A recent segment on the Today show highlighted public concerns regarding hospital acquired infections – specifically, those that can be contracted from medical devices and surgical instruments. The report presented the case that even if proper sterilization processes are followed, there remains a strong chance that surgical equipment will be contaminated with blood, tissue, and fluids from previous patients.
In particular, the Today show focused on the idea that certain new and ‘complex’ medical devices were being constructed out of materials that made them very difficult to completely clean. Some of these tools were associated with a frightening, yet anecdotal ’100 percent’ rate of ‘contamination’ according to interviews with a clinical engineer on the program.
Representing the industry was a prepared statement from AdvaMed, which reiterated the fact that medical device reprocessing is a strictly controlled process that must keep in line with FDA regulations. AdvaMed also stated that manufacturers provide detailed guidelines and instructions for reprocessing with each medical device, relying on facility staff to follow these directions explicitly.
Using AdvaMed’s written communication to NBC as a springboard, it is possible to expand on the limited amount of time given to the concept of medical device reprocessing by the Today show in order to demonstrate just how pressing a concern this is for the industry. In fact, at the 2011 AAMI/FDA Medical Device Reprocessing Summit, significant attention was devoted by attendees to simplifying reprocessing instructions and combating many of the challenges identified by the television program.
The Summit clearly illustrated the level of engagement by medical device manufacturers and health care professionals with regards to creating an environment where patient safety is the most pressing priority. 275 representatives from across the medical spectrum attended the gathering, which was an extension of an FDA reprocessing workshop from the previous summer. Some of the major concerns that were addressed included:
- How to properly establish adequate cleaning validation protocols
- Standardizing reprocessing instructions
- Improving best practices by evaluating human factors, work environment factors, and strengthening training and education.
AAMI/FDA Summit participants also worked together to create an agenda identifying the steps that needed to be taken in order to achieve these goals, as well as create awareness regarding the importance of cleaning and decontamination, sterilization, and proper medical device storage. The full AAMI/FDA report that resulted from the Summit meeting is available online and offers a far more balanced and in-depth perspective on the multi-faceted issue of patient safety and medical device reprocessing than is possible to offer within the limitations of a morning news program.
Make sure to follow the Aptiv Medical Device blog as we continue to take a close look at the issues surrounding medical device reprocessing and protecting public health.
adapted and republished from Aptiv Solutions Blog
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