Van der Stähl Scientific has coined the term “forced policy compliance” with the development of our medical packaging machinery that requires the unit to stop packaging based on user defined intervals to determine if the packaging equipment is creating passable seal strength. This FPC system creates a firewall designed to thwart seal failure on a medical devices pouch that could compromise device sterility. If the seal strength doesn’t meet a quality team’s pre-determined peel values, the sealer will no longer work until a 4-digit supervisor pass code is entered in order to access machine settings and to remedy pouch failure. We all want to assume everything is going well in our cleanrooms and that the operators are preforming quality tasks as outlined in their training . But can we count on employees performing test and checks when unsupervised? Cleanroom workers are often itinerant, some are per diem, and they are often the lowest paid, least trained employees in the building. Why then, would you expect they would have the same level of commitment and understanding that your quality group has? They simply won’t. Forced compliance is not at all “big brother.” It’s trending now, that we all are part of a forced compliant system. Last year I received a ticket in the mail with a picture of me driving through a stop light – accidentally I may add. This automated cop caught me red handed, compliance goes way up when we are being watched and checked. And the message is clear. You don’t have to comply with our rules, but if you don’t, there’s a penalty. Better yet, we have a system that won’t allow you to make that mistake. FPC systems in sterile packaging is essential. We cannot risk the sterility of our products based on hope. We must have systems and firewalls and gates that encourage and demand that our process stay intact. Medical device packaging is far to important to not look for better perhaps automated ways to stay compliant.
These are surgical devices and their loss of sterility can risk lives. We must use every reasonable tool in our toolbox to be certain that our products make it to the point of use with sterility and device efficaciousness in tact. Van der Stähl Scientific has a host of forced compliance systems with more in the works that will make your job easier and could save countless lives by abating patient contact with unsterile devices. We invite you to ask us how.