Cause of Device-Related Incident
Device factors

Clinical Specialty or Hospital Department
Infection Control; Obstetrics and Gynecology; OR / Surgery

Device Factors
Design / labeling error; Improper maintenance, testing, repair, or lack or failure of incoming inspection

Document Type
User Experience Network (UEN) reports

External Factors
*Not stated

Mechanism of Injury or Death
Infection

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection

UMDNS
Forceps, Laparoscopic [11-779]; Forceps, Dissecting [15-800]; Trocars, Abdominal [14-155]

The Difficulty of Reprocessing Reusable Rigid Laparoscopic Forceps and Other Endoscopic Accessories: Are Disposables the Answer?



User Experience Network™ [Health Devices Jan-Feb 1994;23(1-2):57-8]

Hospital

While unwrapping reusable rigid laparoscopic forceps after steam sterilization, our OR staff noticed that the inner wrap was stained with dried blood. We believe that this problem occurred because the designs of many of our reusable rigid endoscopic instruments make thorough cleaning difficult, and we are concerned that we may be using contaminated instruments on our patients. The operator's manuals for some of these instruments do not provide adequate reprocessing instructions. Can ECRI provide us with guidance on reprocessing our rigid laparoscopic forceps and other reusable rigid endoscopic accessories?

Also, disposable (single-use) instruments can be costly, but can help ensure sterility for each patient. When are disposables more appropriate to use than reusables during rigid endoscopic procedures, such as laparoscopy or arthroscopy?

ECRI

Reprocessing Rigid Endoscopic Reusables

We have examined the design of several brands of reusable rigid laparoscopic forceps and found some of them to be difficult to clean, as your hospital has, primarily because of the inaccessibility of their long shaft. Many manufacturers have improved the design of these instruments to facilitate cleaning by, for example, providing a cleaning port for the shaft, permitting disassembly for more thorough cleaning (including the ability to clean the inside of the shaft with a brush), incorporating internal seals that prevent debris and fluids from entering the lumen or shaft, and combining single- or multiple-use disposable jaws (e.g., scissors) with a reusable shaft and handle. If your hospital's current supply of reusable rigid laparoscopic forceps cannot be adequately cleaned, the manufacturer should exchange or replace them with forceps that are designed to facilitate cleaning.

For reprocessing reusable rigid laparoscopic forceps or any other reusable endoscopic instruments, we recommend that you use the following practices and procedures in accordance with the cleaning instructions provided by the instrument's manufacturer. During cleaning, wear appropriate eye and face protection, as well as gloves and other protective clothing, to protect against exposure to bloodborne pathogens, as recommended by OSHA in its bloodborne pathogens standard. (For in-depth discussion, analysis, and recommendations regarding this standard, see our Guidance Article, "OSHA's Bloodborne Pathogens Standard: Analysis and Recommendations," in Health Devices 22(2), February 1993.)

  1. Immediately after use. Place the soiled instrument in water or a cleaning solution immediately after use to moisten the soil and prevent blood, mucus, and other debris from drying on the instrument. If a cleaning port is available, irrigate the instrument's shaft while opening and closing the instrument's jaws to remove debris.
  2. Disassembly. If the instrument is designed to be disassembled before reprocessing, separate it into each of its components, as recommended in the operator's manual.
  3. Enzymatic detergent soak and manual cleaning. If you soak the instrument in an enzymatic detergent solution before cleaning, be sure that the solution is at the correct temperature and proper concentration. Completely immerse the instrument, with its jaws open, in the solution for the amount of time recommended on the detergent's label. If a cleaning port is available, irrigate the instrument's shaft with the detergent solution, while opening and closing the instrument's jaws, to remove debris. Also, clean each of the instrument's components and shaft, when possible, with a clean, appropriately sized soft-bristle brush to remove organic debris.
  4. Rinse. Rinse all of the instrument's components thoroughly with water to remove dislodged debris and the detergent solution.
  5. Ultrasonic cleaning. The cavitation action of ultrasonic cleaners can remove particles of debris from areas of the instrument inaccessible to a brush. Place the disassembled instrument in an ultrasonic cleaner to which you have added a detergent solution formulated for use by the manufacturer of the ultrasonic cleaner. Refer to the instrument's operator's manual to ensure its compatibility with ultrasonic cleaners.
  6. Rinse. Rinse all of the instrument's components thoroughly with water to remove any remaining debris or detergent residues that could interfere with the sterilization process.
  7. Visual inspection. Visually inspect the disassembled instrument for cleanliness, and clean off any remaining debris.
  8. Lubrication. Use a lubricant as recommended by the instrument's manufacturer on all of the instrument's moving parts to ensure that they move freely and will not "freeze up" during use.
  9. Reassembly. Reassemble the instrument either before or after sterilization according to the manufacturer's instructions. Before reassembly, visually inspect each component for damage; after reassembly, inspect the instrument for proper operation. If the instrument is to be stored or if it is to be sterilized by ethylene oxide (EtO) gas, be sure it is thoroughly dry.
  10. Sterilization. Hospitals typically choose one of three methods to achieve sterilization: use of pressurized steam, EtO gas, or a liquid chemical germicide (LCG) soak. Steam is preferred if the instrument can withstand high temperatures and pressures because it is both effective and inexpensive. EtO gas requires that the instrument be subjected to an aeration period of several hours, which is impractical in a busy endoscopy unit, and LCGs require that the instrument be rinsed with sterile water after soaking to remove chemical residues, which can be time-consuming and expensive (but harmful to the patient if not done).

