Medical Design Technology

Packaging/Sterilization

E-Beam vs. Gamma Sterilization

May 23, 2013 2:39 pm | by Larry Nichols, COO, and Bob Starrett, CTO, NUTEK Corporation | Nutek Corp. | Articles | Comments

Many 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
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Improving Patient Safety with Unique Device Identification

May 23, 2013 11:35 am | by Warren Ward-Stacey, Sales Director, PRISYM ID | Blogs | Comments

Medical 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 Corp. | Blogs | Comments

Ordinarily, 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 | Comments

Pregis 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 | Comments

The 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 | Comments

In 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 | Comments

They 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 | Comments

The 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 Modification

SANUWAVE Receives U.S. Patent to Sterilize Blood Using Its Shock Wave Technology

April 11, 2013 1:54 pm | by Globe Newswire | News | Comments

SANUWAVE 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

Fusion Laser Series with Upgraded Motion Control System

April 4, 2013 11:20 am | by MDT Staff | Epilog Laser | Product Releases | Comments

Epilog Laser, the leading producer of CO2 and fiber laser engraving, cutting and marking systems today announced it has added the Fusion and FiberMark Fusion to the company’s product line.

LISTED UNDER: Precision Cutting Tools | Marking Machines | Marking Products

High Performance, Low-Cost Barcode Readers

March 29, 2013 10:23 am | by MDT Staff | Cognex Corp. | Product Releases | Comments

Cognex Corporation, the world's leading supplier of industrial ID systems, announced today that it has added two new models to the DataMan® 50 series of compact barcode readers and a new DataMan 60 series with three models that offer Ethernet connectivity.

LISTED UNDER: Bar Coding Equipment

Walk-Away Tube and Vial Labeling

March 26, 2013 10:59 am | by MDT Staff | Computype, Inc. | Product Releases | Comments

Computype, Inc., in partnership with Nautilus Systems, today announced the launch of the Flexible Tube and Vial Feeder (Flex TVF), an innovative new system for automatic downstream feeding of tubes and vials that helps increase efficiency.

LISTED UNDER: Labeling

UL Labels Reduce Product Approval Costs

March 13, 2013 11:49 am | by MDT Staff | Product Releases | Comments

Custom printed labels that are attractive, durable, and meet UL, ETL, TÜV, CE, and CSA requirements for components and end products are available from Nameplates For Industry, Inc.

LISTED UNDER: Identification Products

Tamper-Evident Folding Boxes

March 8, 2013 11:12 am | by MDT Staff | Product Releases | Comments

Rondo-Pak, a leading provider of quality folding cartons to the pharmaceutical, biotech and medical device industries, has developed a folding box with a ground-breaking tamper evidence feature that already surpasses future first opening verification security requirements.

LISTED UNDER: Other Packages

Porous Microbial Barrier with High Airflow for Medical Device Packaging

February 22, 2013 10:12 am | by MDT Staff | Product Releases | Comments

Porex offers P3 Technology, a new venting capability for ethylene oxide (EtO) sterilization in medical device packaging applications. The initial offering will be specialty porous PTFE films that are outstanding sterile barriers with high airflow.

LISTED UNDER: Microporous | Clamshells/Blisters | Lidding

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