FDA Finalizes UDI System

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The U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) to give an exclusive identifier for all medical devices. They are now requesting comments from the clinical community. 

Why is this important to value analysis practitioners? First, it will help you with your product recalls since you will have a unique number to search for in your databases. Second, it will help you in the classification of your products in your MMIS and EMR system, since the FDA will provide you with a naming scheme and unique product numbers to catalog your products and then charge for them.

In addition, the FDA has mandated that manufacturers must show their lot or batch numbers, expiration date, and manufacturing date on their labels.  

Manufactures of Class III or high-risk medical devices are required to comply within one year.  Class II or moderate-risk device manufacturers must comply within three years, and Class I or low-risk medical device manufacturers, if covered under this regulation, will have five years to comply.

Cerner, Epic Dominate EMR healthcare market  

Chances are that if you work at a 200-bed hospital or larger, your hospital’s new EMR system is either Cerner or Epic, since they have captured three-fourths of the large hospital EMR contracts as reported by KLAS research.

If you are interested in how our industry is struggling with this issue (i.e., new EMR system) you can read the full report at Klasresearch.com/klasreports/#krms/48/0.

What Do Medical Students Think About Their Future in Healthcare?

A new report conducted by Epocrates which surveyed 1,000 medical students in 50 states finds that:

  • The Affordable Care Act will result in them practicing more preventative care, offering expanded patient coverage, but they will spend less time with their patients and lose clinical autonomy.
  • 76% felt uninformed about the Act.
  • 28% felt informed or somewhat informed about the Act.
  • Only 17% plan to go into solo or partnerships after their internships.
  • 37% expressed dissatisfaction with the practice management training they received in medical school.

If you would like to read more about the survey it can be found here Epocrates Study Results.

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