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 3
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