Engineers who create innovative packaging systems for sterile medical devices must be aware of mistakes that are commonly made in their industry so they can actively work to avoid them. Too often medical device packaging is improperly designed and/or validated, which causes an array of issues for medical professionals and their patients.

The international packaging standard (ISO 11607) “specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.”

Manufacturers can avoid packaging pitfalls by having well-defined standards that comply with the FDA and ISO 11607.

For example, Packaging Compliance Labs has three standards by which they validate their packaging:

  1. A manufacturer must be able to consistently form and seal a package, meeting requirements for the strength and seal of the bond after heat-sealing, the seal’s visual aesthetics, and the ability to open the package. If the end-user in an ambulance, hospital, or clinic has trouble opening a package, it may rip or tear, exposing the device inside to contamination and rendering it unusable.
  • The package design must be sufficiently robust to withstand shipping through all types of climates and a variety of physical hazards. PCL simulates different types of hazards that packages might encounter, exposing them to sub-zero, desert, and tropical conditions, dropping, compression, vibration, impacts, and altitude simulations.
  • A package must be able to maintain its integrity over time. For a sterile, disposable device package, that’s usually two years, Furchak noted. PCL uses real-time aging in a controlled environment as well as accelerated aging, which requires baking the package. “Forty days in the oven is equivalent to one year sitting on the shelf,” Erickson said. If the material hasn’t weakened too much and the heat seals remain secure, a company can officially market the device with the validated expiration date claim.

Medical device manufacturers should follow Packaging Compliance Labs’ lead by defining their own standards for compliance. If this is done well, they are more apt to avoid common mistakes that medical manufacturers make.

Common Mistakes Medical Manufacturers Make

  1. Compromised sterile barriers

The sterile barrier is the most important part of a medical device package. If a medical professional does not realize that a sterile barrier is compromised, they are putting their patient at serious risk.

There are several reasons why sterile device packaging might fail:

  • Packages that have paper on one side and foil or Tyvek poly on the other might not be compatible with every device a company manufactures.
  • Devices that are heavy or irregularly shaped can cause a seal to rip or puncture packaging.
  • Heat-sealed packages that are not tested for integrity may have folds or gaps in the seal which can allow bacteria to enter the package.
  • Improper labeling

To be sure sterile device packaging is properly labeled up until the point of use, the manufacturer should conduct tests that simulate the conditions of distribution, storage, and use, and make necessary adjustments. As this takes extra time and money, some manufacturers make labels that fail to comply with the FDA so they can get their products on the shelves faster.

This is not only irresponsible, but it is dangerous. If a medical establishment is waiting for their shipment of sterile devices and they arrive mislabeled or without labels, they will have to send the devices back.

  • No plan for when things go wrong

Sterile device packaging manufacturers should determine a “worst-case scenario” that simulates everything that could go wrong during design, production, shipping, storage, and use. This will position the manufacturer to get through an unexpected event with as little disruption as possible.

  • Not having proper protocols in place

Protocols provide a map for how a product will be tested and dictate the test’s purpose, responsibilities, parameters, scope, setting, the equipment that is needed, and criteria for passing the test. Without proper protocols, manufacturers risk their products being tested inadequately and inconsistently.

Once protocols have been set up, manufacturers should also set up a map for validation, which lays out the materials and processes that go into producing the final product. For a safe product to reach the end-user, every single step of protocol and validation needs to be met. Otherwise, the product should be recalled and redesigned.

  • Improper secondary packaging

Manufacturers use cartons, boxes, and other secondary forms of packaging to ship their sterile medical devices to other locations. Some companies will attempt to save on space and shipping costs by putting as many sterile packages into secondary packages as possible, which creates friction between the sterile packages that can cause pinhole defects.

Manufacturers should use secondary packages that are large enough for sterile packages to have some room to move, but not enough to be damaged during transport.

  •   Accelerating shelf lives

Some manufacturers will shorten a sterile package’s shelf life in an attempt to reduce costs and the amount of time it takes to get a product on the market. Accelerated shelf lives are caused by performing temperature tests at unusually high temperatures that cause packages to melt, warp, and incur other defects. Most often, the resulting shelf lives are unrealistic and therefore unethical – especially in the medical field where sterile devices are used to save lives.

Package Sterile Devices with Confidence

Explore Van der Stahl Scientific’s MS-451 medical pouch sealer, tester, and visual inspection device. This medical device heat sealer helps to assure your device will arrive sterile as it incorporates a pouch testing and inspection function within the medical device packaging machine.  

We understand that providing your customers with medical devices that are safe and packaging that is reliable is your top priority. Let us help you reach your goal and save more lives. Request a quote for your facility.