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The Health Sciences Wire - Issue 07

The July, 2020 edition to take a closer look at:
• Getting medical devices to market through US FDA Emergency Use Authorizations (EUA)
• Manufacturers shifting gears to help with pandemic fight
• Safety, performance and certification testing for ultraviolet light
• Dietary supplement safety
• Connected system risk management for healthcare facilities
• Standard update for nurse call systems
• Healthcare asset management
• Event hosting in a socially distant world

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July 6, 2020

US FDA Emergency Use Authorizations: Meeting safety and performance standards

To help maintain reliable supplies of medical devices and equipment needed during the ongoing COVID-19 public health crisis, the US Food and Drug Administration has established emergency market access pathways.

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How Non-Medical Device Manufacturers can Assist with COVID-19

Deborah Jennings-Conner, Engineering Director for UL Healthcare, discusses how non-medical device manufacturers can pivot their processes during COVID-19 to help build much needed materials and products while maintaining compliance.

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Ultraviolet (UVC) Light Testing and Certification

In the current global situation, questions surrounding sanitation, germicidal properties and UVC devices are in focus more than ever before. Safety considerations around UVC lighting are critical with so many new products entering the market. Our on-demand webinar, Ultraviolet Light in Germicidal Devices: Safety Considerations, and our chart of eligible UVC safety certifications take an in-depth look into performance testing for products in consumer, commercial and healthcare applications.

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Verifying Dietary Supplements to Help Keep Customers Safe

Maintaining personal health is a topic on many minds these days, with consumers more interested than ever in dietary supplements for long-term, sustainable health. Read more about how verifying dietary supplements can help keep customers safe.

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Connected System Risk Management for Healthcare Facilities

Connected system risk management is crucial for the security, safety and operational risks associated with connected medical devices, laboratory equipment and data systems in healthcare facilities and the future of patient care.

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Healthcare Asset Management

Effective management of healthcare assets, including medical devices, equipment and supplies, is essential for improving how governments, healthcare providers and the public respond to future pandemics and other health crises.

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Nurse Call UL 1069 Standard Update

On April 23, 2020 the 7th Edition of UL 1069 was published, following the previous dated revision from April 26, 2019. The latest changes to the standard include shared hospital networks. While this technology may have been utilized in the past through isolated I/O ports on Nurse Call Centralized Equipment, it is now specifically permitted by the standard. The main acceptable use is to interconnect two separate nurse call systems that already meet the minimum requirements in the standard. Additionally, UL 1069 lays out documentation requirements for the capability and capacity of the interconnecting network. These updates build upon the changes from April 26, 2019 and outlined requirements for the incorporation of a “Real Time Location System,” or RTLS. Modern nurse call systems have incorporated technology to track the location of nursing staff. This update to the standard allows for the detection of staff presence in a room and then the cancelation of routine calls.

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UL uses technology to continue to host informational events

The onset of COVID-19 has forced people and businesses to reevaluate daily operations. Through collaboration, innovation and technology UL has come up with ways to still engage with people while providing valuable information and ideas.

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UL Healthcare’s Pamela Gwynn Receives 2020 IEC 1906 Award

UL Healthcare extends hearty congratulations to Pamela Gwynn, Principal Engineer at UL Healthcare!

Pamela has been awarded the 2020 International Electrotechnical Commission (IEC) 1906 Award in recognition of her achievements contributing to the IEC’s mission.

The IEC 1906 Award was created in 2004 to honor individuals whose work and expertise help advance IEC’s goals and activities worldwide. Pamela will officially receive the 2020 IEC 1906 Award at the UL National Committee Council Meeting scheduled for this coming fall in Boston.