User Experience Network™ [Health Devices Jan-Feb 1994;23(1-2):57-8]
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
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?
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),
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
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.
- 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.
- Rinse. Rinse all of the
instrument's components thoroughly with water to remove dislodged debris and
the detergent solution.
- 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
- 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.
- Visual inspection.
Visually inspect the disassembled instrument for cleanliness, and clean off
any remaining debris.
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.
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.
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
- 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