Packaging/Sterilization
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UDI Inspection Guidelines
June 13, 2013 2:06 pm | by Jonathan Ludlow, Machine Vision Promoter, Microscan Systems | Microscan Systems, Inc. | Articles | CommentsNew unique device identification labeling rules are on the way for medical devices, so it’s best for engineers to be aware of what impact they may have prior to them being mandatory. This article looks at the main points behind the coming rule and the considerations for ensuring proper symbol quality and label/mark verification.
LISTED UNDER: Laser Marking | Printing | Surface Modification
Addressing HAIs and Antimicrobial Materials (A Roundtable Q&A)
June 10, 2013 3:38 pm | by Scott Fallon, former GM, Global Specialty Products, SABIC Innovative Plastics | Sabic Innovative Plastics | Blogs | CommentsScott Fallon, formerly the general manager of Global Specialty Products for SABIC’S Innovative Plastics business, was a part of the staff written article, “Materials Impact Medical Device Design Trends.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.
LISTED UNDER: Antimicrobial | Polymers | Gas Plasma
A Laser’s Role in Medicine
June 7, 2013 3:18 pm | by Tracey Ryba, Product Manager—Lasers, TRUMPF Inc. | Articles | CommentsThe use of lasers in the development of medical devices through to their actual usage in the devices themselves has been a steadily growing trend. The capabilities and functionality they offer to both design engineers as well as healthcare professionals is varied and beneficial. This article looks at the advantages lasers offer in the development of medical devices.
LISTED UNDER: Laser Micro-Machining | Laser Sintering | Laser MachiningICP Medical LLC Introduces Timestrip Technology to its Rapid Refresh Privacy Curtain System
June 6, 2013 10:00 am | by The Associated Press | News | CommentsICP Medical LLC has recently announced a partnership with Timestrip, makers of a time monitoring device. The technology will be utilized in ICP Medical LLC’s line of privacy curtains used in healthcare facilities nationwide. The Timestrip’s color-coded label monitors elapsed time and indicates when curtains should be replaced.
LISTED UNDER: Curtains/Dividers | Sterilization Services
Materials Impact Medical Device Design Trends
June 3, 2013 2:22 pm | by Sean Fenske, Editor-in-Chief, MDT | Eastman Chemical Company | Articles | CommentsThere are an array of factors that impact the design of medical devices, from available components to healthcare trends. In this Roundtable presentation, participants spoke to the way in which healthcare trends are impacting material development and, as a result, how materials are then impacting medical device design.
LISTED UNDER: ABS | Acetals | Acrylics
Ethylene Oxide Versus Radiation Sterilization
May 30, 2013 3:52 pm | by Wendy Wangsgard, Radiation Sterilization Study Director, and Courtney Lang, Ethylene Oxide Sterilization Study Director, Nelson Laboratories | Articles | CommentsEthylene oxide and radiation sterilization make up two of the most common forms of sterilization for medical devices. As the device is prepared for release to market, knowing which type of sterilization to use for each product can save time and money.
LISTED UNDER: E-Beam Equipment | E-Beam Monitoring Devices/Supplies | EtO Equipment
E-Beam vs. Gamma Sterilization
May 23, 2013 2:39 pm | by Larry Nichols, COO, and Bob Starrett, CTO, NUTEK Corporation | NUTEK Corporation | Articles | CommentsMany of the sterilization issues concerning gamma and electron beam radiation are the same. This point is supported by the fact that both technologies are governed by the same ISO standards when applied to medical device sterilization—ISO 11137 and ISO 13409. Both technologies have been proven effective at sterilization and are accepted worldwide.
LISTED UNDER: E-Beam Equipment | E-Beam Monitoring Devices/Supplies | Gamma Equipment
Improving Patient Safety with Unique Device Identification
May 23, 2013 11:35 am | by Warren Ward-Stacey, Sales Director, PRISYM ID | Blogs | CommentsMedical device manufacturers should welcome the proposed ruling for Unique Device Identification (UDI); however, being compliant by the effective date (based on classification) for some organizations may be a concern. UDI aims to identify errors involving medical devices and provide more rapid resolution of device problems.
