Disinfection and Sterilization of Ratcheted Instruments

Every Ambulatory Surgical Center (ASC) is required to have an active facility-wide infection prevention and control program. The program is intended to promote the surveillance, prevention, and control of healthcare-associated infections and other infectious diseases. If an organization is found to have egregious infection control issues – those that may cause or are likely to cause serious injury, harm, impairment, or death, and that threaten the health and safety of patients − then an immediate jeopardy citation may be issued for the failure to protect patients from harm.

Sterilization and disinfection of surgical instruments is one of many key areas to focus on to help protect patients from transmission of infectious pathogens. Hinged, ratcheted instruments pose a special concern because of the potential for pathogens to exist within the teeth of the instrument and transmit infection to a subsequent patient.

At the time of survey, Surveyors will inspect surgical instruments in peel packs and surgical instrument trays to verify proper sterilization. Ratcheted instruments such as hemostats, clamps, and scissors observed in the closed position indicate improper sterilization procedures and will result in a deficiency that also may include immediate jeopardy.

Other issues that result in deficiencies are inadequate staff training and competency and lack of adequate oversight by the infection prevention and control professional.

Relevant Standards

Below is a summary of relevant standards from the 2020 Accreditation Requirements for Ambulatory Surgery Centers.

Standard 12.00.03 – Infection Control Program

The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines.

Healthcare-associated infection (HAI) risk mitigation measures: Surgery-related mitigation measures include addressing aseptic technique practices used in surgery, including sterilization or high-level disinfection of instruments, as appropriate.

Standard 12.01.01 – Decontamination and Sterilization: Policies

The ASC has policies and procedures approved by the medical staff that address the following practices, as appropriate:

1. Decontamination and cleaning of surgical instruments.
2. Preparing, assembling, wrapping, and distributing of sterile equipment and supplies.

Standard 12.01.02 – Decontamination and Cleaning of Surgical Instruments

The ASC must be in compliance with its policies related to collecting, receiving, decontaminating, and cleaning surgical instruments. The ASC must train staff to ensure competence with the cleaning and decontamination of surgical instruments. Required elements include instruments with ratchets in the open position in preparation for sterilization.

Standard 12.01.10 – Compliance with Cleaning and Sterilization of Surgical Instruments and Scopes

The ASC has policies and procedures approved by the medical staff that address the cleaning of surgical instruments and scopes. The ASC must be in compliance with its cleaning, sterilization, and storage policies. And the ASC must ensure that staff are competent with performing cleaning and sterilization procedures.

Tips for Compliance

To maintain compliance, policies and procedures must be developed and based on nationally recognized guidelines. The policies and procedures must be approved by the infection control committee.

• Education, training, and competency evaluation must be provided upon hire and regularly thereafter for the individuals who are sterilizing equipment. Providing education to the staff using the equipment is highly recommended.
• Instruments should not be used if they are found closed when peel packs or surgical instrument packs are opened. The instruments must go through the entire sterilization process again.
• A monitoring program should be in place to audit sterilized instruments to ensure compliance with the defined sterilization process.

Resource

The CDC provides detailed information specific to instrument processing in Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. The guide covers the principles of cleaning for sterile processing, and additional details are found on page 37 in the Cleaning section.

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Meeting the Challenge

This year's HFAP Quality Review, Meeting the Challenge, examines the most frequent deficiencies cited in 2020 across hospital, clinical laboratory, and ambulatory surgery center surveys. 

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