Showing posts with label device. Show all posts
Showing posts with label device. Show all posts

Saturday, July 15, 2023

AHRQ Report on CPAP Devices - Consider The Ramifications

There's a lot to take in here.  You'll need to read the entire article to unpack the findings.

According to the article:

"Spoiler alert: The report, Long-Term Health Outcomes in Obstructive Sleep Apnea: A Systematic Review of Comparative Studies Evaluating Positive Airway Pressure and the Validity of Breathing Measures as Surrogate Outcomes, does not answer the main clinical question it asks. Rather, for each outcome—cardiovascular disease, driving accidents, diabetes, mental health, cognitive function, quality of life, and many others—it details why the evidence is inadequate, over and over again." 

Read the full source article:  The Most Disturbing Findings of the AHRQ Report on CPAP Devices (Editor’s Message) - Sleep Review

Return Home:  The Designated Representative and Exemptee Blog

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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):

Thursday, April 5, 2018

New Products Wow at Medtrade Spring | HomeCare Magazine

Updated February 19, 2022

You might also like:

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Updated September 29, 2020

You might also be interested in: 

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Updated October 19, 2018

    • Caire’s FreeStyle Comfort portable oxygen concentrator as this year’s gold winner 
    • Abely’s portable electric recliner, the Abelift, took home silver; and 
    • 3B Medical’s CPAP hose cleaner, the Lumin Bullet, took home bronze
- -   original post follows below  - -

View the list of winners:   New Products Wow at Medtrade Spring | HomeCare Magazine:

"Medtrade Spring 2018 attendees voted on their favorite new products in the long-running New Product Pavilion Providers’ Choice Awards, sponsored by HomeCare Magazine. Top vote getters at the Spring version of the nation’s premiere HME-focused trade show were:"

'via Blog this'


California Home Medical Device Retailer (HMDR) Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch)
Training certification course for California HMDR Exemptee license applicants  -  Earn a course completion certificate - for home medical device retailers

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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):

Tuesday, August 22, 2017

FDA Offers Draft Guidance to Further Secure Drug Supply Chain | RAPS


Updated October 13, 2023

One of the original links broke.

You might also be interested in:

---  the original post follows below  ---

Read the full article: FDA Offers Draft Guidance to Further Secure Drug Supply Chain | RAPS:

"Last Friday, FDA released new draft guidance to help industry, state and local governments categorize the entities in the drug supply chain in accordance with the DSCSA and help clarify which companies are engaged in activities that require licensure and annual reporting.

The 18-page draft, titled "Identifying Trading Partners Under the Drug Supply Chain Security Act," notes the confusion related to defining wholesale distributor and wholesale distribution, as well as confusion over what an affiliate of a manufacturer means."

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Training program for California drug or device wholesaler license applicants
Training program for California third party logistics (3PL) providers license applicants


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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):

Thursday, August 11, 2016

Encourage Referral Sources to Take Survey on Effects of Bidding Program: AAHomecare Blog


Read the full post: AAHomecare Blog: Encourage Referral Sources to Take Survey on Effects of Bidding Program:

"The brief survey gives medical professionals the opportunity to share their perspectives on issues they may have faced on account of reduced availability of HME in a changing competitive environment."

'via Blog this'

Here are the AAHomecare survey links:

"Ask your referral sources to participate in the survey!  They may either take the survey online or they can complete a printable version
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Training for California HMDR Exemptee license applicants


CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

Friday, June 19, 2015

Who Offers Exemptee Training?

SkillsPlus International Inc. offers the highly respected California Home Medical Device Retailer (HMDR) Exemptee Course listed below. 

This training course is very popular for its convenience, and availability 24 hours a day & 7 days a week!  Buy now and gain immediate access to the course.
Learn more: Exemptee training taught by SkillsPlus International Inc.

Q & A:

Question: Who offers California HMDR Exemptee Training Certification?
Answer: SkillsPlus International Inc. is a highly recommended provider of California Exemptee certified training for home medical device retailers (HMDR).



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):

Tuesday, May 5, 2015

And the Winners Are... | HomeCare Magazine

Read the full article and see the winners: And the Winners Are... | HomeCare Magazine:

"In the final days of Medtrade Spring, held March 30-April 1 in Las Vegas, the votes were tallied and trophies were presented to the winners of the biannual Innovative HME Retail Product Awards, sponsored by HomeCare magazine. There were 12 product contendees from 11 companies."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

- - -

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):

Thursday, April 17, 2014

CMS readying for background checks | HME News

Updated October 3, 2021

You might also be interested in:

---  the original post follows below  ---

CMS readying for background checks | HME News:

"Once fully implemented, the background checks will be completed on all individuals with a 5% or greater ownership interest in a provider that falls under the high-risk category. This category applies to DME and home health and hospice providers who are newly enrolling in Medicare, and those who have been elevated to the category in accordance with enrollment screening regulations."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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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):

Thursday, July 18, 2013

How To Contact CDPH HMDR - Medical Device, HMDR, Exemptee

Updated August 7, 2023:

Contact The California Home Medical Device Retail (HMDR) Program at the CDPH

According to their website, there are a couple of ways to get in contact with the California Department of Public Health (CDPH) - Food and Drug Branch, for medical devices, home medical device retail (HMDR), Exemptee, and more ...

