Advanced Instrument Processing Solutions

The Potomac Labs team is pleased to present commonly asked questions encountered in sterile processing.

Charles Ciullo, our Director of Sterile Processing, is here to answer your questions.

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I personally would suggest you go with disposable tray liners.  For as long as I can remember most of the institutions I have worked in used green huck towels as tray liners, as corner protection under heavy trays and wicking in basin sets etc.., we did it because it is what we had always done. Now new questions on this practice are arising with good reason. If your institution does not have its own laundry facility you send your laundry out to have it washed, do you know what the laundry facility uses to launder these towels? Is there any residual detergents left in these towels after they are laundered? Residual chemistry in huck towels can deposit on instruments during steam sterilization, many laundry facilities use a high alkaline detergent followed by an acid rinse, residue of the chemistries depositing on instruments can cause corrosion. The washing chemistry is not the only factor here, dye transfer from towels onto instruments also comes into play. I know many of us have seen plastic sterilization cases stained from the dyes in towels, if this dye is transferring onto the plastics cases and staining them, is it transferring onto the instruments too? (my guess here would be yes) Now you have these residual chemistries (detergent and dye) on your instruments and I’ve already stated they can cause corrosion of instruments, but they can also cause allergic reactions in those people sensitive to them, something you don’t want occurring at the surgical site.

Lastly there is the problem of lint. We have all been told that these towels are “lint free” but I assure you if you run a lint brush over them it is not coming off clean. What happens when lint, even the tiniest piece gets into the surgical site, the body reacts to it.  Lint is a foreign body it doesn’t belong where it is so reactions such as granulomas and adhesion formation can occur. Also since a particle of lint is much larger than most bacteria, the body will react to it before it detects the bacterial cells allowing them time to replicate and cause major problems.

Sterile huck towels were originally just used to dry hands post scrub before gloving, we in healthcare are the ones who have repurposed them for a hundred other uses than they were originally designed without a second thought.

What you are seeing on your instruments is pitting corrosion. Pitting corrosion begins when the passivation layer of a stainless steel instrument is compromised, usually by a scratch. This sets up a situation where you have two different metals exposed, the chromium oxide passivation layer and the iron based steel. When these metals are exposed to an electrolyte, like sodium chloride solution or blood, the more active metal, in this case the stainless steel, begins to corrode at an accelerated rate, while the more noble metal (less active) corrodes at a much slower rate, through an electrical exchange between the two metals (also known as galvanic corrosion) To make things even more complicated the dissolved oxygen in this solution comes into play oxidizing the steel (rust). This chloride based corrosion increases with longer exposure to sodium chloride solution or blood, when exposed to halides (like povidone-iodine) and when instruments are not dried completely at the end of your W/D wash cycle. Even the chlorine in your tap water can increase the corrosion. If you use softened water in your W/D, “salt slippage” from it can hasten the corrosion process too. The rust ring you see around that tiny pin hole will give you an idea of the extent of the damage to your instrument, so that tiny hole can be hiding a large cave underneath it, and that cave is capable of harboring bio-burden, so it might be time to take that instrument and “kiss it goodbye” (if you have an instrument repair contract, check with them to see if your instruments are repairable)

There are a few ways to prevent this corrosion from happening. One is to clean instruments at point of use, by wiping them down with sterile water. I know you are thinking  “yeah you tell the folks in the OR to do that”. I suggest you and your manager meet with the OR director  tell them the problem you are experiencing (take pictures of the instruments) and quote them AORN PNDS:170;198 (Perioperative Nurse Data Set)  “Keep instruments free of gross soil during surgical procedures” and from the same document “Cleaning and decontamination should begin as soon as possible after use. Preparation for decontamination should begin at point of use”. Explain the cause of this corrosion, how detrimental it is to instruments and how much it will cost to replace them.

On the SPD/CSSD side of this equation you must be just as diligent, as soon as instruments arrive in decontamination start cleaning them. The longer the sit, the more they will pit.Have your water quality assessed, I cannot stress this point enough. Water is the true cleaning agent in decontamination, detergents just facilitate the job. Water with too many contaminates leads to a bad cleaning process, excessive use of detergents and deposits on instruments. It is  unfortunate that many institutions in the U.S. would rather spend  money on detergents etc. instead of spending the money to make their water more aggressive (e.g. DI, RO water). If you use softened water in your W/D have the water checked to see whether or not you have “salt slippage”. Lastly make sure when your instruments come out of the W/D they are dry, if they are not have the dry cycle adjusted so they do exit the W/D dry.

