For healthcare professionals, ensuring medical devices are clean, functional and stored in a sterile environment is crucial for keeping patients and staff safe from harmful bacteria.
In particular, the process of packaging medical instruments and ensuring the seals on peel pouches remain reliable can present numerous challenges for healthcare facilities, such as evaluating whether seals are efficient across pouch types and avoiding breaks in seals that could allow foreign substances to enter the packaging.
In a May 30 webinar sponsored by Healthmark Industries and hosted by Becker's Hospital Review, Stephen Kovach, director of education for Healthmark, discussed how healthcare facilities can properly seal a peel pouch and strategies to test and verify the sealing process.
The FDA classifies packaging used for sterilization as a Class II medical device. Packaging material is intended to allow healthcare providers to sterilize an enclosed medical device and to maintain the device's sterility until use, according to the agency.
"Traditionally, peel pouches are sealed in two different ways: heat sealing or by self sealing," Mr. Kovach said. "Both have positive and negative features, but when examining the different methods of sealing peel pouches, the concern is figuring out how you can ensure you have a reliable seal that will hold once it is sealed."
Here are five tips to ensure peel pouches are properly sealed.
1. Know the positive and negative aspects of sealing techniques. The two sealing techniques (heat sealing and self sealing) have various benefits and setbacks. For example, in self sealing, there is a high risk of air channels and the integrity of the seal depends on the user's handling. "The quality of self seals is difficult to control because some people push harder when they seal, and others don't push as much," Mr. Kovach said. "Additionally, self seals have a limited shelf life because the glue dries out." On the other hand, heat seals provide air-tight closure against contamination and have closing processes that can be easily verified.
2. Verify seals according to type. "The majority of healthcare facilities are using a combination of heat seal and self seal pouches, which means it is critical to verify the seals in two different ways," Mr. Kovach noted. "If you don't have a good seal, it opens up pathways for microorganisms to enter the packaging." For example, during the sterilization process, seeing air pockets in self seal pouches is a sign the device is not properly sealed.
3. Implement seal quality tests. For example, hospital staff can use a dye penetration test for mechanically produced seals. Dye tests can be used in both heat and self seal techniques. In these tests, staff can place the ink dye test in the pouch before sealing and apply sufficient pressure to the pouch with their fingers.
"Using this method, staff can see where the ink comes through, signaling a break in sterile technique through the gaps in the dyes that would not show up visually," said Mr. Kovach, adding that the test immediately identifies irregularities in the seal.
4. Maintain proper temperature, pressure and dwell time. "It is important to recognize each pouch has its own specific range of temperature," Mr. Kovach noted. Each pouch also requires the application of a certain amount of air pressure and a specific dwell time, which designates how long heat and air pressure need to be applied to create the seal. "If the temperature is too high, the packaging can be burned, and it will not remained sealed," Mr. Kovach added.
Continuous feed type sealers allow an adjustable depth of seal as well as equal pressure and temperature. "Depending on what type you have, it will only seal during that specific temperature," Mr. Kovach noted. "If you are not in the correct temperature range, the heat seal cannot be maintained."
5. Document peel pouch seal verification testing. A process verification program is necessary to ensure all hospital sterilization and packaging processes are effective and reproducible. For example, hospital staff can look at the date and time of the seal and make sure there are no gaps in the seal to verify the efficacy of the hospital's packaging processes. "This should be done every day," Mr. Kovach noted. "It could even be done on every shift to make sure it is working properly."
This documentation can come from training and in-service education provided by the peel pouch manufacturer or the company that sells the hospital sealing products. "These companies should be making sure your sealing process is working properly and your staff is providing a good seal," Mr. Kovach said. "Whoever you're buying it from, bring in someone from your company to look at your pouching techniques and make sure your staff is providing the best patient care."
To listen to the full webinar recording, click here.