Japan Health System Improves Patient Safety with Adoption of NRFit™ Neuraxial Connectors, GEDSA Announces

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Devices Meet Global ISO Standard That Sets a New Level for Protecting Patients

NRFit offers a safer connector for healthcare providers

Around the world, hospitals are doing the right thing by adopting connectors made to a unified global standard. One near miss, patient injury or death is one too many.

All hospitals across Japan have completed adoption of ISO-compliant NRFit™ neuraxial connectors designed to improve patient safety by reducing the risk of medical device misconnections, the Global Enteral Device Supplier Association (GEDSA) announced today. NRFit replaces legacy connectors that are prone to wrong-route delivery of medication, which can result in patient injury or death.

To address patient safety concerns, the ISO standard used in NRFit (80369-6) was developed by international clinical, technical and regulatory experts in partnership with global manufacturers, suppliers and distributors. All medical devices that connect to the neuraxial route will eventually use the ISO 80369-6 design, including spinal needles, syringes and syringe caps, monometers and others.

“Around the world, hospitals are doing the right thing for patients by adopting connectors made to a unified global standard,” said Michael Cusack, Executive Director of GEDSA. “One near miss, patient injury or death is one too many.” GEDSA is a nonprofit organization formed to help introduce the new standards and help guide the transition to safer connectors for healthcare providers and their partners.

Under the guidance of the Japan Ministry of Health, Labor and Welfare, NRFit is now used in more than 8,000 hospitals and more than 100,000 outpatient clinics across the country.

“Strong collaboration among hospitals and distributors was key to a smooth launch across thousands of care facilities,” said Yoshihisa Kato, medical marketing director in Japan for Smiths Medical. “We also conducted intensive outreach and education for clinicians to ensure they understood the importance of the change and how implement the transition.”

Next Step: Safer Enteral Feeding Connectors
Japan is now moving forward with adoption of ENFit® enteral feeding devices made to the same rigorous global ISO standards. Like NRFit, ENFit replaces legacy devices that are prone to misconnections. For instance, medication meant for a feeding tube can be accidentally sent into an IV instead, with potentially tragic results.

While global NRFit adoption is in its early stages, hospitals throughout Europe have successfully adopted ENFit- branded ISO 80369-3 compliant devices over the past two years. ENFit adoption is nearing completion in Australia and New Zealand with China and Brazil ready to adopt in 2021. In the United States, leaders in patient-centric care are now using ENFit, including the Mayo Clinic, Sharp Memorial, Banner Healthcare and Kaiser Permanente. Nearly half of top 25 hospitals in the US News & World Report rankings have adopted ENFit, according to feedback collected by GEDSA through its membership.

“NRFit and ENFit are the first steps for hospitals in a longer-term process of implementing a comprehensive system of ISO-compliant connectors across care settings,” Cusack said. “By setting a single global standard, we can reduce complexity and risk to fully protect patients.”

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