I’ve included here a picture of pitting corrosion and a diagram of the process of chloride pitting so you can see how that tiny hole can be hiding a cave.

First off, have your water quality checked, the culprit of that bluish/grey stain is most likely a high silica level in your water. Silicates are one of the most common minerals found on earth,(quartz, sand and glass are all silicon dioxide) and with water being a “universal solvent” it is no wonder that water running over the earth’s surface can contain high levels of silica.  The deposits it leaves on surgical instruments is usually, as you described, an iridescent bluish/grey or snake skin pattern and are most common with neutral pH wash cycles or alkaline wash cycles with no or insufficient neutralization in the rinse cycle of the Washer/Disinfector. If you are already using Deionized  water throughout your W/D wash cycle, the silicates can come from silicic acid slippage from an overused, exhausted DI system that probably needs to be changed more frequently. If you are only using DI water in your final thermal rinse, you might try adding an acid rinse cycle prior to the final thermal rinse to help stop these silicate deposits. (no, the acid will not harm your instruments if dosed properly, please see http://www.potomaclabs.com/education/2011/12/we-use-only-neutral-ph-enzymatic-detergent-in-our-facility-why-would-we-want-to-use-an-acid-rinse-in-our-washer-disinfector-if-we-are-not-washing-with-an-alkaline-won%e2%80%99t-the-acid-rinse-harm-o/)

If you do not use DI water at all in any part of your wash cycle, I suggest you somehow convince your institution to invest in a Deionizing system. Silica and other mineral deposits are a common cause of the corrosion of surgical instrumentation. If the process is not “nipped in the bud” your facility will constantly be investing in instrumentation that could have been in service much longer.

   Silica deposits on instrumentation

I suggest you stay with the Class 5 Integrating Indicators for now. Class 6 Emulating Indicators are cycle specific, so if the indicator says prevac, 270°F/132°C 4minutes, that Class 6 indicator can only be used in that cycle, not in any other. If you run a gravity load at 250°F/121°C for 30 minutes you will need a separate Class 6 indicator specific for that load. Although a Class 6 can be used as an internal indicator in packs, trays, and rigid containers, as can a Class 3, 4 or 5 CIs  (Chemical Indicators) only a PCD (process challenge device) with a Class 5 integrating indicator and a BI (Biological Indicator) can be used to monitor implant loads and verify the lethality of your sterilization cycle when you do your weekly
(preferably daily!) testing. Yes you could use a Class 6 in the set with the implants, if you have one specific to that trays sterilization parameters, but in the case of an early release of implantable items for an emergency, before the BI results are available, only the results of a Class 5 CI can be used, because they mimic the biological response of the spore contained in the BI when exposed to the optimal saturated steam conditions.

Current Class 6 CI’s are formulated with a complex indicator ink that produce a color change when two or more of the chemical reactions the ink was formulated for are met.  Each ink is formulated to respond to a specific cycle, so in that case you could say they are more accurate, because they will only change color when the cycle they are formulated for has met its sterilization parameters (time, temperature and saturated steam)

Class 5 CIs are formulated to react to 3 stated value temperatures 250°F/121°C, 275°F/135°C and one temperature in between (plus time and saturated steam) to mimic the death curve of a BI. Also the value of 250°F/121°C must be met for longer than 16.5 minutes to mimic this curve.

Again, because you will need a different Class 6 CI for each specific cycle you run in your facility, you will have to increase the amount of inventory you purchase. That and the fact that only Class 5 CIs are recognized for use with a BI PCD at the present time, I would have to suggest you stick with the Class 5 Integrating Indicators.

Loaner instruments have been the bane of the Sterile Processing Department for what seems like an eternity. Every Sterile
Processing Technician , including myself, has a hundred or so horror stories of having to deal with them . I am going to skip my usual long crazy tirade here (yes I could really go nuts with this) and just start with my suggestions.

First, NEVER CUT CORNERS….NEVER!  Ethically you are obligated to “do the right thing” by complying with the manufacturers IFU for cleaning and sterilization. If loaner instruments arrive at 10:00am and are needed for an 11:30am case, you “cutting corners” to get them done only placates the surgeon and the sales rep. who brought them in at the time they did, the patient, who is your main concern does not benefit from this at all.  Ask yourself, would I want these instruments that have been improperly processed used on a member of my family or myself?  I’m sure the answer will be NO. I understand that this means you will have to “take a stand” and explain your actions to the everyone who is expecting these instruments to be ready (yes, I know they will be screaming about it too), so calmly explain that it is your ethical obligation to “do the right thing” (see above) and ask them if they would want improperly processed trays used on them or their loved ones.

