Israeli Ministry of Health to doctors: Warn epilepsy patients from iPads
Following Smallah’s request, the Ministry of Health ordered sellers in Israel to pass the information to all doctors. The European manufacturer Cybronics, issued a letter clarifying to keep patients away from the iPad. A mother to an epileptic patient from center of the country, noticed unfamiliar symptoms of her son after playing on the iPad. In his body was implanted Vagal pacemaker to treat epilepsy. Unsuccessful attempts to obtain information about the relationship between the iPad and the pacemaker, led the mother to the company that makes the pacemaker abroad, where she was explained what was not known to doctors and to the Ministry of Health in Israel – The iPad runs the pacemaker unnecessarily disrupting its regular activities. “What bothers me is that they did not inform this to us before the transplantation. Do you think we would have implanted a pacemaker – that was not designed to save lives – to the boy, if we had known that he would have to stay away from the iPad for all of his life ?”
Sh., mother of 14 -year-old epileptic patient from the center of the country is angry. On the one hand, she knows now that tablets and maybe even smartphones, could possibly disrupt the pacemaker activity implanted in the body of her son. On the other hand she can not tell him to stay away from these devices permanently.
“Even without this, it’s not easy to be a mother of a child with epilepsy, or in general, a child who is not like others – it is not easy to be”, says Sh’ to Smallah” So now he has also to stay away from devices that have become in recent years an integral part of all our lives? “
T, an epileptic who suffers from severe seizures. Three months ago his parents were convinced to implant Vagal pacemaker in his body. This is a device with one purpose – to improve the quality of life of patients with epilepsy. It is implanted in the underarm area and transmits electrical pulses through the electrode in the left vagus nerve in the neck and from there to the brain.
According to Sh., two months after surgery, her son played with the iPad for about two hours and suddenly the pacemaker was turned on unnecessarily, causing his voice to shake for about a minute and he coughed and felt strangled. The phenomenon repeated itself several times. Only as he left the iPad , the pacemaker relaxed.
When the parents of T’ turned to his attending physician, she said that she did not know of a connection between the use of the iPad and disruption to the operation of the pacemaker. If she had known it, she would have informed them about such a basic detail. Even in ‘ Sigma ‘, the company which markets the pacemaker in Israel, they were unmoved .
“The CEO laughed at me at first, he told me it’s crap, that there is no connection between the iPad and the pacemaker” recalls Sh’ her first conversation with ‘Sigma ‘. ‘When I told him that I checked online and found a warning of the manufacturer from using iPads next to transplant pacemakers patients, he immediately determined that there is no connection between the two pacemakers and said it is impossible that there is something I know and his company does not know.”
When the parents of T’ realized that nobody in the country is aware of the impact of the iPad on their son’s pacemaker, and nobody cares, they conducted a home experiment by themselves.
Because they knew the pacemaker was turned on by a magnet, they decided to bring the iPad to another device powered by a magnet – Compass.
“Once we did it, the compass went crazy. We realized immediately, that this is exactly what is happening in T’s body as he approached to the iPad ,” says Sh’.
What happens to T’ when the pacemaker reacts like this to closeness to the iPad?
“The Pacemaker works at regular time intervals, as soon as the patient feels an epileptic seizure coming, he deliberately turns the pacemaker on, and it increases the rate of electric pulses the pacemaker sends to his brain and their intensity. The situation becomes, that regardless of seizures he receives electrical pulses. Let’s just say that if there was no pacemaker and he was suffering from severe epileptic attack, we’d give him medicine, for example , Valium. Imagine if we give him this drug more often than necessarily ? It certainly would have affected him.
So we believe this is the case with electrical pulses.” Sh’ added that her son felt ill also after running the pacemaker, “He had nausea and sore throat. We do not know how many times the pacemaker was turned on without control, but once we noticed the phenomenon, I counted at least five times it was turned on for two hours, not to mention that an unnecessary activation of the pacemaker shortens battery life and battery replacement in such cases is done by surgery, which definitely harms the purpose of improving the patient ‘s quality of life.”
Sh., who believes in the importance of sharing of such information, was not satisfied only with approaching to the marketing company, and to the manufacturer abroad. She also turned to Smallah.
Following a request of Smalla from the Ministry of Health, the marketer passed guidelines to all physicians who treat with the same pacemaker in the country, so that they will inform their patients about the need to stay away from tablets.
“Cybronics” company published a letter following the incident, sharpening to its customers around the world, that the iPad may disrupt the activity of the pacemaker.
In the letter, adressed to “all interested parties”, Sh’s case is described and her complaint about unnecessary activations of the pacemaker, near the ipad device.
