Medical Practice Trends Podcast 20: Medical Device Regulations and EMR


MPT Podcast 20Medical Device Regulations and EMR, with guest Mike Meikle, Hawkthorne Group. 

This Issue (5:38):

  • What is the Medical Device Data System (MDDS) regulation?
  • How does this affect practices that use EMR?
  • Why your EMR vendor may not be giving you accurate information about MDDS
  • Does the MDDS rule have any “teeth”?

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Do EMRs Make Practicing Medicine Safer or More Dangerous?

Recently I wrote about a Harvard study that found evidence that physicians that use electronic medical records systems (EMRs) are less likely to be involved in a malpractice lawsuit. But regardless of whether your charts are better documented and therefore make you less of a target for a claim, does using EMR make you practice medicine better?

According to the Huffington Post Investigative Fund, there have been several cases of EMRs gone amok. In most cases there was no harm to patients. But they quote Dr. Jeffrey Shuren of the FDA as attributing six deaths and 200 injuries to poorly implemented CPOE (computerized physician order entry). Many critics of the government’s EMR implementation plan point to these cases as examples of not enough regulation and oversight.

On the other hand, the ONC (Office of the National Coordinator [for Health Information Technology]) spokesman says the they are working closely with a number of organizations including the FDA to improve safety. Critics say that the ONC has too friendly a relationship with the EMR industry, and feel that the FDA needs to be given more authority to collect and analyze errors caused by EMR systems.

Are EMRs Bad For Your Health?

In an article on the Huffington Post, the FDA is quoted as saying that errors attributed to the use of electronic medical record systems were responsible for dozens of injuries and six patient deaths. This, say critics of EMR, flies in the face of the assumption that adoption of EMR/EHR will improve patient safety and save lives. Some university studies have looked specifically at hospital-based systems and found that some of them had actually caused more adverse drug events than would have been expected, especially since these systems are supposed to have fail-safe mechanisms against just such occurrences.
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