What does a medical device recall mean?

Probably nothing is more frightening than finding out that one of your medical devices has been recalled. This is especially true if the device is inside your body, such as an artificial hip, pacemaker, etc. 

Before you panic, however, the Food and Drug Administration advises that a recall can mean one of three things as follows: 

  1. The device itself is defective. 
  2. It could pose a health risk for you. 
  3. It is defective and its defect poses a health risk. 

Recalls come in two kinds: correction recalls and removal recalls. Both the FDA and the device’s manufacturer have the authority to initiate either kind. 

Correction recalls 

If your doctor notifies you that your medical device has become subject to a correction recall, this is not terribly serious. It simply means that you should make an appointment with him or her so (s)he can check the device and make sure it is still working the way it should be. For instance, if you have a pacemaker, its battery may need recharging or replacement. 

Removal recalls 

Removal recalls are more serious. Here the FDA has determined that the device is inherently dangerous and poses a significant health risk. The manufacturer then notifies all the physicians who used the device. Your doctor, in turn, will notify you that you need to make an appointment with him or her as soon as possible so (s)he can explain the situation to you. (S)he will also tell you about the risks involved in surgery to remove and replace the recalled device as opposed to your health risks if you decide to leave it in place and continue to let him or her closely monitor its performance. 

Breaking down the Glasgow Coma Scale

Most people in Medina likely understand that traumatic brain injuries are very serious incidents; what they may not know is exactly how prevalent they are. Many might assume that by describing them as “traumatic,” authorities are only referring to those brain injuries that either kill victims or leave them dealing with severe physical or mental impairments. In reality, TBIs describe everything from concussions to fatalities, and they happen with almost frightening regularity throughout the U.S. Indeed, information shared by the American Association of Neurological Surgeons shows that there are roughly 1.7 million TBI cases in America every year. 

The family members and friends of TBI victims often want to know in the immediate aftermath of their injuries what their long-term prognosis will be. While that may be impossible to predict with certainty, the Glasgow Coma Scale can offer an accurate assessment of the extent of their injuries (from which their potential for recovery can then likely be inferred). This clinical observation test measures a TBI victim’s responses in the areas of eye movement, verbal capacity and motor skills. Per the Centers for Disease Control and Prevention, point values are assigned in each of the aforementioned categories as follows: 

  • Eye movement: 1-4 points 
  • Verbal response: 1-5 points 
  • Motor skills: 1-6 points 

Higher point totals in each category indicate that a patient’s response was closer to the standard baseline. Each category’s scores are then added to come up with a final tally. A score of eight or lower indicates that a person has suffered a severe brain injury. Any recovery from such an injury will likely be limited. However, even mild or moderate TBIs can cause damage that could require extensive (and costly) recuperation.