Update, Endoscope Alerts issued by VA & Olympus

According to the alerts, see below, the VA and Olympus were both aware of potential contamination problems as least as early as December 22, 2008.

January 26, 2009
"On December 22, 2008 the Department of Veterans Affairs National Center for Patient Safety issued a Patient Safety Alert entitled “Improper set-up and reprocessing of flexible endoscope tubing and accessories”. (This document can be accessed at http://www.patientsafety.gov/alerts.html.) This alert was issued in response to an event involving Olympus endoscopy equipment in use at a Department of Veterans Affairs Hospital."

From MyEndo.com
http://www.myendosite.com/

AL09-07
AL09-07 December 22, 2008
Item: Improper set-up and reprocessing of flexible endoscope tubing and accessories
Specific Incident: Correct tubing modified with an incorrect connector was used to attach an Olympus flexible endoscope to its irrigation source (Olympus Flushing Pump and accessories). This resulted in a backflow of body fluids into irrigation source tubing (where backflow should not occur) during an endoscopic procedure.
Specifically, during some endoscopic procedures, the facility used an Olympus Auxiliary Water Tube (MAJ-855) that was modified to have an Olympus Washing Tube (MH-974) connector attached instead of the connector intended to be used with the Olympus Auxiliary Water Tube (MAJ-855).
Figure illustrating translucent tubing with green connector. Caption: "Incorrect connector - This is the correct tubing, but it has wrong attached."
Incorrect connector
This is correct tubing, but it has the wrong green connector attached.
The Auxiliary Water Tube (MAJ-855) is required to connect the Auxiliary Water Port on the endoscope to the Olympus Flushing Pump (OFP) Filter (7501335), which is connected to the OFP Irrigation Tube (7501669). (See the photograph in Attachment 1, which depicts proper set-up of the equipment.) The MAJ-855’s connector has a one-way valve and is a standard feature on the MAJ-855. The MAJ-855’s one-way valve prevents backflow of body fluids from contaminating the
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AL09-07
OFP Filter (7501335) and OFP Irrigation Tube (7501669). The Washing Tube’s (MH-974) connector does not have a one-way valve.
While in the process of investigating the issue other problems were also discovered:
1.
When the Olympus Auxiliary Water Tube (MAJ-855) with proper connector was used for clinical procedures, it was being reprocessed at the end of each day, instead of between each patient as required by the manufacturer’s reprocessing instructions.
2.
The OFP Irrigation Tube (7501669) and OFP Filter (7501355) were being reprocessed at the end of each day. The OFP Irrigation Tube (7501669) and OFP Filter (7501355), shown in the photograph in Attachment 2, are to be discarded at the end of each day per the manufacturer’s instructions.
Improperly setting up (e.g., using incorrect connectors) and/or incorrectly reprocessing endoscopic tubing and accessories may place patients at risk from blood borne pathogens or other types of infections.
NOTE: While the Specific Incident and General Information sections of this Patient Safety Alert reference a specific manufacturer’s endoscopic tubing and accessories, THIS PATIENT SAFETY ALERT APPLIES TO ALL FLEXIBLE ENDOSCOPIC TUBING AND ACCESSORIES, REGARDLESS OF MANUFACTURER OR MODEL.
General Information: Tubing design may have contributed to the reported event. Both of the tubings, while different in diameter and length, have green connectors. The green connector on the Washing Tube (MH-974) has one less wing than the green connector on the Auxiliary Water Tube (MAJ-855). See photographs of the tubings below, which show the connectors. NOTE: The manufacturer uses green connectors to indicate that the tubing is to be reprocessed, not discarded.
Illustration of translucent tube with light green connector at the right end
Olympus Washing Tube (MH-974) Its green connector has only 1 wing. -
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AL09-07 Photo of translucent tube with green connector on the end Caption: Olympus Auxiliary Water Tube (MAJ-855) - Its one-way valve has 2 wings.Olympus
Auxiliary
Water Tube
(MAJ-855)
Its green
connector with
one-way valve
has 2 wings.
Actions: The Facility Director (or designee) will ensure that all of the following three actions are carried out by close of business January 7, 2009:
1.
All personnel who perform procedures with flexible endoscopes and/or reprocess endoscopes and their tubing and accessories have read this Patient Safety Alert.
NOTE: Ensure you have identified all areas in your facility where reprocessing of flexible endoscopes occurs, which may include, but are not limited to the following: Ambulatory Surgery, Endoscopy, GI, GU, OR, Respiratory, SPD, Urology, and Clinics to include CBOCs.
2.
For those facilities using the Olympus Flushing Pump and compatible endoscopes, ensure that:
a.
