Coronavirus (COVID-19) Update: FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test

 

One of the few reliable (or so we thought) and easy Coved-19 tests available is the Abbott ID NOW.  Unfortunately now, well over 60 days into the pandemic here in the U..S., comes word from the FDA that the test might not be quite a reliable as first thought.  Here is the information staring from the FDA:

Today, the U.S. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false negative results.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test. This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

The FDA is sharing early information available about potential inaccurate results in the spirit of transparency. The agency has been working with Abbott to analyze the information gathered to date and has worked with the company on a customer notification letter to alert users that any negative test results that are not consistent with a patient’s clinical signs and symptoms or necessary for patient management should be confirmed with another test.

The FDA looks at a variety of sources to identify and understand potential patterns or significant issues with the use of the Abbott test. No diagnostic test will be 100% accurate due to performance characteristics, specimen handling, or user error, which is why it is important to study patterns and identify the cause of suspected false results so any significant issues can be addressed quickly.

The agency is aware of some scientific studies that have identified accuracy issues with Abbott ID NOW and is investigating whether it could be due to the types of swabs used or the type of viral transport media (material used to transport the patient’s specimen). While there is important information to gather from these studies, it should be noted these studies have limitations, including small sample size, potential design biases, or tests that may not have been executed according to the manufacturer’s instructions for use, an important part of scientific research. This is why external scientific studies are one part of the FDA’s overall evaluation of a diagnostic performance.

The FDA has received 15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results. The agency is reviewing these reports. It’s important to note that the adverse event reports the FDA receives from manufacturers, health care providers, health care facilities, and patients can be incomplete, inaccurate, or unverified, so agency staff must meticulously comb through the reports to identify crucial data to support any signals or patterns about device use.
Moving forward, Abbott has agreed to conduct post-market studies for the ID NOW device that each will include at least 150 COVID-19 positive patients in a variety of clinical settings. The FDA will continue to review interim data on an ongoing basis. The information gathered from the post-market studies can further help the agency understand the cause or patterns of any accuracy issues and inform any additional actions the company or the FDA should take.

The FDA will keep working with Abbott to further evaluate these accuracy issues and will publicly communicate any updates.

CAO Group Announces PPE Product Line Aegis PPE product line available now for Dental Offices

 

The day that seemed like it would never get here has finally arrived.  Most dental offices will re-open on May 18th… at least here in the Midwest.  I know that Utah has been back to work for at least a couple of weeks while other states, like New Jersey, are still under quarantine guidelines.

However, whether you are ready to open or at starting to gear up, things in the dental industry have changed… drastically.  Offices across the country and now working hard to find the proper PPE (Personal Protective Equipment) to keep staff and patients safe from the continued threat of Covid-19.

This is a strange time in the profession.  As the supply chain struggles with shortages and counterfeits of trusted products, suddenly every office is ordering the same product as every other office and the supply chain is groaning under the stress.  Dentists need *reliable* PPE and it seems that even things like face shields are shoddily made and in short supply.  Wouldn’t it be great if a *trusted* name in dentistry could help with the supply problem?

Well help is here.  CAO Group, a company that has been making dental products for years has now announced the Aegis PPE line.  This is a new venture for CAO Group, but one I commend them for.  They’ve made a lot of great dental products over the years and when they saw the problems with PPE that dentists were battling, they were quick to jump in and help.  Here is the info on this new company:

The CAO Group, Inc. (CAO) announces both the launch and availability of their AegisTM brand Personal
Protective Equipment (PPE) product line to help dental practices come back to operation under COVID-19
pandemic conditions.

The Aegis PPE line consists of, but not limited to, the following items: Aerosol VacStation, Infrared
Thermometer, Coverall Suits, Protective KN95 Masks, Surgical Masks, Protective Goggles, and Face Shields.
Each product has unique features to protect staff in dental practices. Aegis VaStation features a three stage6
filtration and UV light with a flow rate of three cubic meter per minutes and low noise. The three-stage
filtration includes a moisture filter, a HEPA H13 filter for particles as small as 2.5um, an active carbon filter for
solvent and active particles. The UV light is 275nm wavelength of light intensity. Aegis infrared thermometer
are FDA cleared class II medical device and measure body temperature with no contact less than 1 sec. Please
visit www.caogroup.com and amdlasers.com for details of products.

