Advanced Instrument Processing Solutions

OSHA Bloodborne Pathogens Standard 29CFR-1910.1030 states:
Gowns, Aprons, and Other Protective Body Clothing. Appropriate protective clothing such as, but not limited to, gowns, aprons, lab coats, clinic jackets, or similar outer garments shall be worn in occupational exposure situations. The type and characteristics will depend upon the task and degree of exposure anticipated.190.1030(d)(3)(xi)

So what does that mean to you as a sterile processing technician? Because you deal with liquids in decontamination, your gown choice should be impervious to liquids!

ANSI/AAMI PB70 “Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities” classifies gowns (and drapes) used for protective apparel into four levels: these levels are based on fluid penetration tests as defined by the AATCC (American Association of Textile Chemists and Colorist) and the ASTM (American Society for Testing and Materials International):

Level 1 Gowns: Are generally best used for contact isolation and not for decontamination. They allow less than 4.5g of liquid penetration under normal atmospheric conditions (based on AATCC 42 test for fabrics resistance to rain penetration)

Level 2 Gowns: Are best for small bedside procedures. They allow less than 1.0g of liquid penetration (AATCC 42 test) and are resistant to liquid penetration up to 20cm of water pressure (AATCC 127 test) 

Level 3 Gowns: Are the gowns that ANSI/AAMI suggests for use in decontamination. They offer increased barrier protection and are resistant to strike through. They allow less than 1.0g of liquid penetration (AATCC 42) and are resistant to penetration up to 50cm of water pressure (AATCC 127).

Level 4 Gowns: Are intended for the surgical field, although I would argue the fact that these should be used in decontamination too. Not only are they as resistant liquid penetration as Level 3 Gowns, but they are also resistant to penetration by blood borne pathogens (ASTM test F1671using synthetic blood and surrogate microbes to test for viral penetration under continual liquid contact).

So all that being said, make sure you are using Level 3 gowns in your decontamination area, because those yellow isolation gowns don’t provide enough protection!

Now that you’ve got me thinking about PPE, I feel the need to elaborate a little more here. Please make sure that ALL of your PPE is correct:

1. Exam length gloves that only cover your hand (up to your wrists) are not long enough! Rule of thumb: if water from the soak sink can easily get inside the gloves while you work, they are not long enough. Also make sure the gloves you are using don’t tear easily.
2. Masks should be as impervious to liquids as your gown is; and unless you don’t breath through your nose, it needs to be covered by your mask, too.
3. Your eye protection should be sufficient to protect your eyes in case of any large splashes of liquid; we have all dropped something in a sink full of water at home and know water happens. Your protective eyewear should cover your eyes so that NOTHING will splash over it and INTO your eyes. I would suggest a disposable full face shield with a foam pad that seals above the eyebrows.

I know that working in decontamination can be uncomfortable with all this gear on, especially if the temperature is above 65°F in the room (which it shouldn’t be). However, wearing proper PPE is “for your own good,” as my mother would say.

In the end, it is your employer’s responsibility to supply the proper PPE, and YOUR responsibility to wear it.

First, let me again clarify that I suggested the use of alcohol for disinfection, as opposed to a halogen (bleach) or a quaternary ammonium compound, because alcohol is not corrosive to stainless steel surfaces. Alcohols are effective at killing a wide range of micro-organisms (bacteria, fungi and mycobacteria) as well as inactivating viruses. They are not, however, effective against spores and some hydrophilic viruses.

Alcohols work by denaturing cellular proteins and dissolving some cellular lipids. Since proteins denature more quickly in the presence of water, and water is needed for alcohol to cross the cell wall, alcohols are most effective below 90% concentration. Above 90% concentration, alcohol will only dehydrate the cell wall without entering the cell and denaturing its proteins.

The two most common types of alcohol used in healthcare are ethyl and isopropyl. Since 70% isopropyl is less dehydrating to living tissue than 70% ethyl alcohol, 70% isopropyl is normally the choice for skin antiseptic and the most prevalently used. 70% isopropyl alcohol is also a common choice as both an antiseptic and disinfectant because of its relatively low cost (90% isopropyl cost more because of its higher alcohol content).

