Unclean Reprocessed Medical Devices Cause Concern

Safety concerns regarding reusable medical device has been brought to the surface. Organizations such as the FDA and CDC, and companies who make medical devices are worried over whether devices are being cleaned enough to use over and over again, especially with the device’s complex design.

According to News Medical Life Sciences, medical device manufacturers are held with the responsibility of making sure that reprocessing procedures are active and taken seriously. Before medical devices can officially enter the market, they need to be approved by the FDA. Medical device manufacturers must make sure that the design of a reusable device can be easily well-cleansed and sterilized. Labs even test how well these products can be cleansed. The steps for reprocessing and use of the product also need to be clearly writer for the user. After this, test results are submitted to the FDA by the manufacturer where the product is either approved or declined.

While the idea of reprocessing a medical device seems simple, there are various factors that can prevent a device from being cleansed and sterilized thoroughly. Reasons could be that the steps to do so were not properly followed, resulting in poor cleaning or healthcare associated infection (HAI). However, sometimes even when the directions are followed, the cleansing process was not enough to prevent infection.

According to Medical Life Sciences, this arthroscopic shaver from a hospital was not cleansed properly, causing a patient to receive an infection. The patient has an infection in part of the shoulder bone and rotator cuff.

There have also been many instances when duodenoscopes caused an HAI Carbapenem-resistant Enterobacteriaceae (CRE). While the cleaning procedure was followed, the procedure itself was not enough. The tip of the duodenoscope is very small, making effective cleaning difficult.

According to News Medical Life Sciences, “Sterility is acceptable if the sterilization process produces a sterility assurance level (SAL) of 10-6.” Devices must be cleansed before sterilization to reach this level. However, just because a device is sterilized, does not mean that it is effectively sterilized. If any steps are missed in the sterilization process, or if a device is not used for its actual purpose, that can also result in an infection.

Devices are made in certain ways and are made with certain materials in accordance with its true purpose.

One design that has not caused many issues are the newest models of laparoscopic instruments. This is because the device can be taken apart for cleaning. These instruments are taken apart, cleansed and sterilized, and then pieced back together.

The final concern revolves around setting sterilization standards and training people to do so. The demonstration of cleaning devices may not be thorough, causing people to not follow the steps properly.

To fix these issues, standards are in the process of being updated. The FDA is trying to pay attention to these issues before medical devices are even approved. Furthermore, they state that only devices that can be considered for approval are those that can be sterilized in standard cycles.