Defective Packaging Causes Medical Device Recalls
Medical devices are used every day to save lives. However, compromised medical devices are frequently released into the marketplace, jeopardizing the life of the end user.
DDL Inc. COO, Patrick Nolan, comments on the presence of many packaging-related recalls in the FDA's latest product recall report.
Why have packaging issues come to the forefront?
Packaging has not been on the FDA's radar that much in the past. There is now a new focus on the importance of packaging in delivering a medical device to the end user. Ever since the publication of the first edition of the ISO 11607 standard in 1997, packaging has gradually hit the spotlight where now it is seen as an integral part of the complete medical device development process.
Where are medical device manufacturers leaving themselves the most vulnerable when it comes to packaging?
Many of the recalls are related to the manufacturing process where a package is not sealed properly. This is a function of a poor or non existent operational validation and little or no quality assurance procedures to ensure that defective packaging is detected before being distributed. Another common problem exists when a device manufacturer tries to get its product to market without performing all of the necessary qualifications and validations. For a device package design, an operational and performance qualification should be performed to ensure that the product and package are fully compatible and capable of withstanding the dynamic and environmental hazards associated with getting the device to the end user.
Which types of devices are commonly subject to packaging problems?
Devices with a high profile are most commonly subjected to packaging problems because many of them are very light and are packaged in standard pouch packages. One problem is that the pouch is too small and it becomes difficult to make good seals. Many of the poor seals that cause recalls are due to ‘puckering’, or wrinkling because the seal machine operator could not make a good seal due to the pouch being too small for the device.
In addition, these high profile products can cause abrasion, slitting, puncturing and other dynamic related effects during shipping and handling.
Another common mistake is using a pouch package for a massive product. Here the device often ‘blows through’ the seal during dynamic related events.
How can certifying packaging with ISO 11607 help?
By performing a robust package validation in accordance with the provisions of the ISO 11607 standard, a device manufacturer can prevent very costly recalls due to silly mistakes in manufacturing or poorly designed packaging systems. The package design process can be performed in parallel with the device development by doing preliminary evaluations for dynamic and environmental effects in accordance with the standard, thereby reducing the time to market.
Performing validations that are recognized by regulatory agencies can reduce scrutiny during audits thereby reducing the regulatory burden on staff. Confidence displayed by healthcare workers in the packaging may lend to an increased level of medical device sales.
Can you give any experiential examples of how DDL has help medical device manufacturers with packaging problems?
DDL is unique in the packaging business, we believe, by providing what we call PackAdvice. We do more than just perform the test method. If we see a problem with a package, we will consult with the device maker and point out any potential deficiencies. There is no cost to the customer for this advice and experience. There have been many times where we’ve received packages for testing that we know are not going to have a chance of passing the test procedures. We’ll talk with the customer and indicate our concerns. We hope that the customer will follow our advice and not waste their money by trying to validate a package design that we know will have problems. That’s not always the case, so inevitably we’ll be helping the customer later after he experiences packaging failures.