‘Cybronics announced that although they warned in its provisions and instructions from all devices emitting electromagnetic radiation, the doctors and the agents who sell the pacemaker need to sharpen to patients the explanation about what devices are involved, because the public is not necessarily aware of the electromagnetic radiation emitted by many devices.
Ministry of Health’s response:
The Ministry of Health contacted Sigma to clarify the matter.
It turns out, that the manufacturer’s instructions to the doctor and the patient (in user manual) state, as is generally accepted, that environment with strong electromagnetic radiation may affect the pacemaker. However, even the manufacturer of a consumer device that emits electromagnetic radiation has full responsibility to warn its users from such phenomena.
There are differences between different manufacturers of devices with electromagnetic radiation and therefore the pacemaker manufacturer required in his own guidelines – to keep them off the chest at distance of 8 inches (20 centimeters).
Based on guidance from the Ministry of Health, marketer of the Vagal pacemaker passed clearer focused message in addition to the general message to all doctors who treat with it.
Doron Debbie, CEO of Sigma, which markets the pacemaker in the country, said in response:
1) I would like to say that indeed we received a complaint from the mother who contacted us directly. She claimed, that when the child held the ipad more than two hours in a row on the abdomen ( lying on your back and probably just adjacent to the pacemaker ), it seemed that after long time of use, the iPad turned the pacemaker on (in addition to its random normal operation) and the child reacted as sometimes he responds when the pacemaker is working.
2) In the manufacturer’s instructions for the doctor and patient, it has always been written (as is common with electrical pacemakers in general and not just our pacemaker) that a strong electromagnetic
3) We have not received any written complaint of the doctors caring for the child , and when we asked them the doctors told us they had not seen it, but that this was a subjective claim of the mother.
4) We recommended that the mother take her son to the doctor and we started immediately complaints procedures in front of the pacemaker’s manufacturer.
5) Even if the mother’s complaint was indeed correct and involuntary (or programmed) activation of the pacemaker happened, there is no immediate danger (according to the manufacturer) to the patient or to the pacemaker (the pacemaker anyway is powered in regular programming every few minutes).
6) According to the manufacturer’s instructions (appear in the Bulletin of the pacemaker), in the case of running the pacemaker because of an electromagnetic field, the pacemaker returns to its normal operating format immediately when removing it from the field.
7) I never told the mother that there was no connection between the pacemaker and specific devices (as she claimed ). We clarified to the mother, that we have not received such complaints so far and that we do not know every specific problem between the pacemaker and the iPad device. However, we reminded to the mom, that there exists a general warning for each device which emits electromagnetic radiation, and we offered her to avoid using the device adjacent or close to the pacemaker until checking the complaint. Her answer was that she did not intend to prevent her child from playing on his iPad.
8) We have never received a similar complaint from a patient or a doctor in Israel so far.
9) Following the request of the mother, we immediately turned overseas to the manufacturer, the manufacturer asked us for all pacemaker data and other data for a thorough examination of the pacemaker.
10) Despite this, to the best of our knowledge, following recent widespread use of Apple’s iPad and similar devices, the manufacturer intends to refine and focus his message soon for doctors and patients.
11) After receiving a formal response from the manufacturer, we sent a clearer focus in addition to the existing general message to all physicians who treat patients with Vagal pacemaker and through them to the patients, with the following formulation:
“Magnets that are found in several tablets and covers, such as Apple iPad ® products, may be strong enough to cause in certain conditions casual / temporary turn on of the Vagal stimulus. Patients transplanted with Vagus Nerve Stimulation (VNS)pacemaker, should use with reasonable care around devices that create a strong electric or magnetic field, and keep away from those instruments at least 15 inches from the area in the body, where the pacemaker is implanted.”
12) We intend to refine the message in a more detailed way, in conjunction with the manufacturer and the Ministry of Health, in more channels to doctors and patients (there are hundreds of such patients in Israel). Also the manufacturer intends to update the official guidelines for physicians and patients around the world soon, and to mention in the guidelines specifically also ” iPad devices.”
13) From an investigation we conducted with the doctor who examined the patient close to the event , there was no change in the parameters of pacemaker programming as a result of the incident. According to doctor, the prescribed measurements carried out in the clinic, were tested and found negative.
14) Please note the pacemaker has U.S. FDA and European CE approval for more than 15 years. It is sold in more than 90 countries in the world, and more than 100,000 pacemakers were already implanted in the world. Dozens of medical studies have been published in the world, showing high safety and high efficacy for drug-resistant epilepsy using the pacemaker.
Here is the website where this article was found. It has been translated. http://smalla.co.il/?p=18