June 22, 2009
More On The Veterans Affairs Colonoscopy Situation
By Michael D. Shaw
A number of weeks ago, we covered the sad story of how colonoscopes became contaminated at certain VA Medical Centers, leading to thousands of patients being notified that they should be tested for HIV and Hepatitis B and C. An investigation determined that an incorrect connector, which could allow backflow and contamination of the irrigation solution, was the cause.
On June 16th, the VA’s Office of Inspector General issued a report entitled “Healthcare Inspection: Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities.”
In preparation of the report, inspectors visited those facilities which had been under media scrutiny—the Miami, Murfreesboro, and Augusta Veterans Affairs Medical Centers. Applicable regulations, policies, procedures, and guidelines were reviewed. In addition, 26 inspectors conducted unannounced site visits at 42 other randomly selected facilities to examine pertinent endoscope reprocessing documentation.
The 45-page report pulls no punches…
Facilities have not complied with management directives to ensure compliance with reprocessing of endoscopes, resulting in a risk of infectious disease to veterans. Reprocessing of endoscopes requires a standardized, monitored approach to ensure that these instruments are safe for use in patient care.
The failure of medical facilities to comply on such a large scale with repeated alerts and directives suggests fundamental defects in organizational structure.
As such, three major recommendations were made to the Acting Under Secretary for Health:
- Ensure compliance with relevant directives regarding endoscope reprocessing.
- Explore possibilities for improving the reliability of endoscope reprocessing with VA and non-VA experts.
- Review the Veterans Health Administration organizational structure and make the necessary changes to implement quality controls and ensure compliance with directives.
One finding that seems to be getting media attention is contained in Table 5—Sample and VA estimates of compliance with standard operating procedures and competence in accordance with VHA directive 2009-004: “Colonoscope Reprocessing.”
Based on the actual sample data, only 47 percent of of 38 facilities were in compliance with both SOPs and competence. Using a statistical model to predict performance system-wide, compliance with both SOPs and competence was estimated at 42.5 percent.
While this seems awful, the plain truth is that we have nothing to compare it with. Who knows how other hospitals or clinics would fare if subjected to the same testing? As it is, poor infection control is still a major issue in health care. Many authorities believe that CDC’s official figure of 1.7 million hospital-acquired infections per year, with perhaps 90,000 deaths, understates the problem by a considerable margin.
Although the VA report details the matter of an incorrect connector being used, it does not suggest—as do media reports—that this could have occurred based on the recommendation of a certain automated endoscope reprocessor (AER) manufacturer. In fact, as emphasized repeatedly by the VA, the manufacturer of the endoscope itself recommends only manual—and not automatic—reprocessing of the particular tube that lies at the heart of the contamination problem.
Experts speculate that since the correct fitting—provided with a one-way valve—would not allow automatic reprocessing, a connector without the one-way valve would have been put in its place, for reprocessing only. Of course, the correct connector must be put back into the scope before use on a patient! Apparently, sometimes this was not done.
Furthermore, according to one expert I interviewed, the AER manufacturer recommended this procedure by virtue of a technical bulletin, but the procedure was never validated by the FDA. If true, this is a serious violation. However, the AER manufacturer might have chosen to do this in light of the FDA’s apparent non-enforcement (or at best weak enforcement) of its own Warning Letter against another—much larger—AER manufacturer.
Regulatory enforcement can be complex. In a recent case, the FDA sent a warning letter to Matrixx, the manufacturer of Zicam cold remedy products, asking that the company stop marketing them, based on many reports that they could cause a loss of the sense of smell (anosmia). Customers were advised to stop using the products at once. FDA also mentioned in the letter that by virtue of the claims being made on the package, they are drugs subject to FDA enforcement.
In the same Warning Letter, though, the agency acknowledges that “many homeopathic drug products are manufactured and distributed without FDA approval under enforcement policies set out in the FDA’s Compliance Policy Guide entitled “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15).” Evidently, once a problem is noted, full FDA rigor comes into play. I realize that this makes little sense, as the bulk of what the agency does is pre-market approval, to protect the public in the first place.
Since homeopathy is defined as “a system of medical practice that treats a disease by the administration of minute doses of a remedy that would in healthy persons produce symptoms of the disease treated,” and since zinc gluconate does not cause cold symptoms, it is most unclear why Zicam would be considered homeopathic.
In this era of ever-expanding government, perhaps we should be increasing common sense and integrity, and not just power and budgets at the regulatory agencies.