LISTED UNDER: Labeling | Labeling
Changing from Gamma to E-Beam
May 21, 2013 2:38 pm | by Larry Nichols, COO, and Bob Starrett, CTO, NUTEK Corporation | NUTEK Corporation | Blogs | CommentsOrdinarily, changing from a validated gamma sterilization process to E-beam sterilization requires running a dose mapping study and doing a dose verification study similar to a routine quarterly dose audit. The standard radiation validation requirements of ISO 11137 require that data be “available to show that, using the same sterilization dose, microbial inactivation is not affected by differences...
LISTED UNDER: E-Beam Equipment | E-Beam Monitoring Devices/Supplies | Gamma Equipment
PE Resin Blend Sheet Foam with Multidirectional Stretch
May 21, 2013 2:25 pm | by MDT Staff | Pregis Corporation | Product Releases | CommentsPregis has introduced Stretchfoam, an “industry first” proprietary polyethylene (PE) resin blend sheet foam with multidirectional stretch for protective packaging applications. Stretchfoam represents the latest addition to the company’s Microfoam line.
LISTED UNDER: Resin | Polyethylenes | Other Packages
Single Mode Fiber Laser Markers Offer Processing Advantages
May 20, 2013 4:12 pm | by Dr. Geoff Shannon, Laser Technology Manager, Miyachi Unitek | Miyachi Unitek Corp. | Articles | CommentsThe fiber laser marker has become commonplace for mainstream marking applications, providing excellent high speed contrast marking of steels and plastics, as well as materials micromachining, including cutting, drilling, scribing, and ablation. Lasers with better beam quality can mark or machine faster, and provide better feature resolution and improved process quality.
LISTED UNDER: Laser Micro-Machining | Machining Equipment & Tools | Laser Marking Error-Free Labeling—Accuracy, Traceability, and Compliance
May 3, 2013 11:43 am | by Warren Ward-Stacey, SVP of Global Sales, PRISYM ID | Blogs | CommentsIn an era of intense media pressure, growing patient power, and escalating litigation, it is extraordinary that so many medical device recalls are due to labeling errors. After years of robust, highly compliant medical research and product design, ensuring the correct information is included with each device should be a given.
LISTED UNDER: Identification Products | Bar Coding Equipment | Labeling
Hospitals See Surge of Superbug-Fighting Products
April 29, 2013 9:24 am | by Mike Stobbe, AP Medical Writer | News | CommentsThey sweep. They swab. They sterilize. And still the germs persist. In U.S. hospitals, an estimated 1 in 20 patients pick up infections they didn't have when they arrived, some caused by dangerous 'superbugs' that are hard to treat. The rise of these superbugs, along with increased pressure from the government and insurers, is driving hospitals to try all sorts of new approaches to stop their spread.
LISTED UNDER: Cleaning Supplies | Cleaning Systems and Chemicals | Garments/Apparel
Meeting the FDA’s Mandates for Unique Device Identification
April 22, 2013 2:22 pm | by Hiroshi Ono, Group Product Manager, Roland DGA Corp. | Roland DGA Corporation | Articles | CommentsThe FDA’s UDI rule is on its way and will impact virtually everyone in the industry in one way or another. While the rule has its benefits, getting to compliance will not be achieved overnight. This article provides an overview of the direct part marking technologies required to comply with the UDI rule and offers a solution that addresses the shortcomings of several other technologies.
LISTED UNDER: Laser Marking | Printing | Surface ModificationSANUWAVE Receives U.S. Patent to Sterilize Blood Using Its Shock Wave Technology
April 11, 2013 1:54 pm | by Globe Newswire | News | CommentsSANUWAVE Health has received a patent issued by the U.S. Patent and Trademark Office entitled "Method and Devices for Cleaning and Sterilization with Shock Waves." The claims of the patent relate to a new method that sterilizes blood by applying external shock waves to destroy blood pathogens contained in bags, pipes and tubes.
LISTED UNDER: Other Equipment
