The work we do at Polymer Solutions Incorporated (PSI) impacts the health and safety of the global community. Sometimes it’s because the materials we test are components used in transportation; other times it’s because our testing is in support of government defense work. Additionally, a lot of the work we do is for the medical device and pharmaceutical industries – directly or indirectly verifying products are safe for the human body.
Recently our work hit incredibly close to home. One of our scientists, Kimberly, required a surgical procedure to help with persistent sinus and nasal issues. “Before surgery I had a lot of facial pain, fatigue, and I completely lost my sense of smell,” Kimberly explained. Her medical problem required a surgical solution to include a medical device. Specifically, she required a device that our company regularly tests, PROPEL Mini. PROPEL Mini is a medical device created by Intersect ENT, a medical technology company dedicated to advancing the treatment of ear, nose and throat conditions.
According to Intersect ENT’s website, PROPEL mini is a dissolvable sinus implant “clinically proven to improve frontal sinus surgery outcomes.” The testing we do on this device is part of Intersect ENT’s diligence to produce products that truly benefit patients in a safe way. They use our lab for surveillance testing of each medical device lot, to be certain it will perform as expected in the human body. The big picture goal is patient safety. “I was thrilled when my doctor told me I would be receiving two medical devices we have been testing onsite,” Kimberly said. “It gave me peace of mind because I trust the good science we practice here.”
Fortunately for Kimberly, the surgical procedure and medical device achieved the desired results. “When I came out of surgery it was incredible how I could breathe without any pain and I had regained my sense of smell again,” she exclaimed. “The surgery was a success and thanks to the medical devices, it cut my recovery time in half, which helped me get back on my feet and into the laboratory again.”
While we hate Kimberly required surgery, we are honored to have a role in ensuring the safety of the device. In fact, our nerdy-excitement was such that we went and tracked down the actual lab notebook page used to document the analysis for the specific lot of devices used in Kimberly’s surgery. We were able to readily find this information and learn which scientist was responsible for confirming the medical devices for Kimberly’s surgery was going to be safe and perform as expected. How cool is that?
This brings up an excellent concept of quality management systems and documentation. As our Quality Assurance Manager, Cedric Sirmons, shared, “Good documentation practices are of paramount importance for ensuring data integrity.” The excellent documentation practices we use within our lab create a number of great outcomes. At the highest level, it ensures the data we produce is reliable. We document all aspects of testing so that it can be demonstrated how results were achieved, who achieved those results, and on what piece of instrumentation the results were achieved, just to name a few aspects.
Excellent documentation also creates accountability. In a traditional sense of the word, the scientist documents exactly what they did and how, thus attaching their name to the process and end results. In a more broad sense, it holds our entire company accountable for the way we conduct testing and the practices we use to support our testing. Those practices include equipment calibration, instrument qualification, and effective training of our team.
Each day in our labs we conduct analysis knowing the results produced are impacting the local, national, and global community. This extremely personal perspective of how our testing is helping improve patients’ lives gave us fresh commitment to the great science we know and love at PSI.