Ms. Chobin warns,
however, against look-
ing for the best possi-
ble price at the
expense of quality
service. "Partnering
mom-and-pop repair
shops might save you
money on the front
end, but you might
not get the value-added service and quality of repairs endoscope man-
ufacturers and larger third-party companies," she says.
3. What's the quality of the work?
The FDA requires endoscope manufacturers to establish and maintain
instructions and procedures for performing and verifying that their
servicing meets specified requirements, says Lucy Guan, MSc, a sen-
ior analyst at Design Resources Group. On the other hand, she adds,
there is no FDA requirement for third-party companies to maintain a
quality management system or track and report adverse events related
to the devices they repair.
Dr. Chen says endoscope manufacturers will emphasize that they
have the correct parts, repair manuals and factory-trained technicians
to return a product to its original specifications. He adds that endo-
scope manufacturers will also advertise that their factories are certi-
fied and inspected by the FDA, and that their parts and materials are
FDA approved.
"Facilities who choose endoscope manufacturers for their repairs
can be confident that the company uses proprietary replacement
parts," says Dr. Chen.
3 2 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J A N U A R Y 2 0 1 9
• LEAK TEST Tiny holes in the insertion tube could allow fluid to enter and damage
the scope's interior components.
Pamela
Bevelhymer,
RN,
BSN,
CNOR
