A new proposal has been outlined by the U.S. Food and Drug Administration which advocates an end to the use of all electrical stimulation devices (ESDs) due to their risk to patient health.
ESDs involve placing electrodes on the skin of the patient and electrical shocks are transmitted. They are used to try to stop individuals from carrying out aggressive behavior or self harm by conditioning methods.
The FDA has said that the risk to the public health is both unreasonable and substantial, and there is no way that the risk can be reduced simply by changing the label on the product. Therefore the FDA signaled it has now taken the rare step of banning the use of the medical devices in the future.
The FDA made its decision after looking at a whole range of clinical and scientific evidence and talking to experts, along with relatives of patients who have been on the receiving end of ESD treatment. In addition, the agency took account of the risks, both physical and psychological, associated with the use of the devices – which include anxiety, self harming behaviors which become worse and not better, post traumatic stress symptoms, pain, burns, damage to tissue and additional unexpected shocks if the machine were to malfunction.
An additional issue cited by the FDA is that many of those on whom the devices are used do not have the ability or capability to say when they are in pain, and the actual reaction of the patient is difficult to predict due to sweat levels, where the electrode is placed, and body chemistry. Hence the pain level can vary dramatically from patient to patient.
It appears that at this time only 45 to 50 patients are being treated with such devices at only one facility in the United States, which is the Judge Rotenberg Educational Center in Canton, Massachusetts.
According to the FDA there are alternatives for those patients who are self injurious or aggressive, and it urges health care providers to look for different ways of treatment – be they behavioral or the use of medication. The FDA has said that in some cases patients will need a gradual change from the device to different treatment methods, but the FDA maintains that it is are ready to work with medical professionals until ESDs are totally removed from the marketplace.