Webinar Recap: Tools For Creating Compliant Labels For Medical Devices

by Laura Johnson, on December 17, 2021

Last month, we joined Epson and 3M to host a webinar where we shared insight on how medical device manufacturers can create a compliant and efficient labeling process; from label management and color label printers to suitable inkjet label materials and labels that endure sterilization.

Loftware covered some important topics for medical device manufacturers, such as traceability and how to overcome the challenges of postponement labeling and kitting. Here’s a brief recap:

Traceability is key 

Traceability means different things to different roles in an organization.

Finished goods and product traceability can be accomplished using Unique Device Identifiers (UDI), a serialized Global Trade Identification Number (GTIN) or GS1 serialized label. Product serialization is a necessary component of traceability as goods move from manufacturing into the supply chain and to the healthcare provider or patient. GS1 has a set of guidelines for how the lot/batch, expiry, or use by date and serial number must be encoded into the barcode on every label. This helps manufacturers to be compliant and easily share and access information in the supply chain.

The other form of traceability is focused on the manufacturing process itself, for example, who initiated the print and the time and date stamp or the audit history and traceability around the overall label management, version control, and printing processes. This level of transactional traceability is imperative for systems of record to retain for many years, and in some instances, forever.

Postponement labeling and kitting

Sometimes, manufacturers don’t have visibility into the final destination for their products. To address this, they have to produce another label, called a postponement label, that contains the information required by the destination. It can be hard to ensure that the information needed is available. And then you have to link the postponement label data to the original batch or product and pair it with the outbound shipping information. It can be a lot to manage. Having a labeling system that has bi-directional communication with systems like SAP and Oracle helps to verify that the most current template, the right information, and translated phrases or multi-lingual documentation are being printed.

When it comes to kitting or custom packs of components needed for a specific procedure or use, having items packaged together eases ordering, fulfillment, and receiving. During the packaging process, an associate works from a picklist to identify items to include in the kit. They scan serialized information or capture the batch or lot information. Loftware has customers that use a combination of technologies like web-based printing solutions and configured user interfaces to easily guide fulfillment associates through the printing process.

To learn more about key challenges facing medical device manufacturers, and how cloud-based label management can help, download a recent Loftware report here. 

Topics:Medical DevicesLife SciencesLabelingStandardization