Lean In: Clinical Challenges
The primary mission of a healthcare organization is to care for people. Patients undergoing procedures and surgeries in an operating room suite expect that the entire team will do whatever is necessary to provide excellent quality care and keep them from harm. Although the patients and families may not think specifically about the Sterile Processing Department (SPD) and its role in their care, they are dependent upon SPD to provide sterile, safe and functional instruments and supplies.
A well-functioning SPD is a key to achieving positive clinical outcomes. It is the management’s responsibility to provide the team with the resources it requires to do their jobs well. Each leader has their own perspectives, overviews, and concerns when it comes to the challenges that hinder the ability of the team to operate and sustain an outstanding Sterile Processing Department and culture.
Sterile Processing Leadership
Improper routine maintenance of instrumentation – It is difficult to maintain a ready inventory when there is improper maintenance of instrumentation. In addition to not providing a fully functional instrument to the operative field, a poorly maintained instrument is at risk of failure and/or breakage. No one wants an inferior clinical outcome or retained foreign body as a result of instrument failure or unavailability.
Inaccurate sterilization methods or records – When there is a concern regarding post-procedure infections or complications, it is critical to be able to trace a specific instrument and it’s handling back to a specific patient, time and date. The inability to trace an instrument’s life cycle is an obstruction to process improvement and increases patient risk. It is a patient safety issue.
Inability to locate recalled items – There is a regular and consistent stream of notices and recalls that impact SPD items. A patient safety risk is created without the ability to track these items and either remove them from inventory or mitigate the problem with the inventory item. The SPD staff should be able to easily locate every instrument or inventory item placed in their care. The patient should be able to trust that the recalls and regulatory requirements have been reviewed and that practices are up-to-date.
Inability to track instruments to a patient – The Perioperative Leadership is responsible for the entire patient experience. If there is a question about the role an instrument or inventory item played in a complication or inferior clinical outcome, then it is the leader’s responsibility to investigate the clinical episode to look for root causes and opportunities for improvement. Patients and families are typically focused not only on what happened to them but how the organization can guarantee them that it won’t happen to anyone else. If you can not track your inventory, it is difficult to offer this reassurance.
Improper maintenance of instrumentation – A well run, high capacity operating room typically has a strong instrument maintenance program. When instruments are not well maintained, or not available because last-minute maintenance must be done or can’t be done, it becomes much more difficult to be efficient. Inefficiencies in the OR translate into a decrease in available time to perform surgeries and certainly have a clinical impact on the patient population. SPD delays and inefficiencies increase patient anesthesia and infection risks, as well as potentially delaying urgent surgical cases from being scheduled in an expeditious manner.
Lack of appropriate pre-soaking procedure – The Perioperative Services Leadership has oversight for the entire OR process, including what happens at the surgical field. If the surgical assistants and technicians do not pre-soak or pre-clean the instruments appropriately and consistently prior to returning them to SPD, the risk of bioburden increases which potentially impacts the safety of the patient. Continuous education and training are requirements.
Healthcare Senior Leadership
Surgeon dissatisfaction with bioburden, defects, and inefficiencies – Surgeons determine where they feel the most comfortable operating based on clinical outcomes, nursing care, efficiencies, and customer service. If an operating room has SPD issues that may contribute to an increase in complications and infections, surgeons will not only complain but may find other hospitals in which to practice that may be more responsive to their clinical and operational concerns. In these competitive and transformational times, the surgeon’s patient safety concerns need to be addressed immediately and a viable, successful action plan put in place.
Surgical site infections – Inefficiencies and instrument processing failures in the operating room and sterile processing may increase the risk of surgical site infections. Your community counts on your organization to do everything possible to keep them safe and mitigate risk.
Non-compliance with recalls, IPAC requirements and regulatory requirements – It is the responsibility of all staff, at all levels, to manage the steady flow of regulatory information into the organization. Recalls, infection control requirements and regulatory requirements must be attended to and acted upon to protect patient safety. The consistent and universal way in which the organization processes incoming guidance and implements action plans protects patient safety and quality clinical outcomes. Increased infection risk based on deficiencies in both high and low-level disinfection of medical equipment is one of the Joint Commission’s top ten scored findings over the last couple of years.
Malpractice claims due to instrument failure and/or bioburden – The malpractice environment is complex enough without worrying about controllable and preventable factors in the operating room. There are no circumstances under which bioburden is acceptable on an instrument that is brought to the operating room table. A preventable instrument failure that contributes to an inferior clinical outcome is unacceptable. Pro-active improvement plans in the operating room and SPD decreases the organization’s legal vulnerability.
 See https://www.tso3.com/sterizone#resources
 See https://www.tso3.com/wp-content/uploads/2019/04/MK-0066_01_New-Standard-of-Care-for-Duo-Reprocess-Terminal-Sterilization….pdfCenters for Disease Control and Prevention. https://www.cdc.gov/infectioncontrol/
 See guidelines/disinfection/sterilization/other-methods.html#anchor_1554397475
 American Lung Association. https://www.lung.org/our-initiatives/healthy-air/outdoor/air-pollution/ozone.html#atrisk
 Evan Goulet, PhD, April 2015, Medical Device and Diagnostic Industry. See https://www.mddionline.com/why-manufacturers-should-consider-nitrogen-dioxide-sterilization
 PLoS One. 2015 Jun 22. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4476675/
 New Jersey Department of Health. See https://nj.gov/health/eoh/rtkweb/documents/fs/1376.pdf
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