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Hon. Harry E. Mitchell (D-AZ), Chairman, House Veterans' Affairs Oversight and Investigations Subcommittee, called for more centralized control of the veteran's health system and expressed outrage over recent cases of veterans who may have contracted diseases through reported improper reprocessing of medical equipment. The Committee hearing on the matter was held June 16. (See our prior coverage at DM 8830 and DM 8928).

The hearing focused on VA reports of improper reprocessing, incorrect usage, and substandard cleaning of endoscopic equipment at facilities in Murfreesboro, Tennessee; Augusta, Georgia; and Miami, Florida. The hearing also focused on the findings of a recently released VA Office of Inspector General (OIG) report following unannounced visits to more than 42 facilities operated by the Veterans Health Administration (VHA).

VHA employees exposed veterans to possible harm by using a wrong valve, not cleaning parts of endoscopic equipment correctly, using the wrong disinfectant to clean equipment, failure to reprocess the flush tubing leading to the scopes correctly, and connecting water tubing in the middle of procedures and not in the beginning. All mistakes were human error due to lack of enforcement of proper procedures, according to the Committee.

"Exposing our veterans to that type of risk is unacceptable, and frankly I'm outraged at the thought of them having to worry about the possibility of being infected," Chairman Mitchell said. "The VA now has to work to implement standardized procedures and training to ensure mistakes like these will never happen again. It must work harder and longer to regain the trust of the veterans it serves and care for those who have been exposed."

According to Hon. Cliff Stearns (R-FL), 13 veterans have been diagnosed with Hepatitis B, 34 with Hepatitis C, and six with HIV after being treated at the facilities; an estimated 10,000 patients may be at risk of infection.

While it's still unknown if these diseases were contracted because of the improper use and sterilization of the medical equipment, the results of the unannounced inspections by the OIG led to the conclusion that serious management issues need to be addressed by VA hospitals nationwide with respect to industrial reprocesses such as proper disinfection of reusable endoscopes.

Discovering the Problem

In December 2008, staff members at the Murfreesboro, VA Medical Center observed discoloration in the tubing that supplies water to flush the colonoscope during an endoscopic colonoscopy. Realizing the potential dangers associated with contaminated fluid, the staff investigated further and determined two shortcomings:
1. They were not using a water irrigation tube with a check valve designed to prevent contaminated fluid from the patient from flowing back into the scope and irrigation water tubing.
2. The Auxiliary Water Tube (MAJ-855) had been altered with an incorrect connector.
In short, the Murfreesboro staff were not changing and reprocessing the MAJ-855 in accordance with set manufacturer protocol.

"Reprocessing procedures are defined by the endoscope manufacturer and generally involve careful cleaning of the entire external and internal surfaces with an appropriate cleaner, brushing any interior channels, and subjecting the entire scope to high level disinfection or sterilization as recommended in the manufacturer's instructions," reported William E. Duncan, M.D., Ph.D., MACP.

As a result of mishandling the manufacturer's protocol, a Patient Safety Alert (AL09-07) was issued to the entire VA system on December 22, 2008. The alert warned of using the correct valve and stressed the importance of following instructions given by manufacturers. Weeks later, 16 additional facilities reported they had in some way not reprocessed their endoscopes in accordance with manufacturers' instructions.

Finding the Solution

In response to the findings, the House Committee on Veterans' Affairs held the recent hearing and called for more centralized control of the veteran's health system.

John D. Daigh Jr., M.D., CPA, Assistant Inspector General for Healthcare Inspections, served as a witness in the hearing, commenting that VA medical facilities, in fact, have not complied with multiple directives to ensure endoscopes are properly reprocessed. Dr. Daigh reported, "unannounced OIG inspections last month found that medical facilities:
· Have the appropriate endoscope Standard Operating Procedures (SOPs) available 78 percent of the time.
· Have documented proper training of staff 50 percent of the time.
· Are compliant with both recommendations 43 percent of the time."

The meeting explored a number of steps to be taken by the VA to correct previous pitfalls experienced with the set up, use, reprocessing, and maintenance of reusable endoscopy equipment at VA medical facilities across the country.

Future directives include outlining the responsibility for reprocessing endoscopes as described in the VA Handbook "Supply, Processing, and Distribution (SPD) Operational Requirements" so that it is International Organization for Standardization (ISO) 9001 compliant. ISO is the world's largest developer and publisher of international standards, predominantly considered the standard for quality medical systems.

In addition, a workgroup is tasked to continue to investigate ways to simplify reprocessing protocols and training needs as well as equipment maintenance and training services.

CNN Medical Correspondent Judy Fortin also reported that veterans will not be charged for any of the treatments they receive going forward.

More information on the investigation of endoscopy procedures by the US Department of Veterans Affairs, "Endoscopy Procedures at the U.S. Department of Veterans Affairs: What Happened, What Has Changed?" can be found at:
http://veterans.house.gov/hearings/hearing.aspx?newsid=417

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