“Protecting office staff shall be the number one priority for dental practices” said, Densen Cao, PhD, Founder
and CEO of CAO. “Protections in dental practices must be advanced to a new standard under COVID-19
pandemic. Our recommendations for additional procedures for protecting dental staff are as follows: 1. Check
patient temperature as part of check in; 2. Use coverall suit, goggles, KN95 or surgical masks, and face shield to
protect staff during the procedures; 3. Use aerosol vacuum station to suck away aerosol during the procedures;
4. Disinfect routinely between patients.”

Aegis PPE products are available on caogroup.com, amdlasers.com, and certain dental distributors.

About CAO Group, Inc.

Counterfeit N-95 Masks Begin to Enter Market - Buyer Beware

 

On Friday of last week, the New York Times published an article about the sudden influx of counterfeit N-95 masks entering the U.S. supply chain from our friends in China.

For those of you not well versed in mask terminology, at true U.S. certified respirator (even though it *looks* like a mask) has a snug fit and is referred to as an N-95.  Other countries have similar standards, but their names for the devices vary, adding to the confusion.  The China equivalent of the U.S. N-95 is called a KN-95.

Due to the global pandemic and the shortage of PPE (Personal Protective Equipment) that it created, the U.S. relaxed testing standards and was allowing KN-95 masks to enter the U.S. supply chain without testing.

About 3 weeks ago, some tests were performed and massive amounts of failures were noted.  This lead to the U.S. banning 65 of the previously approved 80 Chinese manufacturers.  Unfortunately because, for some unknown reason, the failures were not reported for about 3 weeks, that meant that these inadequate masks entered the U.S. supply chain and were put into circulation for healthcare workers on the front lines.  Basically that means that doctors & nurses were gearing up in these masks to go into rooms with patients known to have Covid-19, thinking they were wearing the best PPE they could get.

Why it took 3 weeks for the U.S. government to take action remains a mystery.

The full story can be accessed here.  

Hawkeye Key Logger Comes Amid Pandemic Concerns

 

Not everything that you receive electronically dealing with Corona Virus fears is being sent to you out of concerns for your safety.  A recent spate of emails, in fact, is being sent in hopes of capitalizing on fears of safety.

It seems that recently emails are being sent that “appear” to be from the WHO’s Dr. Tedros Adhanom Ghebreyesus.  This email reports to be offering “drug advice” to unsuspecting users.  In reality what is being delivered is the Hawkeye Key Logger program. 

Key Loggers are named because they truly have the ability to record every key stoke entered into a computer and can then send this information back to whoever sent the malware in the first place.  It basically allows an unknown person to see everything that happens on the infected computer.  In addition to stealing keystrokes and sending them along, Hawkeye can also capable of stealing credentials such as user names and passwords from email accounts and web browsers installed on the computer

The secret to avoiding these types of programs and situations are the ones I’ve discussed before.  “Think before you click” is the best advice I can give.  If you do not open files attached to emails, you won’t have many problems to deal with… so don’t open files sent to you unless you can verify the person who sent them to you.

It’s bad enough that we have to deal with the Covid-19 outbreak without having to worry about scams associated with it.  Unfortunately, that’s the world we live in...

ITC Judge’s Initial Determination Rejects Align Technology Claims against the 3Shape TRIOS scanner

 

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There have been rumblings lately about the lawsuit between Align and Trios.  It seems that Align had sued Trios for violating patents, among other things.

Today comes word that, at this point in time, 3Shape seems to be in the clear.  Here is the info:

3Shape today announced that the company has received a favorable Notice of Initial Determination regarding the 3Shape TRIOS scanner. The Notice of Initial Determination was issued by Administrative Law Judge MaryJoan McNamara of the U.S. International Trade Commission (ITC) following the ITC’s investigation of the complaint, filed by Align Technology, Inc. against 3Shape in December 2018, which is the third ITC case filed by Align against 3Shape

On April 30, 2020 Judge McNamara found that 3Shape did not commit any unfair acts in connection with the 3Shape TRIOS scanner as asserted by Align, ruling that there was no violation of the patents asserted against the TRIOS scanner. Thus, 3Shape will continue to sell, supply and service 3Shape TRIOS scanners in the USA.