Always remember that in order for alcohol (or any other disinfectant) to be effective, the surface where it is being applied must be clean and dry (soil and moisture will inactivate disinfectants). Additionally, that surface should be saturated for the proper amount of time in order for disinfection to take place.

Finally, I also suggest that you download and print a copy of the CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities 2008” (click this link). It is a great resource to have on hand and has a wealth of information on disinfectants and sterilants.

Yes, you should be disinfecting the chamber every evening using 70% isopropyl alcohol. After emptying and rinsing the chamber, dry it with a huck towel to remove excess moisture, then saturate the surface of the chamber with alcohol. If you have a small ultrasonic where you can control the emptying valve, keep the valve closed while you are doing this to keep the surface of the chamber moist with the alcohol. Let it sit saturated for at least 5-10 minutes before emptying the chamber and let it air dry. This will stop the odor problem you are having by killing the cause, which are the bacteria growing in your ultrasonic. Please only use alcohol to do this since other disinfectants, like bleach or quaternary ammonium compounds, will react with the stainless steel chamber of your ultrasonic and damage it.

Remember, you should be disinfecting all work surfaces (countertops) and re-usable cleaning brushes at the end of the day, too. 70% isopropyl alcohol is great for both surfaces and brushes: it is less expensive that other disinfectants, and will not react or leave residue on surfaces like other disinfectants can. Again, make sure these surfaces are saturated for at least 5-10 minutes. If you have a washer/disinfector, your brushes can be run in the wash cycle with a thermal rinse to clean and disinfect them too–just make sure that their manufacturer states that they can be disinfected this way before doing so.

My first suggestion is to refer you a previous blog question regarding cloudy enzymatic detergent solution (I have noticed our enzymatic detergent becomes cloudy in hot water.  Why does that happen?)

Low foaming detergents usually cloud in hot water for a reason: the “cloud-point surfactants” contained within are what makes these detergents low or non-foaming. My other suggestion is to ensure that you use the right amount of detergent (dosing per gallon) in your sink and ultrasonic cleaner. Overdosing the detergent, especially one with a cloud point surfactant, will increase the cloudiness of your solution once the detergent is brought to its “cloud point” temperature.

I also suggest that you have analysis performed on the water used in your sink and ultrasonic. The chemistry of your water may be reacting with the detergent you are using, causing excessive clouding. Once you get the results of your water testing, contact your cleaning chemistry manufacturer with the results to see if they have any special dosing ranges for your water type.

Adding coloring and fragrance to an enzymatic detergent are nice for the reasons you stated… but did you know they reduce the ability of that detergent to rinse free? Coloring agents in detergents can be from plant sources, but more than likely they are the product of chemical salts. If you have read any of my earlier posts, you will realize we don’t want more of these in our wash.

Fragrances can also be sourced from plants or produced in a laboratory, and they are more complex in their composition. Fragrances need to be semi-volatile for you to be able to smell them, yet they cannot completely evaporate from the solution they are in. Because of these traits, they are difficult to completely “rinse free” in the wash cycle. A good example of this is laundry detergent with fragrances (and/or colorant)–even though your clothes have been washed and rinsed, you can still smell the fragrance of the detergent in the clothes (yes I know many laundry detergents are formulated to do just that). If you are allergic to the fragrances (or colorant) used, even though you may not smell (or see) them on your clothes, your skin will let you know that they are still there. This is why Hypoallergenic Laundry Detergent is usually fragrance and color free.

After much testing, the producers of Power Zyme realized this held true for enzymatic detergents when cleaning surgical instruments. Although surgical instruments are not porous like fabric, the residue of fragrances and coloring agents still presented themselves on the instruments when they were tested.

Might I suggest that if you need verification of a detergent add for your soak sink, utilize another method such as a two-colored wall card on a peg that you turn over after detergent is added. If your ultrasonic cleaner has a heater on it, you will know Power Zyme is present because it will cloud (see “our enzymatic becomes cloudy” post).

