March 7, 2011
By Derek Hatchett, Director, Emerging Technologies
When the ECRI Institute, an independent organization that evaluates medical devices and procedures, issued its 2011 list of the Top Ten Health Technology Hazards, reprocessed flexible endoscopes made the list for the second year in a row. “At minimum, endoscope reprocessing problems, when discovered, can inconvenience patients and create anxiety; at worst, they can lead to life-threatening infections,” the report says. With tens of thousands of patients undergoing such procedures each year, the issue begs resolution. ECRI said its list was compiled based on “a review of recent recalls; analysis of information found in the literature” and the organization’s “experience in investigating and consulting on device-related incidents.” Most notable was the widespread incidence of contamination of endoscopic equipment at VA hospitals that exposed thousands of veterans to the risk of infection, including HIV.
Recent developments in medical device design are paving the way for a new class of disposable endoscopes, disposability that will virtually eliminate the risk of cross-contamination. Endoscopes need to be small in diameter, a fact that was at odds with high-resolution photo optical equipment where bigger was synonymous with better Until recently, that is. There has been tremendous progress in the arena of small, low-cost, high-resolution camera sensors that can be used in the distal end of scopes. The camera is connected to a monitor at the proximal end of the scope by very small, low-voltage wires running the length of the scope. The technology is attaining (and soon to be surpassing) the performance of higher-cost plastic and glass optical fiber scopes.
This low-cost, disposable visualization technology has been finding acceptance in traditionally “blind” procedures, such as pulmonary sample collection. Low-resolution cameras aid clinicians in navigating to the optimal organ sample site, where the sample can be collected, sequestered and sent out for analysis. Afterwards, the entire collection device is sanitarily disposed. The only capital component of the system is the monitor, which is remote from the patient. And eventually, even the monitor will be considered disposable if costs come down sufficiently.
Not only do such disposables greatly enhance patient safety, they actually help the healthcare institution reduce costs, a priority goal in medical device design. A recent independent study by Ximedica showed that the disposable replacement component was one-third the cost of reprocessing and cleaning a traditional flexible endoscope.
Physicians who have used various disposable visualization devices in the prototype stage indicate that the image quality is sufficient for diagnostic purposes, but FDA standards require a greater minimum resolution for endoscopes used in the gathering of diagnostic imagery.
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