the set-up shown in Attachment 1 is being consistently utilized. NOTE: In the photograph, the fluid flows from the Olympus Flushing Pump (located on the right) to the Olympus Endoscope (located on the left). Ensure that the OFP Irrigation Tube (7501669) is placed in the proper orientation through the OFP Cassette.
b.
personnel who use and/or reprocess endoscopes and their tubing and accessories understand that:
i.
they shouldn’t modify, create, or enhance manufacturer tubings and accessories.
ii.
the Olympus Auxiliary Water Tube (MAJ-855) is supplied non-sterile, and needs to be reprocessed before initial use and after each patient using steam sterilization (refer to the instruction manual for your particular endoscope).
iii.
the OFP Filter (7501355) and OFP Irrigation Tube (7501669) are supplied non-sterile, must be sterilized prior to initial use, can be utilized all day, and must be
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AL09-07
discarded at the end of each day, as per the manufacturer instructions.
iv.
the OFP Fluid Container (7501352) is supplied non-sterile, must be sterilized prior to initial use, can be utilized all day, and must be reprocessed using steam sterilization prior to next day’s use (refer to the instructions for the Olympus Flushing Pump).
NOTE: If tubing and accessories from another manufacturer are used, they must be compatible with your particular Olympus products (flexible endoscope and flushing pump) and must be set-up and reprocessed or disposed of in accordance with the manufacturer’s instructions. Note that the set-up and reprocessing instructions could differ from Olympus’ set-up and reprocessing or disposal instructions.
3.
Regardless of manufacturer or model of flexible endoscope,
a.
confirm that you are using the proper tubing and accessories (in the correct sequence and orientation) when conducting clinical procedures with flexible endoscopes.
b.
ensure that personnel who use and/or reprocess endoscopes and their tubing and accessories understand that they shouldn’t modify, create, or enhance manufacturer tubing and accessories.
c.
ensure that reprocessing personnel follow manufacturer’s instructions for cleaning and reprocessing flexible endoscope’s tubing and accessories. And, assure that any items that are single patient use are reprocessed (if reusable) or disposed of (if disposable) after each patient and that any items that are single day use are disposed of at the end of the day.
d.
if you identify any issues in terms of incorrect set-up during clinical procedures or failure to adequately clean or reprocess flexible endoscope tubing and accessories, report them in an Issue Brief through your Network Office to VA Central Office.
e.
ensure that locally-developed Standard Operating Procedures (SOPs) exist for reprocessing flexible endoscope tubing and accessories that are in accordance with the manufacturer’s instructions, and provide access to the SOPs to all personnel who reprocess these flexible endoscope tubing and accessories. Document that personnel who reprocess flexible endoscope tubing and accessories have read the most current SOP(s) and have been evaluated for competency to reprocess flexible endoscope tubing and accessories.
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AL09-07
Additional Information: If you don’t have current instruction/use manuals for the Olympus Flushing Pump, the Olympus Auxiliary Water Tube (MAJ-855), and any other Olympus devices, contact Olympus to obtain a current version.
Guidance – regarding notification of any patients that may have been exposed to blood-borne pathogens as a result of possible improper equipment set-up or reprocessing – is not addressed in this Patient Safety Alert. Guidance will be offered in accordance with VHA Directive 2008-002, Disclosure of Adverse Events to Patients.
See also Patient Safety Alert AL08-13, regarding improper reprocessing of flexible endoscope biopsy valves: http://www.patientsafety.gov/alerts/FlexibleEndoscopeBiopsyValvesAL08-13.pdf
Source: VA Medical Center
Attachments: 1) Photograph depicting correct set-up when using the Olympus Flushing Pump
2) Photograph showing the OFP Filter (7501355) and OFP Irrigation Tube (7501669)
Contacts: Olympus Regulatory Affairs, (800) 258-5187;
Dr. Gary Roselle, Director, National Infectious Diseases Program, (513) 475-6398;
Bob Osburn, Executive Manager for SPD, National Infectious Diseases Program, (202) 437-3958; or
Lori King, Biomedical Engineer, NCPS, (743) 930-5890.
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AL09-07
ATTACHMENT 1
Photograph depicting the correct set-up using the Olympus Flushing Pump
Photo illustrating connection of Olympus Flushing Pump (OFP), OFP Fluid Container, Cassette, Footswitch, Irrigation Tube, Filter, Auxiliary Water Tube and Endoscope Page 6 of 7
AL09-07
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ATTACHMENT 2
Photograph depicting the OFP Filter (7501355) and OFP Irrigation Tube (7501669)
Photo illustrating clear OFP irrigation tube with filter connected to one end
OFP Filter (7501355)
OFP Irrigation Tube (7501669)
++++++++++++++++++++++++++++++++++++++++++++++

