Changes to ISO 11607 parts one and two have left Medical Device Manufacturers (MDMs) wondering how new requirements will impact their business and efforts to prepare for the EU MDR. These regulatory changes add new requirements for package usability and sterile barrier systems and will use new terminology throughout the standard. With results aimed at improving care outcomes and patient safety, these changes establish consistency across global packaging and validation requirements. Here’s a rundown of what you can expect to see as these changes take effect in the coming months.
Issuing instructions: Usability requirements
Changes to ISO 11607 place greater emphasis on the importance of usability evaluations because of the key role they play in package design. New usability requirements aim to provide clinical staff with necessary instructions for use. Instructions must identify a clear location on the package to begin opening it, provide instructions on the opening technique, and describe how to present the product into the sterile field while preventing contamination or damage to the contents. Proper instructions for use are critical to infection prevention efforts and patient safety. MDMs will now be required to complete usability studies that prove the instructions are intuitive and effective.
Protecting patients: Establishing a sterile barrier system
Regulators will be looking to see that your sterile barrier system’s configuration will remain intact and prevent the possibility of microbial contamination. Your packaging should guide clinicians on how to inspect package integrity before use to ensure contents are presented aseptically. Product packaging should provide understandable steps for safe and proper use, so that the product remains sterile from the time the barrier is broken to when it’s presented into the sterile field.
Walking the talk: Standardising terminology
Although syntax may seem trivial compared to other impending changes, creating consistency in the language used across documents will help set a benchmark for global standards.
How to determine your package testing and validation needs
While ISO 11607 updates align with expectations for MDR, implementation is where the regulatory bodies diverge. Package testing will be mandatory for compliance with ISO 11607, but this is still a grey area when it comes to MDR. As it currently stands, testing is not mandatory to meet the General Safety and Performance Requirements (GSPR) with sufficient justification for safety and compliance. The reality is many legacy devices either lack this information or have undergone packaging changes that prompt retesting. Risks of non-compliance include added costs for package redesign or retesting of products, package failure, patient safety issues or having to pull a product from market altogether.
Determining your needs for package testing and validation starts with conducting a thorough gap analysis. Remember, revalidation is required if you’ve made any changes to the packaging, materials or handling processes since the last testing of the product. To achieve ISO 11607 compliance, you will need to refer to ISO 16775 to decide which tests to perform, once associated risks in your packaging have been identified. As for MDR, many legacy products currently on the market will need more documentation than most companies have available after performing a gap analysis. Because of this, both MDR and ISO 11607 will require package integrity testing, in most cases.
Securing a partner
Diligently vetting a potential Contract Research Organisation (CRO) partner is an important step to get you on the right testing path. Here’s some key things to consider:
- Expansive accelerated aging: CROs need the capability of simulating a variety of environments that the device could be exposed to over the course of its life. This capability is particularly important in testing for accurate aging information. These manipulations should consider temperature, period of time, package types and materials.
- In-house distribution testing: A CRO that can conduct complete performance validation testing in-house helps avoid hazards that can arise when multiple labs are involved.
- Environmental conditioning: Exposing packages to freezing, tropical and dry conditions supports its ability to withstand various “worst-case” scenarios. While aging testing helps establish a shelf-life, environmental conditioning ensures product stability during and after distribution.
With changes to ISO 11607 and MDR’s looming deadline on 26th May 2020, being organised and employing strategic partnerships is the way to earn regulatory approval.