How the FDA May Have Enabled the Recent Epidemic of Endoscope Related Infections

The Federal Drug Administration (FDA) and its 510(k) Clearance program may have played a role in preventing potentially dangerous endoscopes from being adequately tested before being released to the market. Because endoscopes are highly regulated medical devices, the FDA’s approval processes should be able to catch any critical health risks posed by their use. However, the expedited nature of the 510(k) Clearance process may have allowed Olympus duodenoscopes to slip through the cracks.

As this article by Gordon Gibb at explains:

“The FDA 510(k) Clearance program is available for any medical device update deemed similar to an existing device – such as an endoscope or duodenoscope – already on the market and performing within specifications. This spares the manufacturer from undertaking the due diligence of an exhaustive clinical trial normally required to approve a product for market, to assure it is safe and effective for the requisite patient cohort.

However – as has been the case with the complexities of duodenoscopes – the design updates approved within the 510(k) framework did not pick up, or so it has been alleged, on unique risks posed by the updated design not necessarily associated with the original design.

The FDA noted in February of 2015 that duodenoscopes have what are known as ‘elevator mechanisms’ that allow the doctor to alter the angle of the device. However, the elevator had the potential to effectively prevent adequate sterilization.

The 510(k) Clearance program was originally envisioned to place promising drugs and devices into the market faster, so patients could benefit more quickly. Critics of the loophole opine that the end result is the movement of potentially unsafe products into the market and into widespread use with the general population without proper vetting, while sponsoring corporations reap the benefit of fast tracked revenue streams.”

Read the entire notice here: Endoscope Disinfection Problems Extend Beyond Devices Themselves

It’s hard to pin down exactly how much regulations played a part in the recent outbreak of endoscope related infections. Endoscopes themselves will always pose a potential source of infections at hospitals and healthcare facilities, and they must be prepared to minimize this risk. Staff must make sure that their cleaning processes are well-vetted, standardized and closely followed in order to minimize the risks on their hospital. Solutions such as those from Mobile Aspects can also go a long way towards standardizing the systems and processes by which scopes are reprocessed, and they can provide warnings whenever breakdowns occur.