Andrea Ortegon - Comment

In the medical world, there become many situations when you are in need to stop bleeding ASAP. This can be done with the absorbable hemostatic devices. These devices can be in many different widths, lengths and absorbable volumes. With the classification change from III to II it would not change the medical product but change the degree of scientific knowledge needed to use this product. I believe that this classification change would benefit all who use hemostatic devices, especially those of the absorbable kind. Having worked with patients that have varying wounds having a medical device that can absorb a high amount of bodily fluids is a great assistance when cleaning and caring for wounds. The main focus of the hemostatic device is to control bleeding when it cannot be controlled by conventional means, such as using a cautery gun or ligation or tying of the blood vessels. The hemostatic device can also be used when it is difficult for the surgeon to access the bleeding area(s). The class II reclassification would not change how the medical fields use this device but it would lower the costs associated. When devices are class III it is priced at a higher rate and has to be determined by scientific data that this device is needed. In 1976 when Congress classified all transitional devices, including absorbable hemostatic devices as new drugs into class III. Changing the classification would make this medical device easier to purchase for hospitals or clinics. There are many risks involved with using the hemostatic devices, but there are always going to be risks when you are dealing in the medical fields. Some of the more severe risks would be hematomas, infections, wound dehiscence, foreign body reactions, immunologic reactions, adhesion formation, failure to absorb, embolization, and nerve damage or paralysis. Please make the change of the classification. The medical field needs to be able to bring this device throughout the medical community.