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Is That Instrument Safe to Use on a Patient?

08/30/2022

By Sylvia Garcia-Houchins, RN, MBA, CIC, Director, Infection Prevention and Control, Office of Quality and Patient Safety, The Joint Commission

Editor’s Note: Some of this information has been previously published in OR Today.

Cleaning instruments for ambulatory surgery centers (ASCs) is a daily, routine procedure for staff. Sterile processing and perioperative staff work together to ensure instruments used during surgical procedures are clean, sterile and safe for use. Most surgical staff would agree that “if it isn’t clean, it certainly isn’t sterile.”1 

If tissue, bone or other soil is left behind on a surgical instrument, this unsterile condition obviously could carry risk of infection to the next patient, and it should not be reused. Yet, Joint Commission surveyors have noted that staff do not seem as concerned about using surgical instruments that contain pitting, etching, corrosion, oxidation, cracks, damaged insulation and/or connectors, and even those with pieces of the instrument missing. Some staff even continue to use instruments with flaking or sticky instrument tape.

Identifying, Tracking and Trending Soiled Instruments
Identifying unsafe conditions should involve all staff, including those in sterile processing and other areas that use instruments. At most healthcare organizations, identification of an instrument with bioburden leads to an “incident report” and an investigation into error with the current process. Others track a soiled instrument directly to an individual employee and subsequently use it as an opportunity to review normal practices and provide constructive feedback. Additionally, some healthcare organizations collect data and trend the number of soiled instruments found as a quality indicator. Trending totals may be used as an opportunity to ensure all users report instruments with bioburden and follow manufacturer instructions for use for reprocessing instruments.  

Joint Commission surveys routinely identify breaks in processes that may increase the likelihood of ineffective instrument cleaning. Observing the following helps ensure proper instrument cleaning occurs:

  • Are manufacturer instructions for use available to staff performing reprocessing and has staff been trained on these instructions?
  • Are users removing soil and keeping instruments moist as indicated in each instruments’ instructions for use?
  • Is terminal cleaning completed as soon as possible after use? Or, are instruments sitting for extended periods before being cleaned?
  • Are cleaning chemicals being diluted appropriately? Are cleaning solutions maintained at the correct temperature?
  • Is the instrument inspection process before packaging occurring in a well-lit location with magnification?
Other areas of concern are damaged instruments and improperly applied instrument tape. Damaged instruments may not function properly. Impact of instrument damage on the provision of safe care needs to be assessed and often results in the decision to completely remove an instrument from service until it can be repaired. Instruments with identification tape that is peeling, cracked or has evidence of corrosion could potentially flake particles into an open wound during surgery and result in a foreign body being left in the wound. Such instruments should be taken out of service, and if necessary, replaced. Staff should work together to ensure potentially unsafe instruments (such as those with bioburden or physical compromise) do not enter the sterile field.

Reprocessing Single-use Devices (SUDs)
In addition to instruments in disrepair making their way to the sterile field, Joint Commission surveyors have unfortunately noted with increasing frequency, the reprocessing of single-use devices (SUDs) – items labeled by their manufacturer as “single use” or disposable. These devices often consist of lower-quality material and as a result, develop pitting and oxidation which indicates a possible hazard. 

Reprocessors are regulated by the Food and Drug Administration (FDA) and are subject to all regulatory requirements currently applicable to the original device manufacturer, including premarket submission requirements. If a healthcare organization reprocesses an SUD, it is dangerously allowing itself to become a manufacturer of a medical device – and thus assumes all of the manufacturer’s liability, should that device fail. In addition, it takes on the liability of possible FDA rule violation. SUDs must be removed from trays and discarded or sent to an FDA-approved reprocessor of SUDs.

Key Actions for Instrument Safety
Sterile processing and perioperative staff should follow these key actions to ensure their instruments are appropriate for use on patients:

  • Review the manufacturer’s validated reprocessing instructions before reprocessing any device. Ensure that following the instructions will meet the level of reprocessing based on use of the item and that appropriate equipment and products are available to assist staff in following the instructions.
  • Correctly dismantle and inspect instruments for soil or damage. Staff should request, and leaders should provide, necessary lighting and tools such as lighted magnifiers to ensure ample vision while inspecting instruments in sterile processing areas.
  • Establish effective maintenance and refurbishment processes to keep instruments in optimal condition.
  • Feel empowered to identify instruments of subpar quality and prevent their use – even if it causes delaying or rescheduling affected cases.  
  • Receive clear training and direction on when to remove an instrument or seek guidance from a supervisor while identifying an item that is no longer safe to undergo reprocessing.
  • Ensure staff at point-of-use can identify when an instrument should not be used – even if it is in sterile packaging – and know how to return and report the occurrence for quality monitoring.
  • Train users to appropriately discard SUDs and support the process by providing disposal containers at point-of-use for safe disposal.
  • Train users on key issues that can lead to damage of instruments and devices, including erroneously using delicate instruments meant for use on tissues or on other items (e.g., gauze, tape, tubing, etc.); prolonged exposure to blood and other body fluids or allowing these substances to dry on instruments; use of saline or corrosives such as bleach or inappropriate cleaning chemicals; use of abrasives; or transporting instruments incorrectly causing risk of damage.
  • Create an effective process for identifying instruments that require repair or replacement, including in areas where they are used since sometimes instruments are damaged during use.  
  • When tracing sterilization practices, periodically open and inspect instruments in peel pouches and trays to ensure they are appropriate for sterilization and use.
  • Create a “good catch” reporting process that rewards identification of instruments that should not be reprocessed or used so tracking and trending is accurate for budgeting and quality purposes. 

It is imperative ASC leaders and staff work together to prevent use of soiled, damaged or inappropriately reused instruments. Protecting patients from harm related to medical devices should be top priority for healthcare providers. All staff involved in reprocessing and use of instruments during healthcare procedures must take personal responsibility for both providing and using safe instruments and preventing use of unsafe instruments. Healthcare staff must be empowered to immediately stop progress and ask, “Is this instrument safe to use on a patient?” 

1ECRI If It’s Not Clean, It’s Not Sterile: Reprocessing Contaminated Instruments. Event Reporting & Analysis – Alerts. Published 4/11/2017. Accessed November 21, 2021 at https://www.ecri.org/components/PSOCore/Pages/e-lert041117.aspx.

Sylvia Garcia-Houchins is the Director of Infection Prevention and Control in the Division of Healthcare Improvement at The Joint Commission. Garcia-Houchins has over 30 years of experience in infection control in both hospital and long-term care settings, as well as eight years of clinical microbiology experience. Most recently, she served as the Director of Infection Control at the University of Chicago Medicine and was also an intermittent consultant for Joint Commission Resources, Inc.