Forum Topics RMD RMD Recall

Pinned straw:

Added 12 months ago

Unsure what if any the practical implications of this are yet ...

ResMed has issued an urgent field safety notice for certain models of its AirFit masks that contain magnets, citing issues around interference with medical implants. In a letter sent to patients on 20 November, the US-headquartered company updated the contraindications and warnings in the user guides for the masks. The masks affected include multiple AirFit models from its full-face mask, nasal mask, and non-vented mask ranges and are used to deliver air from a positive airway pressure (PAP) device

The masks use magnets to provide easier attachment and detachment to headgear. The company says their use is especially important to patients with dexterity vision impairment, or those with disabilities. The safety notice is due to reports of magnetic interference of the magnets with implanted devices in the patient. ResMed has submitted five reports of serious harm, potentially caused by this issue, to regulatory authorities. No deaths have been reported. ResMed said that medical device function could be affected, whilst ferromagnetic implants could change position because of mask magnet proximity. Active medical implants that could be affected include cardiovascular devices such as pacemakers, and implantable cardioverter defibrillators (ICD). Neurostimulators and cerebrospinal fluid (CSF) shunts can also suffer from interference, along with diabetes devices such as insulin/infusion pumps. ResMed also stated that patients with metallic implants containing ferromagnetic materials are contraindicated for using the masks. This includes, among others, patients with stents, valves, and flow disruption devices. ResMed warned users to keep the mask magnets at least six inches away from medical devices or implants that may be affected. According to the letter, ResMed has sold tens of millions of masks across the last nine years

ResMed is not the only company to run into problems with magnetic masks. Philips, which has battled large recalls across its respiratory medical devices, alerted customers to safety issues of its continuous PAP or bi-Level PAP therapy masks after reports similarly designed magnets were affecting implanted devices. The US Food and Drug Administration (FDA) tagged Philips' recall as Class I, the most serious classification. The recall involved over 18 million devices sold in the US


DISC: Small position Held in RL & SM

mikebrisy
Added 12 months ago

I'm no expert, however, I doubt this is significant.

People with medical implants with ferromagnetic components generally have to manage the risk of interference from external magnets. For example, the powerful magnet of an MRI creates huge intereference with anything ferromagnetic. My expectectation is that there will be a strengthening of controls (via patient information and directions to prescribing clinicians) to give clear instructuctions, and/or assess risk and/or limit use.

Of course, regulators will assess the safety noticies and the remedies being proposed by the firm and have the power to issue a recall notice. However, it is unclear to me that this would result in this case. My reason for holding this view is that patients with ferromagnetic implants have a broader risk exposure to manage. I would think the worst case scenario would be that affected patients would be advised or required to be issued a replacement device without magnets. However, even in that case, the exposure to $RMD would be minimal.

This is of a fundamentally different level of seriousness to the Phillips recall, which was due to material degradation of an integral component within the device. A sound abatement polyeurethane foam was found to degrade, creating risk that particles of the foam might find their way into the device airway and enter the patient.

At this stage $RMD clearly don't consider it a material event, given they haven't disclosed anything. But perhaps it is still under consideration by the FDA?

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Scott
Added 12 months ago

@Remorhaz thanks for highlighting this.

This isn't a recall (at the moment). It is a safety warning. In addition to @mikebrisy comments above there are some others

  • Phillips has just settled a class action for $500M relating to the toxic foam issue.
  • Phillips has had a series of recalls including one for magnets. In their case it was a recall and the FDA gave it the highest rating - class 1
  • RMD has sold "tens of millions of magnet-equipped masks that it’s sold around the world between 2014 and now, ResMed has only received five reports of serious harm potentially related to the magnet issue that had to be passed on to the relevant authorities.

"Elsewhere, strong magnets have become a fixture in consumer electronics: famously in the case of Apple's recent iterations of iPhones and its MagSafe line of chargers, mounts and accessories. The FDA re-upped its public warnings in 2021 against having those devices in close proximity with cardiac implants; don't keep your phone in your shirt pocket if you have a pacemaker, for example. A 2022 study, meanwhile, showed that smaller accessories such as magnetic earbud cases could still be strong enough to interfere with medical hardware." https://www.fiercebiotech.com/medtech/resmed-warns-against-using-magnetic-cpap-masks-around-pacemakers-other-implants

I agree with @mikebrisy . Based on the current information this isn't material - not even a recall


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Solvetheriddle
Added 12 months ago

i get the felling with the high level of shorting in RMD, every potentially negative story will be given a strong run

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