FDA Issues Safety Communication About Philips Recall - Sleep Review

• California Exemptee License Training Certification Course - Buy Now!
  For home medical device retailers (HMDR). 
• FDA GMP online training courses offered by SkillsPlus International Inc.

According to the article:

"The US Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.

If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021."

Read the full source article:  FDA Issues Safety Communication About Philips Recall - Sleep Review

Related news:

• PHILIPS ISSUES RECALL - HME News
• PHILIPS RECALL: AASM CALLS FOR SUPPORT FROM CMS, PAYERS

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- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

OIG report catches $34m in CMS overpayments to med device suppliers over 3 years - MassDevice

• California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)

Read the full article:  OIG report catches $34m in CMS overpayments to med device suppliers over 3 years - MassDevice

"The U.S. Dept. of Health and Human Services’ Office of the Inspector General recently published a report claiming that the Centers for Medicare and Medicaid Services overpaid medical device suppliers by $34 million"

Read the OIG report:
Medicare Improperly Paid Suppliers for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Provided to Beneficiaries During Inpatient Stays (PDF)

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

UPS Opens Its First Facility To Offer Comprehensive Medical Device Replenishment Services

• California HMDR Exemptee Training Certification Class for home medical device retailers (HMDR) - Buy 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 for your license application.

Updated February 26, 2021

The link in the original post broke.

You might also like:   

UPS opens comprehensive medical device replenishment services facility - Healthcare Packaging

- - -  the original post follows below  - - -

Read the full article: UPS Opens Its First Facility To Offer Comprehensive Medical Device Replenishment Services - MarketWatch:

"As part of its long-term strategy to support medical device manufacturers, UPS® UPS, +0.06% today announced the opening of a new healthcare-compliant distribution and warehousing facility in New Jersey to support the growth of its customers. The multi-client hub is the first in UPS's network to offer medical device companies comprehensive logistics services such as autoclave capabilities, instrument inspection and surgical set replenishment, among other services.

The 208,000-square-foot facility is healthcare-dedicated and strategically located near UPS's air hub at Philadelphia International Airport."

'via Blog this'

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• California HMDR Exemptee Training Certification Class for home medical device retailers (HMDR).  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 for your license application.

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

HMDR & Medical Device Contacts - (CA Dept Public Health - Food & Drug Branch)

• Buy Now! California Exemptee License Training Course
• California HMDR Exemptee Training - online training certification class for home medical device retailer (HMDR) Exemptee license applicants. This online course is also recommended for HMDR supervisors and leadership. State-approved by the CDPH.

Updated March 9, 2026

For questions regarding:

• Medical Device Safety Inspection         
• HMDR Safety Inspection         
• Medical Device Export/ Export Document Program        
• Industry Education and Training        
• HMDR Out of State Registration        
• HMDR Exemptee Licenses 

Visit the source: California Home Medical Device Retail Program

Return Home:  The Designated Representative and Exemptee Blog

• California HMDR Exemptee Training - online training certification class for home medical device retailer (HMDR) Exemptee license applicants. This online course is also recommended for HMDR supervisors and leadership. State-approved by the CDPH.

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  About The HMDR Licensing Program
• 
  CA Home Medical Device Retailer (HMDR) FAQs
• 
  California HMDR Laws

California HMDR Licensing Program Home Page - CA Dept of Public Health

California Home Medical Device Retailer (HMDR) Licensing Program

HMDR Licensing Program Home Page - CDPH:

"This program licenses California [Home Medical Device Retailer] 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."

'via Blog this'

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Training program for California Home Medical Device Retailer (HMDR) Exemptee license applicants - Earn a course completion certificate

AAHomecare tells Senate: Stop audits until backlog clears | HME News

• The best choice for Exemptee training! California Exemptee Training - for HMDR (home medical device retailers). $525 per student (no extra fees to retake quizzes). State approved by the California Department of Public Health. Earns a course completion certificate suitable for your Exemptee license application. #HMDR #HME #DME #HMDRexemptee
  

AAHomecare tells Senate: Stop audits until backlog clears | HME News:

"The battle to fight audits has gained strength ever since a Dec. 31 memo from Chief Administrative Law Judge (ALJ) Nancy Griswold cited a backlog of 357,000 pending appeals pending, and suspended assignment of hearings for appeals dating to July 15, 2013. It could be at least two years before those appeals get assigned to an ALJ. "

'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):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Don’t Skip The DQSA Definition of Terms Section - RxTrace

Follow the link below, and heed Dirk Rodgers/RxTrace advice. Here's a sampling of glossary terms that might interest you:  dispenser, distribution, exclusive distributor, repackager, 3PL provider, wholesale distributor.

Don’t Skip The DQSA Definition of Terms Section - RxTrace:

"Section 581, Definitions, is a special glossary of terms whose definitions only apply within the text of the law.  So if you read the other sections and you assume the dictionary or the everyday definition of certain terms, you will miss the full meaning of those sections."

'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):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• CA Designated Representative & Exemptee Training Course - Enhanced for iPad (drughealth.blogspot.com)

Policies and Procedures - California HMDR Facilities Must Have Them

• Register now to take this course: California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)

Updated September 8, 2021

A link broke in the original post. Here's how to enroll in the SOP Course.

Pricing – Standard Operating Procedures Course

• $100 per student when co-purchased with our California Exemptee training course.
• Select our Writing Standard Operating Procedures (SOP) Course as an optional “add-on” course when you purchase our California HMDR Exemptee license training certification course (in other words, buy the Exemptee course, then add the optional SOP course during registration).

---  the original post follows below  ---

Policies And Procedures For California HMDR Facilities

California HMDR facilities shall have written policies and procedures.  Make sure you know how to write them, have them in place, and follow them. Your staff should be well-versed with them, and you want to make sure that they are following them.  You might want to consider taking:
Writing Procedures: Drug and Device Wholesalers and HMDR - an online training course

CA HMDR Facilities Must Have Policies and Procedures | SkillsPlus International Info:  'via Blog this'

Section 111656.3 starts out with:  

"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "  

Notice the phrase, " . . . shall have written policies and procedures . . . "

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---------------

California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• CA HMDR Facilities Must Have Policies and Procedures (skillsplusinfo.blogspot.com)
• CA Pharmacy Designated Representative - Online CBT Training (skillsplusinfo.blogspot.com)
• CA Home Medical Device Retailer Exemptee License Application (skillsplusinfo.blogspot.com)
• Problems With Standard Operating Procedures? We've Got Templates (skillsplusinfo.blogspot.com)

FDA - Medical Devices and Disaster Preparedness

• Buy now! California HMDR Exemptee License Training Certification Course

Updated March 17, 2026

Whether it's a hurricane, gas main explosion, or something else, it's important to be thinking about how it'll affect one's use of a medical device in the setting of a disaster, according to FDA Offers Tips about Medical Devices and Hurricane Disasters.

The recent devastating gas main explosion in San Bruno, CA, just 20 minutes by car from where I live, highlights the need for preparedness.

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