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The Importance of Surgical Instrument Maintenance and Patient Safety, part 1

More than 200 million surgeries are performed worldwide each year, with more than 48 million of those surgical procedures taking place in the United States, according to the most current data gathered from the CDC and The National Center for Health Statistics.Surgical instruments and reusable devices are a majorinvestment for hospitals. Based upon a 250-bed hospital, the average facility may invest between $2–3 million in surgical instruments and equipment.3

Operating rooms are the revenue generator of the hospital, and surgical instruments play a large role in performing surgical procedures. Surgeons highly depend upon them to perform as intended. How long should our surgical instruments last? That depends on many factors.

Instrument lifecycle
Let’s begin by reviewing the surgical instrument lifecycle. Instrument manufacturers perform many quality assurance tests, along with a final quality assurance check prior to shipment. Hospitals are advised to inspect the instruments upon receipt to ensure the devices did not incur any damage in the delivery process. Inspection may be listed several times throughout the instrument manufacturer’s IFUs and in AAMI ST79. AAMI ST79 shares the importance of recognizing that some areas of damage “…may go undetected with the unaided eye, therefore, in addition to visual inspection, lighted magnification…” is also recommended.Inspection is an important step to perform throughout all processes in the surgical instrument lifecycle.

Following instrument inspection, the manufacturer’s IFUs also state that facilities are advised to incorporate proper care and handling to the instrument throughout each of the processes. Proper care and handling entails precleaning (point-of-use cleaning), proper transportation, manual cleaning, rinsing, ultrasonic cleaning, lubrication, sterilization, inspecting, and testing.


German-quality surgical instruments used for surgical procedures are made from 300- or 400-series stainless steel, involve many patterns and designs, and are manufactured by highly skilled craftsmen. As mentioned, throughout the manufacturing process, instruments are placed through various quality assurance tests before they are shipped to the customer. One of the manufacturing processes is a step known as passivation, which provides the instrument with its corrosion-resistance properties.

Passivation is a chemical bath that creates an oxidized layer on the surface of the instrument. Through routine use and exposure to air, the oxidation process continues, effectively creating and maintaining a protective barrier to most stains and corrosive elements.Older instruments are usually well protected by these repeated exposures to oxidizing conditions that exist during reprocessing. It is important to note that stainless steel, despite its name, does have its weaknesses, and instruments can become damaged through improper use.5

Instrument care
It is important to understand how instruments are cared for prior to, during, and following surgery. The first step in instrument care is precleaning, also called point-of-use cleaning. Point-of-use cleaning allows Instruments to remain clean during the surgical procedure. This step is critical and directed in the manufacturer’s IFUs to allow the surgeon to receive an instrument free of blood and debris, and to prevent bioburden and biofilm from forming on the instrument. Biofilm may begin to form within minutes; therefore, according to the guidelines, instruments should be wiped with sterile water throughout the procedure and sprayed with an enzymatic cleaner at the completion of the surgical procedure to begin the process of breaking down bioburden prior to being transported to the SPD for manual cleaning.

Using saline to clean instruments or excessive soaking of instruments in any fluid (saline or water) will, over time, display as pitting on surgical instruments. Pitting is observed as small pockets or divets on the instrument. Once an instrument shows signs of pitting, it may be buffed out by a qualified repair technician. Note: Due to their complex designs, once pitting shows signs in the boxlocks, the teeth of forceps, or under the insulation in a laparoscopic instrument, it may be difficult to remove the pitting and can even break down the instrument if not addressed in a timely manner.

Transporting instruments
How instruments are transported to the SPD is important. We often see surgical instruments piled in a basin or an instrument pan, tangled, with instrument tips peeking out through the perforations in the instrument trays. Delicate scissors are sometimes placed at the bottom of the pan and heavy items, such as rongeurs or mallets, are placed directly on top of them. Careful placement—separating dirty from clean, heavy from delicate—along with tip protection is the best practice to protect instruments from any potential damage or breakage.

Water and detergent
Water quality is an important factor in caring for surgical instruments. Commonly, water type in the SPD is either deionized or distilled, or reverse osmosis is used. AAMI ST79 and AAMI TIR34 share language on the importance of water quality, referring to the instrument/device manufacturer’s IFUs regarding the type of water that is compatible with the device.

Detergents used for manual cleaning must be compatible to the device. Enzymatic detergents should have a neutral pH and be low foaming. Follow the manufacturer’s IFUs for proper concentration, temperature, and contact time.

Next issue, we will discuss the importance of ultrasonic cleaning in instrument maintenance and patient safety.

 

 

 

 

 

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

 

References

  1. https://nchstats.com/category/surgery/
    https://pssjournal.biomedcentral.com/articles/10.1186/1754-9493-8-9
  2. https://www.advisory.com/-/media/Advisory-com/Research/TI/Events/Webconferences/2014/A-Smarter-OR-021014.pdf
  3. AAMI ST79
  4. http://www.storm2k.com/surgicalinstrumentation.pdf
  5. http://www.judd-medical.co.uk/careandmaintenance2.html

 

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