In the wake of several recalls of medical devices, including one of the largest in history in June last year by Philips Respironics (Philips), affecting more than 15m devices worldwide, medical experts say this ongoing public health crisis highlights the need for reforms to medical device regulation to better protect patients.
In an editorial in JAMA Network, Harvard University’s Dr Kushal Kadakia, Dr Joseph Ross (Yale School of Medicine), and Dr Vinay Rathi (Massachusetts Eye and Ear Infirmary) write that in 2021, Philips recalled 14 models of ventilators and positive airway pressure machines (both bilevel positive airway pressure [BPAP] and continuous positive airway pressure [CPAP] machines) using polyester-based polyurethane (PE-PUR) sound abatement foam, because of concerns that foam degradation could harm patients through inhalation of toxic particles and emissions.
The US Food and Drug Administration (FDA) categorised this recall as Class I (the most severe designation), indicating reasonable probability that device use could cause serious adverse health consequences or death.
In April, Philips received a subpoena from the US Department of Justice for information on events leading to the recall, and as of July, the company was in discussions “regarding the terms of a proposed consent decree to resolve the identified issues”.
In August, the FDA reported that it had received more than 69 000 reports of adverse events – including cancer, pneumonia and chest pain – and 168 reports of death linked to the recalled devices. This ongoing public health crisis highlights the need for reforms to medical device regulation in the US to better protect patients.
Clinical and regulatory context
The recalled devices are used for the treatment of obstructive sleep apnea (CPAP and BPAP devices) and respiratory insufficiency (ventilators) in a wide range of populations (paediatric and adult) and care settings (home and facility). The FDA classified the Philips devices as moderate risk (i.e. Class II).
The agency requires Class II devices to undergo review via the 510(k) pathway for marketing authorisation. Premarket clinical studies are typically not required for 510(k) clearance. Instead, manufacturers must demonstrate that a device is “substantially equivalent” to a previously cleared predicate device and conforms to device-specific controls.
For example, manufacturers of CPAP and BPAP devices must demonstrate that patient-contacting portions of the device are biocompatible and that the device can withstand typical forces expected during use.
After clearance, FDA oversight of moderate-risk devices, like Philips’, is largely passive. The FDA rarely requires postmarket surveillance studies and instead relies on mandatory adverse event reporting by manufacturers and user facilities (e.g., hospitals).
However, adverse events are under-reported because patients and clinicians are often unaware whether and how to submit actionable reports, and manufacturers exercise considerable discretion over what events must be reported. When safety issues are identified, manufacturers are expected to voluntarily initiate recalls and communicate and implement plans to correct or remove affected devices.
Market history of recalled Philips devices
Philips’ recalled devices (three ventilators, six BPAP machines, and five CPAP machines) received FDA clearance between 4 March 2009, and 18 October 2013, without requirement for premarket or postmarket clinical studies. Publicly available documents for these devices and their 21 unique predicates do not reference PE-PUR foam. Therefore, it is unclear when Philips modified devices to include PE-PUR foam, whether Philips reported this design change to FDA, and what non-clinical testing Philips may have conducted to assess PE-PUR foam degradation.
On 14 June 2021, Philips recalled devices containing PE-PUR foam manufactured before 26 April 2021, stating that it had received several complaints of black particulates within air circuits and reports of mild adverse events. Philips denied receiving reports of device-related deaths, but noted the foam’s potential for toxicity and carcinogenicity. Given these substantial risks, the firm announced plans to replace PE-PUR foam with new materials.
On 26 August 2021, the FDA initiated a 10-week inspection of Philip’s manufacturing facility that identified the firm’s failure to adequately analyse, address and report mounting safety concerns. The FDA investigators discovered that Philips had received more than 1 250 consumer complaints about foam degradation since 2014, many years before the company initiated the recall.
Between April 2016 and January 2021, the firm conducted at least 14 assessments demonstrating the potential harms of foam degradation and emissions. In 2015, Philips began implementing preventive maintenance measures, and in 2018, it began replacing components (including foam) for select devices already in use. However, the firm did not disclose safety concerns or attempts at corrective action to FDA.
Although Philips ultimately recalled the faulty devices, the firm’s announcement was not the end of the story. In March, the FDA ordered Philips to adequately notify all patients, clinicians and supply chain intermediaries affected by the recall within 45 days. The FDA issued this atypical mandate after determining that Philips had not appropriately alerted patients and other consumers to the recall, provided clinicians with necessary facts to counsel patients, or communicated the device replacement process clearly to patients.
