Advanced Instrument Processing Solutions

Archive for the ‘Cleaning Standards’ Category

We have a lot of problems cleaning the soil off of the Bi-polar and Mono-polar surgical instruments at our facility, do you have any suggestions?

The problem of cleaning  eschar off of electrosurgical instruments has been an issue since these instruments first started being used.  As you know these instruments are used to cauterize tissue to minimize the amount of bleeding at the surgical site. This is done by passing an electrical current through the instrument either through opposing tips with different electrical charges or through a mono-polar tip that passes the current through the patient to a grounding pad. In the case of mono-polar cauterization the tip of the instrument touching the tissue does the brunt of the work, while the weakened electrical charge passes through the patient to the grounding pad. (I hope that everyone is checking the insulation on their electrosurgical laparoscopic instruments after each use, since a break in the insulation can cause a “misfire” during a surgical procedure. Electrical current can pass through breaks in the insulation, and if this break is close to any other organ the current will take the closest route out of the instrument, damaging tissue that was not meant to be cauterized).  When these tips cauterize,  tissue, blood and body fluid are basically cooked onto the instrument. This burned on tissue or Eschar (your new $50.00 word) should be removed AT POINT OF USE. Many surgical “kits” come with a little scouring pad that the surgical tech should use to remove the eschar AT POINT OF USE. Each time the instrument is used the eschar should be removed, but we’ve all seen those bipolar forceps with layer upon layer of burned on blood and tissue come into decontamination.  I have capitalized and underlined “at point of use” twice now for a reason, The Association of Surgical Technicians, AORN, and AAMI all state in their recommended best practices that “The cleaning of instruments should begin during the surgical procedure to prevent drying of blood, soil and debris on the surface and within lumens.”(AST RSOP for the Decontamination of Surgical Instruments, Standard of Practice I). If you are constantly receiving electrical surgical instruments with layers of eschar on them, then someone in the OR is not doing their job correctly. Here I would suggest you get together with your manager arm yourself with photographs  of the instruments as evidence and written recommended best practices, the A.S.T. version is readily available on line and set up a meeting with the Director of the OR.

Now as far as the removal of eschar from electrosurgical instruments, my first recommendation would be the use of a stiff plastic brush, soak your instruments as recommended in their IFU preferably in a high quality multi-enzymatic detergent (see our deconex® Power Zyme    http://www.potomaclabs.com/power-zyme.php). Brush them under the soak water surface to remove the eschar. If staining from the burned on tissue is still a problem, and the material you are cleaning is stainless steel, I would suggest you use a surgical stain remover (deconex® 34GR is great for the removal of both organic and inorganic stains on surgical instruments and Washer/Disinfectors  http://www.potomaclabs.com/deconex-34gr.php) again refer to the IFU of the product you are using.

One more suggestion I would like to make is that if you are in a larger institution and have more than one washer, you dedicate one of your washers for instruments that are difficult to clean. Use a two component cleaning chemistry system in your washer (deconex® Twin pH10/Twin Zyme  http://www.potomaclabs.com/deconex-twin.php) Two component cleaning chemistries like the “Twin system” employee both an enzymatic detergent and a mildly alkaline detergent  that when combined in the washer/disinfector  form an extremely effective cleaning system and have demonstrated efficacy in cleaning  hard to clean instruments like the DaVinci Endowrist instruments.

 

Our ASC is trying to figure out the correct standards for how often to change the water for cleaning instruments before reprocessing?

The water in the manual soak sink and ultrasonic cleaner should be changed when it becomes visibly soiled and at least once each shift. The soak sink and ultrasonic cleaner should be rinsed clean before refilling and at the end of the day or between shifts should be disinfected with a lint free cloth soaked in 70% alcohol.

If you are cleaning intraocular instruments, The American Society of Cataract and Refractive Surgery, The American Society of Ophthalmic Registered Nurses and AAMI ST79, Annex N all recommend that the water be discarded after EACH set cleaned. Also for intraocular instrument after cleaning and a tap water rinse all instruments should be rinsed in sterile, distilled or deionized water. This sterile water rinse should provide flow of water over and through the instruments, should not be done in a basin with agitation and should not be reused.

