Wednesday, March 6, 2013

Frequent errors to consider with drug device combinations

The focus of many of today's drugs are how users are suppose to use them.  Many times the drug/device combination comes into play.  Devices include prefilled syringes, pen injectors and aerosol delivery and the safety of the user depends heavily on their knowledge of how to use the product.  I recently came across an explanation of the draft guidance from Molly Follette Story, PhD.

In this presentation, she takes  a lot of time looking at the frequent combination product errors:

Dosing Devices:
  • • Inappropriate device forthe drug product
  • • Use errors due to unit of measure confusion
Pen injectors and autoinjectors:
  • • Inadequate product differentiation
  • • Unusual or unexpected device operation
  • • Confusing or complex device controls
  • • Electronic display legibility or message clarity
  • • Userinjury due to lack of protection againstincorrect use
Transdermal Patch Products:
  • • Where to apply?
  • • How many patchesto apply?
  • • How to apply?
  • • How long to wear?
  • • Whatto do during activities of daily living: showering,swimming, exercise?
  • • Whatto do if patch falls off?
  • • How to remove?
  • • Howand where to dispose?
This May 14-15, 2013 in Bethesda, Maryland, we'll be hosting the Human Factors for Drug-Device Combination Products.  We'll be looking at many of these factors, including receiving an look inside the FDA from QuynhNhu Nguyen, Lieutenant, U.S. Public Health Service, Biomedical Engineer/ Combination Products Human Factors Specialist, Center for Devices and Radiological Health, US FDA when he presents USA Regulatory Expectations for the Application of Human Factors Engineering for the Development of Drug Delivery Combination Products.  For more information on this session and the rest of the agenda, download the brochure.  If you'd like to join us, as a reader of this blog, when you register to join us and mention code HF2013JP, you'll save 20% off the standard rate!

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