Healthcare Hygiene magazine December 2019 | Page 30

FDA Convenes
Advisory Panel for
Further Understanding
of the Duodenoscope-
Related Infection Risk
By Kelly M. Pyrek
As
part of its dialogue around EtO sterilization of
medical devices in early-November hearings, the
General Hospital and Personal Use Devices Panel of the FDA’s
Medical Device Advisory Committee addressed the challenges
around processing of complex medical devices such as
duodenoscopes. The panel examined data in the Medical
Device Reports (MDR) and post-market surveillance studies,
as well as reviewed the challenges with implementing new
reprocessing methods and adoption of new technologies.
Overall, 1,115 duodenoscope reports related to a patient
infection, exposure or device contamination for devices
marketed inside and outside the U.S. were received from
January 2015 to mid-2019, according to the FDA. The
number of reports related to patient infection was 553;
patient exposure to an infectious agent numbered 54, and
contamination without the mention of patient exposure or
infection totaled 508. The MDR data indicate a decrease in
the number of reported infections from 247 MDRs in 2015
to 55 MDRs reported in the first half of 2019.
Of these 1,115 duodenoscope reports, 858 were associated
with duodenoscope models marketed in the U.S. There
were reports of patient infection (378), patient exposure
to an infectious agent (49), and contamination without the
mention of patient exposure or infection (431). These reports
are related to adverse events received inside and outside the
U.S. Of the 378 reports received of patient infection associated
with duodenoscope models cleared in the U.S., 270 of these
reports occurred in this country.
The panel was asked to comment on FDA’s previous
actions and whether the trajectory that FDA had taken to
reduce the risk of infections continued to be appropriate.
To review the actions taken by FDA, following the agency
being alerted in 2013 by the Centers for Disease Control
and Prevention (CDC) about potential association between
multidrug-resistant bacteria and duodenoscopes, the agency
stepped up its oversight and discovered that the reported
cases of infection were occurring despite confirmation that
the users were following proper manufacturer cleaning and
disinfection or sterilization instructions.
In 2015, the FDA solicited expert scientific and clinical opin-
ion from healthcare, consumer and industry representatives
related to reprocessing of duodenoscopes based on available
scientific information. Following two days of presentations,
testimony and other input, panel participants were asked to
answer questions focused on duodenoscope and AER safety
and effectiveness, notably strategies to promote adherence to
30
reprocessing instructions, the CDC’s Interim Duodenoscope
Surveillance Protocol, and risk communication. Potential
strategies emerged in the following areas:
1
Manual Cleaning and Human Factors
Manual cleaning prior to disinfection or sterilization
is critical to effective reprocessing. To ensure that manual
cleaning is performed consistently and accurately, the
panel recommended strengthening competency training
for reprocessing staff in healthcare facility reprocessing
departments and incorporating human-factors testing
when developing reprocessing instructions. It is important
to consider the device, end user and use environment when
developing reprocessing instructions. Thus, human-factors
testing ensures that end users will be able to understand
and correctly follow the reprocessing instructions in
the labeling.
2
Device Design
Duodenoscopes should be designed to enable
meticulous cleaning and disinfection or sterilization;
manufacturers were urged to design duodenoscopes
that enable thorough cleaning and effective reprocessing
through device disassembly or disposable parts.
3
Microbiological Culturing of Duodenoscopes
Healthcare facilities may perform microbiologic
culturing, which involves sampling duodenoscope channels
and the distal end of the scope and culturing those samples
to identify any bacterial contamination that may be present
on the scope after reprocessing. The FDA recommended
additional data and validation testing to demonstrate the
methodology is robust and demonstrates consistent and
reliable culturing results before health care facilities can
incorporate as a best practice.
4
Supplemental Measures to Enhance Duodenoscope
Reprocessing
Additional strategies can reduce the risk of infection
transmission, such as: microbiological culturing, steriliza-
tion, use of a liquid chemical sterilant processing system
and repeat high-level disinfection as part of strict adherence
to the manufacturer’s reprocessing instructions.
In October 2015, the FDA ordered U.S. duodenoscope
manufacturers Olympus, Fujifilm and Pentax to conduct
post-market surveillance studies to better understand how
these devices are reprocessed in real-world settings and their
impact on duodenoscope-transmitted infections. In February
2018, the FDA, CDC and American Society for Microbiology
(ASM) released voluntary standardized protocols for duodeno-
scope surveillance sampling and culturing. In March 2018, the
FDA issued warning letters to all three manufacturers for failure
to provide sufficient data; the manufacturers then submitted
plans outlining how study milestones would be achieved.
In December 2018, the FDA issued interim results from
the ongoing mandated post-market surveillance studies
of duodenoscope reprocessing. Interim results indicated
higher-than-expected contamination rates after duodenoscope
reprocessing. Facilities and staff that reprocess duodenos-
copes are reminded of the importance of manual cleaning
prior to disinfection or sterilization and proper servicing
of duodenoscopes.
december 2019 • www.healthcarehygienemagazine.com