As far as covering the smell of blood, might I suggest the following:
A. Changing the solution in your sink and ultrasonic more often
B. Wearing your PPE mask over your nose
C. Investing in some fragrance plug-ins or a reed diffuser (I’m only joking here)

I know that the smell of blood can be annoying, if not sickening, but it is part of the job. And if it bothers you that much, perhaps you might consider using some lavender essential oil on your face mask and thank your “lucky stars” you are not doing fecal disimpactions in the OR!

Again, I must say the goal in decontam is to clean the instruments and have them free of residuals from both the procedure they were used in AND the detergent itself.

Following my attendance at last week’s AAMI/FDA Summit on Medical Device Reprocessing, I feel impelled to get up on my “soap box” and repeat the sentiments I heard over and over at the summit:
• Elevate Reprocessing to the Level Where We Need It to Be
• Mandate Certification

Yes, I was shocked and amazed too, but there really are people who understand the problems encountered by the Sterile Processing community on a daily basis. They spoke up, and I cannot agree more!

I have witnessed many changes in Sterile Processing since the 1980s, and the processes for cleaning and sterilization have become more and more complicated; yet, the monetary compensation for those who perform this job has remained less than adequate.

Let me ask you:
• How many children do you know say “I want to be a Sterile Processing Technician when I grow up”?
• How many people do you know are even remotely aware of a job or department in the hospital called Sterile Processing?

It is high time that we elevate ourselves as Sterile Processing Techs and get the recognition we deserve.

First and foremost, GET CERTIFIED! It doesn’t matter if certification is mandatory or not in your state. It makes no difference to me with whom you are certified (CBSPD or IAHCSMM). Just get it!

Here’s why I feel so strongly about certification: I am fortunate enough to have worked with people in the past who foresaw the day when certification would become mandatory in my home state of New Jersey. So I took their advice and received my first certification in 1991. This put a few more pennies (yes pennies, not dollars) in my paycheck; however, when the state mandate was passed, I, and many others like myself, was ready for it. Here’s another way to think of it: when a physician becomes Board Certified, it reflects his/her exceptional expertise in a particular specialty. So I ask, if you were searching for a plastic surgeon, would you be satisfied with just any surgeon, or would you select one who was board certified? Certification demonstrates your understanding of the subtle nuances of your job. Furthermore, certification not only proves that you can perform day in and day out, but it also shows you can apply that understanding on paper. So go out and show your exceptional job expertise by getting certified!

Getting certified is only the start. Once you are certified, it is crucial to STAY certified! Go attend as many educational seminars as you can and obtain the CEUs you need (get a few extra for your own good) to keep your certification current. The field of Sterile Processing is constantly evolving: techniques from 25 years ago are outdated, and the instruments and equipment we work with are becoming more and more complex, so stay current with your certification and education. Remember, this is not only for yourself, but also for the people you do your job for–the patients.

Lastly, join your local Central Supply/Sterile Processing organization. Membership has its advantages, such as discounted admission to their CEU seminars. They often can act as advocates for you and your peers when it comes to legislation in your area. Remember, there is power in numbers and solidarity: the more members in your local organization, the more likely they will be to work for its members. Also, once you are a member, remember not to lose your voice. Speak up and let them know your concerns.

I truly believe that we Sterile Processing Technicians are the First Line of Defense Against Infection and the Unsung Heroes of the hospital; however, we will only be taken seriously and receive the recognition we deserve, both verbally and monetarily, if we all:
• elevate ourselves
• get certified
• stay educated
• enlist our legislators to mandate our certification

Above all, the sense of pride and accomplishment that you feel in becoming certified and staying educated will become a driving force in your life, because you will know that you are doing the best job you can for the patients who are ultimately under your care.

Enough Said!

