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."

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.

RLDatix’s safety and risk management software, meanwhile, allows organizations to capture information about adverse events, including whether a medical device was involved. This provides them with the opportunity to proactively address medical device errors by working with RLDatix to identify correlations between IFUs and safety events, thus increasing the likelihood that they will learn from these events and prevent their recurrence in the future.

The combination of both companies is expected to help healthcare delivery organizations use data-driven insights to help prevent safety events from occurring. It is also expected to further catalyze Applied Safety Intelligence and move RLDatix away from reactive management to proactive prevention, while strengthening its enterprise compliance capabilities to allow customers to more effectively align with the Joint Commission and other global accreditors.

"Compliance is a global issue, and with our footprint of 3,500 customers in 19 countries, RLDatix can deploy oneSOURCE’s offerings to healthcare organizations around the world," said Agrawal. "This acquisition also allows RLDatix to bring more comprehensive product offerings to facilities outside of acute care, including senior living and long-term care. COVID-19, meanwhile, has only heightened the need for access to up-to-date IFUs."

No financial details of the acquisition were disclosed.