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The U.S. Food & Drug Administration recently published "Technical Considerations for Additive Manufactured Medical Devices," a guidance document for industry and the FDA staff and said it is the world's first agency to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.

The document, available at, addresses a range of issues, from design, software, and materials (both starting materials and reuse of materials) to post-processing, device testing, biocompatibility, and labeling.

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Posted by on in Uncategorized

Prolonged blasts of arctic air throughout much of Eastern United States in December and January have reminded us just how severe and dangerous winter weather can be, especially for those who find themselves outdoors in it.

Anyone exposed to extreme cold, such as in a work environment, may be at risk of cold stress – when body heat is lost faster than it can be produced. What constitutes cold stress and its effects can vary from region to region. That means that in places typically unaccustomed to wintry weather, even near-freezing temperatures are considered factors for cold stress. Such weather-related conditions may lead to serious health problems.

OSHA's Cold Stress Guide at offers a number of tips for avoiding cold stress on the job, while reminding employers of their responsibility to keep workers safe under Section 5(a)(1) of the Occupational Safety and Health Act of 1970.

According to the guide, “Employers should train workers on how to prevent and recognize cold stress illnesses and injuries and how to apply first aid treatment. Workers should be trained on the appropriate engineering controls, personal protective equipment and work practices to reduce the risk of cold stress.”

Some of these are common sense practices, like wearing inner and outer layers of clothing to stay both dry and warm, donning a hat and/or hood, and putting on waterproof and insulated gloves and boots.

Others involve taking frequent breaks in a warm area, working in pairs so either one might spot danger signs, and notifying a supervisor or calling for medical help immediately if a worker has signs or symptoms of hypothermia or another cold-related illness or injury.

Still others involve engineering controls like providing radiant heaters to warm workers in outdoor security stations, and where possible, shielding work areas from drafts or wind to cut down on wind chill.

Perhaps the two most salient points in OSHA’s Cold Stress Guide are recommendations that both employers and employees be proactive and alert, both good practices for dealing with winter – and workplace safety – in general.

There were a total of 5,190 fatal work injuries recorded in the United States in 2016, representing a 7-percent increase from the 4,836 fatal injuries reported in 2015. That’s according to the most recent Census of Fatal Occupational Injuries (CFOI) from the U.S. Bureau of Labor Statistics (BLS).

This marked the third consecutive increase in annual workplace fatalities and the first time more than 5,000 fatalities have been recorded by the CFOI since 2008. The fatal injury rate increased to 3.6 per 100,000 full-time equivalent (FTE) workers from 3.4 in 2015, the highest rate since 2010.

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CDC has deactivated its emergency response for the Zika virus and will resume normal program operations. A team of experts from across the agency, called the Zika Coordination and Operations Transition Team (ZCOTT), will lead the transition from EOC activation to routine, long-term activities and will ensure timely coordination and collaboration on scientific, communication, and policy activities.

The agency activated its Emergency Operations Center (EOC) on January 22, 2016 in response to the devastating effects of Zika virus infection during pregnancy.

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Tagged in: CDC zika virus

Posted by on in Noise Measurement

If you’re accustomed to ignoring surveys offered through everything from sales receipts to emails to online pop-ups, here’s one it pays to lend an ear to.

Noise, or undesirable sound, is one of the most common health problems to be found in many workplaces. Practically all workplaces directly involved in manufacturing, construction, or mining create noise as a by-product. While this cannot be totally eliminated, the negative health effects of noise can be limited by wearing the proper personal protective equipment and, in some instances, implementing engineering and/or administrative controls.

Noise can also be detrimental to job performance, increase fatigue, and cause irritability. Perhaps the most widely known harmful result from exposure is noise-induced hearing loss. Such losses can be either temporary or permanent; the extent of the damage is dependent mainly upon the intensity and length of exposure.

In the early 1980s, OSHA announced a hearing conservation amendment (29 CFR 1910.95, Occupational Noise Exposure Standard) that requires hearing conservation programs for all employees exposed to noise on an eight-hour, time weighted average (TWA) in excess of 85 decibels measured on an A-weighted scale (85 dBA). The permissible exposure limit is 90 dBA for an eight-hour TWA. It’s worth noting that continued exposure to more than 85 decibels (dBA) of noise may cause gradual, but permanent, damage to hearing.

The OSHA hearing conservation program for industry has five parts. They are:
-Noise Monitoring: Sound levels must be measured to determine the degree of potential employee exposure and what safeguards may be needed.
-Hearing Testing: All employees in a hearing conservation program must be tested annually.
-Employee Training and Education: Employees in a hearing conservation program must be trained every year on hearing protection.
-Hearing Protectors: Hearing protection devices should be made available to all employees according to the noise risks identified.
-Record Keeping: A company must maintain records on sound level results, equipment calibration results, and hearing test records of employees, along with its educational activities.

Fortunately, a noise survey of a workplace environment can be used identify where high noise levels are most likely to occur, leading to a more efficient hearing conservation program.

Workplace Safety & Health Co., Inc. can provide this service, which can be used to help identify employees who need to be included in a noise control program and whether to implement engineering controls to reduce exposure. Need assistance with preliminary engineering control selection? Give us a call. We can even assist third party engineers with design guidance – telling them what is needed and let them do the design work.

As always, thanks for listening!

Tagged in: noise measurement


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