Safety Communications > Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes

Medical Specialties: Gastroenterology, Infection Control

Device: Olympus Duodenoscope model TJF-Q180V

Olympus
has issued new, validated manual reprocessing instructions for the
TJF-Q180V duodenoscope to replace those provided in the original
labeling. The FDA has reviewed these new reprocessing instructions and
the validation data as part of its ongoing review of the 510(k), and
recommends that any facilities that are using Olympus’ TJF-Q180V
duodenoscope train staff on the new instructions and implement them as
soon as possible.

Summary of Problem and Scope:

As noted in FDA’s February 2015 Safety Communication,
the complex design of ERCP endoscopes (also called duodenoscopes) may
impede effective reprocessing. Reprocessing is a detailed, multistep
process to clean and disinfect or sterilize reusable devices. Recent
medical publications and adverse event reports associate
multidrug-resistant bacterial infections in patients who have undergone
ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing
instructions are followed correctly. FDA has been working with
duodenoscope manufacturers as they modify and validate their
reprocessing instructions to further enhance the safety margin of their
devices and show with a high degree of assurance that their reprocessing
instructions, when followed correctly, effectively clean and disinfect
the duodenoscopes.

In September 2014, Olympus initiated testing to
validate new reprocessing instructions. The cleaning validation reports
were provided to FDA in October 2014. While FDA found Olympus’ cleaning
validation data acceptable, initial high level disinfection reports did
not demonstrate an adequate safety margin, and so Olympus conducted
additional testing. At the end of February 2015, Olympus submitted new
high level disinfection validation data to FDA. The agency has reviewed
this data and believes that, when followed, the new, validated
reprocessing instructions for the Olympus TJF-Q180V duodenoscope are
robust, and demonstrate consistent and reliable cleaning and high-level
disinfection. At FDA’s request, Olympus has issued the new, validated
instructions for reprocessing the TJF-Q180V duodenoscope.

To
validate reprocessing instructions for duodenoscopes, manufacturers
should soil their device with bacteria to simulate use in a procedure
and then demonstrate that the device can be adequately disinfected
through a sufficient reduction in microbes when the reprocessing
instructions are correctly followed. To support high level disinfection
of duodenoscopes, the disinfectant should result in a six-log reduction
in the number of microbes at each of several locations on the scope –
that is a one million-fold reduction; or a reduction of 99.9999%.

The
FDA is closely monitoring the possible association between reprocessed
duodenoscopes and the transmission of infectious agents, including
multidrug-resistant bacterial infections caused by Carbapenem-Resistant
Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia
coli. If not properly reprocessed, residual body fluids and organic
debris may remain in microscopic crevices of the device following an
attempted cleaning and high level disinfection. If these residual fluids
contain microbial contamination, subsequent patients may be exposed to
serious infections. The FDA’s investigation into the possible
association between inadequately reprocessed duodenoscopes and patient
infections, including the agency’s recommendations for health care
facilities, is more fully discussed in its February 2015 Safety Communication.

Olympus sent letters dated March 26, 2015
 to health care facilities and other users of the TJF-Q180V outlining
the new, validated reprocessing instructions, and will soon be
distributing revised user manuals.

Please note the key changes to the reprocessing procedure for Olympus’ TJF-Q180V duodenoscope:

Precleaning:

• During immersion, raise and lower the elevator three times

Manual Cleaning:

• Additional brushing of the forceps elevator recess area
  • The
    revised cleaning procedure requires brushing of the forceps elevator
    recess with two different-sized brushes. In addition to the brush that
    is currently used to clean the elevator recess area, the MAJ-1888 brush
    (or MAJ-1888 equivalent) will be provided for further cleaning of this
    area. Olympus anticipates shipping the MAJ-1888 brushes to facilities no
    later than May 8, 2015.
• Additional flushing of forceps elevator recess area
• Additional raising/lowering the forceps elevator

Manual High Level Disinfection:

• Additional manual flushing steps and increased flushing volume of each endoscope channel, as well as the elevator recess area
• Additional raising/lowering the forceps elevator

In addition, FDA has the following recommendations for facilities and staff that use and reprocess the Olympus TJF-Q180V:

• Implement
  the new manual cleaning and high level disinfection procedures for the
  Olympus TJF-Q180V duodenoscope in accordance with the manufacturer’s
  reprocessing instructions
  • Implement the new TJF-Q180V high level
    disinfection procedure immediately. The high level disinfection
    procedure does not require additional equipment for implementation.
  • Implement
    the new TJF-Q180V manual cleaning procedure as soon as possible. It
    involves the use of a new, smaller bristle cleaning brush (model
    MAJ-1888) which Olympus anticipates shipping to facilities no later than
    May 8, 2015. Continue using the existing cleaning procedure for manual
    cleaning of the TJF-Q180V until the new brush is available.
• Train appropriate staff on Olympus’ new reprocessing instructions and implement them as soon as possible.
• Contact
  Olympus directly with specific questions and concerns or to schedule a
  site visit with their Endoscopy Support Specialists:
  • Technical Assistance Center (TAC), 1-800-848-9024, option 1 Monday - Friday between 7AM EST - 8 PM EST.

FDA’s
recommendations are based on currently available information. If new,
important information becomes available, FDA will update its
recommendations.

As noted inFDA’s Updated Information for Healthcare Providers Regarding Duodenoscopes
issued March 4, 2015, Olympus has a pending 510(k) application for its
TJF-Q180V duodenoscope and the company continues to market its device
while its application is under review. The removal of its device from
the market could lead to an insufficient number of available
duodenoscopes to meet the clinical demand in the United State of
approximately 500,000 procedures per year.

FDA Activities:

The
FDA is actively engaged with other government agencies, including
Centers for Disease Control and Prevention (CDC), and the manufacturers
of duodenoscopes used in the United States to identify the causes and
risk factors for transmission of infectious agents and develop solutions
to further increase the safety margin of reprocessed devices and
minimize patient exposure to infectious agents.

The agency will convene a public Advisory Committee Meeting
on May 14th and 15th, 2015 to seek expert scientific and clinical
opinion related to reprocessing of duodenoscopes and other endoscopes,
as well as use of automated endoscope reprocessors for duodenoscope
reprocessing, based on available scientific information. The committee
will make recommendations on: (1) The effectiveness of cleaning, high
level disinfection, and sterilization methods; (2) the amount and type
of premarket validation data and information needed to support labeling
claims and technical instructions; (3) the appropriate use of other risk
mitigations, such as surveillance cultures; (4) best practices and
guidelines for reprocessing duodenoscopes and endoscopes at user
facilities to minimize the transmission of infections; and (5)
recommended approaches for ensuring patient safety during ERCP
procedures, including a discussion of appropriate patient selection.
Recommendations on these issues will assist FDA in minimizing patient
exposure to infectious agents that may result from reprocessed
duodenoscopes and endoscopes.

The FDA is also working closely with
the manufacturers of reusable medical devices such as duodenoscopes to
ensure that their reprocessing instructions are adequate to clean and
disinfect the devices. The FDA continues to actively monitor this
situation and will provide updates as appropriate.

Reporting Problems to the FDA:

Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Prompt
reporting of adverse events can help the FDA identify and better
understand the risks associated with medical devices. Health care
providers should submit voluntary reports of the transmission of an
infection due to an inadequately cleaned duodenoscope to the agency via
the Medical Device Reporting (MDR) process.

If
a health care provider suspects bacterial contamination—either because
of an increase in infections after ERCP, or because of the results of
bacterial surveillance culturing of duodenoscopes—we encourage the
health care provider to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Model TJF-Q180V Duodenoscopes