Always follow the cleaning chemistry manufacturers IFU for dosing/dilution ratios. Have your soak sink marked so that when you fill it to that mark you know the amount of water in the sink (e.g. 5 gallons) and dose your cleaning chemistry appropriately. The AAMI ST79 7.5.3.2 also recommends that you monitor and document the temperature of your soaking solution to make sure it stays in the correct temperature parameters suggested by the detergent manufacturer.

Our Surgical Center has been having a problem getting loaner instrument trays in a timely fashion. Sometimes we have to “cut corners” to get the trays processed for the surgical cases that needs them. What actions can we take to insure we get the trays in with enough time to process them properly?

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.

 

Update…. Are there any approved values for residual protein on instruments after cleaning?

In September 2011 I received this question from a SPD Tech. in reference to an approved value for the amount of residual soil on surgical instruments by the FDA. My answer was that the US FDA had no approved value number. Although this may be true for hospitals and ASC’s, I was recently informed that there is an FDA approved value for residual proteinaceous soil on surgical instrumentation . This FDA standard is for third party Single Use Device reprocessors and it set at less than six point four micrograms of protein per square centimeter (<6.4µg protein/cm²).

Although I had heard this value before in reference to the cleaning of flexible endoscopes (Alfa et al. 2002) as the average soil marker for biopsy/suction channel of clean flexible endoscopes, I did not know that this value had been set as the FDA standard for SUD reprocessors.

This value is also the basis of cleaning verification tests for flexible endoscopes (eg. Healthmarks ChannelCheck™ ). Who knows, maybe one day this verification value will apply to all surgical instruments processed in Healthcare facilities and not just the SUD Reprocessors it applies to now?…only time can tell.

Our ASC has begun to do cataract surgery, we have not experienced any TASS infections yet and would like to keep things that way. What are your suggestions to our Sterile Processing Technicians when comes to the care of intraocular instruments?

There are multiple and varied substances that can cause the inflammation of Toxic Anterior Segment Syndrome, but in the case of intraocular surgical instruments the cause is most likely debris left from inadequate cleaning, residues from improperly dosed or rinsed cleaning chemistries, endotoxins from manual soak or ultrasonic cleaning chambers, lint from towels used to protect instruments or trays, and inorganic salts deposited from the steam in your sterilizer.

First I would like to suggest that you obtain a copy of the “Recommended Practices for Cleaning and Sterilizing of Intraocular Surgical Instruments” from the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Registered Nurses and familiarize yourself with it.

That being said let me begin with saying that the care of these (and any other surgical instrument for that matter) begins at the point of use, keeping instruments free of debris and moist, with sterile, distilled or de-ionized, water during the procedure will help insure your technicians will be able to clean and sterilize them properly when the procedure is finished. Also the sooner the instruments are decontaminated, once the procedure is finished, the easier they will be to clean. Since Ophthalmic Viscosurgical Device Solutions can harden in minutes, I would suggest the use of disposable cannulas and tubing whenever possible. Any non-disposable cannulas (or instruments) that come in contact with these solutions should be flushed and keep moist with copious amounts of sterile water to prevent deposits.

Once the instruments arrive in decontamination cleaning should begin immediately. Always follow the instrument manufacturers IFU when it comes to cleaning these instruments. If enzymatic detergents are contraindicated for cleaning, do not use them, if they can be used, I would suggest using a neutral pH enzymatic detergent that is both color and fragrance free (please see my answer to the question “We prefer an enzymatic detergent with coloring and fragrance…” for further discussion on this matter). Always follow the detergent manufacturers IFU, when it comes to the dosing of their detergent in solution for cleaning. If you have an ultrasonic cleaner, only use it with those instruments that can be cleaned in it.

When it comes to the cleaning of ophthalmic instruments, it is highly recommended, weather in the manual soak sink or ultrasonic cleaner, that you change the cleaning solution between each tray, to avoid the deposit of debris from previous trays on instruments. Also more frequent cleaning and disinfection of the chamber of your ultrasonic cleaner and soak sink is highly recommended to prevent the build-up of bacterial endotoxins which can deposit on instruments.

Once the instruments have been cleaned with detergent, rinse them with copious amounts of water to remove any detergent residue, tap water may be used here unless contraindicated by either the equipment or detergent manufacturer. This should be followed by a final rinse with sterile, distilled or de-ionized, water. This rinse should provide flow over and through the instruments. The final rinse water should not be reused and agitation of instruments in a basin of sterile water should not be used since any debris
could redeposit this way.

