ELMWOOD PARK, NJ — Few quality standards are more stringent than those for a hospital operating suite. Identifying the proper surgical instrument during a procedure promptly and accurately is vital, but equally important is fully accounting for all instruments after a procedure by returning each one to its outlined and labeled spot on a surgical tray. Forming these trays and screen printing of exacting, durable graphics is the specialty of Medicraft, Inc., a leading developer and manufacturer of custom and standard delivery systems exclusively for the medical industry.
Meeting rigorous demands of medical applications
Medicraft manufactures medical delivery systems from aluminum, stainless steel and plastic, and screen prints graphics on the trays. "We mostly print part numbers and descriptions, but also some graphic images, so our clients can account for every instrument on a surgical tray" explains David Seiz, managing art director at Medicraft's Elmwood Park, NJ headquarters.
Surgeons require specialized sets of instruments for different procedures, and any given set is often used several times per day. After each use, the trays and the instruments must be sterilized in autoclaves subjected to pressurized steam, placing rigorous demands on the screen printed graphics.
"Adhesion is extremely important, as is the quality, consistency and legibility of the graphic image," says Seiz, adding, "We have a multi-step quality inspection system in place. Everything must be perfect for the medical industry and meet our ISO requirements." Medicraft is ISO9001 certified and on the path to achieving an ISO13485 certification, a quality standard for those engaged in manufacturing of medical devices.
Taking screen printing in-house
The company outsourced its screen printing for many years, but recently established its own screen printing department to improve its quality assurance process. "We now screen print about one-third of our trays in-house, and expect that to increase significantly," said Seiz.
Before making the decision to go in-house, Medicraft conducted extensive research on the types of inks that could be used and investigated several screen printing equipment manufacturers. Screen printing has long been the industry standard for printing on instrument delivery systems because of the need to use highly specialized inks that stand up to repeated autoclaving, and due to the varying shapes of the trays. "Manual printing is also critical for quality control to catch impression errors at the source, " he notes.
Evaluating screen printing equipment
Seiz did a significant amount of research before committing to a system, and first evaluated Vastex equipment at 2008 SGIA (Specialty Graphic Imaging Association) show in Atlanta when exploring his equipment options. "When we decided to pull the trigger and go in-house, I visited the Vastex factory in Allentown, PA to review details thoroughly with the sales staff and run tests using our trays. We needed to be certain that the screen printing equipment could accurately print the specialized ink required to meet our quality standard."
Medicraft purchased two, Vastex one-color tabletop 2000HD Heavy Duty Screen Printing Presses and added a Vastex EconoRed 30 Infrared Dryer to cure the ink. The manual presses are constructed with tube steel legs, square steel rotor arms, heavy-gauge steel rotor assemblies and non-warp steel pallets. All critical moving parts, including registration wheel locks, ride on ball bearings. These industrial-grade machines matched Medicraft's requirements for fast set up time, fine registration accuracy and high productivity.
Meeting uncompromising quality standards
Medicraft's lead times are critical, its specialized inks are difficult to work with and its quality standards are uncompromising, all of which place extreme demands on the company's screen printing equipment.
"Every surgical tray that we screen print is evaluated by an elaborate quality control system, and would be rejected if not perfect, but the equipment meets our standards," says Seiz.