If you are a medical device manufacturer that performs medical pouch testing in-house, you need to explore the possibility that your test process may be at risk unless you’re looking outside your own facility. As an ISO 17025 accredited laboratory we are required to participate in proficiency testing also called interlaboratory comparison. For our proficiency testing we work with HN proficiency testing, Inc. In case you’re not familiar with proficiency testing here is a description from HN proficiency testing, Inc.
“Proficiency testing determines the performance of individual laboratories for specific tests or measurements and is used to monitor laboratories’ continuing performance.
Proficiency testing is also called interlaboratory comparison. As this term implies, proficiency testing compares the measuring results obtained by different laboratories”
Over the last 26 years I have encountered several medical device manufacturers that are performing in-house pouch testing (usually tinsel testing using the ASTM F-88 method) only to later find out their test methodology or process was invalid. If you are passing pouch seals from your medical device pouch sealer based on your own in-house testing process, then you must then make certain that the process is sound.
Many of the testing process’ from medical device manufacturers have generated false positive results that have caused a medical device pouch to fail in distribution. There’s a host of reasons why these weak seals are not being caught. Some manufacturers are utilizing medical pouch testing systems that are out of calibration or utilizing machinery that does not conform to a recognized standard such as the ASTM F-88 or that are simply not performing the testing correctly.
In order to help our customers assure accurate in-house medical device pouch testing we developed a valuable interlaboratory comparison program at Van der Stähl Scientific called the “SPOT program” (sterile packaging on track). This monthly testing service can provide better assurance that your internal medical device pouch testing program is valid and accurate. The program is powered by our ISO 17025 testing Laboratories in order to provide an accredited second look at your process.
Each month medical device manufacturers can send to our labs their pouches along with their reporting and we can overlay the medical device seal testing data in order to assure that there is low deviation in results. We can also send a group of pre-cut and sealed specimens on a cohesive pouch material that predictably peels in order to help medical device manufacturers commission in testing equipment through their gauge R&R study.
I cannot stress enough if you are using a medical device pouch sealer and releasing your sterile barrier system into distribution based on your in-house testing, then you need to be performing some type of interlaboratory comparison.
If you are faced with a serious medical diagnosis then surely you would seek a second opinion, opening the portal to more data points will best assure you that you are on a curative path forward. Surprising many medical device manufacturers are seeking comfort that their in-house packaging testing program is sound by simply increasing the cadence and number of pouches tested. An adage comes to mind from the 1990s “garbage in garbage out” increasing the number of unknown data sets will provides zero value, this is the time to focus on mixed data outside your own testing function.
Sure, test often but first be certain that your testing function measures up against a third-party accredited ISO 17025 laboratory, this “2nd opinion methodology” may indeed save you from a medical packaging recall.