Now if this seems to be a reoccurring problem, which it probably is, I suggest before the problem arises again, get together with the staff from the OR, get your Infection Control person involved, talk to the director of your ASC, even get other surgeons involved (they will listen if you explain the legal ramifications of a Surgical Site Infection from improperly processed instrumentation) and work on getting a policy together and in your facilities policy and procedure manual  to control this problem. Here I would suggest you use the IAHCSMM “Sample Policy and Procedure for Loaner Instrumentation”

http://www.iahcsmm.org/pdfs/Loaner_Instrumentation_Sample_Policy_and_Procedure_070111.pdf

as your template. This sample policy is wonderful and covers all the bases, from the responsibility of the OR staff, to the weight of instrument sets, to the responsibility of the sales reps pre and post surgery and of course the responsibility of the SPD/CSSD staff.   Once the policy is complete and documented in your facilities manual, make sure that all the sales reps. who bring you loaner instruments get a copy of it so they know of it and then hold them to it. Without a policy in writing and in your facilities policy and procedure manual, your plight will be a losing battle, so get one started ASAP.

Every Sterile Processing manager wants productive technicians working for them, technicians that will get “the job” done right in the most efficient manner possible, while still adhering to the policies and procedures of the department. Productivity is normally measured by comparing the amount of goods and services produced to the inputs used in the production of those goods and services, simply put, Productivity = output divided by input.

That being said, anyone who has been in the trenches of sterile processing knows that the variables of processing instruments (and by number of instruments I have assumed you were talking about instrument sets/ trays  and not individual instruments) has a very wide range. Instrument sets vary in complexity, an E.R. Suture Set has much fewer instruments than a D&C tray, and a D&C tray has fewer instruments than an Open Heart tray or a Total Hip tray. Also individual instruments themselves vary in complexity, some require disassembly to be processed properly, others do not. Now to make things even more difficult, some instrument manufacturers require extended cleaning or sterilization cycles for their instruments. Also the processing of instruments in different areas of the department varies in difficulty, it is normally more labor intensive to decontaminate the instruments in a D&C tray, than it is to reassemble and wrap said tray.

Since I have brought up the labor intensive decontamination area, a tray that is grossly contaminated or one where the soil has been allowed to dry on the instruments is much harder to clean, than the same tray that was opened in the OR, but not used, both trays are “dirty” and need to go through the decontamination process in the same manner (unstrung, box-locks open etc.) but one of those trays is going to take a heck of a lot more “elbow grease”(and perhaps some cussing) than the other.

The Prep and Pack area has its own set of challenges, we have all encountered the tray that, on assembly, we discovere was missing one very important instrument, and after searching high and low for it, we finally found what we were looking for, but it took time, enough time that we could have assembled two of the same trays had it been complete in the first place.

Now that I have again gone off on one of my little tangents, let me get back to the core point of your question and that is productivity. Here I would first like to suggest you obtain a copy of “ Management Basics for Sterile Processing, Nancy Chobin, R.N. AAS, ACSP,CSPDM https://www.sterileprocessing.org/bookform.htm  and refer to Chapter 4, Productivity and Staffing  which I am about to quote.  First off the most important things needed for CS/SPD  to be productive as a department is,

• A fully trained, educated, competent (and here I add Certified) Staff.

• A Certified  management team to provide accountability and leadership during all shifts the department is open.

• The ability to provide ongoing continuing education to keep the staff current on all new information.

• Copies of all standards, guidelines and recommended practices that are relevant to CS/SPD processes.

• Adequate physical space and appropriate design to permit work to be performed efficiently.

• Adequateprocess equipment that is well maintained.

• Sufficient surgical equipment to reduce the “priority rushes” that often cause errors.

• Sufficient backup instruments to prevent the opening of complete sets to obtain one or two instruments.

• Specialty containers for delicate and microsurgical instruments to prevent damage in transit and processing.

• Team relationships within CS/SPD and with other departments.

• Support from the facility administration for the success of the department.

In order for individuals in the department to be productive you first need an environment that is conducive to productivity. Then if you want to set numbers of instruments or trays you expect to have processed by technicians have time studies done, taking into account all the variables I listed in the beginning of this answer.  How long does it take to clean a D&C tray? How long does it take to clean one that is grossly contaminated? Remember that all services provided by the staff, even telephone coverage must be included in the time and output calculations.

