The health industry relies on medical devices every year to diagnose and treat patients, meaning that it is incredibly important the devices are of the highest quality. Medical device manufacturers are responsible for making sure that their devices arrive safely to the consumer. In order to do so they must anticipate and plan for any issues during the manufacturing, delivery and utilization process that could affect the sterility and functionality of the product. Unsterilized equipment can lead to infection, contamination and even death in patients, and even with current regulations in the health industry, this remains a common issue.
When it comes to ensuring sterility of medical devices, the medical industry uses a measurement called SAL (Sterility Assurance Level) to determine the effectiveness of sterilization processes. According to Medical Design Briefs, there are a variety of tests that can be done to assess SAL, including the following:
Visual Inspection Test Method
This test is used for flexible packaging materials and measures the channels in the seal area to test the strength. This method can detect issues with a 60-100 percent probability rate.
Dye Penetration Testing
This test is used to assess the durability of medical device packaging. Using dye the package is injected to see where any weak spots occur. If the dye breaks through the seal then the item is compromised.
Package Seal Strength Testing
This test assesses the amount of force necessary to separate a test strip from the seal and calculates the strength of a sealed tray or pouch.
Bubble Leak Test
This test is an all-encompassing surface area test of medical device packaging. It assesses if there are any leaks within the seal and anywhere else in the packaging.
However, there is more to maintaining sterility than just packaging. Oftentimes medical manufacturers outsource portions of the operation, which can cause issues with the final product. Since regulations for medical devices are quite severe, if a process is outsourced manufacturers are required to validate the process. This means that the outsourcer needs to be familiar with rules and regulations of sterile medical packaging to meet FDA requirements. Since this is difficult to ensure it is best to only outsource to reputable and knowledgeable medical manufacturers.
Sterile packaging for medical devices is necessary to ensure that the machine is able to do its job properly without contaminating patients. Manufacturers need to take the necessary precautions to make sure that they are delivering quality products that can be used for years to come. If you are a medical practitioner or manufacturer, you should take it upon yourself to evaluate where the devices are coming from and what testing has been done to ensure its effectiveness. This is not only important from an economic standpoint, but also to keep patients safe and in the best care possible. Overall, your devices should be produced in sterile facilities, distributed with care and under arduous processes to eliminate probability of contamination, and ultimately able to perform effectively for the patient.