Medical Device Link.

REGULATION AND STANDARDS

Assistance with interpretation

Intended as a harmonisation standard (with the European packaging standard EN 868-1), a revision to ISO 11607, Packaging for Terminally Sterilised Medical Devices, was issued in May 2006. This new version of ISO 11607 is a more concise approach to the subject and should make it easier for companies that market products in both the United States (US) and Europe. It has two parts: Part 1 focusses on materials and packaging structures and Part 2 covers validation requirements.

The release of any new or revised standard invariably raises questions as individual companies assess what steps are needed to achieve compliance. ISO 11607 is viewed as a consensus standard by the US Food and Drug Administration. Thus its expected adoption by many parties as a formal requirement makes a thorough understanding of its requirements extremely important. To assist with interpretation and compliance efforts, the Association for the Advancement of Medical Instrumentation (www.aami.org) has assembled a Technical Information Report (TIR) for ISO 11607. Once issued (publication is expected in early 2007), the TIR will be a valuable asset to the medical device community and lead to a consensus of interpretation that will benefit everyone. The Technical Committee of the Sterilization Packaging Manufacturers Council, a leading contributor to this consensus effort, works through the Flexible Packaging Association, which is comprised of leading US manufacturers of sterilisable medical packaging and materials.¹

Importance of documentation. A clear emphasis of the revised standard is the need for documentation. The steps associated with the determination of an appropriate package for a medical device must be captured and based on an approach that makes sense.

Early pack design. Medical packaging companies often promote the practice that package design should take place in parallel with device design. This approach reduces the likelihood that market release will be delayed as packaging for the device is hastily developed, a situation that many in the device community may have experienced. Under ISO 11607, package design must take place under the framework of a formal quality system that includes design control and risk management. The TIR will provide an unusually thorough guide to assist medical device companies to determine the requirements of medical device packaging.

Test methods. It is the ultimate responsibility of the medical device manufacturer to select an appropriate package so that the medical device reaches its end user sterile and fit for use. To assist the medical device manufacturer in this decision, medical packaging companies typically provide physical property, regulatory and other technical information. Testing is performed as a means of ensuring the package is appropriate for the task. The revised standard requires that the employed test methods are validated and that the reliability, reproducibility and accuracy are understood. The TIR will offer assistance with this by providing an annex of suggested test methods and guidance on validating these methods or others. Most users will find it convenient to choose test methods from this list; they should select tests that probe material and package attributes that are closely linked to desired performance.

Reduced validation burden. One of the useful aspects of ISO 11607 is the ability to validate families of device packages through selection of “worst-case” configurations. For example, when a range of medical devices is intended for a given sterile barrier system, a rationale could be generated whereby the most demanding device (for example, largest, heaviest or adorned with most fittings) could be chosen for validation, which reduces the need for devices to be tested. This approach can mean a reduced validation burden for the medical device manufacturer. As with all steps in packaging design and validation, a suitable rationale must be documented for justification. The shelf life of a package system must be demonstrated and guidance will be provided in the TIR on acceptable ways of performing accelerated ageing to speed market launch (assuming real time ageing is eventually obtained as well). Similarly, distribution simulation is addressed as well as environmental challenge testing in which a package is exposed to a range of temperature and humidity levels. This differs from accelerated ageing in that the purpose is to determine sensitivities to the different environments that a package may be exposed to during its life cycle.

Clear route to market

Compliance with ISO 11607 is a process whereby companies address the requirements of the standard as they pertain to their medical devices and the packaging, sterilisation and distribution environments that are integral to their utility in the health care market place. It is prudent to consider packaging early in the process of designing medical devices, both to ease the burden of validation and to avoid delays in reaching the market place with a new product. Together with its associated TIR, the revised ISO 11607 should result in less confusion in the medical device industry as practices centre around a common understanding of what is important and why.

Prepared by member companies of the Sterilization Packaging Manufacturers Council of the Flexible Packaging Association, 971 Corporate Blvd, Suite 403, Linthicum, Maryland 21090, USA, e-mail: rsinghal@flexpack.org www.flexpack.org www.sterilizationpackaging.org