A Growing Patient Safety Concern: Improperly Sterilized or High-Level Disinfected Equipment | Joint Commission
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A Growing Patient Safety Concern: Improperly Sterilized or High-Level Disinfected Equipment


May 25, 2017 | 2885 Views

By Lisa Waldowski, DNP, PNP, CIC
Infection Control Specialist
Standards Interpretation Group
The Joint Commission

“Improperly sterilized surgical instruments harming U.S. patients,” “Patient sues hospital for improper sterilization of equipment,” and “Improper disinfection procedures expose patients to infection,” are just a few headlines in recent news. 

Immediate threat to life (ITL) declarations related to improperly sterilized or high-level disinfected (HLD) equipment have increased significantly from 2013-2016. In 2016, 74 percent of all ITL declarations from The Joint Commission were related to improperly sterilized or HLD equipment.

As reports of sterilization and HLD-related issues continue to be received by our Office of Quality and Patient Safety, our surveyors also are seeing it firsthand in hospitals, ambulatory care sites and other health care settings across the country.  

In response to this growing patient safety concern, The Joint Commission issued a Quick Safety this week titled “Improperly sterilized or HLD equipment – a growing problem.” This Quick Safety is an update to one issued in 2014 as sterilization and HLD-related issues have worsened over the past three years. The update provides new details and specifics on how health care organizations can improve compliance with related standards and requirements.

Growing Noncompliance
Health care organizations are struggling with standard IC.02.02.01, Element of Performance (EP) 2, which requires organizations to reduce the risk of infections associated with medical equipment, devices and supplies. EP2 is specific to HLD and sterilization, and is applicable to Joint Commission-accredited hospitals, critical access hospitals, ambulatory and office-based surgery facilities.

Noncompliance with IC.02.02.01, EP 2 has steadily escalated over the years, particularly in ambulatory and office-based surgery facilities, as well as in decentralized locations in hospitals.

Patient Safety Risks
Consequences of failed sterilization processes can result in serious outcomes, including:

  • risk for contamination
  • potential outbreaks, such as HIV, hepatitis B and C, and bacterial infections
  • potential loss of Joint Commission accreditation
  • potential loss of deeming status from the Centers for Medicare & Medicaid Services (CMS)
  • negative publicity, with potential consequent revenue losses
  • litigation

Common Path to Outbreaks
As an infection control specialist, I often discover that these serious outcomes result from a long-standing issue and that the true scope of the problem is not known until there is an outbreak. Many noncomplying organizations report:

  • mistaken belief that the risk of passing bloodborne pathogens or bacterial infections to patients is low or nonexistent
  • lack of staff knowledge or training to properly sterilize or HLD equipment
  • lack of safety culture that supports the reporting of safety risks
  • no dedicated staff person to oversee proper sterilization or HLD of equipment

I encourage you to read the full Quick Safety for safety actions to consider, as well as examples of locations where sterilization and HLD processes are conducted.

Health care organizations need to prioritize improving sterilization and HLD efforts year-round and well before a survey occurs to best protect patients. Together, we can work to change news headlines from reporting on sterilization or HLD-related outbreaks to touting reductions in outbreaks through quality improvement efforts.

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