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Safe and Secure: Medical Device Packaging

Mon, 11/18/2013 - 1:51pm
Tom Egan, Vice President, Industry Services, PMMI

Medical device packaging needs to maintain product performance, support patient safety, and protect confidentiality

As any manufacturer knows, product packaging plays several prominent roles. It encases a product, preventing it from damage once it leaves the manufacturing facility, while also serving as a canvas for vital product information and brand marketing. Due to the inherent nature and importance of healthcare products, medical device packaging goes well beyond simply protecting the product during shipping or displaying conventional product and brand information.

From the point of manufacture to the end-user—typically a medical facility or private home—medical device packaging plays an extremely important role, ensuring performance over the duration of a product’s lifecycle, enhancing patient safety, and communicating and protecting vital product and patient information. Working with an experienced packaging provider can help manufacturers to utilize recent advancements in medical device packaging and materials science.

Single-use Product Packaging
Due to their convenience, ease-of-use, and relatively low cost, single-use medical device products, such as catheters and syringes are gaining popularity for use in hospitals and private homes. With that in mind, medical device manufacturers must perform a delicate balancing act when specifying materials for packaging. Clearly, cost is a major concern. However, with medical device packaging, performance and regulatory compliance must come first.

Performance
When considering packaging materials, the team must consider the packaging format to be used plus where and how the package is being stored. This is important because both temperature and handling can degrade packaging, potentially affecting the medical device’s proper function. For example, medical devices that require cold storage must utilize packaging that can withstand low temperatures without becoming brittle or cracking. Choosing a material that can handle wide environmental fluctuations maintains the product shelf-life, and supports the safe and effective performance of a medical device.

Regulatory Compliance
For medical device packaging, there are strict process controls in place to ensure patient safety. For example, per Code of Federal Regulations (CFR) title 21 (21 CFR 820.30), the FDA considers packaging as part of the overall medical device design and development process, requiring quality assurance testing and validation. According to the FDA, defective packaging can cause approval delays and has been the focus of product recalls. Working with a knowledgeable packaging provider at the design stage can help to streamline this process.

Already an issue with single-use medical devices, the environmental impact of discarded packaging introduced into the waste stream is another factor to consider. Packaging materials that can be disposed of in an environmentally sound manner are good for the environment and the brand, as well. Choosing recyclable materials is a step in the right direction towards sustainable packaging.

Cutting Costs
Finally, there is the bottom line to consider. In order to remain competitive, medical device manufacturers must find ways to minimize costs without sacrificing quality. This means specifying packaging materials that are high-performance without increasing operational costs. The right packaging partner can help guide medical device manufacturers when specifying material.

Enhanced Packaging for Sterilization
With safety top-of-mind for manufacturers and end-users alike, single-use medical devices are often sterilized before leaving the facility, while medical devices that are used multiple times—such as those found in a hospital—are typically sterilized on-site. Either way, proper sterilization is a primary concern for medical devices and it is no less important for product packaging.

Used to eliminate infection-causing micro-organisms, modern sterilization techniques are effective methods for assuring patient safety. However, these techniques can have a detrimental effect on many materials used in packaging. Medical device packaging must be able to withstand harsh environments associated with popular sterilization techniques, including steam autoclave, and gamma radiation.

A commonly used technique, autoclave sterilization typically reaches temperatures of over 130°C. It is vital to utilize packaging materials with a high level of durability and temperature resistance to maintain integrity when exposed to a steam autoclave.

With the increased use of pre-packaged disposable medical devices and instruments, low temperature sterilization methods such as gamma radiation are becoming the popular choice for high volume sterilization. However, over-exposure to gamma radiation can result in the degradation of packaging materials. Again, specify the sterilization process to be used so that the right material is identified to ensure the overall effectiveness of the packaging, as well as the medical device within it.

Monitoring Vital Data
Advanced embedded coding and tracking systems allow for manufacturers to monitor product and patient data. However, it is important that patient information is secure and this begins with the coding on medical device packaging. As this information is extremely important for patient safety, as well as sensitive and private in nature, medical device manufacturers are responsible for ensuring the absolute accuracy and security of such data.

Advanced coding and tracking systems used by medical device manufacturers on their packaging provide data that becomes part of the patient confidentiality record. Accurately coded data is part of the package, including product serial numbers, lot codes, dates of manufacture, and contents. This provides easy tracking and allows visual verification, ensuring that the code and package are correct and protecting patient safety.

Patient privacy is also an issue when coding and tracking personal information. Medical device manufacturers must ensure that complete package information is transmitted to a completely secure manufacturer-controlled database.

Driven by necessity, advances in medical device packaging have yielded several functions that go well beyond that of conventional product packaging, from ensuring product performance and patient safety, to protecting the environment and securely capturing vital data.

The healthcare supply chain must adapt as demand for convenient and easy-to-use single-use medical devices continues to increase. Cost-effective packaging is needed to support the shelf life of these single-use devices. In addition, medical device packaging must meet stringent regulatory standards aimed at protecting the patient, as well as the environment.

Sterilization—key to patient safety—must be factored in to material choice and packaging design. Finally medical device packaging serves as a secure source of traceable information that ensures the right product is going to the right place. By working with a strong packaging provider with industry experience, design know-how and materials science expertise, medical device manufacturers can successfully deliver on these requirements.

Pharmaceutical manufacturers seeking the latest technology in medical device packaging will find unique resources and educational opportunities at Pharma EXPO (November 2-5, McCormick Place, Chicago, IL). Co-located with PACK EXPO International 2014, the event is collaboratively produced by PMMI, the Association for Packaging and Processing Technologies, and the International Society for Pharmaceutical Engineers (ISPE) and will offer comprehensive educational programming.

For more information, visit www.pharmaexpo.com

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