OLYMPUS AMERICA INC.
3500 CORPORATE PARKWAY,PO BOX 610, CENTER VALLEY, PA 18034-0610
TELEPHONE (484) 896-5000
1
--- Important Safety Notice ---
January 26, 2009
On December 22, 2008 the Department of Veterans Affairs National Center for Patient Safety issued
a Patient Safety Alert entitled “Improper set-up and reprocessing of flexible endoscope tubing and
accessories”. (This document can be accessed at http://www.patientsafety.gov/alerts.html.) This
alert was issued in response to an event involving Olympus endoscopy equipment in use at a
Department of Veterans Affairs Hospital. From the onset of this report, Olympus America Inc. has
worked closely with the Department of Veterans Affairs National Center for Patient Safety to review
the events leading up to the publication of this alert.
Olympus would like to remind our customers of the proper use of the OLYMPUS accessory parts
mentioned in this alert. These devices are pictured below.
As evidenced in the photograph, the tubes are quite different in appearance. The MH-974 is
approximately 10 inches in length whereas the MAJ-855 is approximately 4 feet in length.
Function
• The MH-974 Washing Tube is designed for EVIS160/140 endoscopes that have an elevator
wire channel and for EVIS 140/240 endoscopes that have an auxiliary water channel. The
MH-974 is used in the reprocessing room to flush reprocessing fluids through the elevator
wire channel and auxiliary water channel during endoscope reprocessing. The MH-974 is
also used to flush sterile water through the auxiliary water channel during patient exams in
the endoscopy room. The water must be injected manually via a syringe.
• The MAJ-855 Auxiliary Water Tube is used during patient exams to flush sterile water
through the auxiliary water channel to wash the endoscopic field of view. The water may be
injected manually via a syringe or a flushing pump. The MAJ-855 also is used to flush
Proximal connector does
not contain any valve.
Labeled MH-974.
Proximal connector
contains internal oneway
valve. Labeled
MAJ-855
MH-974
Washing Tube
MAJ-855
Auxiliary Water Tube

Olympus notice letter alerting that "customers may be inadvertently neglecting to appropriately reprocess the MAJ-855 Auxiliary Water Tube"

Here is an excerpt from the February 11, 2009 notice letter sent out by Olympus to all users of their equipment. We are awaiting a reply from Olympus to see if they were the supplier of the endoscopes to the VA facilities in Miami. When we receive their reply we will post it.


This is the html version of the file http://www.olympusamerica.com/files/MAJ-855_CustomerLetter_2112009.pdf.

Page 1
OLYMPUS AMERICA INC.
3500 CORPORATE PARKWAY, PO BOX 610, CENTER VALLEY, PA 18034-0610
TELEPHONE (484) 896-5000

February 11, 2009

IMPORTANT SAFETY NOTICE
Dear Olympus HealthCare Practitioner:

It has come to our attention that some customers may be inadvertently neglecting to appropriately reprocess the MAJ-855 Auxiliary Water Tube. This notice is to remind you that the MAJ-855 Auxiliary Water Tube must be reprocessed each time it is used in an endoscopy procedure, regardless of whether the auxiliary water feeding function was used during the procedure or not. Olympus is not aware of any injuries that have occurred as a result of this reported breach in reprocessing.
The MAJ-855 Auxiliary Water Tube is pictured below and can be positively identified by the model name (“MAJ-855”) embossed on the green Luer connector. This connector contains a one-way valve that prevents fluid from flowing backward through the tube and prevents water from freely flowing out of the distal end (metal connector) of the tube when disconnecting a syringe or pump from the green Luer connector.

