(800) 369-0899
(215) 569-4000
Contact Us Today
When it comes to medical devices, packaging is second only to the product’s design. Poor packaging, which may impact a device’s sterility and safety, can cause harm and even death to a patient. Medical device packaging issues triggered the highest number of FDA recalls in the decade between 2007 and 2017, with the exception of devices that broke during or after implantation.
The final count was 39 recalls for breakage and 37 for sterility. Device design issues accounted for 27 recalls during this period.
Medical device packaging is both an art and a science. The device must arrive at its location in packaging with no rips, tears or holes, and obviously no broken seals. Depending on the device type, once it arrives at a doctor’s office, hospital, or other medical facility, it could end up stored away for years, and must remain sterile.
Cost conscious manufacturers want to use the smallest container possible for medical devices, which may save them money, but is more likely to compromise the package. According to Food and Drug Administration (FDA) standards, manufacturers must meet certain requirements in medical device packaging.
These include:
Consistent form and sealing of medical device packaging – The seal must meet FDA regulations regarding strength of the bonding post heat-sealing. The seal must also meet visual aesthetic standards.
Just as important, the user must have the ability to open the package without difficulty. Issues in opening a medical device package may cause tearing or other problems that render it nonsterile and therefore unusable.
Packaging durability – The design of a medical device package must prove strong enough to withstand all types of shipping conditions, along with changes in temperature and handling. Such packaging means the device must not break, and the packaging not tear, if it is subject to vibrations, impact with other packages, or even dropping.
Packaging sterility and integrity – Medical device packages must maintain sterility and integrity for a prescribed time, generally two years. In some instances, the FDA permits marketing of medical devices whose expiration dates have passed if the heat seals on the package are intact and the material has not weakened.
Other considerations involving medical device packaging safety include the size question. Despite their quest for small packages, manufacturers cannot ship a device in a package that is either too big or too small. For sterility purposes, all raw materials must create an effective microbial barrier, and such materials must be easily traceable.
The manufacturer’s equipment must produce standard and measurable packaging that meets performance specifications. Regular quality assurance checks are necessary to ensure packaging continues to meet the standard.
If you or a loved one has been injured because of medical device packaging issues, you need the services of the experienced Philadelphia medical device lawyers at Brookman, Rosenberg, Brown & Sandler. To make an appointment in our Philadelphia office, call us at 215-569-4000, or contact us online to provide you with legal advice concerning your case today.