


Question:  Is there anything that states you can’t have tape on the instruments?
Answer:  AAMI ST79 used to provide instructions for marking surgical instruments. They no longer reference this. I will again refer you to the manufacturer’s IFUs for this question. If you choose to mark your instruments by taping, dipping or baking, be sure to follow the manufacturer’s IFUs for the instruments, tape and other processes to ensure that it is being properly performed. In my experience, I have found that marked instruments are rarely maintained. When I inspect instruments, I find material that is cracked, chipped, broken, flaking, and over or improperly used (tape wrapped around the instrument as many as five to ten times). Through everyday use, these instruments are often separated and do not make it back into the original set that they are intended for. I often find sets with numerous colors that do not match. I recommend using the original identification marking provided by the manufacturer of the instruments. This marking will give you exactly what you need to assemble an instrument set accurately. As long as the information matches what is on your set count sheet. 

 


Question:  Is there a good and reliable checklist to have to assure nothing is being overlooked in regards to what surveyors are looking for?
Answer:  There is not a specific checklist to prepare for JCAHO. There is a document that can be used to create a formal JCAHO checklist. AAMI ST79, our national standards and recommended practice guide provides all of the information needed to comply with a JCAHO survey. Many companies and CSD consultants have AAMI Audit type checklists. I would check with some of my sales representatives to see if they would be willing to share them with you. Also, I don’t know of any completely comprehensive checklists out there. You should always refer to the national standards to ensure that all of your bases are covered. I also recommend reaching out to any CSD supervisor, managers or directors that you may know. Ask what the surveyors were looking for in their facilities. I can tell you that endoscopes are currently a very hot topic.


Question:  What is the best practice for handling hand washed instruments (that can’t go through the automated washer per manufacturer instructions) after they have been decontaminated? Most of ours get soaked in enzymatic solution for the required time, brushed and scrubbed accordingly, and rinsed according to manufacturer instructions then placed on a clean towel and sprayed with alcohol (if possible). Should we wear gloves to assemble these items since they did not go through the washer? do you have any recommendations to make the instruments “safer” to handle?
Answer:  I will refer to individual manufacturers’ IFUs to answer these questions. The goal of the decontamination process is to render instrumentation safe to handle on the clean side.
Devices that you deal with on a daily basis could require varying levels of decontamination depending on the biohazard that the device presents according to AAMI. If proper decontamination is performed, you should be safe to handle on the clean side. If I were a JCAHO surveyor and walked into your assembly area and noticed staff wearing gloves, I would immediately think that there is an issue with cleaning performed in decontamination. If this is the case, that dirty instruments are frequently coming to the assembly area from decontamination, this is a separate issue. There needs to be a good policy and procedure in place that discusses cleaning and disinfection. There should also be accountability to this policy. Meaning, if this is a frequent occurrence, it should be dealt with either through education and training or through punitive measure if it happens to be the same person committing the error.  

 


Question:  What is the best way to release an instrument set that hasn’t cooled off completely?
Answer:  There is not a best way to release an instrument set that is not properly cooled. AAMI ST79.8.8.1 specifically states that sets should not be released until they are completely cooled; “they should not be touched during the cooling process”. “A minimum cooling time of thirty minutes is recommended”, the rationale goes on to say, “adequate cooling could take two hours or more”. It goes on to state, “if rigid sterilization containers are not allowed to cool properly before being removed from the sterilizer cart, re-condensation of steam vapor can occur”. Many facilities have begun utilizing a temperature gun to ensure that the sets have reached room temperature prior to removing them from the sterilizer cart. I recommend that you follow the manufacturers’ IFUs, the national standards and recommended practices to write a policy and procedure surrounding the safe release of sets to your end users.


Upcoming Speaking Engagements with Bob Marrs

January 21
South Texas IAHCSMM Meeting
University Hospital
San Antonio, TX

Please contact us with any questions at Aesculap_Consulting.BBMUS_Service@aesculap.com.

 
 

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