Neurological injuries, to include neuropsychological disturbances, can be completely disabling and adjusting to these changes can be a challenge. The individual may have to learn to deal with and accept the life-long physical and mental changes and the impact on their family and vocational function. Thus, the residual disability from a TBI must be objectively assessed to support the damages impacting the ability to work and change in quality of life. 

Need help on your TBI case??? Contact Aguirre Legal Nurse Consulting. We can assist you in analyzing the medical records, providing a summary or research and even locating medical experts to support your case. Call us at (443) 598-2562.   

The FDA has concluded their investigation into testosterone replacement therapy (TRT) and based on the evidence, there is an increased risk for cardiovascular side effects associated with these products. This week, they announced an update with official recommendations for use and distribution of TRT.

The FDA only approves the use of TRT in men who suffer from low testosterone levels in conjunction with an associated medical condition confirmed by laboratory tests. It is NOT an approved treatment for men with low testosterone due to aging stating, “the benefits and safety of this use have not been established.”

In the Safety Announcement released on March 3, the FDA is now requiring manufacturers to make specific changes for labeling testosterone products:

1. There must be clarification of FDA-approved uses for TRT.
   
2. There must be a warning for possible increased risk of heart attacks and stroke associated with testosterone use.

The FDA is also requiring manufactures to conduct more research examining further the correlation between testosterone and cardiovascular side effects among users.

In April 2013, a Sentinel Event Alert provided by The Joint Commission cited 98 alarm-related events over a 3 ½ year time frame. It reported 80 of those events actually resulted in death and 13 caused permanent loss of function. This was a result of  “alarm fatigue;” a new phenomenon characterized by caregivers becoming overwhelmed, distracted or desensitized by the large number of physiological alarms generated by modern monitoring systems. In fact, a recent study reported by the American Nurses Association shows that, in a single month, there are more than 2.5 million alarms triggered on bedside monitors!

Medical device alarms aid in timely, life-saving interventions that have been instrumental in improving patient outcomes. However, as discussed in my last blog, technology is not foolproof. In nursing school, we teach, “treat the patient, not the machine.” Current monitoring systems do not take into account differences between patients. There is not a “one size fits all” setting and this can lead to many clinically insignificant alarms. As a result, alarms are sometimes disabled, silenced or the volume is turned down to an inaudible level. Obviously, this increases the risk for missing an important alarm that could potentially make a difference between life and death.

There are a variety of medical device alarms in a hospital to inform about changes in a patient’s status or circumstance that could adversely affect the patient’s care. For example, physiological monitors will alarm when a patient’s heart rate, blood pressure or oxygenation falls outside of specified parameters. Ventilators will alarm when breathing circuits become disconnected. Infusion pumps will also alarm when an IV solution runs out or when there is air in the IV line. These examples all necessitate an action by a healthcare worker in a timely manner. 

Nevertheless, there are also many alarms for conditions that may not be as clinically significant. For example, an alarm warning when an EKG electrode has poor contact with the patient’s skin or an alarm warning when a patient bends his arm to eat something because it momentarily occludes the IV line. Minimizing the number of clinically insignificant alarms can facilitate better recognition of conditions that truly require attention. 

Any failure for staff to be informed of a valid condition in a timely manner or failure to take necessary action to an alarm can be considered an alarm hazard. As a result, The Joint Commission announced a new National Patient Safety Goal (NPSG.06.01.01) on clinical alarm safety. Hospitals will be expected to develop and implement policies and procedures for alarm system management as well as provide staff education no later than January 1, 2016.