Given the extreme variables of the job, (and the fact that time studies are not my specialty) I have always found it difficult to set productivity numbers for technicians in CS/SPD, it has always been plain as the nose on my face who was goofing off and who was diligently working.  Also, if you promote a team environment in your department the rest of the team will not be happy with the employee who is not pulling their weight.

I do understand that you may need documentation of sub-par performance to initiate disciplinary action or you made need these calculations to justify OT or increased department staffing and that is why I have suggested the above reading.

Your question “What was modified in the original Greene & Veseley   test method for BFE? Why is the modified used?” has left me a little perplexed.

When I was answering the query that I received on fluid resistant masks I based my answer on the newest ASTM (ASTM F2100 – 11 Standard Specification for Performance of Materials Used in Medical Face Masks) which was published in 2011. Although I mentioned the modified Green and Veseley test, I  would have to say that since it was originally received for publication in 1961(making it a two years younger than myself) its methodology is a little antiquated compared to the newer ASTM testing. Also since it uses a human subject and counts all CFU’s that are expelled through a mask and deposited on an agar plates in an Anderson impactor, while said human is enunciating prescribed words , the Greene and Veseley test is far less controlled than the ASTM Testing , which uses a test microbe (Staph. Aurues) aerosoled to a prescribed size and pressure and counts the CFU’s that pass through the material being tested (this method also uses
the Anderson impactor for colletion of CFU’s).

As far as the difference between the original and modified Greene and Veseley tests, I am going to take an educated guess here (I have never claimed to be a scientist of any sort, I am first and foremost a Certified Sterile Processing Technician, with too many years for my own good of experience in the trenches) and that is that the modified test employs the use of a sampling chamber and Andersen impactor. To quote the original article  from the  Jounal of Bacteriology   …..
“ Sampling Chamber.  The sampling chamber was a plywood box (5′ x 16” x 16”) mounted vertically on an angle iron frame. A high efficiency (>99%) fiberglass filter formed the top surface of the box. A fixed metal port projected from the tapered bottom of the box and served as a connection to the air sampler. A sliding “guillotine-like” panel with a flexible plastic collar was provided to permit entry of the subject’s head and neck, at a point 4’ from the sampling port. A glass window was constructed on one side of the chamber for psychological comfort. The only air supply during a test was filtered through the fiberglass and the only source of contamination was the subject. When proper capping was observed and suitable entry precautions taken, a silent subject contributed less than one contaminant/ft³”

Again maybe I’m wrong,  maybe there was another modification I seem to have missed. What I do know is that it is an old test with many controls missing. The newer ASTM testing methods with its controlled microbe, aerosol size, pressure differentials and challenge concentration seems much more reliable than someone saying sing and chew with a mask on in a wood box.

The plight of storage in Sterile Processing is a problem in almost every facility,we start out with just enough room for the trays, instruments and supplies we are working with, the next thing we know we are doing cases with instruments we never had done before and have no place to store them properly. Larger facilities like hospitals can eventually work around this, but ASC’s are always challenged here since space is at a minimum. To tell you the truth it is my belief that the architects who design ASC’s need to start consulting with Sterile Processing personnel before they even put pen on paper to draft the SPD/CSSD area.

A sink in sterile storage would only be to accommodate hand hygiene in that area, and would need to be far enough away from any instrument trays or containers to avoid their sterility being compromised by splashing water. Since your facility is an ASC, I would suggest that you forego the sink, unless there are none in the immediate area and focus more on the storage of instruments themselves. Since stacking wrapped instruments on top of each other is frowned upon by most accreditation organizations and most of their inspectors are now dedicating large amounts of time in SPD, you want to have enough storage space to accommodate your wrapped trays. A sink and the space needed to avoid compromised trays would only take up the room you need for storage. If your facility were a hospital with ample room, I would suggest you had a hand washing sink.

I am sure I do not need to tell you this, but since we are talking about sterile storage make sure you have,

Ample air exchanges in the area (positive pressure a minimum of 4 air exchanges per hour),

Proper temperature and humidity (68°F [20°C] to 75°F [24°C] relative humidity between    35% and 70%) with a way to monitor and
record this.

All stored items should be at least 18 inches from sprinkler heads (ceiling) and at least 8 to 10 inches from the floor. If there is an outside wall in your storage area any storage shelves on that wall must be at least 2 inches away from it.

Also make sure your storage area is cleaned on a regular basis and that you keep a record of that too.

