Improper sterilization and high-level disinfection of equipment challenges organizations

Improper sterilization and inadequate high-level disinfection (HLD) of medical equipment can have devastating effects on patients. Nevertheless, substandard sterilization and disinfection are relatively common findings in on-site surveys at health care institutions seeking accreditation from The Joint Commission. This problem strikes at the core of surgery, and a surgeon’s leadership on this issue can play a large role in enhancing an organization’s processes for sterilization and HLD of equipment.

In on-site surveys conducted in 2016, The Joint Commission reported at least one instance of noncompliance with Infection Prevention and Control (IC) Standard IC.02.02.01, Element of Performance (EP) 2. The rates of noncompliance in the following health care settings were as follows:*

  • Hospitals: 51 percent
  • Critical access hospitals: 58 percent
  • Ambulatory care: 43 percent
  • Office-based surgery: 53 percent

Responding to increased noncompliance

IC Standard IC.02.02.01, EP 2 states, “The practice implements infection prevention and control activities when doing the following: Performing intermediate and high-level disinfection and sterilization of medical equipment, devices, and supplies. It is important to note that sterilization is used for items such as implants and surgical instruments. High-level disinfection may also be used if sterilization is not possible, as is the case with flexible endoscopes.”*

The Joint Commission has been focusing ongoing efforts on educating surveyors on the challenges of sterilization and HLD of equipment, which has resulted in a keen eye on surveying the areas where this equipment is stored and used. As a result, The Joint Commission surveyors are now better able to identify the problem and can provide on-site education to staff so they can better address HLD and sterilization issues.

To further help organizations with compliance and to raise awareness of this critical patient safety issue, in May, The Joint Commission published Quick Safety, Issue 33: “Improperly sterilized or HLD equipment—a growing problem.” This report asserts that the most vulnerable locations for lapses in sterilization or HLD of equipment are ambulatory care sites, including office-based surgery facilities, and decentralized locations in hospitals.

Causes and effects

Many factors contribute to noncompliance. The Joint Commission’s Office of Quality and Patient Safety listed some of those reasons, such as the following:

  • Lack of knowledge or training in proper sterilization techniques, lack of HLD equipment, or lack of access to evidence-based guidelines
  • No oversight by leadership
  • Low priority assigned to sterilization or HLD of equipment
  • Lack of a culture of safety that supports the reporting of safety risks

The consequences of failed processes include the following:

  • Patients placed at risk for contamination
  • Potential outbreaks of infections
  • Potential loss of Joint Commission accreditation
  • Potential loss of Centers for Medicare & Medicaid Services (CMS) deeming status
  • Bad publicity, lost business, and a damaged reputation
  • Litigation

ITL declarations

From 2013 to 2016, The Joint Commission found immediate threat to life (ITL) declarations directly related to improperly sterilized or HLD equipment increased significantly. An ITL is defined as “a threat that represents immediate risk and has or may potentially have serious adverse effects on the health or safety of the patient, resident, or individual served. These threats are identified on site by the surveyor.”

ITL declarations can result in an expedited Preliminary Denial of Accreditation (PDA) decision based on the threat. After notice of the PDA decision, the organization has up to 72 hours to either eliminate the situation entirely, or, if more time is required to solve the problem (such as purchasing and installing a piece of equipment or a device), then the organization must implement emergency interventions to abate the risk to patients; for example, stop performing a certain procedure or implement additional safety measures, within 72 hours. If the situation is not fully resolved within 72 hours, the institution will have a maximum of 23 calendar days to do so. When the situation is fully resolved, the institution’s accreditation status may change from PDA to a time-limited PDA and accreditation with follow-up survey. This restriction will remain in place until an accreditation follow-up survey is conducted to assess the organization’s sustained implementation of corrective actions.

In 2016, 74 percent of all ITLs were related to improperly sterilized or HLD equipment. These lapses can lead to outbreaks of HIV, hepatitis B and C, and transmission of bacterial-infecting agents.


The Joint Commission recommends several actions to improve HLD and sterilization processes. They include the following:

  • Use and follow up-to-date, nationally recognized evidence-based guidelines
  • Verify that the manufacturer’s instructions are easily available to staff and are followed for all equipment, devices, and supplies requiring sterilization or HLD
  • Follow organizational policies and procedures for sterilization and HLD
  • Ensure frontline staff competence, training, and support in sterilization and HLD processes, from point-of-use to storage

The Joint Commission also has the following  recommendations for leadership:

  • Support the length of time needed to conduct the reprocessing steps (in other words, do not rush frontline staff, which could lead to missed or omitted steps)
  • Identify and review causes of instruments received with dried blood/bone/debris at point-of-use (for example, equipment sent back for reprocessing and not to be used on a patient)

The Quick Safety article also features a checklist for leadership to follow to address sterilization and HLD.

Surgical leaders play an important role in eliminating this problem and helping to protect patients, by hiring, supervising, training, and developing staff who are attentive to the details of sterilization and HLD of equipment.


The thoughts and opinions expressed in this column are solely those of Dr. Pellegrini and do not necessarily reflect those of The Joint Commission or the American College of Surgeons.

*The Joint Commission on Accreditation of Healthcare Organizations. Comprehensive Accreditation Manual for Hospitals. Infection Prevention and Control chapter. Oakbrook Terrace, IL. 2017 update. (Manual and corresponding updates are subscription-based.)

The Joint Commission. Improperly sterilized or HLD equipment—A growing problem. Quick Safety, Issue 33. May 22, 2017. Available at: Accessed July 6, 2017.

The Joint Commission on Accreditation of Healthcare Organizations. Comprehensive Accreditation Manual for Hospitals. Glossary. Oakbrook Terrace, IL. 2017 update. (Manual and corresponding updates are subscription-based.)


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