Labeling compliance rules are in place to ensure that medical products make it to the patients that need them. Extreme care should be taken to guarantee they are accurate and easy to read. below are a few of the specifics of proper medical product compliance labeling.
Label Integrity and Inspection
Each label must clearly state what the product is, when it manufactured, where it was manufactured and have product numbers that correspond to the correct item. Every product has to be inspected upon reaching the specific destination for label readability. Any product labeled incorrectly, or missing a label has to be sent back.
Separation for Inspection and Storage
All separate medical products have to inspected and stored in their own area. This is to avoid confusion and mixing up similar looking items. The distance does not have to be great, but enough that there can be no accidental mixing of products. This is why labels that are easy to read are beneficial to the consumer. Having certain individual identifiers prove helpful.
Label Checks and Records
Each medical product has to be checked and determined accurate before being given to a patient. Every item needs to be documented, although these records do not have to be lengthy. It is enough to state the labeling information about product type and specific item code. Mistakes in labeling can cause a patient to receive an item that is not meant for their particular condition. Incorrect labeling will reflect back on your company, since you are responsible for correctly labeling medical products.
Medical products used to sustain life, or used for surgical implant must have a control number. This is for traceability purposes. each item has to tracked and recorded in every phase of getting it to market. Improper labeling could get the whole batch returned.
Sterile Device and Contract Sterilization Labels
Sterile device labels are important and will often get a closer inspection upon receipt. The label must inform the consumer of what portion of the packaging and device is sterile. Some items are only partially sterile. Items that have been sterilized using a third party must have a contract sterilization label. This protects you, as well as informing the end-user that there is another party involved in creating a sterile medical product.
Contact package specialists like Ten E for all of your medical products packaging concerns today!