Current pulse

Expanded ISO 10993 biocompatible adhesives

Epoxy Technology Inc. officials have announced the completion of ISO 10993 testing on three additional products, bringing the total company available biocompatible products to 20, with 9 adhesives having passed ISO 10993 testing. A few epoxies to note in the expanded adhesives line are:

EPO-TEK 353ND-T – Well suited for all conventional sterilization methods: ETO, Sterrad, X-ray, and autoclaving

EPO-TEK OG198-54 – Added performance (shadow curing) with thermal post-curing

EPO-TEK 301 – Having previously passed ISO10993 testing, has now passed more extensive 12-weeks implantation testing

www.epotek.com

Aided visual inspection needed for reusable medical devices

According to Sanovas officials, the medical device industry should be including aided visual inspection as an integral part of the instructions for use (IFU) of reusable medical devices.

“Sophisticated, reusable medical instruments are very difficult to clean,” says Ralph Basile, vice president, marketing, Healthmark Industries, an OEM partner of Sanovas and a supplier of cleaning verification products to healthcare facilities. “A key step in that process is to visibly inspect to ensure there are no residual contaminants on, or inside, the device after cleaning. But this has been nearly impossible to do with only the naked eye.”

Addressing these concerns in reprocessing is a micro digital camera, the MicroCam, which can be incorporated into Healthmark Industries’ Flexible Inspection Scope, allowing reprocessors to see inside difficult-to-clean medical devices.

Already in use by more than two dozen facilities in the U.S., The MicroCam enables central processing departments to see inside medical devices, document what they see, and reprocess the medical device if necessary.

www.sanovas.com

PartMaker mobile app

The PartMaker mobile app for smartphones and tablets is now available from the iTunes App Store or Google Play. The app allows users to see when the next training class will be in their area and check when and where PartMaker will be on display at trade shows and machine tool open houses. The free mobile app also features a link to educational videos hosted on PartMaker’s YouTube channel and a list of available educational webinars. Users can correspond directly with the PartMaker technical support team directly from the app, receiving answers to technical questions on the go.

www.partmaker.com

Medical coatings group established

Whitford Corp., a manufacturer of fluoropolymer coatings for industrial and consumer industries, has established a new group dedicated to supporting the use of its coatings on medical devices. The medical coatings group is now in development at the company headquarters in Elverson, Pennsylvania, before moving to a newly constructed facility expected to be operational by Q3 2015.

“As a raw material supplier for catheter guide wire manufacturers and coaters, as well as countless biocompatible devices, we understand the benefits of our coatings in medical applications. Our decision to establish a dedicated medical coatings group will enable us to support the use of our coatings in medical applications, and to safely be a key supplier to medical device manufacturers,” explains Dave Willis, founder & CEO, Whitford Corp.

www.whitfordww.com

Boston Scientific snaps up Xlumena

Boston Scientific Corp. has acquired Xlumena Inc., a venture-backed medical device company that develops, manufactures, and sells minimally invasive devices for endoscopic ultrasound (EUS) guided transluminal drainage of targeted areas within the gastrointestinal tract.

The Xlumena portfolio includes the AXIOS and HOT AXIOS stent and delivery systems. The U.S. Food and Drug Administration (FDA)-approved stent and delivery system is designed for endoscopic ultrasound-guided transluminal drainage of symptomatic pancreatic pseudocysts. The next-generation HOT AXIOS stent and delivery system incorporates cautery into the delivery of the AXIOS stent. Both systems have CE Mark for facilitating transgastric or transduodenal endoscopic drainage of pancreatic pseudocysts or the biliary tract.

“Our combined technologies enable physicians to diagnose and treat diseases of the pancreatico-biliary system using less invasive procedures,” says David Pierce, senior vice president and president, Endoscopy, Boston Scientific.

www.bostonscientific.com

New addition to Partners in THINC

VMH International, a member of Siemens PLM Solutions Partner, provides integrated software solutions from Siemens, VoluMill, and CGTech VERICUT. VMH evaluates organizations’ parts and processes to determine the best combination of design, manufacturing, tool path, and machine simulation software, and to develop a custom mentoring and training strategy.

“We are committed to collaborating with Okuma and our fellow partners and leveraging our unique suite of software and services to help Okuma’s customers streamline and advance their manufacturing capabilities,” states Vern Heyer, CEO of VMH International.

As a member of Partners in THINC, Siemens PLM Solutions is working with Okuma and other Partners to provide practical solutions to manufacturers’ real-world concerns.

www.okuma.com/partners-in-thinc