System 83 Plus Reprocessing Devices - Potential Risk of Infection

Starting date:

December 4, 2015

Posting date:

December 4, 2015

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-56104

• 
  Issue
• 
  Who is affected
• 
  Report health or safety concerns

Audience

Health professionals in healthcare facilities using the System 83 Plus reprocessing devices.

Key messages

• Reports of infection have been associated with the use of System 83 Plus reprocessing devices in the United States.
• Infection could result from inadequate reprocessing of complex endoscopes such as duodenoscopes with a closed elevator (lifter) channel.
• At this time, it is recommended not to use the System 83 Plus device to reprocess complex endoscopes and to use an alternative method.
• Health Canada is continuing to request and review information from the manufacturer.

Issue

There have been reports of infection at one healthcare facility in the United States following use of a complex endoscope such as duodenoscope with a closed elevator (lifter) channel that had been reprocessed by the System 83 Plus device (Custom Ultrasonics, Inc.).

Products affected

System 83 Plus Endoscopic washer/disinfector

Background information

System 83 Plus Endoscope Washer/Disinfector by Custom Ultrasonics Inc. is designed for the reprocessing of flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

System 83 Plus reprocessing device includes two models. The System 83 Plus 2 is a device with one processing chamber that can process 1 to 2 flexible endoscopes at a time. The System 83 Plus 9 is two 'System 83 Plus 2’ units put together. It has two processing chambers which can process 1 to 2 flexible endoscopes in each independently operated processing chamber.

As a result of an investigation, it has been reported that the System 83 Plus devices may be incapable of adequately reprocessing complex endoscopes including duodenoscopes with a closed elevator (lifter) channel such as the Olympus TJF-180 V.

Based on the information currently available, the most serious adverse events were the outbreak of infection reported at one healthcare facility in the U.S., where a Custom Ultrasonics System 83 Plus device was used to reprocess a complex duodenoscope with a sealed elevator or lifter mechanism. It is considered that risk of infection exists if complex endoscopes are processed in a System 83 Plus device.

To date, no reports have been received by Health Canada of infection associated with System 83 Plus reprocessing devices currently in use in Canada.

The FDA has ordered Custom Ultrasonics to recall all System 83 Plus devices due to violations of the U.S quality system regulation.^{Footnote 1}

Health Canada continues to request and review additional information and will communicate updates should any further action be required.

Who is affected

Information for consumers

Consumers should contact their healthcare professional for more information.

Information for health care professionals

Based on information provided by Custom Ultrasonics Inc. to date, System 83 Plus devices should not be used to reprocess complex endoscopes including duodenoscopes with a closed elevator (lifter) channel; use of an alternative method should be considered.

To minimize the risk of patient infection, it is important to adhere to reprocessing instructions provided by each duodenoscope manufacturer.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site.

Health Canada will be working with the manufacturer to review available information.  Health Canada will continue to monitor the situation and will take further action if needed.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of patient infection or other serious or unexpected side effects with the use of these devices should be reported to Health Canada.

Any suspected adverse incident can be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Telephone: The Inspectorate Hotline: 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738