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Experts Spotlight Inefficient Hospital Protocol for Medical Device Recalls

December 18, 2014  ·  By HM&M

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Patients rely on hospitals to ensure that safety protocols and education for medical staff are current and privy to any changes regarding medical device recalls. For over 45 years, ECRI has helped in this effort by focusing on improved patient care by studying the effectiveness of medical products, procedures, and processes. Based on an article published by Modern Healthcare, ECRI experts reveal certain hospitals are failing to update their medical device recall programs to meet today’s standards.

Over 1,000 medical device recalls were reported by the Food and Drug Administration in 2012, a figure almost doubling the number reported nearly a decade previous. The number and complexity of recalls have increased over the years, which carries concerns regarding hospital efficiency in tracking its defective products.

A Medical Equipment Management Plan issued by the Joint Commission has issued standards for hospitals to:

  • Promote hospital safety and effective use of medical equipment used by medical staff and physicians;
  • Ensure that medical equipment meets the accepted standards for patient use; and
  • Ensure medical equipment maintains specifications to ensure safe operation and readiness for use.

In order for equipment to be deemed safe and readily available for use, manufacturers must properly label its devices and safety alerts and make any reports of malfunction known. Hospitals must then immediately mark any product updates or recalls in their systems. According to the Modern Healthcare article, manual tracking of every defective drug or device can take weeks or months to complete.

The FDA established a unique device identifier (UDI) to track the distribution and use of medical devices. Although new identification tools will help with the efficiency of current recall management programs in hospitals, they are still slowly being integrated into the healthcare system. In the meantime, hospitals may still have a lag in their protocols, which affects patient safety and leaves postmarket surveillance from being brought up-to-date.

It is your right as a patient to be informed of recalls or reports of medical device malfunctions. We are here to help clients who have been injured. If you have been harmed as a result of a defective medical product in Illinois, you should not have to go through it alone. Contact an experienced Chicago product liability attorney today. Call Hurley McKenna & Mertz, P.C. at 312-553-4900 for a free case consultation.”

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