by John R. Fischer
, Senior Reporter | September 16, 2020
Patient safety manufacturer RLDatix has acquired oneSOURCE, a medical equipment SaaS database that provides online access to continuously-updated instructions for use (IFU) and preventive maintenance documentation.
The deal is expected to enhance RLDatix Applied Safety Intelligence framework by helping healthcare delivery organizations abide by global accreditation standards and ensure safe and effective use of medical equipment.
"There is an abundance of research showing that medical device-related safety incidents are far more nuanced than a simple failure of equipment," Sachin Agrawal, president of data, strategy and corporate development at RLDatix, told HCB News. "The contextual use of a particular device as it relates to staffing, workflow, other devices and policies is critical when determining what truly led to a safety event or near miss. By bringing RLDatix’s core incident reporting, investigation and policy management expertise together with the resources made available by oneSOURCE, we will help our clients connect historically disparate dots and drive efficient system improvement."
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Responding to and learning from device problems is one of the top 10 patient safety concerns of 2020, according to ECRI Institute, which found lack of access to current manufacturer IFUs to be a main problem among sterile processing departments responsible for cleaning and disinfecting instruments and equipment. This leads to unsafe sterilization and increases surgical site infections, which have a 3% mortality rate and an associated annual cost of $3.3 billion, according to the CDC.
Hospitals face a number of challenges that prevent them from accessing up-to-date manufacturer IFUs. Medical device sales representatives, for instance, may deliver loaner trays without IFU documents needed for proper cleaning, decontamination and sterilization of instruments and implants. Critical time constraints on sterile processing departments and keeping track of hospital instrument and equipment inventories of thousands of medical devices can also make it difficult to keep up with IFU updates.
oneSOURCE enables healthcare delivery organizations to access IFUs and other maintenance documents so they can be informed on the most up-to-date manufacturer information, including critical recalls. More than 80% of U.S. hospitals use them for surgical instruments and equipment, tissues and implants, dental, and facilities maintenance. A new user platform that provides access to more than 250,000 manufacturers’ IFUs and service manuals was released at the end of August.