……..the question of Mandatory Certification for CSSD/SPD
technicians has become a hot topic. I have always been a proponent mandatory certification for technicians, so when Infection Control Today asked for input on this matter I was quick to jump on my “soap-box” and elucidate my sentiments. Lo and behold what I said must have made struck a chord because it got published (either that or only a few people answered ICT with their ideas).

Those who know me will tell you I’ve never been thrilled with “blowing my own horn”. Even though I might be a “Big Mouth from Dirty Jerzey”
(something I’m proud of) I am a true believer in Humility. That being said I have decided to post my thoughts on mandatory CSSD/SPD Certification here because I truly believe not until every single person, from the managers down, who work in CSSD/SPD get certified (and continue to update certification through education) will things in the realm of surgical instrument processing improve.

I am amazed that there should be any question on whether or not Sterile Processing Technicians should be certified. If I was going for plastic surgery I can assure you that I would be looking for a surgeon who was board certified, knowing that they demonstrated excellence in
their specialty. Should not health care institutions be looking for the same excellence in those that care for their surgical instrumentation?

Speaking for myself, I began working as a Sterile Processing Technician twenty five years ago and have seen significant and drastic changes in the processing of surgical instruments in that time. I must say here, that I was fortunate enough to have worked  with people to whom I will
be forever grateful,  because they foresaw the day when certification would be mandatory in my home state, and so in 1991, I attended a sterile processing educational course, sat for the exam and having passed, first received my certification. Within another 10 years those who had advised me to first do so, were correct and New Jersey became the first state to mandate certification.

Certification mandates in other States, should use those of New Jersey as an example, that all who work in the department from management down, be certified. It is all well and good that some believe that only an R.N. can hold the position of management in Sterile Processing, but an R.N. with no experience or education in Sterile Processing is like asking a Sterile Processing Technician to be first assist in Total Joint Surgery. (I hope I haven’t ruffled any feathers here, I am just speaking from experience).

Getting certified is only the start, keeping certification requires continuing education, which is imperative to keeping up with the changes in the field. The increasing complexity of surgical instrumentation, the different modalities required to care for them, along with the ever changing regulations on their care can only be acquired this way. (Yes word of mouth could do, but wouldn’t you feel more comfortable if someone were shown the way to clean a complex robotics instrument through an accredited educational course then from Mary on the 3-11 shift?)

Here, I would like to bring up recognition and compensation. How many people outside of health care even know that there is such a thing as a Sterile Processing Technician or Department, I can’t tell you how many times I have had to explain to people just what I do for a living,  In
fact it wasn’t until a recently that Sterile Processing got mentioned on the News, and that was not in the most flattering of lights. Most of us who work in the field do it because it is what we love to do and we know that our job is the first defense against infection. A Sterile Processing Technician is expected to give 100% all the time, we know that there is no such thing as almost clean or almost sterile, that there is no such thing as “sterile soil”. Technicians are expected to remember (or at least know where to find) the cleaning, packing, and sterilization instructions for over a thousand instruments that they encounter every day. We need to know how they function properly, which ones need to be disassembled for cleaning, reassembled for sterilization, if there are any special packing/containment requirements their mode of sterilization (or High Level Disinfection)  and if they need to be run in a “special” or “extended” sterilization cycle. Yet for all this knowledge and hard work, technicians are seldom compensated properly and most could be making more money flipping burgers or waiting tables.

Surgical Instrumentation is becoming more and more complex,  many institutions will more than happily get the latest surgical instruments to
placate a surgeon or so that they can tout how they do “fill in the blank” surgery, but few take into consideration whether or not they have the capability to clean and sterilize these instruments.

Instrument manufacturers themselves need to take into account whether or not their instruments can be cleaned properly. The cleaning challenge of the arthroscopic shavers and many surgical suction devices mentioned on the “Today Show” and at the FDA/AAMI workshop’s this past year was a design flaw, these devices contain a dead end that trapped tissue, blood and body fluid, it is next to impossible to get a brush into this “dead end” and once the proteins in the soil here denatured it would take a blow torch to remove it

I foresee a day when “visually clean” will not be clean enough and that some regulatory standards will be set on what “clean” is. We have already begun to move in that direction with the testing of endoscopes for residual protein, hemoglobin and carbohydrates, can the testing for residuals on surgical instrumentation be that far off? Just another task to add to the myriad of things a Sterile Processing Technician must do during the day.

So the question is, why hasn’t Certification for Sterile Processing Technicians been mandated
earlier?  A Hairdresser or Barber needs a Certificate (license) to do their job and Heaven knows they get paid better….isn’t it high time that the people who are the “first level of defense against surgical site infections” be certified and get compensated for the job they do?