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Hidden Danger of Tainted Medical Devices

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  • September 15, 2016

Hidden Danger of Tainted Medical Devices

Threat of Infection from Medical Instruments

A busy hospital “can process as many as 15,000-20,000 surgical instruments in a dayand a patient’s safety depends on these medical devices being properly cleaned and sterilized before reuse but any little slip-up can result in patient cross-contamination. This is a big patient safety issue and often hospital-acquired infections or healthcare-acquired infections (HAIs) due to these dirty medical instruments go undisclosed and unrecorded as it is often hard to pinpoint where a patient’s infection originates.

An employee may skip steps in the medical instrument cleaning process, for example, if the technician needs to turn the job around quickly or the specific medical device is in short supply, there’s pressure on the technician to get the device back up to surgery immediately. These problems have become more of an issue as operations have become less invasive over the last 30 years and therefore tiny medical instruments such as laparoscopic tools and surgical scopes like duodenoscopes have become so mainstream in surgical procedures. “Thirty or 40 years ago, you didn’t have (surgical instrument) cases with 400 pieces in them, said Jahan Azizi, a retired clinical engineer for the University of Michigan Health System, now director of regulatory affairs with HeartSync, a manufacturer of defibrillation electrodes, and an expert on cleaning medical instruments.

These tiny scopes, suction tips and other precise devices can take four hours to clean as well as a keen understanding of science, a higher level of training and education, which was quite unnecessary for this type of surgical instrument cleaning job years ago.

Even when these devices appear to be carefully processed, some medical instruments are notoriously difficult to clean. Hospitals in many big cities across the U.S. have experienced outbreaks of deadly infections caused by drug-resistant superbugs that sit in the cracks and crevices of these tiny scopes and complex surgical devices.

There are guidelines to follow for the recommended best way to clean, disinfect and sterilize medical instruments but these guidelines cover several different processes which could include dry heat, gas, steam, hydrogen peroxide gas plasma and various other chemicals. Also according to the guidelines, the cleaning process should start in the operating room, where these medical instruments should be rinsed immediately after use in an operation as this stops the coagulation process. Skipping any step can leave blood, bone, tissue or mucus to dry on the instruments, making it harder to remove later. Several processes of cleaning medical devices follow from ultrasonic high frequency water baths to high heat steaming, however, even in all of these processes, things can get missed and “anything…that you can’t see with the naked eye may have the same problem, so there’s dried blood falling on that patient, said Azizi.

There has now been a recent study on medical scope contamination which is hinting at a surprising cause for the contamination of medical scopes nationwide: gas relief drops. This routine practice of regularly injecting these liquid gas drops into scopes to reduce the bubbles inside the body which hinder surgeon’s visibility, may actually be helping bacteria grow and thus making the bacteria hard to remove. 

The scariest part of all is that we actually have no real handle on how many people die from superbug and drug-resistant infections due to lax hospital standards. There have been 10,000 deaths linked to antibiotic-resistant infections in the state of Texas alone from 2003 to 2014 and to think of the tens of thousands of other possible wrongful deaths that can be linked to antibiotic-resistant infections nationwide over the past years, it is a staggering number to imagine. What’s more unfortunate is that many of these drug-resistant infection fatalities are going unrecorded on death certificates which is clearly a problem that needs to be addressed more thoroughly than it has been in the past. Currently, Director Freiden of the CDC (Center for Disease Control) said that there is “no simple way to code for drug-resistant infections on death certificates and “is supporting states’ efforts to respond to antibiotic resistance and help protect Americans from this threat.” 

The FDA (Food and Drug Administration) is also working with federal partners and manufacturers to better understand the critical factors contributing to bacterial infections associated with duodenoscopes and other medical devices and how to best mitigate these risks.

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