Changes to medical device components may be prompted by several causes: supply chain issues, design changes, inter-device compatibility or component manufacturer changes. Various factors must be considered when faced with such modifications, and processes must be implemented in advance as part of a robust Quality Management System to handle such changes and the associated considerations. Based on the various causes for component changes, processes must address changes driven from the supply side and from the manufacturer of the finished medical device.
Change control and steps to ensure safety and performance
As part of change and design control for medical devices, the impact on the safety and performance of the device – and ultimately the user and patient - must be assessed. A robust change control process assesses the impact of the change on the following aspects and conclusions drawn:
- Device performance testing
- Device safety testing
- Production process validation
- Risk management
- Any other aspects of design verification and validation
- Regulatory authorization
A component change may generally be described as a design change if it impacts the form, fit, or function of the finished medical device. Therefore, the first step of a change evaluation is whether the change constitutes a design modification. Regardless of this determination, other aspects must also be assessed to ensure the change does not impact safety and efficacy of the finished device:
- Does the change require any device performance testing to be repeated? That is, does the new or modified part impact the function of the device? If device performance may be impacted, one or more verification tests performed during design controls may need to be repeated.
- Is any safety testing potentially impacted by the change? If the device is constructed of a different material, there may be a change in the biocompatibility profile of the finished device (relevant for any portions of the device that contact the patient or fluid/gas that is administered to the patient). A material change may also impact ethylene oxide sterilization residuals, and a change to dimensions or shape may require assessment for revalidation of the sterilization process.
- Does the component change impact the risk management file? Specifically, are there new or revised risks associated with the device? If any verification or validation testing is repeated because of the device change, the risk file will require updates to reference new reports.
- Is the new component compatible with the existing production process? Or might there be impacts on the finished device that require revalidation of production processes for fitting, connecting, gluing, welding or other processes that may be impacted by a change in dimensions, material or surface finish?
- Are there other impacts to the design, process, or use of the device because of the change? This is where the use of risk management as a design tool is critical – by brainstorming hazards that lead to hazardous situations and ultimately potential harms to patients or users (of any degree), one can more completely assess the impact of the change on the finished product. For example, the change may require revision to labeling to include modified instructions or disclosure of new or revised residual risks.
- Does the change require a submission to a regulatory authority? Regulation, guidance and the content of the original submission should be consulted to determine if a change notification – or even an entirely new submission – is required. If not, a justification should be drafted and maintained with or referenced in the change notification. The justification should cite the regulation and guidance used for the decision with supporting information.
Preparing for eventual changes requires that the above considerations are built into a change control process. Before these assessments are made, simply recognizing a change, potential change, or upcoming change as soon as possible is critical. To do this, an understanding of change control requirements among your internal and external resources (i.e., suppliers) is paramount.
Ensuring that your suppliers submit notification of changes prior to implementation is critical for manufacturers of finished medical devices. As the supplier of thousands of medical device components, Qosina employs a robust change management process for customers who purchase medical device components. A few elements of this process include:
- Regardless of the recipient, change notifications received by Qosina are funneled to a single process for handling. All change notifications are logged for tracking and subject to change notification controls.
- A change notification committee conducts regular meetings during which supplier change notifications are reviewed. The committee evaluates the nature of the change, determines the affected Qosina customers, and requests additional information from the supplier as needed.
- A notification to Qosina customers is generated for each change and is routed through a change notification system for approvals by relevant Qosina representatives. The notification is intended to be as informative as possible to customers.
- Once approved, the change notification is distributed to any customer who has purchased the part in the last seven years or sampled the part in the last three years.
- Qosina’s Customer Service department provides support for customers impacted by a change notification by opening a customer support case. Qosina can assist customers with changes by:
- Providing technical information and documentation for new or revised parts
- Placing a last purchase for the original part to ensure continued inventory
- Identifying alternate suppliers for a part
- Identifying a replacement part if a part is discontinued or otherwise requires replacement
- Arranging for alternate manufacturing arrangements if a vendor discontinues a part
Qosina can also assist manufacturers mitigate the impacts of supplier change notifications before they are even realized. During the product development process, Qosina can identify multiple sources to ensure continued part availability during supply chain challenges. Qosina’s offering of products, assurance of supply, sourcing specialists and documentation library allow customers the ability to mitigate risk and get ahead by utilizing Qosina as a first and second source for components.
