TJC Warns Immediate Threats to Safety ‘Spiking’ Over Single-Use Devices

By A.J. Plunkett

Check your emergency rooms, outpatient clinics, wound care clinics, ambulatory care sites and anywhere else where pandemic-related equipment shortages have forced your facility to go outside normal supply lines for replacement medical devices.

You could be saving yourself an immediate threat to health and safety (ITHS) citing by The Joint Commission (TJC), which could then threaten your accreditation and ability to offer services.

TJC has seen an “exponential spike” in ITHS cites in the past four weeks in which hospitals were found to be reprocessing single-use devices or not cleaning them according to manufacturer’s instructions for use (IFU) because they were unfamiliar with those instruments, said Robert Campbell, PharmD, BSCSP, director of the Standards Interpretation Group and Medication Management at TJC.

Instead of just the occasional ITHS investigation, TJC has called at least three or four threats a week, said Campbell during a presentation Wednesday as part of the virtual Executive Briefings for 2021.

Both medical and sterile processing staff need to be aware of whether those new devices are single-use or if the manufacturer’s instruction for use are different from the devices normally used, Campbell warned.

Work with your compliance managers, infection prevention and control, purchasing department as well as the central processing department where devices are disinfected and sterilized to identify new devices and ensure that the single-use devices are not reused. Staff also needs to be educated on the problem.

Reuse either on purpose or by accident is citation waiting to happen, said Campbell.

And anyone in charge of disinfection or sterilization also needs to check the manufacturer’s IFU on new devices because the chemicals, the time of cleaning or any other part of the process may be different from the devices they are used to handling, he said.

ITHS citations could result in your facility losing accreditation, which means the hospital will not be able to bill Medicare for procedures done during that time.

For more on this year’s Executive Briefings, the first since the pandemic was declared in the spring of 2020, see future articles on the Accreditation & Quality Care Center and in Inside Accreditation & Quality.

A.J. Plunkett is editor of Inside Accreditation & Quality, a Simplify Compliance publication.