Showing posts with label devices. Show all posts
Showing posts with label devices. 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

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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, November 7, 2013

Drug Supplier Will Acquire Pharmaceutical Wholesaler - CEMag

Updated August 17, 2021

The original link broke.

You can still read about this story here:

---  the original post follows below  ---

Drug Supplier Will Acquire Pharmaceutical Wholesaler - CEMag:

"ScripsAmerica Inc. has signed an agreement to acquire PIMD International, LLC, a wholesale distributor of prescription drugs as well as medical supplies and devices.

Based in Miami, PIMD International LLC serves as a pharmaceutical wholesaler to pharmacies, hospitals, and physician's offices in the US. The company also sells medical supplies in all health care settings and online. PIMD, which will become part of ScripsAmerica, provides its customers with access to specific medications for their end users."

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):

Monday, June 17, 2013

FDA - Hurricane Checklist - Medical Devices

Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to: . . . "  (follow the link above to the FDA's checklist)

More specifically for medical devices:

Medical Devices

  • If you have a "life-supporting" or "life-sustaining" device that depends on electricity, you should contact your healthcare provider for information on how to maintain function in the event of a loss of power.
  • Keep your device and supplies clean and dry. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events.
  • For more information, see FDA Offers Tips about Medical Devices and Hurricane Disasters15 (en EspaƱol16).

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California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health (Food and Drug Branch). For home medical device retailers.
California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health (Food and Drug Branch). For home medical device retailers.

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 3, 2012

Florida Certified Designated Representative (CDR)

About Florida Certified Designated Representative (CDR) Exam Prep :

"Drugs, Devices, and Cosmetics Program - Certified Designated Representative: All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment."

'via Blog this'

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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, June 16, 2009

Pharmacy Designated Representative Training Requirements

Pharmacy Designated Representative Training Requirements

If you're new to the pharmacy world of the Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:
A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.
There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:
Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.

The trick then becomes finding a way to fulfill the training program requirement. I've posted links to training and certification service providers below.

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Training programs for California Designated Representative license applicants - Earn a training affidavit

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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