Health Problem Addressed: Umdns GMDN
Health Problem Addressed: Umdns GMDN
UMDNS GMDN
10950 Colonoscopes 36117 Flexible video colonoscope
Product description
These devices consist of a proximal housing, a flexible insertion
tube, and an “umbilical cord” connecting the light source and the
proximal housing. The proximal housing, which is designed to
be held in one hand, typically includes the eyepiece (fiberoptic
models only), controls for distal tip (bending section) angulation
and suction, and the working channel port. Colonoscopes have
several hollow channels for suction, water and air delivery, and
insertion of accessory instruments and cannulae. The distal tip Use and maintenance
of video colonoscopes includes a charge-coupled device (CCD) User(s): Gastroenterologist
that serves as a small camera and electronically transmits the Maintenance: Medical staff; technician;
image from the CCD to an external video-processing unit. biomedical or clinical engineer; central
sterile processing technician for cleaning and
Principles of operation disinfecting
Video colonoscope insertion tubes contains a fiberoptic light
bundle, which transmits light from the light source to the tip of Training: Supervised training with experienced
the endoscope. Each fiberoptic bundle consists of thousands users
of individual glass fibers coated with glass causing internal
reflections that allow light transmission through the fiber even Environment of use
when it is flexed. The light is used to illuminate the field of view Settings of use: Gastroenterology lab or suite,
in the patient’s colon. Video images are detected by the CCD operating room
and are then transmitted to the video processor and then display
Requirements: Stable power source; access
monitors or recording devices.
to anesthesia and patient monitoring; oxygen
and suction should be available; endoscopy
Operating steps suite should have direct external ventilation,
The patient typically lies on his or her side on a procedure table.
HEPA filtration
Patients typically will require anesthesia or conscious sedation
before insertion of the colonoscope. The colonoscope is inserted
into the colon via the rectum by a gastroenterologist. Video Product specifications
images are typically viewed throughout the procedure on a video Approx. dimensions (mm): 1,700
monitor. These images can then be recorded, printed, stored on Approx. weight (kg): 5
digital media, or transmitted to another location for simultaneous
Consumables: NA
viewing. The gastroenterologist manipulates the direction of the
device using controls on the colonoscope control housing. Price range (USD): 25,000 - 41,000
Typical product life time (years): 4 - 5
Reported problems
Shelf life (consumables): NA
Although rare, trauma to the colon and adjacent organs during
colonoscopy can result in complications such as bleeding, peritonitis,
and appendicitis. ECRI Institute has received reports of difficulty Types and variations
in inserting forceps through the instrument channel of contorted Video; fiberoptic
colonoscopes, causing delays in procedures. Problems have
occurred related to blockage of the air channel from inadequately
rinsed disinfectant or retrograde flow of protein material into the
channel during a procedure. Also, patient infection is a common
mainly from improper cleaning and disinfection procedures.
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).
http://www.who.int/medical_devices/en/index.html Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.
© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.