Tuesday, May 25, 2010

Common HMDR Renewal Inspection Violations

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)

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Tuesday, May 18, 2010

Proposed CA Budget Cut To In Home Care

Kaiser Health News reports, Schwarzenegger Budget Proposal Cuts In-Home Care.

In summary:
Schwarzenegger proposed ending the entire state welfare program along with most state-subsidized child care, cutting mental health services by 60 percent and considerably slashing in-home care services for elderly, sick and disabled people.
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Tuesday, May 11, 2010

CA Designated Representative - Qualification Requires 1 Year Experience

Applicants often have questions about the work experience requirement. Bottomline, the requirement is non-negotiable, you either have the required work experience or you're not eligible.

I've reproduced the requirements for your reference:

CA DESIGNATED REPRESENTATIVE CERTIFICATION REQUIREMENTS


An individual applying to become a designated representative shall meet the following requirements:
- Be a high school graduate or possess a general education development equivalent
- Have a minimum of one year of paid work experience related to the distribution or dispensing of dangerous drugs or dangerous devices or meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board, and
- 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.

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Friday, May 7, 2010

FDA Orders Recall and Destruction of Baxter Colleague Infusion Pumps

Updated August 25, 2016:

You might also be interested in this FDA communication:
Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences: FDA Safety Communication

- -  original post follows below  - -

Uh-oh. The FDA believes there may be as many as 200,000 of these pumps currently in use. And they want them recalled and destroyed, as announced in FDA Issues Statement on Baxter’s Recall of Colleague Infusion Pumps.

The FDA has been working with Baxter since 1999 to correct numerous device flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues. In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Since then, Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect leading to the permanent injunction.

If you have questions about what this might mean for you, then read this, FDA - Questions and Answers About the Baxter Colleague Recall, Refund, and Replacement Action.

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Tuesday, May 4, 2010

FDA Wants Infusion Pump Risk Reduction

The U.S. Food and Drug Administration (FDA) announced a new initiative to address safety problems associated with external infusion pumps, which are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner.

As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance today of a new draft guidance and letter to infusion pump manufacturers. FDA is also announcing a May public workshop on infusion pump design, and launching a new Web page devoted to infusion pump safety, FDA - Infusion Pumps.

Although this is directed toward manufacturers, it's probably a good idea for everybody using pumps to follow what emerges from this initiative.

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Saturday, May 1, 2010

FDA Urges Companies To Prevent Cargo Thefts

According to this blog post, the FDA wants companies to review their security practices to prevent "cargo theft" from warehouses and tractor trailers, FDA Wants Companies To Prevent Cargo Theft.

This should be of some interest to wholesalers handling a variety of FDA-regulated products such as prescription or over-the-counter medicines, medical devices, or infant formula.

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