View the full webpage:  Home Medical Device Retail Program

Contact

Telephone Number:
(800) 495-3232

Overnight Mailing Address:
​​California Dept. of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
Sacramento, CA 95814

Regular Mailing Address:
California Dept. of Public Health
Food and Drug Branch
PO Box 997435, MS 7602
Sacramento, CA 95899-7435

FDB Email Address:
FDBMedDevice@cdph.ca.gov

Return Home:  The Designated Representative and Exemptee Blog

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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, June 22, 2013

The Exemptee Institute


Home - Exemptee Institute of SkillsPlus Intl Inc:

"Since 2002, SkillsPlus Intl Inc. has offered an approved California Department of Public Health Home Medical Device Retailer (CDPH HMDR) training certification course. Establishing our Exemptee Institute is our commitment to offer the highest quality Exemptee training certification course available on the market."

Return Home:  The Designated Representative and Exemptee Blog





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, June 19, 2013

CA HMDR Licensing - Info - Forms - FAQs

HMDR Licensing Program Home Page:

"The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws."

Return Home:  The Designated Representative and Exemptee Blog

- - -

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, June 1, 2013

"Stop This Train Wreck" - Instead, support HR 1717 (to replace CMS competitive bidding)

‘There’s No More Room for Apathy’ -- HME Business:

"Providers must refuse to give in to “apathy” and must form a dedicated and united front in support of gaining as many co-sponsors as possible for H.R. 1717, the bill that would replace competitive bidding with the market pricing program, said Tom Ryan, CEO of New York provider Homecare Concepts. Ryan made an impassioned call to action for providers to support the bill while speaking to attendees of the American Association for Homecare’s Washington Legislative Conference."


Return Home:  The Designated Representative and Exemptee Blog

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, May 1, 2013

Merger - AAHomecare & NAIMES


AAHomecare and NAIMES Merging -- HME Business:

"The American Association for Homecare and the National Association of Independent Medical Equipment Suppliers will merge their organizations, with combined Association to maintain the AAHomecare name and continue to do business from AAHomecare’s Washington, D.C. address."

Return Home:  The Designated Representative and Exemptee Blog

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):

Tuesday, January 22, 2013

Exemptee Licensing Info and Resources - Exemptee Institute

Licensing - Exemptee Institute of SkillsPlus Intl Inc:

"The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws.

Useful License Links & Resources . . . "

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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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):

Tuesday, January 8, 2013

HMDR FAQs - Now Available from CDPH!

Updated June 4, 2025

The HMDR FAQs are available on the California Department of Public Health Home Medical Device Retail Program website.  (NOTE: the CDPH inconsistently posts the FAQ document)

"The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety Section and is governed by law found in the California Sherman Food, Drug and Cosmetic Law.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program.  This section of the Sherman Law can be found by following the link below.  It is in the Adobe PDF format so you will need an Adobe reader program to open and print the document.  Also found below is a link to the compiled Frequently Asked Question (FAQ) list. "

'via Blog this'
Return Home:  The Designated Representative and Exemptee Blog

- - -

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):

Thursday, December 13, 2012

FDA on Making Medical Devices Safer at Home


Updated September 9, 2025

The original link broke.

You might also be interested in:
Home Use Devices Initiative - FDA.gov:   https://www.fda.gov/medical-devices/home-use-devices/home-use-devices-initiative

---  the original post follows below  ---

Follow the link below for additional free consumer information and resources:

Consumer Updates > Making Medical Devices Safer at Home:

""(Home use) devices once were designed only to keep you alive. Now they're designed to keep you as independent as possible," according to Mary Brady, MSN, RN, a senior policy analyst at FDA's Center for Devices and Radiological Health (CDRH).

However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.

There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn't hear an alarm on his ventilator signaling that the tubing had become disconnected."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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):


Monday, November 19, 2012

California HMDR Exemptee Training Requirements

Q.  I'm submitting an application for a Home Medical Device Retailer (HMDR) Exemptee license, as a new applicant. What are the things that I need to pay attention to, regarding training requirements?

A.  According to the referenced CDPH HMDR license application form:
  • New applicants must meet minimum qualifications, including proof of completing a training program (that addresses 5 topic areas).
  • In order to prove training completion, the applicant must submit a copy of the completed training certificate (or transcript).
  • Specifically, in the Minimum Qualifications - Training Programs section: Indicate by yes or no the training you have completed specific to the five topics listed. Attach copies of certificates or transcripts.
Be forewarned, the application states, "Unsigned or incomplete applications cannot be processed and will be returned."

Reference:
Application for Home Medical Device Retailer (HMDR) Exemptee license - New and Renewal (Form CDPH 8695 (04/18))


California HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):

Wednesday, November 14, 2012

California HMDR Law (Home Medical Device Retailer)

Updated January 26, 2022

HMDR Law and FAQ:
"The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety and Youth Tobacco Enforcement Section and is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program.  This section of the Sherman Law can be found by following the link below.  It is in the Adobe PDF format so you will need an Adobe reader program to open and print the document."

'via Blog this'

California HMDR Sherman Law (FDB) 

Return Home:  The Designated Representative and Exemptee Blog

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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):

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