Showing posts with label problem. Show all posts
Showing posts with label problem. Show all posts

Tuesday, May 25, 2010

Common HMDR Renewal Inspection Violations

Updated June 9, 2026

The PDF is no longer posted on the program's website.

---  the original post follows below  ---

California HMDR renewal inspections can take place annually, unannounced, at any HMDR facility during normal business hours. A customer complaint or other referral may trigger an inspection.

Common violations reported include:
  • Dispensing legend devices without a valid HMDR exemptee on premise
  • Lack of dispensing records for legend devices
  • Inadequate procedures for the cleaning and repair of rental devices
  • Inadequate staff training or patient/caregiver consultation
  • Inadequate record of complaints or review of customer complaints to prevent reoccurrence
Source:   California HMDR FAQ Listing (PDF) - find this PDF on the California Home Medical Device Retail Program website

Return Home:  The Designated Representative and Exemptee Blog

Buy now! California Exemptee license training certification course
Buy now! California Exemptee license training certification course


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, March 16, 2010

FDA Warning - DST Might Create Problems For Medical Equipment

Updated November 29, 2025:

The original link broke.

You can still read something that's related here:

---  the original post follows below  ---

When I went to work yesterday, under Daylight Savings Time, my meeting times for recurring meeting times in a popular web meeting software application were inconsistently wrong. Now apply the time change problem to medical devices.

The FDA advises in, Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way:

"If you have any medical equipment that uses, creates or records time information about your diagnosis or treatment and the manufacturer has not updated it, the equipment may not work properly when Daylight Saving Time (DST) starts and ends."

Return Home:  The Designated Representative and Exemptee Blog

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