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NSAI Named 11th Notified Body Under EU MDR

&#nl The European Commission has authorized the National Standards Authority of Ireland (NSAI) as the 11th notifi

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UK Introduces New Legislation to Overhaul Medical Device Authority

&#nl The UK government plans to update its regulatory framework for medical devices by the end of this year. &#nl

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Mask Maker Warned for Unapproved Device

&#nl The FDA hit Phoenix, Arizona-based devicemaker CPAPNEA Medical Supply with a warning letter for marketing a

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No Reported Device Shortages From Coronavirus Outbreak, FDA Says

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  string(65) "Eastman Launches Next-Gen Copolyesters for Medical Device Housing"
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Eastman has launched a new portfolio of next-gen Tritan MXF copolyesters that offer chemical resistance, higher impact strength, and easier processability for the housing and hardware of electronic medical devices. The company unveiled the new copolyesters at MD&M West 2020.

&#nl

“Most electronic medical devices have an enclosure that meets a UL 94 V-2 flame resistant rating, and customers came to us asking for higher impact strength,” Ellen Turner, Eastman’s global market development manager, medical devices, told MD+DI. “If you look at failure modes, there’s something to be learned from testing that looks at impact—these devices are being dropped and bumped all the time.”

&#nl

The impact resistance of durable medical equipment can change over time as surfaces are repeatedly cleaned with strong chemicals, whose stringency hospitals have been stepping up year after year.

&#nl

Eastman had developed a four-step testing protocol for determining how disinfectants affect impact resistance. “Customers really like our four-step test, and they asked for higher-impact-resistant materials,” Turner said. She added that “polycarbonate/ABS is the most widely used incumbent for enclosures, but it is failing.”

&#nl

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&#nl

Switching to Tritan MXF copolyesters shouldn’t be “a great leap for processors for regular and high-flow applications,” said Turner. “If customers have an existing tool, they don’t have to buy a new one—they should just be able to use the existing tool with some minor modifications.”

&#nl

All Tritan MXF materials can be used with more than 30 different disinfectants, and “we are always testing new disinfectants,” said Turner. Such wide compatibility gives the “medical device seller an easier job,” she said, “as hospitals are trying to kill pathogens while requiring some flexibility to change disinfectants based cost and efficacy. They want to decide based on patient safety.”

&#nl

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&#nl

Medical device companies “would want to test more thoroughly to enable such claims and meet RFPs from hospitals,” she added. “Such testing would be more of a differentiator at this point, but at some point in the future, companies won’t be able to sell products that aren’t compatible with disinfectants.” Hospitals are asking for testing and certifications, she said, because it can be very costly for hospitals to replace damaged equipment and to suffer outages when equipment is down.

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Eastman has launched a new portfolio of next-gen Tritan MXF copolyesters that offer chemical resistance, higher impact strength, and easier processability for the housing and hardware of electronic medical devices. The company unveiled the new copolyesters at MD&M West 2020.

&#nl

“Most electronic medical devices have an enclosure that meets a UL 94 V-2 flame resistant rating, and customers came to us asking for higher impact strength,” Ellen Turner, Eastman’s global market development manager, medical devices, told MD+DI. “If you look at failure modes, there’s something to be learned from testing that looks at impact—these devices are being dropped and bumped all the time.”

&#nl

The impact resistance of durable medical equipment can change over time as surfaces are repeatedly cleaned with strong chemicals, whose stringency hospitals have been stepping up year after year.

&#nl

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&#nl

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&#nl

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&#nl

Switching to Tritan MXF copolyesters shouldn’t be “a great leap for processors for regular and high-flow applications,” said Turner. “If customers have an existing tool, they don’t have to buy a new one—they should just be able to use the existing tool with some minor modifications.”

&#nl

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&#nl

When speaking about Eastman’s four-step testing protocol for impact strength after exposing materials to disinfectants, Turner also pointed to other efforts such as the emerging certification from the Healthcare Surfaces Institute. The group seeks to create standards for different devices that would deem certain products “cleanable and durable for healthcare,” she said.

&#nl

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Eastman Launches Next-Gen Copolyesters for Medical Device Housing

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Bluetooth-Related Cybersecurity Vulnerabilities Put Medical Devices at Risk

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A family of 12 cybersecurity bugs associated with Bluetooth Low Energy (BLE) may introduce risks for some medical devices. The SweynTooth bugs can't be exploited over the Internet, but a hacker within radio range could launch attacks to crash targeted devices, disable their BLE connection until a restart, or in some cases even bypass BLE's secure pairing mode to take them over. Medical devices like pacemakers and blood glucose monitors are among those most at risk.

&#nl

 

&#nl

Thermo Fisher Makes Its Move to Acquire Qiagen

&#nl

After months of rumors, Thermo Fisher Scientific is finally acquiring Qiagen for $11.5 billion. The proposed acquisition is set to close in the first half of 2021. This is one of the largest deals Thermo Fisher Diagnostics has ever been involved with, topping the company’s 13.6 billion acquisition of Life Technologies in 2014.

&#nl

FDA Steps Up Response to Coronavirus

&#nl

FDA said it will allow laboratories to begin using coronavirus tests before the agency has completed a review of their emergency use authorization requests. The action is expected to allow the diagnostics industry to respond to the developing situation much more rapidly and effectively.

&#nl

 

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Bluetooth-Related Cybersecurity Vulnerabilities Put Medical Devices at Risk

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A family of 12 cybersecurity bugs associated with Bluetooth Low Energy (BLE) may introduce risks for some medical devices. The SweynTooth bugs can't be exploited over the Internet, but a hacker within radio range could launch attacks to crash targeted devices, disable their BLE connection until a restart, or in some cases even bypass BLE's secure pairing mode to take them over. Medical devices like pacemakers and blood glucose monitors are among those most at risk.

&#nl

 

&#nl

Thermo Fisher Makes Its Move to Acquire Qiagen

&#nl

After months of rumors, Thermo Fisher Scientific is finally acquiring Qiagen for $11.5 billion. The proposed acquisition is set to close in the first half of 2021. This is one of the largest deals Thermo Fisher Diagnostics has ever been involved with, topping the company’s 13.6 billion acquisition of Life Technologies in 2014.

&#nl

FDA Steps Up Response to Coronavirus

&#nl

FDA said it will allow laboratories to begin using coronavirus tests before the agency has completed a review of their emergency use authorization requests. The action is expected to allow the diagnostics industry to respond to the developing situation much more rapidly and effectively.

&#nl

 

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Medtech in a Minute: SweynTooth Bugs, Thermo Fisher Makes a Move for Qiagen, and More

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Knowledge of Cancer Risk, Health Promotion Varies Widely

FRIDAY, March 6, 2020 -- Cancer risk awareness varies by socioeconomic status, according to the results of the Internati

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