What is the sleep apnea device market

Medical devices for sleep apnea: death if ventilated

The devices are designed to help people with respiratory arrest during sleep. They increase the risk of death for some patients.

The manager of the sleep laboratory at the Nuremberg Clinic demonstrates how to attach a mask to treat sleep apnea. Photo: dpa

BERLINtaz | The devices should help prevent sudden respiratory arrests during sleep and thus save lives: so-called adaptive servo fans (ASV) from the Australian medical device company ResMed, which are also used in Germany. The medical devices look like face masks with a snorkel and can precisely determine the inhalation and exhalation pressure for each breath taken by the user. If the breathing is out of balance, they automatically change their pressure support and thus avert the risk of an insufficient supply of oxygen. A blessing - it was believed for over a decade.

But now clinical studies by the manufacturer ResMed have shown: Of all devices that are supposed to reduce the risk of death, there is a fatal danger: There is a "serious safety risk", warned the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn in mid-May. The regulator strongly advised patients to contact their doctors.

For those patients who not only suffer from central sleep apnea, but also from a weak heart (insufficiency), the risk of dying is 33.5 percent higher if they use the breathing apparatus than if they do without it completely warned the BfArM.

This was preceded by a seven-year clinical study by the manufacturer on 1,325 patients. "We were very shocked by this study result - to see that our therapy not only does not solve the risk of mortality, it actually increases it," said Holger Woehrle, ResMed Medical Director Europe, of the taz.

Deliveries stopped

Deliveries have been stopped until further notice; it may be advisable for patients - after consulting their doctor - to forego ventilation masks entirely. The worrying thing is that, according to Woehrle, "there is currently no indication of a technical defect in the device."

Rather, the manufacturer suspects “a medical effect”. It is possible that the breathing intervention has such an adverse effect on the stress-hormone balance in this one patient group that some patients die. The manufacturer Philips now also wants to check its devices.

Until results are available, ventilatory therapy should be discontinued or not even started in patients in the risk group, advised Philips. The various manufacturers do not disclose how many ventilators are sold, with reference to competitive pressure.

Only affects patients with heart failure

The German Society for Sleep Research and Sleep Medicine, the German Society for Pneumology and the German Society for Cardiology emphasized that the safety instructions refer exclusively to patients with central sleep apnea in combination with heart failure. Sleep doctors estimate that across Germany there are around 3,000 to 5,000 people. According to the medical societies, treatment alternatives are "only available to a limited extent" for this group.

So far, so unsatisfactory. But why was the risk only now recognized? ResMed devices have been in use in Europe since 2001 - that's 14 years. 14 years in which people may have died without even realizing that the device they trusted was doing them more harm than good. “In the past 15 years, sleep medicine has developed rapidly,” says Holger Woehrle.

It is only recently that sleep apnea has been studied in conjunction with other diseases. That means: When the device came onto the market, only its ability to regulate nightly breathing pauses had been examined - but not the possible risks in the event that further illnesses existed.