FDA advises testing for Zika in all donated blood

Press release from the FDA…

“As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

The FDA first issued guidance on Feb. 16 recommending that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain Whole Blood and blood components from areas of the U.S. without active virus transmission. All areas with active transmission in the U.S. are currently in compliance with this guidance. The revised guidance announced today recommends that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.

The FDA is updating its guidance after careful consideration of all available scientific evidence, consultation with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy. Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and it has shown to be beneficial in identifying donations infected with Zika virus. Expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced.

Zika virus is transmitted primarily by the Aedes mosquito. Zika virus can also be spread by sexual contact. Although 4 out of 5 people infected with Zika virus never develop symptoms, when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes). In addition, Zika virus infection during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

The first local or non-travel related transmission of Zika virus in the U.S. by mosquitoes was reported from Puerto Rico in December 2015; and soon thereafter, local transmission was reported in American Samoa and the U.S. Virgin Islands. In July 2016, the first cases of local or non-travel related transmission of Zika virus in the continental U.S. were reported in Miami-Dade County, Florida.

In addition to protecting the nation’s blood supply, the FDA works to protect the safety of our nation’s supply of human cells, tissues, and cellular and tissue-based products; supports the development and availability of diagnostic tests that may be useful for identifying the presence of or prior exposure to the Zika virus; works with commercial and government developers to advance the development of investigational vaccines and therapeutics; and monitors for fraudulent products and false product claims related the Zika virus.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”




Donnie’s Story

Next time you need to teach your employees about arc flash protection, head over to donniesaccident.com and download the video about Donnie’s arc flash accident. There are a couple of different ones to choose from but all of them speak volumes through images and testimonials about why anyone working with electricity needs to be wearing PPE.

Donnie's_Story


If You Play a Wind Instrument, Read This!

Have you ever heard of “Bagpipe Lung”? You probably haven’t; nor have most people. If you play a wind instrument though, you should understand what it is… it could mean your health and even your life.

Bagpipe

Bagpipe lung comes about when the bacteria that grows inside a wind instrument is inhaled into the lungs and results in hypersensitivity pneumonitis. Most people’s immune system is able to properly handled the bacteria and allergens that they inhale but others are hypersensitive (hence the name of the disease) and the result can be a damaged respiratory system or even death. Hypersensitivity pneumonitis is most often associated with mold or birds but can also come from wind instruments.

The disease was first diagnosed in a bagpipe player, which of course, is how we got the name of the disease. Bagpipes, because of the complexity of the instrument and the various materials involved, are more prone to bacteria but no wind instrument is exempt.

So how do you protect yourself if you play a wind instrument? Clean the instrument properly after each use and allow it to drip dry is really the best course of action.

Aside from that, listen to your body. If you start getting a persistent dry cough, get tested and let your doctor know that you play a wind instrument. You might even teach them something about hypersensitivity pneumonitis.



Overtime Work = More Pay

Current salary thresholds mean that companies can make a worker a salaried worker to avoid paying them overtime. Current salary thresholds now sits at $23,660.00. An employee who is salaried at that level of pay but who is working 50 or even 60 hours a week is often making less than minimum wage. That’s about to change. Watch the video below to see how you might be entitled to more pay or less work.

Overtime


OSHA Fines Increase by as-much-as 78%

From our friends at Accuform

Earlier this month the Occupational Safety and Health Administration (OSHA) increased the maximum penalty by 78% for the first time in 25 years.

The new penalties took effect on Tuesday, August 2, 2016. Any citations issued by OSHA on or after this date will be subject to the new penalties if the related violations occurred after November 2, 2015.

Here’s what the changes look like dollar-wise:

Type of Violation                 Current Maximum            New Maximum
Penalty                                  Penalty
Serious                                    $7,000 per violation        $12,471 per violation
Other-Than-Serious
Posting Requirements

Failure to Abate                   $7,000 per day                   $12,471 per day

Willful or Repeated           $70,000 per violation      $124,709 per violation
Source OSHA

Adjustment to Penalties

To provide guidance to OSHA field staff on the implementation of the new penalties, OSHA issued revisions to its Field Operations Manual. To address the impact of these penalty increases on smaller businesses, OSHA will continue to provide penalty reductions based on the size of the employer and other factors.

State Plan States

States that operate their own Occupational Safety and Health Plans are required to adopt maximum penalty levels that are at least as effective as Federal OSHA’s.

For More Assistance

OSHA’s On-site Consultation Program provides professional, high-quality, individualized assistance to small businesses at no cost.

OSHA also has compliance assistance specialists in most of their 85 Area Offices across the nation who provide robust outreach and education programs for employers and workers.

To read more about these changes please visit https://www.osha.gov/penalties/, here more detailed information can be obtained on how these increases could impact you.

Ultimately a safe-workplace can help to avoid fines levied by OSHA. Accuform encourages you to team up with your local Safety/MRO Product Distributor to learn more about further building a culture of safety at your workplace.

Have a safe and great week!