Thursday, November 3, 2022

Pulse Oximeter Accuracy and Limitations - FDA.gov

Doctors have long known that pulse oximeters are less accurate in estimating blood oxygen levels in non-white patients, but the discrepancies were considered insignificant. The COVID-19 pandemic exposed some of the real dangers of these flaws, as the devices gave falsely high oxygen readings in patients with dark skin.

"The FDA announced a virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on November 1, 2022, from 9 a.m. to 6 p.m. Eastern Time. For additional meeting details, see the meeting announcement in the Federal Register. 

The committee will discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations. The committee will also discuss factors that may affect pulse oximeter accuracy and performance, the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, and the amount, and type of data that should be provided by manufacturers to assess pulse oximeter accuracy and to guide other regulatory actions as needed."

Source:  Pulse Oximeter Accuracy and Limitations: FDA Safety Communication - FDA.gov

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#HMDR #HME #DME #Exemptee #HMDRexemptee #CDPH #FDB

Wednesday, October 26, 2022

"HalloThanksMas" Season Is Here!

Complete your state license training now, before the holiday season starts!

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Happy holidays!!!

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Saturday, August 27, 2022

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Learn more, and purchase an online training course:

All of these training programs are approved by the California State Board of Pharmacy. Successful course completion earns a training affidavit to include in your California Designated Representative license application. Each course covers the required topics specified in the license application form.

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SkillsPlus International Inc. proudly offers the largest selection of Board-approved training programs for California Designated Representative license applicants and their supervisors/managers.
SkillsPlus International Inc. proudly offers the largest selection of Board-approved training programs for California Designated Representative license applicants and their supervisors/managers.

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Saturday, August 20, 2022

CMS Discontinues Use of Certificates of Medical Necessity for DME - HomeCareMag

Updated June 15, 2026

You might also like:

Standard Documentation Requirements for All Claims Submitted to DME MACs - CMS:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=55426

---  the original post follows below  ---

According to the article:

The best California HMDR Exemptee training certification course for home medical device retail Exemptee license applicants and their supervisors & managers. State-approved by the CDPH.
California Exemptee Training
"As part of its ongoing efforts to increase access to care and to reduce unnecessary administrative burden for stakeholders, the Centers for Medicare & Medicaid Services (CMS) will be discontinuing the use of Certificates of Medical Necessity (CMNs) and Durable Medical Equipment (DME) Information Forms (DIFs) for claims with dates of service on or after Jan. 1, 2023. CMS suppliers must continue to submit CMN and DIF information for claims with dates of service before Jan. 1, 2023 if it is required."

Read the full source article: CMS Discontinues Use of Certificates of Medical Necessity for DME - HomeCareMag

Read more about this change here:  Elimination of Certificates of Medical Necessity & Durable Medical Equipment Information Forms - MLN Matters (pdf)

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     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Friday, July 22, 2022

California HMDR Exemptee Online Training Certification Class

California HMDR Exemptee online training certification course

California HMDR Exemptee Online Training Certification Class - for home medical device retailers​
- for home medical device retailers​

Buy Exemptee training now!

If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate accepted by the California Department of Public Health - include it in your license application.

  • $525 per student. 
  • Earns a course completion certificate accepted by the California Department of Public Health. Covers required topics specified in the Exemptee license application form
  • Learn more and buy - no extra fees to retake quizzes

Nearly 10,000 students have taken our state license-related training programs.

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Wednesday, July 6, 2022

FDA Issues Two DSCSA Draft Guidances

The FDA issued 2 DSCSA draft guidances:

Date PublishedTypeTitle
7/05/2022Draft GuidanceIdentifying Trading Partners Under the Drug Supply Chain Security Act
7/05/2022Draft GuidanceDSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry

View the full list of Drug Supply Chain Security Act Law and Policies - FDA.gov

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For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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