Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.
Medical device labels play a critical role in ensuring patient safety by providing all necessary information about the device's intended use, warnings, and Instructions for Use (IFU). Therefore, all medical device manufacturers must have in place a procedure for updating and maintaining labels.
Maintaining and updating medical device labels have the following benefits:
- Improves patient outcomes and safety.
- Helps adhere to Regulatory compliance. Medical device labels need to adhere to legal criteria such as the Quality System Regulation (QSR) of the US Food and Drug Administration (FDA) and the European Union’s Medical Device Regulation (MDR).
- Prevents legal and monetary repercussions. If a medical device label is discovered to be false or in violation of Regulatory compliance, the maker may face legal and monetary repercussions. Label upkeep and upgrading aid in reducing these risks.
- Up-to-date labels can improve product performance.
- Improves overall customer experience and satisfaction.
- Improves the manufacturer’s brand reputation and prevent device recalls due to mislabeling.
The process of updating labels forms a critical component, and the following are the steps:
- Review of modifications: The label should be reviewed for any modifications needed. The product information may require an update, Regulatory requirements may have to be changed, or other revisions may be required.
- Drafting of updates: The label updates are drafted after the changes have been identified. It is important to check the updates for accuracy and comprehensiveness and to make any necessary edits or revisions.
- Approval of updates: The appropriate party, i.e., either the Regulatory body, quality control, or the medical device manufacturer, should approve the draft labels.
- Label printing: Following approval of the revisions, the new labels are printed and distributed to the appropriate parties.
- Implementation of changes: While doing so, the old labels must be removed and discarded. This prevents confusion or misuse. The new labels need to be implemented immediately after approval.
- Documenting changes: To maintain accountability and traceability, the modifications made to the labels of medical devices should be noted, recorded, and documented along with the date of adoption.
Maintaining medical device labels involves ensuring that the device label is compliant and up-to-date with the respective Regulatory body.
The specific steps involved in maintaining medical device labels depend on the Regulatory requirement of the relevant jurisdiction. However, the following are some necessary steps to be followed:
- Establishing a label maintenance program: All the information pertaining to the maintenance tasks to be completed over time needs to be laid out in a documented plan.
- Monitoring label changes: It is crucial to keep track of modifications made to a medical device or its labeling to ensure that the information is accurate, updated, and consistent with all applicable laws.
- Label test and verification: These tests and verifications are conducted to check the legibility, durability, and accuracy of the labeling. This ensures that it is effective and meets the Regulatory requirements.
- Documenting label-related activities: All labeling-related operations, such as adjustments, testing, and other upkeep procedures, should be documented.
- Managing label-related documentation: This involves developing and upholding a system for categorizing labeling-related records, including labeling requirements, standard operating procedures (SOPs), and other records.
- Ensuring validation and control: It is critical to evaluate labeling processes and establish controls to handle risks linked to labeling. This ensures the process is reliable and consistent.
To sum up, maintaining precise and accurate labeling for medical devices is a vital part of ensuring patient safety and Regulatory compliance. By adopting best practices for updating and maintaining medical device labels, manufacturers ensure that their devices are used safely and effectively by both healthcare professionals and consumers.