Deciding between Disposables and Reusables

Determining whether disposable or reusable instruments are more appropriate for a particular rigid endoscopic procedure, as well as for other surgical applications, is often difficult, requiring an assessment of the infection risk to the patient and the healthcare worker, reliability in performance, and the costs associated with their use.

Disposables may be favored over reusables if they offer improved performance and safety. For example, disposable abdominal trocars may be safer for the patient because their tips are virtually guaranteed to be sharp. In contrast, the tips of reusable abdominal trocars may become dull after only a few uses, requiring a greater force to enter the fascia and peritoneum, which may increase the risk of inadvertent organ or major blood vessel injury. (An alternative approach may be to purchase a backup set of reusable trocars, scheduling periodic sharpening; this service is currently offered by some reusable trocar manufacturers to prevent the use of dull instruments.) Other advantages of disposables include reduced risk of postoperative patient infection and elimination of the need to reprocess them after each use.

Although disposable instruments help to ensure sterility, they may not necessarily be the optimal choice. Many surgeons consider the performance and precision of many reusable endoscopic instruments to be superior to those of disposables (with some exceptions, such as disposable abdominal trocars). For example, because of its usual stainless steel construction, the reusable arthroscopic cannula, into which the arthroscope and other instruments are inserted, may be less susceptible to breakage at its distal tip during normal instrument operation than a disposable arthroscopic cannula made of a less durable plastic material. Several reports in the FDA database document breakage of the distal tip of disposable arthroscopic cannulae from five different manufacturers. Some of these reports note that not all of the fragments from the broken tip were retrieved at the time of the procedure, which could result in serious patient infection. One hospital reported that it replaced all of its disposable arthroscopic cannulae, which repeatedly broke at their distal tip, with reusable cannulae, eliminating the breakage problem. Most reusable arthroscopic cannulae can be easily reprocessed, posing virtually no risk of cross infection, and usually cost significantly less per procedure than disposable arthroscopic cannulae, even when taking into account their higher initial cost.

One of the major disadvantages of disposables, in addition to their high per-procedure costs, is their high inventory and disposal costs. Also, as noted, they may not perform as well as their reusable counterparts, and the effect of disposing plastic, nonbiodegradable contaminated instruments into the environment should not be ignored. The disadvantages of reusables include the problems and risks associated with reprocessing, such as personnel exposure to patient contaminants and LCGs (e.g., 2% glutaraldehyde), the effects of EtO gas on the environment, the time required for reprocessing (which can be a problem when instrument availability and time between patient procedures is limited), and difficulty in cleaning.

In conclusion, we recommend that hospitals assess the relative advantages and disadvantages of disposables and reusables and determine the applications for which either is more appropriate. To control costs without sacrificing performance or safety:

  • Replace all reusable instruments that cannot be adequately reprocessed with other reusable instruments that are designed to facilitate cleaning and have validated cleaning instructions.
  • Use disposable instruments when reusables cannot be reprocessed adequately or when they offer significant clinical performance advantages over reusables.

UMDNS Terms

  • Forceps, Laparoscopic [11-779]
  • Forceps, Dissecting [15-800]
  • Trocars, Abdominal [14-155]

Cause of Device-Related Incident

Device factors: Design/labeling error; Improper maintenance, testing, repair, or lack or failure of incoming inspection

User error: Failure to perform pre-use inspection

Mechanism of Injury or Death

Infection 


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