Medical device packaging is just as important as the product itself, as it plays a pivotal role in ensuring both patient and product safety. From preventing outside contamination to protecting devices from damage during transportation, storage, and handling, maintaining high packaging standards is essential to ensuring device integrity. Therefore, regulatory agencies place strict compliance requirements on medical packaging to reduce potential risks and uphold device quality standards.
Materials
The materials used in medical device packaging may vary depending on the type of product. However, all materials used in packaging have to adhere to FDA and ISO standards. Medical device packaging materials must be:
- Made from known and traceable components
- Created with non-toxic, non-leaching, and odorless matter
- Free from any compromising damages, including holes, cracks, tears, creases, and thinning
- Capable of protecting against a range of variables, such as humidity, temperature, bacteria, mold, dirt, and light
Sterilization
Sterile packaging is essential for medical and healthcare devices. If products become contaminated during processing, shipping, handling, or storage due to faulty packaging, they run the risk of inflicting serious harm on unsuspecting consumers. All medical device packaging requires a sterile barrier system (SBS) that can effectively protect against microorganisms, moisture, and other contaminants. Additional protective packaging is sometimes added over the SBS for extra safeguarding. All medical device packaging companies must follow FDA regulations and have facilities equipped to manufacture according to ISO compliances.
Labeling and Instructions
While correct labeling is a must for just about every product on the market, it’s vital for medical device packaging to follow FDA packaging and labeling requirements. These include adding clearly defined expiration dates to ensure users are aware of safety timeframes and unique device identifiers (UDI) that designate specific batch and lot information. UDIs are used for identifying issues with specific batch numbers and product recall information. Even labeling misprints can cause significant product recalls, so these details must be carefully met. Medical device packaging must also include detailed instructions on how to safely use the product. Warning indicators for side effects or improper use must also be available on packaging.
Inspections
Because anything from a tiny tear to a labeling misprint can trigger major recalls, manufacturers must maintain the highest level of quality control and care when creating medical device packaging. Inspections should be completed at each major stage of production so clients receive safe, compliant packaging for their products.