Adding Instructions for Use to Medical Pouches
Medical device manufacturers have often struggled with including multiple-page instructions for use (IFU) with sterile medical packaging. Including paper materials inside sterile packaging could present contamination challenges, and leaving an IFU loose inside a shelf pack could risk misplacement. Responding to a customer challenge, Robinson Printing & Creative Media (Temecula, CA) has developed a potential solution.
In-Sheet consists of a laminated and adhesive-backed IFU that can be mounted to the outside of a medical device pouch or box. A unique flexo process laminates a prefolded document and adds an adhesive backer. Mounting the In-Sheet to the outside of the device package may eliminate the need to sterilize the document and ensures the instructions cannot damage the device. It also ensures the documents cannot be separated from the device. Because the laminate is flexible, it can be easily mounted to both pouches and boxes.
|In-Sheet laminates a large-size IFU for application to pouches and boxes.|
As a certified supplier to the medical industry, Robinson Printing & Creative Media can typically turnaround an IFU with In-Sheet in only ten-business days following the final approval of the customer-supplied artwork. (Only five business days are needed for IFUs without In-Sheet.
Robinson Printing & Creative Media also offers a map-fold format. Using customized folding equipment, Robinson can fold an oversized document down to a small footprint. Such a proccess could more closely match the document to the size of the accompanying medical device. The format could be used for IFUs with several languages.
Complete control is maintained in a specially equipped, quality controlled facility, from printing to folding to In-Sheet application.