Following the final rinse all lumened instruments should be dried with medical grade compressed air. When assembling instrument sets, closely inspect all instruments for defects or debris, a lighted magnifying glass is highly recommended here. If you normally use huck-towels to line your instrument sets, please make sure that they are both lint and detergent residue free. Call your linen provider to find out what chemistry is used to wash these towels because a highly alkaline detergent may transfer chemicals from the towels to the instruments during sterilization, I have even seen the dye from new huck-towels transfer to trays so find out from your linen supplier if they have ever had any incidence with this problem.  A better choice for tray liners are the specially made disposable dye and residue free paper liners you can get from many sterilization supply companies.

Since dissolved inorganic salts in the steam of your autoclave can deposit on your instruments and my trigger inflammation, have the quality of your steam checked, at least on a yearly basis.

 

 

 

We use a TOSI test on a plastic strip in our washer for washer verification; however, you recommend the TOSI test with a metal coupon. Is there a difference between these two tests?

Yes, there is a BIG DIFFERENCE between the two tests!

What you are using is actually called a Browne STF load-check: this test consists of polysaccharides (sugars), protein and lipids, derived from eggs and porcine (pork), that are printed on a plastic strip. This plastic strip is placed in an L shaped perforated metal holder prior to washer testing.

The TOSI test (Test Object Surgical Instrument) is composed of purified bovine (beef) proteins, haemoglobin, and blood fibrin layered on a stainless steel plate. Furthermore, the metal plate has been scratched to replicate the surface of surgical instruments and covered with a see-thru plastic holder that replicates a box-lock. The plastic holder itself is capable of clipping into a wire sterilization/washer basket prior to washer testing. The producers of this test also make a similar test for washers with lumen cleaning capability.

There are also other tests on the market to verify your cleaning processes. Wash-Check, for instance, consists of proteins mixed with a solvent polymer metered on a metal plate. It has a special holder for placement in the washer that replicates a box-lock. This company also produces a similar lumen cleaning test.

When I mentioned washer verification tests in the past, I reiterated AAMI’s recommendations that washer–disinfector verification tests be performed on a metal coupon since this most closely replicates the surface of surgical instrumentation. Of these tests, AAMI also considers tests composed of “blood test soil” to be the most “valuable as a quality assurance indicator for functionality of a washer-disinfector.”

The ASTM (American Society for Testing and Materials International) also states in their Blood Cleaning Efficiency of Detergents and Washer Disinfectors (ASTM D7225-06), “the regular use of blood soil test is a systemic challenge to the functioning of an automated washer” and recommends these tests be performed on “stainless steel plates.” The ASTM also gives recommendations on what this soil should be composed of. The ATS (artificial test soil) used on TOSI tests is extremely safe: yes it is composed of bovine blood, but this a highly purified product so there is no fear of “catching anything.”

During my years of working in Sterile Processing, it has been my experience that most of the soils I cleaned off instruments in “decontam” were blood based. Rarely, if ever, did I see sugar and eggs on a Finochetto retractor! Moreover, the majority of the instruments placed in the washer-disinfector were made of stainless steel. Since blood is the major source of soil on surgical instruments (and most often it is coagulated and dried on stainless steel), it poses the greatest challenge in cleaning. I believe it only makes sense that we challenge the cleaning efficacy of our washers with the same soil substances and under the same conditions.

The other thing to remember is this: these tests are not made for specific washers; rather, they are made for testing ALL washers and made to challenge the efficacy of YOUR wash cycle. If a test doesn’t pass, it is not because it is too difficult for your washer to clean. Instead, it means the washer needs to be checked! There could be multiple reasons why. For example, a spray arm could be blocked and not turning, or the wash cycle water temperature is too high or low. Perhaps the machine is not dosing the correct amount of detergent to get the job done, etc. The list goes on and on.

What we all need to remember is this: the primary reason for testing washer-disinfectors is the fact that it is a replicable cleaning process that needs to perform correctly every time it is used.

So ask yourself: why wouldn’t you want a test that replicates the worst case scenario in your washer?