In the last two years, a series of adverse events have occurred in patients, linked to the use of a variety of endoscopic medical devices that were improperly reprocessed and maintained. After further investigation, the FDA determined that not only were most hospitals not meeting the manufacturer guidelines for proper reprocessing, but also that those guidelines were not sufficient to prevent the spread of infection in the first place.
In the aftermath of several deaths and more than 250 reports of infection, new sanctions are being placed on medical device manufacturers for better oversight and more complete reporting of the risks associated with their devices.
What Went Wrong
The endoscopic devices that have been linked with infections are used in minimally invasive surgeries, as well as in routine endoscopic procedures. These devices vary in size and complexity, utilizing fragile cameras, which allow doctors to visualize internal cavities through relatively small incisions. These devices must be disassembled as far as possible and disinfected using proper procedures and supplies prior to reuse.
The combination of improper care alongside inadequate guidelines can lead to undesirable effects, such as the development of internal biofilms in the inner nooks and crannies of endoscopic devices. In the recent outbreaks, many of the affected medical facilities have uncovered a non-compliance with manufacturer recommendation for decontamination and reprocessing these devices. These issues are the likely contributors to the recent infections associated with endoscopic and other minimally invasive procedures.
Under current federal regulations, medical facilities are required to track the spread of infectious diseases and report to device manufacturers when there are cases that may be directly associated with their products.
Device manufacturers are expected to take steps to investigate the claims and notify other medical facilities of the risks. Should the investigation uncover flaws in the recommendations, they must issue updated instructions and/or a recall flawed devices for upgrade to minimum standards of infection prevention.
In contrast, medical facilities are only expected to report to the FDA if these infections are linked to actual deaths, leaving a gap in the amount of information that regulators have to issue warnings and prevent the use of unsafe medical devices on patients.
In the wake of increased adverse events associated with endoscopic devices, the FDA is seeking to improve control of medical devices coming into the United States from foreign countries, while updating minimum reporting standards. These measures are aimed at improving awareness to device-related events that may put patients in immediate danger.
Some professionals have advocated for the assembly of a committee charged with thorough vetting and validation of such devices before going to market.
Others have argued that more reporting is needed by medical facilities, and greater accountability for device manufacturers to provide meaningful guidelines that healthcare facilities can rely upon.
It has also been suggested that manufacturers be subject to heavier fines and sanctions in cases where death has occurred as a result of negligence.
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