Medical devices undergo rigorous testing and evaluation before they are allowed to be marketed and sold. But did you know that the design of medical device packaging can be just as important as that of the device itself?
For many devices, the packaging must keep the device sterile
, both in storage and in transit. It must be able to withstand physical extremes but be easy for the end user to open. Device packaging, in short, is a complex topic with several constraints for materials and design.
In this article, we will explore some of the medical device packaging standards and the considerations that go into the design and testing of medical device packaging
Many medical devices, especially those that get implanted in a patient’s body, must be kept sterile from the time of manufacture until their use.
Even a tiny defect in the packaging can allow the device to become contaminated with pathogens, causing infections and severe postoperative complications for the patient.
For this reason, most medical device packaging regulations are concerned with maintaining the sterility of the device.
The two major device packaging standards for sterile medical devices are subparts of the ISO 11607 standard.
Additionally, the U.S. Food and Drug Administration (FDA) recognizes International Safe Transit Association (ISTA)
standards. This compliance ensures no compromises to the testing of the integrity of medical device packaging during transit.
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This medical device packaging standard, published by the International Standards Organization (ISO), covers the materials used to create packaging and the design of sterile barriers.
It states that to ensure sterility, medical device packaging materials must be:
- Made from known and traceable materials
- Intended specifically for medical device use
- Free of defects such as holes, tears, and thinning
Thus, material selection is an important aspect of the device packaging design. The device manufacturer must demonstrate that it is aware of the composition and its acquisition.
Additionally, the manufacturer must have a quality inspection process to identify any defects before using the material.
ISO 11607-1 also covers testing methods for sterile barrier systems. Testing methods include:
- Visual inspection
- Bubble leak tests
- Microbe challenge tests
It is also crucial to conduct tests that examine seal integrity and seal strength. The medical device manufacturer should decide which test (or tests) to conduct for package design and risk.
ISO 11607-2 concerns the validation requirements for forming, sealing, and assembly processes for sterile protective packaging.
This standard is similar to the quality standards that guide the design and manufacture of the device itself. However, this medical device packaging standard also helps the medical device industry validate that the sterility barrier design goes through a high-quality manufacturing and assembly process.
Medical device packaging standards are not just important when the device is in the manufacturer’s warehouse or at the customer’s site. The medical packaging must be sufficiently robust to survive the trip from one to the other.
The ISTA defines testing procedures for medical packaging for all modes of transport. These methods test how well that packaging withstands the vibration, shock, temperature and pressure extremes, humidity, and other environmental factors associated with transportation.
Although medical device packaging regulations are of critical importance, they aren’t the only considerations for medical device manufacturers. Some other medical device packaging requirements include:
- Shelf life: Many medical devices have a finite shelf life, beyond which efficacy and safety cannot be guaranteed. The packaging, therefore, must maintain its integrity for at least the shelf life of the device.
- Storage conditions: Some medical devices, such as diagnostic test kits, must be kept at ultra-low temperatures until used. The packaging must also withstand those temperatures (in addition to the freeze-thaw cycle) without cracking or deforming.
- Ease of use: Although medical device packaging must withstand extreme temperatures and rough handling, it must also be easy to open by the end user (such as a doctor, nurse, EMT, or patient) without damaging the device, thus risking contamination. As a result, it is crucial to test the opening of the device packaging under sterile conditions.
These and other medical device packaging requirements make device packaging a vital aspect of medical device development, requiring highly specialized knowledge and skills.
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