05-29-2011 03:46 PM
We have an isolator and some technicians prefer to use the nylon liners inside the gloves. We use sterile gloves as the glove of the isolator and we change them per user which is per shift. We do not double glove in the CAI. We do double glove in the CACI, bringing the sterile glove into the CACI to place over the non-sterile chemo glove box glove, to meet the requirement for double gloving for hazardous drugs.
For our CAI, we sterilize the gloves after changing them with a sterile 70% IPA alcohol wipe. We also spray them frequently during the shift, after bringing items into the direct compounding area and before they compound and after clearing the DCA after compounding complete to leave them clean until the next compounding event occurs. We do random glove tip sampling to assess our process. It seems to be working. We have had a few isolated positives that we have ID'd through our lab but in reality, it is not > CFU per glove so looking at USP 797 and its threshold, we seem to be doing OK. Thoughts?
05-30-2011 11:20 AM
If the end justified the means, I would say that what you are doing glove-wise in your CAI is just fine. However, although you are certainly reducing the bioburden on the gloves (apparently enough so that MOST of the time you are passing the gloved fingertip microbial testing), I believe that Eric will tell you that USP 797 calls for sterile gloves and you are not really sterilizing your gloves when you use a 70% sterile IPA wipe on them. Doen't seem fair, does it?
Robert Martin, PharmD
05-31-2011 08:23 AM
A couple things come to mind when I read your post. First, spraying non-sterile gloves with sterile IPA will disinfect them but NOT sterilize them. What type of microorganisms have you recovered from the gloves? Are they gram positive or gram negative organisms? Finding microorganisms on gloves within an isolator means to me that there is room for improvement relative to component handling and disinfection. Of all of things we can do to protect patients, wearing sterile gloves and using proper aseptic technique are two of the simplest things we can do. Ends don't justify the means to me as you describe your situation, especially when you routinely follow the requirement of the chapter when working in your CACI. The $64,000 question is would you make a nonhazardous drug CSP in your isolator with nonsterile gloves that may or may not have microorganisms on them for yourself or a loved one? Why do we think it is OK to not comply with this requirement of the standard? With all due respect, it appears that you are placing the wants of your technicians over the needs of the patient. Just saying...
05-31-2011 08:57 AM
Just some thoughts...forum posts make it impossible to read intent but understand I am typing this message very appreciative of your contributions to this forum and want to engage you respectfully. I am also typing this with a smile on my face. When does "fairness" trump patient safety especially when the appropriate procedure occurs in the CACI? Depending on the state that Patti practices in, there is also an issue of complying with pharmacy laws. If you fly on a plane, do you want to land safely MOST of the time? We have a huge responsibility to do what is best for the patient first and foremost regardless of the personal preferences of employees (beit technicians or pharmacists). Imagine trying to explain this position in a court of law to the family of the patient harmed or killed from a contaminated CSPs because MOST of the time we didn't have a problem when wearing nonsterile gloves. Doesn't work too well for me. It is a little dramatic but one way to test the decisions made and position taken. Thanks for "humoring" me.
05-31-2011 12:44 PM
I think I misunderstood your post re: sterile gloves in the CAI. How are you using them and the nylon glove liners? Please forgive my early rant. Thanks for your help.
06-01-2011 10:27 AM
I totally agree with you. The "doesn't seem to matter" comment was meant to be tongue-in-cheek but upon rereading it I do see how it could be misconstrued. I realize that this is not something to joke about. I, too, am a bit of a stickler for the rules and am a bit offended when they are not followed.
Thanks for being a champion in bringing these issue to the forefront.
06-03-2011 09:22 AM
You're forgiven . I know sometimes meaning can be misunderstood when communicated like this, versus face to face. I have been "struggling" with USP 797 compliance not just with techs but upper management really, not my manager. We definitely use STERILE gloves for our CAI. Some techs use nylon liners INSIDE the sterile glove because they like the feel better but these nylon liners are NEVER inside the hood or in contact with CSP's. We use the STERILE glove in place on the non-sterile CAI glove, we do not double glove in the CAI. This is not what we do in our CACI where we leave the non-sterile nitrile chemo gloves and double glove with a sterile chemo glove when compounding. In our CAI, every shift, we change gloves, (coincident with personnel change). They change the sterile glove to their size, disinfecting the gloves with 70% sterile IPA after doing the glove change. We spray again after bringing items into the CAI for compounding and preparing for compounding but before they compound, and again they spray after the compounding event, to leave the gloves disinfected in the hood for next compounding event. We have had 1 colony of bacillus, 1 colony of coag-neg staph, and 1 colony of gram neg non-enteric rod on 3 individual gloves. According to USP 797, during actual compounding, this meets the reg because it is less than 3 colonies per pair of gloves. Is this correct? is this process OK do you think? Let me know. I have asked our network director about using sterile clorox wipes on our gloves in addition to 70% sterile IPA because of the bacillus colony. I have yet to hear.
06-05-2011 09:54 AM
Thanks. I hadn't had my coffee before I answered the post. Thanks for the clarification. You refer to spraying quite a bit but does your staff wipe the components and their gloves also? In one of the other posts I made, I attached an article about cleaning contaminated keyboards. I attached it again. The key activity appears to the wiping action to remove any offending microorganisms. Bacillus and and a gram neg rod are microorganisms we don't want to see in an isolator. Technically you meet the CFU levels but understand those levels are examples and ideally should be less for such a critical environment. I would strongly recommend that you use a sporicidal agent (dilute bleach, or Accel TB) routinely to address the bacillus and gram negative-microorganism. Hope this helps.