Medical device labeling: The unsung pillar of patient safety and compliance

Medical device manufacturers face several inherent challenges in managing their labeling process:

 

Ensuring accuracy, traceability, and control of label data are key factors. The complexity of labeling is often underestimated. Labeling professionals must often manually extract crucial information from disparate and unstructured sources, such as raw Word documents. If the information on the label is false, missing, or misleading in any way, it may not only risk contravening regulations but also lead to adverse outcomes for patients.

 

Translating content for global markets is a significant pain point for labeling professionals. Source content, typically in a single language like English, must be translated for each end customer, often disrupting the labeling process and supply chain. In addition, each piece of supplier information requires translation. Without a centralized repository for both source and translated content, medical device manufacturers risk errors in managing individual labeling elements.

 

Escalating compliance expectations also results in intensified scrutiny and complexity. Simultaneously, there are also harmonization efforts underway. Consortia like the International Medical Device Regulators Forum (IMDRF) are issuing guidance on globally harmonized labeling principles for medical devices, such as guidance on the content of the label, IFUs, and information intended for the patient, to support safe and effective use.

 

The global implementation and varying applications of UDI databases across different health authorities create additional complexity. Manufacturers must manage the creation and assignment of a UDI to each specific device or packaging, as well as generating and populating all the associated data elements. In addition, they must ensure its consistent application across diverse regulatory frameworks, with limited capabilities to do so efficiently.

 

The pressure of getting products to market may clash with the demands of accurate, compliant labeling. This tension intensifies as competitive pressures grow. Balancing speed and predictability for business success requires overcoming the complexities of label generation and approval.

To achieve effective labeling, medical device companies need to have control over the label content and processes. Digital transformation is key to ensuring:

The current pace of labeling complexity is outpacing the capabilities of traditional processes. Digitization breaks down these barriers so organizations can maintain an integrated view of data into the future.

 

Mastering labeling complexity necessitates tight integration with the end-to-end documentation process. Reliance on traditional, static documentation and siloed systems often leads to heavy dependence on manual human intervention. While human oversight is critical, there is a pressing need for robust systems and processes, particularly where patient outcomes are paramount. Without such systems, content reuse is limited, and managing change is extremely complex.

 

Trusted data is fundamental to reuse. Medical device manufacturers must consider how to manage their library of knowledge to ensure proper governance and availability for all current and future use cases. It is necessary to control the potential for duplicate information to prevent conflicts and ensure consistency. This becomes more important as AI is starting to become more commonplace and integrated into the technological landscape.

 

RWS Tridion Docs brings a business-wide, standardized process to medical devices documentation, streamlining the flow of information across the business. Based on DITA , Tridion Docs manages the entire process – not just IFUs and documentation, but also translation, localization, validation, integration, and flexible publishing. Talk to us about what we can do for you.