Two New Boosts for Patients' Safety

One development is FDA's proposed rule for most medical devices distributed in the United States to be labeled with a unique device identifier. The other is a new Hand-off Communications Targeted Solutions Tool™.

Two work products released in the past 10 days are meant to increase the safety of patients in health care settings and to address significant risk sources. The Food and Drug Administration proposed a rule on July 3 to have most medical devices distributed in the United States carry a unique device identifier, or UDI, fulfilling a law Congress passed in 2007. On June 27, the Joint Commission Center for Transforming Healthcare released the Hand-off Communications Targeted Solutions Tool™ to help with the process of passing information about patients from one caregiver to the next or one team of caregivers to another.

Described as an application that uses a step-by-step process to measure an organization's performance and direct it to proven solutions, the tool combined with solutions from the center's Hand-off Communications Project has helped health care organizations reduce readmissions by 50 percent and the time needed to move a patient from the emergency department to an inpatient unit by 33 percent.

Hand-off solutions from the center are described using the acronym SHARE, and they address specific causes of unsuccessful hand-offs. SHARE refers to:

  • Standardize critical content, including providing details of the patient's history to the receiver, emphasizing key information about the patient when speaking with the receiver, and synthesizing patient information from separate sources before passing it on to the receiver.
  • Hardwire within your system, which includes developing standardized forms, tools, and methods.
  • Allow opportunity to ask questions, which includes using critical thinking skills when discussing a patient's case as well as sharing and receiving information as an interdisciplinary team (e.g., a pit crew).
  • Reinforce quality and measurement, which includes demonstrating leadership commitment to successful hand-offs.
  • Educate and coach, such as by teaching staff what constitutes a successful hand-off, standardizing training on how to conduct a hand-off, providing real-time performance feedback to staff, and making successful hand-offs an organizational priority.

The UDI system envisioned by FDA will assist the agency in identifying product problems faster and targeting recalls precisely. The UDI is a unique code that includes a device identifier and a production identifier (such as the lot or batch number, the serial number, and/or expiration date). FDA conducted four pilot studies during the development of the proposed rule and will accept comments on it for 120 days.

"The safety of medical devices is a top priority for the FDA, Congress, industry, and patients," said FDA Commissioner Dr. Margaret Hamburg, MD. "The unique identification system will enhance the flow of information about medical devices, especially adverse events, and as a result will advance our ability to improve patient safety."

For more information, contact Jay Crowley at FDA's Center for Devices and Radiological Health, phone 301-796-5995, email Jay.Crowley@fda.hhs.gov.

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