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Registered: ‎02-23-2010
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Re: Disinfection of gloves during compounding - a breach to glove integrity?

Judy,

 

Nonsterile gloves are dirty when compared to sterile gloves (see attached picture).  A poster was presented at the ASHP Midyear comparing sterile gloves vs. nonsterile gloves.  In the poster you will find that it was reported 1 out 3 nonsterile gloves grew when fingertip sampling was done. Sterile gloves also grew but I believe it was due to poor technique.  I teach gloved fingertip sampling at the Baxa Star class and after dozens of students, we may have had 1% contamination.  It's all about technique. I also attached an article I was interviewed for re: this poster.

 

Re: Trissel study, in the results section, "Compared with group A, using nonsterile chemotherapy gloves with repeated IPA disinfection (group B) resulted in 3 positive growth samples among 311 individual aseptic technique tests for a contamination rate of 0.96% (p = 0.0029). When sterile chemotherapy gloves were used along with repeated disinfecting with IPA (group C), the contamination rate was lower still with only 1 positive growth sample among 296 individual aseptic technique tests for a contamination rate of 0.34% (p = 0.0005). These reduced contamination rates can be contrasted to group A for years 1 and 2 and its unacceptable 5.2% rate. The apparent difference between groups B and C was not statistically significant (p = 0.3367), possibly because of the low number of contaminated samples. Even so, this result suggests that a contamination below 1% can be achieved if initially sterile protective gloves are used."

 

IPA does not kill spores. http://www.cdc.gov/hicpac/Disinfection_Sterilization/6_0disinfection.html#a1

 

Although these are not statistically significant results, I believe and so did the USP Sterile Compounding Committee that they were clinically significant and on the advice of an expert panel of national/international infection control/microbiologists/clinicians to the USP Sterile Compounding Committee, the use of sterile gloves and sterile alcohol were recommended.

 

IPA is used in laboratories as a medium for bacillus spores, in fact it sporulates the bacillus.  There was a national recall of alcohol prep pads potentially contaminated with bacillus spores http://www.fda.gov/safety/recalls/ucm239219.htm. There were reports that 11 possible deaths were associated with these contaminated alcohol pads.   Here is another link http://www.sciencedaily.com/releases/2012/06/120612144759.htm

 

Not sure where you are going with this post and maybe I'm reading too much into this but it is requirement in the chapter to use sterile gloves and sterile alcohol.  You can most certainly make different decisions but as unpopular as it, it is a requirement of the chapter.  I was one person out of twelve members of the USP Sterile Compounding Committee and the committee overwhelmingly voted to require the use of sterile alcohol and sterile gloves. I hope this helps.

 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.