How Medical Device Packaging Partners Help Reduce Patient Safety Risk

3 Ways a Package Could Compromise Medical Device & Patient Safety

It is imperative that the packaging supplier remain aware of and proactively address three common patient safety risks:

1. Contamination introduced through various production methods or within the supply chain
2. Materials failure that cause punctures, tears, pinholes, or cracks during handling, storage, or use
3. Seal failures that result in a breach in sterilized medical device protections

A packaging partner should be consulted early in device development. Collaborating with a manufacturer’s engineers in the initial project phases helps avoid these potential impediments.

Medical Device Packaging & Patient Safety

When it comes to ensuring patient safety, medical devices carry the brunt of the responsibility. They must function safely, effectively, and, in some cases, over the course of a human lifetime. Understandably, the focus is on designing and developing the best possible devices to meet the need.

However, even the most advanced medical devices can’t perform if they are unsterile, contaminated, or damaged when delivered to healthcare professionals.

That’s where the expertise and guidance of a medical device packaging partner proves invaluable.

During medical device development, engineers commonly identify packaging materials and formats based on the device’s sterilization and protective needs. Their past experience with certain materials may inform certain decisions, which is important in narrowing packaging options. However, arriving at the best solution also takes knowledge of what’s available, the potential limitations of materials, and risks involved.

Medical Device Packaging Vulnerabilities & Validation Testing

Device sterilization and distribution are two post-production areas that pose the greatest packaging failure risks. Manufacturers must be assured that the materials and barrier protections provide needed sterilization capabilities. Further, the package constructions must withstand repeated and/or aggressive handling. Any deviation from expected outcomes or requirements is unacceptable.

Addressing the vulnerabilities takes collaboration between manufacturers and their packaging suppliers to thoroughly test, document, and validate packaging processes.

During these tests, manufacturers usually take the opportunity to push the limits on sterilization, distribution, and stability conditions. Exceeding parameters ensures packaging performs as intended within the operating window to keep medical devices sterile and protected. Data is gathered and submitted to presiding regulatory agencies to establish compliance with medical device packaging standards.

In some instances, packaging partners do pre-work on products that mirrors manufacturers’ package testing. The goal is to provide insights about how a product interacts with the proposed packaging.

At Amcor, we compile a fact book that fully characterizes the physical properties of the specific packaging solution. While manufacturers may choose not to use the information to support filings with the Food and Drug Administration (FDA) and other regulatory agencies, it is a valuable exercise. It gives our customers peace of mind that their medical devices are secure and, ultimately, patients will be safe. It also reinforces quality assurance and may open possibilities for customized packaging should the application require it.

Patient safety is and always will be the focus for any medical device manufacturer. Working with a packaging partner that takes the same approach is essential. Explore key packaging considerations and sustainable Amcor solutions in the The Insider’s Guide to Sterile Barrier Packaging.