These communication deficiencies in part stemmed from Philips’ lack of comprehensive field tracking for the recalled devices, which compelled the firm to rely on durable medical equipment vendors to notify affected patients. In May, after concluding that notification efforts were insufficient to mitigate the public health risks, the FDA proposed to compel Philips to repair, replace, or issue refunds for all recalled devices. As of October, this proposal is pending an FDA hearing with Philips.
Separately, Philips’ devices were also subject to recalls in August for plastic contamination (affecting 386 devices) and in September for magnet safety (affecting >17m devices). These additional recalls also encompass some of the devices already recalled for PE-PUR sound abatement foam, broadening the scope of an already significant public health crisis.
Implications for patients
As of August, Philips had only shipped 1.65m of the 5.5m devices requiring replacement in the US due to foam breakdown. For patients with obstructive sleep apnea, recall-induced demand for new CPAP and BPAP machines has outpaced the capacity of competing manufacturers to produce them.
Many patients with recalled devices have the choice of either continuing potentially deleterious exposure or discontinuing therapy.
Shortages have additionally reduced the capacity of sleep centres to initiate treatment for newly diagnosed patients. For patients with chronic or acute respiratory failure, relying on putatively life-sustaining ventilators now carries potential hazards, which have been exacerbated by the ongoing COVID-19 pandemic. These delays and difficulties may be most likely to affect medically and socially vulnerable patient populations, especially poor, older adults.
Recommendations for physicians and the FDA
In August 2021, a coalition of specialty societies, led by the American Thoracic Society, issued guidance to inform clinical decision-making. These recommendations may help clinicians navigate uncertainties, such as when to discontinue therapy with recalled devices and how to formulate practice-level responses (e.g., developing clinical assessment pathways). However, given the rapidly mounting scale and significance of the recall, additional FDA actions are needed to protect patients.
First, the FDA should implement its May proposal to require Philips to repair, replace, or issue refunds for all recalled devices. Such a mandate could help ensure that Philips increases patient outreach efforts and expedites device replacements. Requiring refunds for recalled devices could also provide patients with the flexibility to purchase devices from competitors rather than waiting for replacements.
Second, the FDA should use its existing authority to order Philips to initiate a longitudinal postmarket surveillance study characterising harms associated with the recalled devices. Requiring Philips to use existing clinical data registries and design the study in partnership with specialty societies could help promote rigorous, timely, and transparent results.
Third, the FDA should convene a meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee. This meeting could help elicit patient concerns, gather expert opinions, and inform subsequent regulation.
For example, the panel could help FDA answer important remaining questions, such as the safety of Philip’s silicone-based foam, the potential contribution of ozone cleaners to PE-PUR foam breakdown, and the applicability of current device-specific premarket controls to degradation under typical conditions (e.g., heat, humidity) of use. The panel could also consider questions beyond foam breakdown, including the recently identified issues with plastic contamination and magnet safety for respirator face masks.
Leveraging independent expertise to clarify these issues could help the FDA address uncertainties for patients and clinicians and contribute to the safety of new models of the devices.
Recommendations for systemic reform
In addition to stemming the fallout from the Philips recall, the FDA’s limited authority for oversight of medical devices should be addressed. The decade-long delay between Philips’ initial receipt of safety complaints and the initiation of the recall reflects the inadequacy of a postmarket surveillance system largely reliant on voluntary action. To prevent such delays, Congress could amend regulations to include pre-specified numerical (absolute or proportional) thresholds for consumer complaints that would trigger a FDA audit.
Furthermore, Philips did not adequately notify affected patients of the recall, even as the FDA depended on the firm to do so. This failure occurred because Philips, as has been the case for other manufacturers of moderate-risk devices, does not track individual devices using product registries or identifier systems. Philips instead relied on durable medical equipment vendors to notify patients about the recall.
However, these contractors may not maintain long-term relationships or records of patients. Integrating unique device identifiers into claims data and electronic health records could permit the FDA to better identify patients using faulty devices.
As of October, the Philips recall remains ongoing, and ventilators and CPAP and BPAP machines remain in shortage. To protect patients and the public health, the fundamental shortcomings in medical device regulation that the Philips recall has exposed should be corrected.
See more from MedicalBrief archives:
Philips recalls 5.5m sleep apnea machines and ventilators in US
Global ventilator safety alert from Philips after one patient dies, four injured
Billions paid out in the US to replace defective heart devices
Medical device regulation in SA is a ‘tangled web’
Doctors in a dilemma as FDA calls a halt to popular LVAD device