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Are Your Reusable Medical Devices Really Sterile?

Are Your Reusable Medical Devices Really Sterile?

Reusable medical devices are in use throughout many healthcare facilities, from the emergency room to the operating room. These devices are typically put through stringent sterilization procedures before they’re deemed patient-ready for reuse. Unfortunately, those sterilization processes aren’t always as effective as most medical professionals – not to mention their patients – would like to believe. How sterile are the reusable medical devices in use throughout your facility? If you’re opting to autoclave medical devices, even according to the manufacturer’s recommendations, rather than choosing single-use devices for your patients, the answer may be, “not as sterile as you think.” 

Biodebris on Sterilized Devices: The Hazards

Sterilization processes, from autoclave to chemical sterilization, are intended to destroy microscopic bacteria, viruses, and other particles that could potentially cause harm to the patients who are next to use the materials. Unfortunately, those sterilization processes aren’t designed to fully filter out larger biodebris. In many cases, biodebris has gotten stuck in devices even after they’ve made it through the autoclave. If it’s spotted before it’s put into use for a patient, the crisis has been averted. Visual inspection, however, isn’t always practical for medical devices that are needed in the middle of an emergency situation. Not only that, but bacteria and other contaminants may not be visible to the naked eye, making it impossible to determine whether or not a device is truly “safe.”

In some cases, that can lead to significant issues. A few years ago, for example, contaminated bronchoscopes that caused significant problems and microbial infections in many patients led to increased regulations from the FDA, including the requirement for visual checks any time a device is reused. Hazards of biodebris on so-called “sterilized” devices could include introducing foreign matter to patients, leading to infection and other problems that could hinder the healing process and even make patients sicker. This is particularly dangerous in the operating room, where exposure to foreign biodebris could make patients very ill.

a top-down view of medical equipment on gray stone background.

Many surgeons believe that once biodebris has been through an autoclave, it’s sterile–even if it’s visible on the equipment. Thus far, no study has definitively proven whether or not biodebris is hazardous after it’s been sterilized. It’s important to note, however, that infection clusters have been observed in cases where biodebris was noted in medical devices, such as this case, where three patients ended up with Staphylococcus epidermidis septic arthritis after having the same repair surgery over a four-day period at a specific hospital.

Patient contamination can cause serious problems: infections, increased healing time, illness, and even, in some cases, death. For this reason, it’s vital to ensure that tools are appropriately sterile before proceeding with medical procedures. Unfortunately, there are few studies that have been used to determine the actual sterility of medical devices that have been autoclaved and marked as safe for reuse. For this reason, these devices remain in use throughout medical facilities – and many of them may lead to significant problems for patients.

Testing Sterility of Reusable Medical Devices

A recent study aimed to test the sterility of medical devices that could potentially be used in surgical situations. The study examined drill bits used in a way that was designed to mimic the surgical process. Researchers allowed the bits to sit for the duration of the surgical process, then sterilized the equipment according to the manufacturer’s recommendations. At the end of the study, bacteria were found on some of the experimental bits. As a result, the team determined that it’s impossible to say for sure that biodebris has been fully sterilized after going through the autoclave process. This simple experiment has left a number of questions for medical professionals, particularly surgeons. While some have often used a “better safe than sorry” approach to visible biodebris found on reusable medical devices, others assumed that the autoclave process was enough to sterilize them. Worse, bacteria found on reusable medical devices after they’ve been used in surgical procedures may not be visible to the naked eye, leading to contamination even when surgeons are unaware of potential problems.

The Solution: Single-Use Medical Devices

Single-use medical devices are the ideal solution to a sterile medical solution. Consider these benefits:

Single-use medical devices are free of contaminants.

They’re packed in sterile environments, where they will not be exposed to potentially harmful bacteria that has the potential to cause illness and infection in patients. That means that they come into your facility clear of potential contamination and are used on your patients the same way. This is a much easier way to cut down on the spread of bacteria, even potentially reducing outbreaks throughout your medical facility. In this way, you can actually cut down on the costs associated with your medical devices since you won’t end up spending more money on patient care when it’s uncovered that your devices led to the spread of infection.

Single-use medical devices won’t spread harmful bacteria from one patient to another. 

This will help ensure that all patients have better outcomes for their procedures. It’s impossible to know what bacteria are being transmitted between one patient and another, even after devices have been sterilized according to manufacturer recommendations. When you opt to use single-use tools for each patient, however, you decrease cross-contamination and make it easier to keep your patients healthy and safe.

Single-use medical devices reduce the instance of healthcare-associated infections.

According to the CDC, healthcare-associated infections can be reduced by as much as 70% by making the transition to single-use medical devices across the facility. This means 70% of your patients who will have smoother recovery periods and better outcomes for their surgical procedures.

The Bottom Line: Single-Use Medical Devices Create Safer Medical Facilities

Single-use medical devices are one of the most effective alternatives to reusable medical devices. They substantially increase patient safety and decrease the odds of secondary infections related to healthcare treatment. Our ONETRAC device, for example, is an incredible surgical tool that can easily be used to decrease cross-contamination during the surgical process.

If your medical facility is ready to make the switch to single-use medical devices, contact us! We’ll work with you to establish what single-use medical devices could help decrease instances of infection throughout your facility.

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