Sterilize daily
The MAJ-855 Auxiliary Water Tube must be reprocessed prior to first use and following each use (i.e., after each patient exam). Whenever an MAJ-855 Auxiliary Water Tube is connected to an endoscope for clinical use, it must be reprocessed before reuse on a subsequent patient, regardless of whether the auxiliary water feeding function was used during the procedure or not.
The one-way valve in the green Luer connector of the MAJ-855 is important for the safe and effective use of this accessory. The one-way valve prevents fluid from flowing backward through the tube and prevents water from freely flowing out of the distal end (metal connector) of the tube when disconnecting a syringe or pump from the green Luer connector. Do not modify this tube or change its connector(s). The connector is not intended to be removed for reprocessing.
In addition to its use during clinical procedures, the MAJ-855 is also used to reprocess 160-series and 180-series endoscopes that contain auxiliary water channels. When the MAJ-855 is used to manually reprocess an endoscope with an auxiliary water channel, the MAJ-855 will be reprocessed along with the endoscope itself.
Page 4
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However, if the endoscope is reprocessed in an automated endoscope reprocessor (AER), and the MAJ-855 is not used to connect the endoscope to the AER, the MAJ-855 must be reprocessed as a separate item.
The MAJ-855 is compatible with all high-level disinfectants that are compatible with Olympus endoscopes, as well as steam sterilization.
Note that if the Olympus OFP Flushing Pump is used, both the Filter and Irrigation Tube for the OFP must be sterilized prior to first use. They can then be used for multiple endoscopy procedures throughout one day without the need for re-sterilization between patient examinations. However, they must be discarded at the end of the day. The OFP Fluid Container must be sterilized daily.
ADDITIONAL INFORMATION
If you require additional information about the proper steps to reprocess Olympus endoscopes or accessories, please contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. The Olympus TAC can assist in answering questions on reprocessing and obtaining additional copies of Reprocessing Manuals for Olympus endoscopic equipment.
Olympus offers an extensive curriculum of educational programs for endoscopy, with specific courses on endoscope reprocessing for both nurses and reprocessing specialists. Please visit our website at www.olympusuniversity.com or call the Olympus Registration help desk at 1-800-231-0016 to obtain more information.
Additionally, Olympus has a webpage dedicated to reprocessing information for Olympus endoscopy equipment. Please visit our website at www.olympusamerica.com/msg_section/cds/index.asp.
Sincerely,
Olympus America Inc.

Veterans at three VA medical facilities potentially exposed to hepatitis during endoscopy

Over the past couple of months three different VA medical facilities have reported that thousands of veterans have potentially been exposed to Hepatitis B or C or HIV due to improper sterilized endoscopy equipment. According to "Dr. John Vara, Chief of Staff for MVAHS, it's not clear what went wrong with the sterilization procedures. One report has Vara saying that "the problem was detected because of a manufacturer's alert and a review of endoscopy procedures." CBS4.com, Peter D'Oench reporting.

Then according to Medical News Today, as reported by Catharine Paddock, PhD: Dr. John Vara, "told the press that during an internal safety review they discovered on 4 March that a part of the equipment used in colonoscopies and other gastrointestinal procedures was not being disinfected, only rinsed. This was contrary to the manufacturer's recommendation, he said."

Regardless of who is at fault, veterans need to get tested to find out their current medical status.

The questions we want to see answered is what prompted the examination of endoscopy procedures and sterilization procedures in the first place. Was it based on information originating from the company or originating from the VA, and what is this information, provide it to the veterans.

For those veterans exposed through the Veterans Affairs hospital in Miami, some 3,260 patients The South Florida Sun Sentinel website reported, "The VA announced special care clinics had been set up in the Miami VA, the Broward County VA Clinic, the Homestead VA Clinic and the Key West VA Clinic to handle screening of patients who may be infected.

Officials also established a special care 24-hour hot line at 305-575-7256, or toll free, 1-877-575-7256."[reported by Mike Clary and Bob LaMendola]

We hope that all potentially exposed veterans will get checked, because as The Channel 4 I-Team reported n March 12, 2009, it "has learned of at least a half-dozen patients who had the procedure there[York Hospital in Murfreesboro] and have tested positive for hepatitis." The question is whether they had hepatitis before being exposed or contracted from the exposure, regardless they got tested and are now, hopefully, receiving proper medical care because they got tested.

Brief History of Endoscopy Exposure Reports

March 24, 2009, Two conflicting Reports:
Medical News Today, as reported by Catharine Paddock, PhD: "John Vara, chief of staff of the Miami VA Health Care System, told the press that during an internal safety review they discovered on 4 March that a part of the equipment used in colonoscopies and other gastrointestinal procedures was not being disinfected, only rinsed. This was contrary to the manufacturer's recommendation, he said."

"Dr. John Vara, Chief of Staff for MVAHS, says it's not clear what went wrong with the sterilization procedures. Vara said the problem was detected because of a manufacturer's alert and a review of endoscopy procedures."[CBS4.com, Peter D'Oench reporting]

On Feb. 9, 2009, Tom Corwin with The Augusta Chronical reported that, "About 1,200 veterans may have been exposed to infection after they were treated with improperly sterilized equipment at the Augusta Department of Veterans Affairs Medical Centers, the health system announced today."

On February 17, 2009, Kristy Davies with the Courier Post Online reported that "Nearly 6,400 patients of the Alvin C. York VA Medical Center [Murfreesboro, Tenn.] will receive letters notifying them that they could have come in contact with contaminated endoscopic equipment if they received a colonoscopy there between April 23, 2003, and Dec. 1, 2008."

On March 24, 2009 Jim Preppard with 10 Connects.com reported that "Officials say about 3,260 patients at a Veterans Affairs hospital in Miami should be tested for HIV, hepatitis and other diseases after receiving colonoscopies with equipment that wasn't properly sterilized."