Reducing Medical Errors

May 21, 2013

Shawn Haggard with a scanner inside Mercy’s

Consolidated Services Center. Product barcode is

critical to the Unique Device Identifier (UDI)

system and tracking medical devices from

manufacturer to patient use.   

Mercy, along with Geisinger, Intermountain Healthcare, Kaiser Permanente and Mayo Clinic, are putting their heads together so patients with implanted devices – everything from heart stents to artificial knees, metal screws to metal plates – have less to worry about.

“Currently, the health care industry does not have a system in place to track medical devices worldwide,” said Robert Rea, M.D., specializing in cardiovascular diseases at Mayo Clinic. “That means whenever something goes wrong with a device, it’s difficult to target recalls and ensure patients with those devices get notified as soon as possible.”

The Healthcare Transformation Group (HTG), a collaboration between the five health care systems’ supply chain divisions, has created a Research & Development (R&D) team, made up of physicians and clinical researchers, to implement the U.S. Food and Drug Administration’s (FDA) Unique Device Identification (UDI), which provides a single, globally accepted way to positively identify medical devices.

“There are millions of people on the planet today with implanted devices,” said Joseph Drozda, Jr., MD, Mercy’s director of outcomes research and the newly named chair of HTG’s R&D Team. “While devices help extend and improve our quality of life, we must be able to quickly identify and correct problem devices. It’s paramount that we improve patient safety.”

If there’s any doubt that the need for better identification of implanted medical devices exists, consider the following:

  • In the U.S. alone, more than a half million people each year undergo knee replacements, knees being the most frequently replaced joint in the body. All in all, more than 90 percent of total knee replacements result in little or no pain and increased mobility.
  • In 2010, one of the leading artificial hip companies recalled 93,000 artificial hips implanted worldwide. The recalled joints failed in one out of eight patients after only five years. The devices that failed, in addition to requiring a new hip replacement, left some patients with fragments that became focal points for infections, nerve and vessel damage, and led to some deaths.
  • Some other widely implanted devices include heart stents, artificial eye lenses for cataracts and metal screws, pins, plates and rods for bone fractures – one of the most common injuries across all ages.
  • More than 2.5 million people in the U.S. each year have cataract surgery and more than a half million have heart stent implants. While stents have saved many a life, lifesavers can come with complications, including clots and blood-vessel blockage.

    With a UDI label, all of these implanted devices would include information about the product name, its expiration date, reference and lot numbers, manufacturer information, bar code, details and an illustration of the item. Ultimately, a UDI helps improve patient safety, identify product problems more quickly and better target recalls.

    “We will be able to identify where a medical device is, from distribution to use in a patient and track it for its lifespan, which will in addition provide valuable data,” said J. Brent Muhlestein, specializing in cardiology at Intermountain Healthcare. “This will be a system recognized around the world, providing greater safety and reducing medical errors.”

    The HTG R&D team is made up of the following representatives:
  • Joseph Drozda, Jr., MD, Director of Outcomes Research, Mercy
  • Jove Graham, PhD, Director of Clinical Research Project Development, Geisinger Center for Health Research, Geisinger Heath System
  • J. Brent Muhlestein, MD, Cardiology, Intermountain Healthcare
  • Liz Paxton, MA, Director of Surgical Outcomes, Kaiser Permanente
  • Robert F. Rea, MD, Cardiovascular Diseases, Mayo Clinic  

    Mercy is the sixth largest Catholic health care system in the U.S. and serves more than 3 million people annually. Mercy includes 32 hospitals, 300 outpatient facilities, 39,000 co-workers and 1,900 integrated physicians in Arkansas, Kansas, Missouri and Oklahoma. Mercy also has outreach ministries in Louisiana, Mississippi and Texas.

    Healthcare Transformation Group (HTG) In 2010, five healthcare systems – Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic and Mercy – formed an action-oriented collaboration to share best practices and drive needed positive change across the health care supply chain. The first focused initiative being addressed is the implementation of GS1® Standards. The collaboration, HTG, evolved as an extension of each member’s involvement in health care’s movement toward standards adoption. HTG members share this common foundation: accelerate change across the supply chain, enhance patient safety, improve supply chain efficiencies, drive the adoption of GS1 Standards with suppliers and communicate in the marketplace through one voice.

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