transmissions of
infection from endo-
scope to patient and
that it stands behind
the safety of its
machines. A compa-
ny spokesman
declined to com-
ment further.
Facilities that use
Custom Ultrasonics reprocessors should transition to an alternative
option "as soon as possible," according to the FDA. "What does that
mean?" asks Lawrence F. Muscarella, PhD, the former director of
research and development and chief of infection control for Custom
Ultrasonics. "That could be 3 months for a facility." Dr. Muscarella,
who left Custom Ultrasonics in 2013, is now an infection control con-
sultant and president of LFM Healthcare Solutions in
Montgomeryville, Pa.
There are practical reasons for not being able to make the switch
overnight — Dr. Muscarella believes the FDA will allow a grace peri-
od — but you want to set a transition plan in motion immediately and
start a paper trail to mitigate your facility's liability. "Document that
you received the recall, develop a written plan and create a timeline
that details what you will do to address the recall," says Dr.
Muscarella.
He suggests facilities seek validation data from all AER manufactur-
ers that show the devices can clean and disinfect duodenoscopes. "A
certification letter from the AER manufacturer must spell out those
terms, not just that they have the data, but that the FDA reviewed and
accepted it," says Dr. Muscarella. "If the manufacturer commits in
8 6
O U T P A T I E N T S U R G E R Y M A G A Z I N E O N L I N E | D E C E M B E R 2 0 1 5
z IN GOOD HANDS Educate and reinforce proper cleaning
and disinfection techniques in the reprocessing room.
Pamela
Bevelhymer,
RN,
BSN