A Belated, Happy Central Sterile Processing Week to All,
Charles

I truly understand the constraints of working in an ambulatory surgery center (ASC) and know you are trying to do the best thing by keeping the instruments moist to facilitate their cleaning the next day; however, I would recommend not leaving the instruments immersed in liquid all night. Instead, you should pretreat them with an enzyme gel/foam, or at least rinse them in sterile water, and then place the instruments in a plastic bag until the next morning.

Soaking instruments overnight, or for prolonged periods of time, encourages the formation of biofilm. These colonies of microbes adhere to surfaces by producing sticky, slimy protective films (polysaccharides). Not only does this layer make it difficult to remove these colonies, but it also protects the bacteria within it from the effects of disinfectants. Needless to say, enzymatic detergents have little or no effect on them. As these bacteria communities grow, they become more difficult to remove and more resistant to disinfectants (and even sterilization). It can take as little as 30 seconds for these microbes to attach to an instrument surface, and a little as a few hours for a mass of biofilm to mature.

Although tap water is chlorinated to reduce the replication of bacteria , biofilms are often found attached to the pipes of water delivery systems, and they are the source of these microbes in drinking water. Incidentally, DI and RO systems are even more prone to biofilms because the chlorination is removed from this water.

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?

Adenosine triphosphate, or ATP, testing only detects the presence of cells on surfaces; it will not detect the presence of protein or carbohydrates. Adenosine triphosphate is a co-enzyme that transports chemical energy within cells for metabolisim.

An ATP test consists of the following steps:

1. An object/surface is swabbed
2. The swab is then brought into contact with an enzyme called luciferase (the firefly enzyme)
3. The swab is then placed in a luminometer
4. Any ATP present on the swab will react with the luciferase and produce light which is read by the luminometer: the more light  produced, the more living organisms are present

This is a great test if you are trying to see how many living organisms are left on a surface following disinfection. What an ATP test won’t tell you is what they are. Furthermore, ATP will not detect the presence of viruses (viruses do not produce ATP).

To check for residual soil on instruments, you are better off with a test specifically targeted for residual protein and hemoglobin. These are also swab tests, and although they do not give quantitative amounts, they are quite sensitive (i.e. ProCheckII™ from Healthmark Industries is sensitive to 1µg of protein). Additionally, these tests do not require the purchase of extra equipment (e.g. luminometer) to interpret the results.

Lastly, the simplest test for blood residue on instruments is still the 3% hydrogen peroxide test.
To perform this test:

1. Place the instrument in question in a basin
2. Pour 3% hydrogen peroxide over it
3. If the solution begins to bubble around the instrument, this indicates there is residual blood soil

At present, there are no quantitative limits of residual protein on surgical instrumentation after decontamination in the United States. Both AAMI ST79 and ISO15883-1 identify “clean” as “the removal of contamination from an item to the extent necessary for its further processing and its intended subsequent use;” however, to this date in the United States, this has been interpreted as “visually clean.”

Recent publications* have demonstrated that even “visually clean” instruments are still capable of harboring unseen protein, lipid and carbohydrate soils. The average residual protein contamination of visually clean instruments in the Baxter study was 380µg. Because of studies like these, and the risks of vCJD transmission, two European nations (Germany and Austria) have begun to set limits of proteinaceous soil on instrumentation.

Germany (DGSV, DGKH, AKI)                             Austria (ÖGSV)
100µg per Instrument                                           50µg per Instrument
20µg per Opthalmic Instrument

As for the testing frequency of instruments or the method presently used to measure residuals in these countries, there is no definitive answer.

I myself recently posed this question of residual protein limits on surgical instruments at an FDA meeting on instrument reprocessing, and I also received no definitive answer.

 
*Publications:

1. Baxter RL, Baxter HC, Campbell GA, Grant K, Jones A, Richardson P, et al. Quantitative analysis of residual protein contamination on reprocessed surgical instruments. J Hosp Infect 2006;63(4):439-44.
2. Alfa MJ et al., Cleaning efficacy of medical device washers in North American healthcare facilities, J Hosp Infect 2009, doi:10.1016/j.jhin.2009.06.030)