Drafting Instructions for Use (IFUs) for medical devices is a delicate but critical task that supports patient safety. IFUs need to include detailed, action-oriented instructions on preparing, administering, handling, storing and disposing of the device. When manufacturers draft IFUs for reusable devices, there are additional challenges they need to consider, starting with reprocessing instructions.
Manufacturers design reusable devices to last beyond a single use. Failure to provide patients and practitioners step-by-step guidance to clean and prepare devices for subsequent uses increases patient risk and invites regulatory problems. Clarity around reprocessing instructions is so crucial that devices often undergo several validations or revalidations to ensure safe use.
When a manufacturer launches a new reusable device or changes the design of an existing one, the reprocessing instructions provided in the IFUs need to be validated or revalidated. Doing so provides evidence that the instructions provided still render the new or improved device safe for use. Cleaning and performance-related studies are the most common ways to validate IFUs in reusable devices. Here’s what manufacturers need to know about each of them.
Cleaning validations
Factors that impact a product’s life cycle and determine its reusability include:
- Materials of construction
- Cleaning instructions
- Disinfection or sterilization instructions
- Points of use
- Disassembly/reassembly instructions
- Packaging materials and tray design (if applicable).
In addition, unique and porous materials, mated surfaces, narrow channels and occluded lumens warrant extra attention when crafting reprocessing instructions as these design characteristics can make a device harder to clean or sterilize.
The cleaning validation is a popular study used on reusable devices because it relies on device cycling. Device cycling is a precursor to testing and requires soiling, cleaning and sterilizing the device. Regulatory guidance, product life cycle and manufacturer input determine the number of cycles needed for each device. Device cycling studies simulate the worst-case scenarios in clinical settings and stress the product to uncover design features that may accumulate soil over time. To simulate a worst-case cleaning scenario, scientists decrease washing and rinsing times, water temperature or detergent concentrations.
Reusable device manufacturers rely heavily on device cycling data to identify deficiencies in design or reprocessing methods. Manufacturers who need to validate or revalidate several devices can group them based on materials, indications for use or product design to save time and reduce costs. The true value of device cycling is that it can help determine whether cleaning instructions in the IFUs need rewriting or if the entire device needs redesigning.
Performance validations
Manufacturers should also conduct a functional performance validation. During the early design phase, a device’s functional attributes are identified and defined. A performance validation is simply a series of tests used to verify that the product executes its function correctly and consistently. This includes its capacity for sterilization and sanitization.
For single-use devices, the performance validation uses devices off the manufacturing line (i.e., never been used). With reusable devices, manufacturers validate newly manufactured devices to prove the product meets the applicable specifications for reusable devices. Because the device is reusable, a manufacturer will often identify a few reprocessing cycles the devices may go through in their product life cycle. Marketing information, risk assessments or material durability assessments often determine the number of reprocessing cycles used.
Devices that have undergone the maximum number of reprocessing cycles may be subjected to a second performance validation. For this additional validation, the reprocessing cycle consists of a combination of soiling, simulated use, cleaning and disinfection/sterilization. Manufacturers must then repeat the validation testing for a given number of cycles. Once all reprocessing cycles are complete, manufacturers need to submit the device for retesting to confirm they meet the prescribed design and functionality requirements.
The data generated from these validation studies allow manufacturers to compare various testing outputs—i.e., new vs. reprocessed devices—and identify potential problems that may arise from a device’s prolonged clinical use. With reusable devices, the continuous cycles of soiling, cleaning and disinfecting or sterilizing can negatively impact the product. Over time, the stacked effects of multiple reprocessing cycles could degrade the device and affect its functionality. Hence, the critical role validation studies play in crafting IFUs that keep devices safe for patients.
Embracing validation for reusable devices
A manufacturer’s responsibility is to ensure the IFUs included with the device are clear and comprehensive. Reprocessing instructions are a critical part of IFUs for reusable devices. Validating reprocessing instructions for reusable devices can be time-intensive and resource-heavy, but it is an essential step in developing or refining IFUs and ultimately supporting patient safety. Manufacturers who recognize the importance of validation studies and have the foresight to enlist a laboratory testing partner can minimize delays in their development programs. Qualified laboratory partners can also advise on the clinical use of devices and additional testing to ensure regulatory compliance.
To learn more about how WuXi AppTec can help you with IFU development and validation testing for reusable devices, contact a representative here.
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient, socially responsible and sustainable solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 5,200 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”
