Let others know...


The Importance of Surgical Instrument Maintenance and Patient Safety, part 3

Last issue, we examined instrument care during ultrasonic cleaning and sterilization. This issue, we will look at instrument care during surgery, the care taken in the sterile processing department with a special focus on insulated laparoscopic instruments, and what can happen when an instrument fails during surgery.

We can work as a team in many ways, but first we must understand the root causes of poor instrument care and how we can prevent these occurrences from taking place. We can enlist the help of a qualified team member or educator who has experience with surgical instrumentation and the processes in the OR and SPD to perform department assessments so we may visually observe the various processes and protocols that occur in the OR and SPD, allowing us to uncover potential gaps. During an assessment, we can follow surgical trays from the time they leave the SPD until the time they are returned. It is important that we observe how instruments are cared for during surgery, how they are transported following the procedure, and how they are cared for in the SPD.

The importance of proper inspection
Instrument inspection, care and handling, and maintenance are all included in the manufacturers’ IFUs. Proper maintenance ensures that instruments remain in good working order before and after each procedure. Proper testing and inspection protects the facility’s investment and ensures each instrument remains in optimal condition. If the blades on the scissors are dull, it may cause snagging on the patient’s tissue. If a needle holder has a loose or broken insert, or a hemostat has loose or missing teeth, or if there are microscopic nicks in the laparoscopic instrument, then patient safety is at risk, which can lead to an adverse event.

Laparoscopic instrument care
Laparoscopic instruments, including bipolar instruments, contain an insulated sheathing that can show wear over time, depending upon use. Intact insulation ensures that electricity is directed to the tip and prevents electricity from escaping along the shaft or handle, which may potentially cause damage to the patient’s tissue and surrounding organs. Insulation failure is cited as being the primary cause of burns during laparoscopic procedures. In fact, 67% of stray electrosurgical burns go unnoticed during surgery, and 25% of the patients who suffer internal injuries stemming from these burns die.1

Why? When the laparoscopic instrument is used during surgery, the surgeon is viewing the procedure on a monitor and focusing on the distal end of the instrument. The surgeon may ask the assistant who is holding the camera to focus closer on the tip of the laparoscopic instrument so he or she may cauterize, grasp, or cut the structure, organ (e.g., gallbladder), or other areas of interest. As a result, the majority of the instrument may go visually unnoticed during aspects of the procedure. If there is a cut or break in the insulation and a patient is burned, the burn may go unnoticed because it is out of the field of view. If the burn goes unnoticed, the patient may be discharged, even though internal bleeding may be occurring. This can lead to death and is considered a preventable event.

All insulated laparoscopic instruments should be tested with an electrical current tester before and after each laparoscopic case, evaluating for integrity, function, and cleanliness. It is important to inspect and test surgical instruments before cracks or microscopic holes form and allow the pitting process to begin. Cracked insulation can allow bioburden to become trapped under the insulation and compromise sterility. If a break in the insulation is observed during the testing, it is important to immediately remove the instrument from the set and send it out for repair to ensure patient safety.

When instruments go bad
Inspection, proper care and handling, and preventive maintenance minimizes the risk for patient adverse events. The FDA has validated manufacturers’ surgical instruments and devices to ensure they are safe for patients. The Medical Device Reporting (MDR) regulation 21 CFR 803 contains mandatory requirements for manufacturers, importers, and device user facilities to report device-related events and product problems to the FDA. Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated malfunctions, serious injuries, and deaths. The FDA uses these MDRs to monitor device performance, detect potential device-related safety issues, and contribute to the benefit-risk assessments of reusable instruments and devices.2

Retained foreign objects is a term that is often thought to apply to sponges left inadvertently inside the patient, but it is important to note that instruments are also known to cause damage or break apart during surgery and may be catastrophic for the patient.

Example of an adverse event involving a pituitary rongeur.U.S. Food and Drug Administration

Imagine the thoughts of the surgeon who has performed this case. He or she has trained for many years and took an oath, primum non nocere, “first, to do no harm.” This spine procedure was most likely performed numerous times by this particular surgeon without any issues. The last thing a surgeon wants is to lose credibility with his or her patients or the public. When the surgeon placed the pituitary rongeur in the patient’s spine, the cup of the instrument immediately broke apart and multiple fragments fell into the surgical site. 

Spine surgery can be challenging. It is a deep, dark, and narrow space that requires a microscope. It is also a delicate procedure where permanent nerve damage may occur. Can you imagine the surgeon’s reaction when the instrument broke apart? An X-ray was used to locate the fragments and multiple attempts were made to retrieve them, but the surgeon was unable to grasp them because the fragments were out of reach. The surgeon made the difficult decision that any further manipulation and retraction on the patient’s tissue may cause nerve damage. The surgeon had no choice but to leave the fragments in the patient’s spine. 

Imagine the surgeon walking down the hall to the waiting area to share this information with the patient’s family members. Can you imagine the family members’ reaction? Patients and their loved ones trust that we, as healthcare workers, are ensuring all areas of care are safe before, during, and after surgery. Although the instrument fractured during the procedure, it was not the surgeon’s fault. It takes a team of people to support the planning, preparation, and support of a procedure, but the surgeon is directly responsible for the surgical outcome. Instruments simply do not fall apart unless they have incurred some type of damage. Proper inspection allows someone to observe the stress fracture(s) prior to being placed in the surgeon’s hands.

Next time in A Closer Look, we will discuss The Joint Commission’s sentinel event policy and the importance of effective communication, documentation, and ongoing education.

  1. https://issuu.com/medlineindustries/docs/orconnectionv3i2/21
  2. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm

 

 

 

 

 

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

Sign up to read Sara Freiberg’s biweekly feature in NewSplash!NewSplash is a free weekly digital newsletter dedicated to providing useful information to CS and IP professionals who strive to keep patient safety high.