Reprocessing of single-use medical devices, a practice that has gained popularity in recent years due to escalating healthcare costs, has been called into question once again after 2 patients have died, at least 7 have been infected and 179 patients may have been exposed to a drug-resistant “superbug” from a contaminated medical device. The devices…
Lakewood, Colorado, October 15, 2014 – Mesa Laboratories, Inc. (NASDAQ:MLAB) (we, us, our, “Mesa” or the “Company”) today announced the acquisition of substantially all of the assets and certain liabilities of the process challenge device business (the “PCD Business”) from PCD – Process Challenge Devices, LLC, a California company (“PCD-LLC”). The acquisition of the PCD Business is…
Previously, we discussed delayed incubation with regards to steam sterilized Self-Contained BI EZTest product (Spore News Vol. 10, No 4). Here, we address delayed incubation with a very different BI used in a different process: DriAmp for Dry Heat sterilization. In the ‘Resistance Performance Tests’ section of the USP, it states to culture a biological indicator (BI)…
By definition, the D-value for a biological indicator (BI) is the time (or dose) required at a specified set of exposure conditions to reduce the viable spore population by one log or 90%. Notice in the above definition that the D-value is for the BI, not the spore. One should not forget that the…
There are many different organizations that reference biological indicator use and often times it can be difficult to stay on top of what the latest standards say with regard to BI monitoring. Whether it discusses how many BIs should be used per load or how a manufacturer should qualify its BI supplier, it is important…
Mesa Labs supplies a Certificate of Analysis for our biological indicators detailing the specific attributes and resistance for that particular biological indicator configuration. The spore population on the Certificate of Analysis is reported as the heat shocked population per unit (biological indicator) with the exception of spore suspensions which are reported per 0.1mL. Each…
As more and more medical devices are developed, there is an ever increasing need to develop BIs that can be used to monitor the processes used to sterilize these intricate devices. If traditional BIs won’t work and these custom BIs aren’t created, the only alternative is to directly inoculate the devices and that presents a…
Mesa expert’s co-author article on minimum incubation times for Biological Indicators Garrett Krushefski and Kurt McCauley of Mesa Biological Indicator division have co-authored an article featured on Pharmtech.com. This article focuses on proposed minimum incubation time for biological indicator grow out times. You can read the article in its entirety at the link below: http://bit.ly/1hni3rQ…
Talk with one of our experts to get your questions answered and see how we can help you solve your BI pain points.
Extended sterilizations cycles are becoming more and more common as manufacturers are incorporating complex materials and designs into medical devices. It can be very difficult for the sterilant to penetrate a narrow path or throughout a very dense or heavy load with traditional sterilization cycle times so increased sterilization cycles are something manufacturers are dictating…