Surgery is a complicated process for a number of reasons. There is the issue that needs to be corrected, the patient, the health of the patient, any pre existing conditions that should be taken into account, the procedure itself, and of course the equipment that is to be used. People trust that all of these factors will be fully taken care of and handled with top notch professionalism, and, especially, that all equipment and surgical components will be safe and functioning properly.
Unfortunately, there are times when this is not the case, and certain things go wrong. One issue that has come to light as of late is that of defective surgical waste systems. These systems appear to be malfunctioning, causing patients to become injured. One system in particular, made by a leading surgical supply manufacturer, has particularly been at the center of alarm due to patient injuries. This system is designed to collect waste and fluid in surgical facilities and operating rooms, but has since been recalled because of reports of serious complications and fatalities. Based on information from the United States Food and Drug Administration (FDA) two versions of the same surgical waste system can pose possibly fatal side effects such as severe bleeding, damage to soft tissue, and damage to organs when not used properly.
A class I recall, the most severe type of recall, was issued in June of 2012 for six models of surgical waste systems made by one manufacturer. The recall was issued after both the manufacturer and the FDA received reports of a patient being injured, and one patient dying due to the use of one of the systems. The FDA states that the injuries and the fatality were due to use of the high flow high suction system, which was not used in a correct fashion.
One model in particular was connected to a tube used for passive chest drainage following an operation, which caused a fatality. The FDA warns that the product instructions did not warn users against doing this, and goes on to state that even when the devices are used in a correct fashion, they can lead to damage of the muscles, soft tissues, and organs which can cause serious harm and even deaths.
A class I recall the most serious of all of the FDA recalls, were issued for all the devices in question. This type of recall suggests that using the device or product in question poses a serious threat to patient health and may result in death.
In September of 2012, the manufacturer of the surgical waste systems expanded the recall to include even more models because the FDA claims the devices were not correctly approved for use. The manufacturer issued a press release that explained the devices were supposed to gain clearance for use through the 510k process, but did not have it at the present time. The press release went on to state that the FDA did not consider the systems to be marketed in a legal manner, since their safety and effectiveness had yet to be determined.
The manufacturer says it has stopped distributing the surgical waste systems to medical facilities. The FDA has also advised medical professionals and facilities not to use the systems any longer. The only time this is to be ignored is if there is no other alternative for patients, and in this situation the risks must be carefully weighed against the possible benefits.