“We are pleased that Judge McNamara rejects Align’s claim that the TRIOS scanner infringes any valid Align patents, like Judge Lord and Judge Cheney did in the two previous ITC cases launched by Align. Further, Judge McNamara found that one of the patents asserted by Align against TRIOS application software was invalid. This is a victory for innovation and the many dental professionals who every day apply innovative dental solutions to provide better dental care for their patients. We are confident that the ITC will follow Judge McNamara’s Initial Determination regarding the TRIOS scanner and its application software at issue,” says Tais Clausen, Co-CEO and Co-founder of 3Shape.

In her ruling, Judge McNamara reached an Initial Determination that certain claims of two other patents asserted against certain 3D model alignment methods when comparing a scan to a Virtual Ortho setup, as well as certain specific methods to align two 3D models in 3Shape’s Compare Model Sets ortho software module were infringed. 3Shape will seek the ITC’s review of this holding.

Innovation is the driving force behind 3Shape. 3Shape has always had the utmost respect for patents and intellectual property. We continue to create groundbreaking technology to advance dental care. That ability has made 3Shape a leader, which is supported by our more than 80 patent families and numerous industry awards.

3Shape will continue to do what we have always done: Work with companies (including competitors) to create exciting and innovative solutions that benefit labs and dentists and improve patient care.

U.S. Department of Labor Issues Additional Respirator N-95 Reuse Guidance

 

Here is the latest info on decontaminating high filtration masks for re-use.  This is through OSHA which is part of the Department of Labor.

WASHINGTON, DC - The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has issued interim enforcement guidance on reusing disposable N95 filtering face piece respirators (N95 FFRs) that have been decontaminated. The action marks the Department’s latest step to ensure the availability of respirators, and follows President Donald J. Trump’s Memorandum on Making General Use Respirators Available.
The guidance applies to workplaces where workers need respirators to protect against exposure to infectious agents that could be inhaled into the respiratory system, including during care of patients with suspected or confirmed coronavirus and other activities that could result in respiratory exposure to SARS-CoV-2, the virus that causes the coronavirus.
If respiratory protection must be used, and acceptable alternatives are not available for use in accordance with OSHA’s previous coronavirus related enforcement memoranda, the National Institute for Occupational Safety and Health has identified available research that suggests the following methods offer the most promise for decontaminating FFRs:
Vaporous hydrogen peroxide;
Ultraviolet germicidal irradiation; and/or
Moist heat (i.e., using an oven).
If the methods above are not available, microwave-generated steam or liquid hydrogen peroxide could also be suitable.
The following methods are not considered acceptable unless objective data that sufficiently demonstrate the safety and effectiveness of such methods become available:
Autoclaving;
Dry heat;
Isopropyl alcohol;
Soap;
Dry microwave irradiation;
Chlorine bleach;
Disinfectant wipes, regardless of impregnation (i.e., chemical saturation); and/or
Ethylene oxide.
Employers should investigate the effectiveness of any particular decontamination method used for the specific filtering facepiece respirator model to be decontaminated. Employers should be able to demonstrate the effectiveness of any decontamination method used against the likely contaminant(s) (i.e., pathogens) of concern, and that the decontamination method used does not produce additional safety hazards.
This interim guidance will take effect immediately and remain in effect until further notice; however, this guidance is time-limited to the current public health crisis. Visit OSHA’s Coronavirus webpage regularly for updates.
For further information about the coronavirus, please visit the Centers for Disease Control and Prevention.
Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to help ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance. For more information, visit www.osha.gov.
The mission of the Department of Labor is to foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States; improve working conditions; advance opportunities for profitable employment; and assure work-related benefits and rights.
Agency
 Occupational Safety & Health Administration
Date
 April 24, 2020
Release Number
 20-759-NAT
Contact: Department of Labor National Contact Center
Email
 DOL-Info@dol.gov

Want to Learn about Digital Caries Diagnosis?

 

In these crazy global pandemic times, a lot of folks in dentistry are spending the downtime taking online CE courses.  

In case you are one of those folks and are looking for info on Digital Caries Diagnosis, I’d like to suggest you check out a webinar I did for Weave recently on that very subject.

A couple of weeks ago I settled down in front of my computer and recorded about 45 minutes of information on how I am now examining and monitoring caries in my patients.

I cover a couple of the diagnostic types of devices available as well as some clinical examples of what both devices cover.  It's not an inclusive list, but I feel this will give you a nice overview of the subject that you can incorporate into your practice once we are cleared for elective treatment.

The good folks at Weave have been nice enough to provide quite a few online CE webinars that they are providing free of charge

If you’d like to view mine, then follow this link.