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The Importance of Surgical Instrument Maintenance and Patient Safety, part 4

Last issue, we looked at instrument care during surgery, the care taken in the sterile processing department with a special focus on insulated laparoscopic instruments, and concluded with what can happen when an instrument fails during surgery and the resulting Medical Device Reporting (MDR) that follows. This issue we will discuss The Joint Commission’s Sentinel Event Policy and the importance of effective communication, documentation, and ongoing education.

In 1996, The Joint Commission adopted a formal Sentinel Event Policyto help hospitals that experience serious adverse eventsto improve safety and learn from sentinel events “…to protect the patient, improve systems, and prevent further harm.” The Joint Commission calls these events “sentinel” because they alert the need for an immediate investigation.1

In October 2013, The Joint Commission issued a Sentinel Event Alert:Preventing unintended retained foreign objects (URFOs). The Joint Commission stated:

“With retained sponges under better control, now we are seeing increased reports of retained small miscellaneous items, devices, and unretrieved device fragments. These include intact but separated parts of surgical items, some of which are not radiopaque, broken pieces of instruments, small microneedles, trocars, guidewires, and sheaths….Various types of providers now must develop standardized processes to account for all of the tools and parts of devices.”2

From 2005 through 2016, the summary data of sentinel events reviewed by The Joint Commission shows a total of 1,231 reported URFO events. Surgical instruments fall within this category. The Joint Commission stated, “The reporting of most sentinel events to The Joint Commission is voluntary and represents only a small proportion of actual events.” Therefore, it is important to note the URFO events that actually occur may be well above the reported 1,231 figure.3

What can lead to a sentinel event?
If the surgeon receives scissors with dull blades, it could affect tissue dissection, and dull scissors may inadvertently pull on the patient’s tissue and potentially cause tissue damage. If the surgeon is using a hemostat, which is used to stop bleeding, and the serrations are loose or missing or the tips do not approximate as intended, that hemostat is considered damaged and is not going to work as intended.

The same is said for insulated instruments. If laparoscopic or bipolar instruments have any breaks (visible or microscopic) on the insulation, the patient could potentially experience a burn. When there is a break in the insulation, an alternate current pathway can result in burns from patient contact with exposed metal. In addition, electrosurgical sparking may occur in a flammable gas environment within the operating room.

If an instrument or device comes back from a procedure and the sterile processing technician observes a missing part or component, we must communicate immediately with the surgical staff members who were involved in the procedure and retrace steps to attempt to locate the missing part or component. Is the missing part or component in the instrument tray, the cleaning sink, or the operating room trash receptacle? Could it be inside the patient? If that is a possibility, contact the surgeon and bring the patient back for an X-ray to confirm patient safety; otherwise, we should report it as an adverse event.

Communicate for greater understanding
Effective communication among perioperative team members is key. Creating hospital protocols, checklists, and guidelines to ensure a standardization of processes goes a long way toward keeping staff informed. Some may even choose to perform a risk assessment. Sharing the importance of the OR staff inspecting the instruments prior to the procedure (at the initial surgical count), at the first closing (second count), and at skin closure (final count) will also help your staff achieve a greater understanding of the overall process. If an instrument is damaged, it should be removed from the sterile field immediately, yet remain in the room until the procedure is completed so we may ensure all instruments are accounted for and documented. It is essential that the OR tags the instrument and communicates the specific issue to the SPD team. A repair tag is simply not enough.

When the OR team is presented with a damaged instrument, communication of items, such as dull or damaged scissors, cracks in the insulation, broken inserts, etc., are addressed immediately following the procedure. This allows the SPD team members to place the instrument to the side to ensure it is not placed back in the set and to address the issue with the repair technician in a timely manner.

Educate
Incorporate education for the perioperative team. Many companies provide education, along with a continuing education credit (CEU), which is valuable to the healthcare teams. Ensure both SPD and OR teams receive education on the care and handling of surgical instruments that supports the regulatory and manufacturer guidelines. When staff work together and are properly trained, patient safety may be improved.

Document. Document. Document.
The old adage is, “If it wasn’t documented, it never occurred.” This is especially true when preparing for a Joint Commission survey. Surgical instruments begin with proper inspection and continue with proper care and handling, where the surgical instrument lifecycle has come full circle after a preventive maintenance plan is incorporated. The goal is to maintain the life of our facilities’ investments and ensure patient safety throughout all processes.

Maintain
Maintaining surgical instruments is a great responsibility for sterile processing staff and operating room staff. Surgery demands a high level of standardization, protocols, checklists, and safety processes in place to help decrease and alleviate human errors. As we continue to see more complex instruments, it remains imperative that we not only inspect instruments for retained debris, but we inspect for proper function, staining, and damage. We have all viewed the various headlines and hospitals in the news. It can happen quickly: a complex instrument has retained debris, even after it went through the proper cleaning and sterilization steps; or an instrument breaks during a procedure and, through further investigation, was found that it was not properly inspected before, during, or after the surgical procedure. We must all work as a team to avoid these adverse events.

Surgical instrument maintenance isdirectly related to patient safety, physician satisfaction, and protecting the facility’s investment. If you are ever asked how long should surgical instruments last, remember the surgical instrument lifecycle. Well-maintained surgical instruments should last for many years. A proactive approach toward protecting surgical instruments will help us avoid any potential patient-adverse events in surgery. Our goal must always entail patient safety first. Our patients are depending on it.

  1. https://www.jointcommission.org/sentinel_event_policy_and_procedures/
  2. https://www.jointcommission.org/sea_issue_51/
    http://nothingleftbehind.org/
  1. https://www.jointcommission.org/assets/1/18/2004-2015_SE_Stats_Summary.pdf

 

 

 

 

 

Bio 

  • 16 years’ experience in the operating room as a CST
  • Clinical specialist for medical device companies
  • Product manager for medical device company
  • Clinical education manager – Integra LifeScience (Jarit Instruments division)
  • Clinical education manager – Northfield Medical
  • AS in surgical technology
  • BA in business/marketing
  • CST, CBSPD, CER certification
  • Voting board member AAMI WG84/ST_91 – flexible endoscopes
  • Member of AAMI, IAHCSMM

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