VersaTREK REDOX Glass Bottle Survey

VersaTREK® REDOX® Glass Bottle Survey
July 2011
VersaTREK® REDOX® Glass Bottle Survey
In March 2010, the International Sharps Injury and Prevention Society
(ISIPS) conducted a survey of microbiology laboratories to determine the
percentage of laboratories that experience breakage with glass blood
culture bottles. The results from the survey appeared on websites
(HealthVIE and ISIPS) as well as the December 2010 bioMerieux
Connections Newsletter authored by Ron Stoker*. This survey left several
questions unanswered with regard to the performance of VersaTREK
REDOX glass bottles. In the following document, a summary of results
from the VersaTREK REDOX glass bottle survey are revealed as well as
TREK Diagnostic System’s position on glass blood culture bottles.
_____________________________________________________________________________
In March 2010, the International Sharps Injury and Prevention Society (ISIPS) conducted a
survey of 276 microbiology laboratories to determine the percentage of laboratories that
experience breakage with glass blood culture bottles. According to the survey, 60% of the
surveyed laboratories experienced breakage of blood culture bottles. Because the survey did not
reveal the breakage per [glass] bottle manufacturer (TREK Diagnostic Systems and Becton
Dickinson), TREK conducted a survey of VersaTREK customers to determine VersaTREK
REDOX breakage incidences. Table 1 represents the questions asked of the surveyed customers.
Table 1
VersaTREK REDOX Survey Questionnaire
What is your yearly VersaTREK REDOX bottle volume?
Do you experience VersaTREK REDOX bottle breakage?
If Yes, how many per year?
Does this occur via pneumatic tube system or other (Please specify)?
Do you use the REDOX Transporter to deliver bottles through the pneumatic tube?
Sites surveyed ranged in bottle volume from 2,700 bottles per year to over 139,000 bottles per
year. A combination of hospital types including community-based to large teaching university
hospitals were surveyed. The customer mix included long-time VersaTREK users, Becton
Dickinson competitive conversions, and bioMerieux competitive conversions where plastic
bottles were used prior to converting to the VersaTREK System.
1 VersaTREK® REDOX® Glass Bottle Survey
In comparison to the survey conducted by ISIPS which quoted close to 30% of the sites
experiencing greater than 6 breakages per year, only 0.13% of the VersaTREK sites surveyed
experienced more than 6 breakages per year. [It should be noted that the breakage was due to
non-compliance of proper packaging for the pneumatic tube]. Sixty-seven percent of
VersaTREK sites use the pneumatic tube system to transport blood culture bottles. Of those sites
which experienced rare breakage with the pneumatic tube system, it was determined to be a
direct result of improper packaging of bottles. Through the use of customized training programs
at the customer site, TREK is able to easily assist customers on how to package properly the
blood culture bottles. Also offered is the REDOX Transporter, the first to market carrier that
allows bottle sets to travel together safely through the pneumatic tube system. None of the
VersaTREK survey sites reported any injury due to bottle breakage compared to the ISIPS report
of 60%. Additionally, several VersaTREK sites with bottle usage from 20, 900 – 92, 400 bottles
per year reported no breakage with VersaTREK bottles.
In summary, numerous VersaTREK sites indicated they had not experienced breakage, and of
the sites that did report rare breakage, it resulted largely from noncompliance of pneumatic tube
packaging. TREK is proud to announce that with over a half of million bottles accounted for in
the survey, the total bottle breakage reported was only 0.0098%. We attribute this extremely
low and rare rate to the robust design of the glass mold. VersaTREK REDOX blood culture
bottles are made of a robust molded glass that is resilient to breakage under normal use.
Worth noting, is that plastic bottles are not always a reliable substitute to glass bottles. For
example, as reported on the MAUDE Adverse Event Report on the FDA website, there are two
incidences citing BioMerieux’s BacT/ALERT MP plastic culture bottles. The first incident
involved an inoculated BacT/ALERT MP plastic bottle that had cracks around the neck of the
bottle when it was pulled out of the instrument. In the event report, under the manufacturer
narrative it states, “There is a potential for an adverse event were this to recur and the integrity of
a positive bottle were to be compromised. In the event of breakage, the user could be exposed to
aerosolized Mycobacteria samples that can have significant health effects.” The second event
also involves a BacT/ALERT MP plastic bottle. In this incident the integrity of the bottle had
been compromised and it leaked inside the instrument which caused the bottle to stick into the
instrument cell.
TREK continues to maintain its stance on glass blood culture bottles due to potential issues
associated with aging plastic such as loss of vacuum, loss of moisture, oxygen and carbon
dioxide transfer rates, the potential for media degradation and the issues reported to the FDA
cited in the above paragraph. With millions and millions of glass blood culture bottles
manufactured every year, TREK and their customers can remain confident that they are using the
highest quality of glass blood culture bottles as proven through the data from this survey.
*Note: Ron Stoker, owner and executive director of ISIPS, is also a member of bioMerieux’s
speaker bureau and is engaged in consulting work on behalf of the company.
2 VersaTREK® REDOX® Glass Bottle Survey
References
bioMerieux, Connections Newsletter (2010, December), Vol 7, pgs. 4-6
Stoker, R. healthVIE.com. Sharps Safety (2010, November), Microbiology Laboratory Risk
Assessment of Blood Culture Bottle Breakage
http://www.biomerieux-usa.com/upload/ISIPS%20Stoker%20Letter%20onBD%20Article-1.pdf,
website accessed July 13, 2011
http://www.linkedin.com/in/ronstoker, website accessed July 13, 2011
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=871867,
website accessed on July 13, 2011
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=980268,
website accessed on July 13, 2011
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