Medical Device Link.

Originally Published PMPN May 2002

MEDICAL

Just when industry has settled into placing product codes, lot codes, and expiry dates onto packages, it may want to consider a fourth element—the serial code.

Daphne Allen, Editor

Adding a printer to form-fill-seal lines has been an incredible time and money saver for many medical device firms. They have reduced inventory costs associated with stocking different preprinted supplies. They have made labeling changes quickly and eliminated waste associated with registration problems.

One method of printing directly onto medical packages as they are being formed, filled, and sealed offers the ultimate in product identification and protection—serial coding. In addition to carrying a lot code and an expiration date, each product is marked with a unique number that is part of a series. The numbering system can be downloaded from a database, which can be easily accessed with today's programmable printers.

Serial coding facilitates responses to two unfortunate realities often facing the medical device manufacturer: recalls and unauthorized product distribution, also know as diversion.

Recalling Products

If a problem is discovered with a medical device, whether it is an over-the-counter product or a surgical item, manufacturers typically recall the entire lot of which the device is a part. For some whose lot sizes reach a thousand or more, recalls involve considerable costs and waste. Even if the problem only affects a certain number of devices, the entire lot is pulled.

Unless the manufacturer employs serial coding. "If firms employ serial coding and discover a problem in packaging or manufacturing, they can recall a series within a lot, not the entire lot," explains Joe Martin, general manager of Multivac Corp.'s (Kansas City, MO) medical division. "They can rely on an evaluation of machine parameters to identify the point at which the process went awry."

If manufacturers monitor the parameters of their packaging lines and can identify the point in the lot at which the problem necessitating the recall occurred, they may be able to find the affected group of products through their serial codes. For instance, consider a recall in which nurses notice a few packages whose seals are not intact. If those packages are part of lot B2500, which includes packages serialized with numbers 1001 through 2000, the manufacturer can investigate the conditions under which those packages were formed and sealed. If the firm learns that the heating platen dipped below its ideal sealing temperature halfway through the lot because of a power surge but returned to that setting quickly before being noticed, the manufacturer can compare the sealing log with the coding log and recall packages numbering 1450 through 1700, for instance. Such a precise recall would allow the firm to leave products numbering 1001 through 1449 and 1701 through 2000 on hospital or store shelves, reducing waste and preventing out-of-stock situations.

Serial coding may also prevent recalls. If these same insufficient seals are noticed prior to shipping, the manufacturer can review the parameters, identify the problem and the affected packages, ensure the integrity of the rest of the lot, and pull only the affected series from distribution.

Fighting Diversion

In addition to easing the stress of a recall, serial coding can also help identify illegally distributed devices. Diversion of drugs is much more common, but as patients rely on and obtain more and more devices for managing chronic conditions themselves, like syringes for injectable drugs, transdermal patches, and diagnostic devices, these moderately priced items will fall victim to unscrupulous distributors.

While diverted products may be authentic, they may not have been stored according to manufacturer instructions or they may have been taken out of multiple-dose secondary packages for individual sale, providing patients with partial regimens. In addition to threatening health, unauthorized distribution can also eat away at manufacturer profit. And at manufacturer reputation, if the products lose their effectiveness from improper storage or partial administration.

Serial codes, however, can help ensure that products are being sold with authorization. For instance, cities often have several different points of sale, like chain stores as well as mom-and-pop liquor stores. It is not immediately alarming if stores in a general area sell products with the same lot number, since one lot may be distributed to several locations in one area. However, if each package carries a serial code, investigators can be absolutely sure that a particular series is being sold in the right store.

Serial coding may be helpful in combating counterfeiting. Tom Pugh, vice president of Bell-Mark Sales Co. (Pine Brook, NJ), explains that serial coding can trip up counterfeiters because they may not realize that sequential numbering is being used and copy a serial code onto multiple products. If investigators come across multiple items bearing the same serial code, they will know immediately that a product has been duplicated.

Tools

Multivac's Martin says many printers can produce serial codes, such as ink-jet printers and thermal-transfer printers. Most can be mounted onto form-fill-seal machines and can print before or after sealing and cutting.

Bell-Mark's EasyPrint thermal-transfer printers are fully programmable. With its VersaStyle design software, users can create batch and bar codes, dates, and other variables. On-board memory stores several codes, including product, lot, and serial codes.

Technology Concepts Inc. (Golden, CO) offers the ThermaPrint direct-to-package thermal-transfer printer for printing text, codes, and logos at 300 dpi resolution on Tyvek, poly, foil, and chipboard. The system is easily programmable, with the ability to operate from a database, says president Leo Tomajko. The system includes a ribbon-saving feature in which the amount of ribbon used equals the print area, not the package area, thus lengthening ribbon life.

NuTec Systems Inc. (Lawrenceville, NJ) offers its new m600 for printing bar codes, numerical codes, and text. The m600 uses Hewlett-Packard cartridges along with NuTec's hardware and control unit for producing 600 dpi resolution characters. The entire printing technology is located in the cartridge, eliminating spare parts and solvents. Guided by a controller with 16 Mbyte of memory, the m600 works in real time, suiting it for serial coding. Numbers and letters can be printed clearly as fine as the lettering on a dime, which could help manufacturers tuck in serial codes amongst other required print.

Image courtesy of Bell-Mark Sales Corp.

Copyright ©2002 Pharmaceutical & Medical Packaging News