Last week, Medicare emailed beneficiaries the following alert regarding the Philips medical device recall:
The statements are true, but the overall message omitted any reference to crippling supply shortages and uncertainty related to the manufacturer’s corrective plans currently awaiting FDA approval. The emphasis on supplier responsibility, without any discussion of the environment in which those suppliers are operating, creates unrealistic expectations that are counterproductive to the agency’s assumed purpose. If the notification was meant to calm beneficiaries, the authors’ lack of context had the opposite impact.
If CMS had asked for my editorial opinion, which they certainly did not, I would have humbly submitted the following draft.
Recall Alert for Certain Philips Medical Devices
Philips recently issued a product recall for specific ventilators and sleep apnea devices.
If you have a device included in the recall, it is important that you register it with Philips. As the manufacturer, they are working with the Food and Drug Administration (FDA) to get approval to provide repair kits and/or suitable replacement equipment. Registering your current device allows Philips to communicate with you as soon as new information is available about when and how to get your machine fixed.
There is no quick fix. Philips is one of the largest manufacturers of CPAP, BiPAP, and certain ventilation devices used by Medicare patients. This recall affects nearly four million machines, and Philips estimates it could take a year or more to repair or replace them all. Thanks to COVID-19, similar equipment from competing manufacturers is in short supply due to lengthy transportation delays and extreme shortages of labor and raw materials.
In the meantime, talk to your doctor as soon as possible about whether to continue using your recalled equipment until an alternative is available.
The recall certainly exacerbates the difficulties already set in motion by competitive bidding and the COVID-19 pandemic. Patients should have a clear understanding of their rights, but absent realistic expectations, the situation is worse for all.