By Nathan Costiuc, MSN, APRN, FNP-BC
There’s no denying that reliable respiratory equipment has become critical amid the COVID-19 pandemic. Yet new patient concerns have recently resulted from the June 14 Philips Respironics recall of several models of ventilators, BiPAP and CPAP machines due to a manufacturing defect. After navigating the challenging implications and potential harm to patients, on August 10, sleep leaders with credibility across the respiratory health care community gathered for a panel discussion to explain and educate the public on their response to Philips’s decision. With Laree Fordyce hosting, panelists included Dr. Teofilo Lee-Chiong; Rita Brooks, MEd, RPSGT, REEG/EPT, FAAST; Marietta Bibbs, BA, RPSGT, CCSH, FAAST; and Julie Dewitte, RPSGT, FAAST, RCP, RST.
Dr. Lee-Chiong, who serves as the medical liaison lead for sleep and respiratory care at Philips, began the panel by describing the manufacturing defect and the research process that ultimately led to the recall. The devices under scrutiny were those which utilized a specific sound abatement foam constructed from a polyester-based polyurethane (PE-PUR). Through Philips’s research, the company discovered that this foam had the potential to release several dangerous chemicals, including volatile organic compounds dimethyl diazine and phenol diazine.
There were two avenues that led to these chemicals being deposited throughout the machines. The first was via foam degradation, which occurred “naturally by a process called hydrolysis, meaning it degrades over time with heat and moisture.” The hydrolysis could be accelerated by inappropriate cleaning techniques like ozone treatment and could ultimately lead to black foam particulates being deposited in the humidifier, tubing or mask, causing potential oral or inhalation ingestion of the chemical substances.
Dr. Lee-Chiong noted, however, that the smallest particle size found was 2.7 microns, which is too large to cause significant deep lung tissue damage. The second chemical emission route occurred via off-gassing, a phenomenon typically present only in new devices. In this less-common scenario, chemical ingestion occurred without particulate involvement, and the exposure risk decreased significantly after the first few uses of the device.
The defect impacted 3 in 10,000 devices, which worked out to 486 formal complaints for 15.6 million devices shipped that year. A total of 11 complaints reported alleged harm sustained due to the foam, and five of these cases involved equipment inappropriately cleaned in ozone devices.
“The symptoms were related to acute foam exposure and were not specific. These included headaches, upper airway irritation, cough, chest pressure; there was one sinus infection and one patient was given an inhaler … and there was no evidence of lung inflammation or pneumoconiosis,” Dr. Lee-Chiong explained.
While the two diazine substances have been recognized as potentially carcinogenic, there is no data that has linked these compounds to a specific cancer or serious patient harm. Further, acceptable exposure levels for these chemicals have not been established.
Clinical Responses to Philips’s Recall
Following Dr. Lee-Chiong’s discussion, Laree Fordyce, BTech, CCRP, RPSGT, RST, CCSH, the director of clinical sleep services at Maple Respiratory Group, presented on behalf of Brooks, director of diagnostic services at Capital Health System, and detailed Capital Health’s response to the recall. She shared that as soon as the news surfaced, all patients actively receiving PAP therapy were identified using existing records. General messaging to properly inform them about the recall was drafted by sleep center leadership, legal and safety advisors.
Also according to Brooks, all relevant medical and office staff were trained, and staffing hours were increased for the purpose of contacting patients about the potential risk. Physicians allotted dedicated telemedicine visits to address concerns and craft strategy plans with patients. Patients who owned or rented respiratory equipment from their DME provider were given instructions on how to escalate the issue with Philips directly.
For equipment being used in the sleep center itself, the sleep center ordered alternative ResMed devices but still had not received them by the date of the webinar, said Fordyce. In lieu of equivalent equipment, existing devices were inspected, and an additional bacterial filter was inserted to prevent foam particulate transmission throughout the machines. For patients needing in-lab PAP titrations, a waiver was drafted and approved by system leadership and legal teams, allowing patients the option to still receive therapy on filter-fitted machines.
Bibbs, system manager for BayCare’s sleep center, next went into detail on a slightly different approach to the recall. Rather than fitting existing equipment with additional bacterial filters, the BayCare team made the choice to completely remove all affected respiratory devices. Whereas the system’s hospitals used newer equipment and were not heavily impacted by this decision, the sleep center depended more heavily on the specific models that fell under the scope of the recall.
By pooling resources across the system, they were able to secure three Trilogy EV300 ventilators. These could perform most of the PAP titrations needed for the center but required extra staff training due to the additional complexity. This has, unfortunately, placed an increased financial strain on the center, so equivalent ResMed VPAP devices will be used as soon as orders can be fulfilled. BayCare’s in-house DME provider took on the burden of contacting patients, providing education and advising them to make collaborative decisions with their physicians on whether to work with existing equipment or secure newer models.
Julie Dewitte, assistant department administrator for Kaiser Permanente’s Sleep Disorder Center, added how her system had navigated the recall. As a tertiary center serving the needs of complex patient cases, the system’s approach was proactive and took place in three phases. Phase 1 consisted of outreach to potentially affected active PAP patients. Calls focused on patient education about the recall and a guided visual inspection of the devices in question.
Any devices that contained visible black particulates or were greater than four years old were immediately exchanged for equivalent ResMed devices in collaboration with a contracted DME provider at no charge to the patient. Patients who felt they could use their devices without the humidifier were educated on how to apply bacterial in-line filters to prevent particulate spread.
Dewitte explained that an emphasis was placed on what the filters could or could not do, how long they could last and what sort of signs could indicate that the filter would need to be replaced. Patients who refused a ResMed exchange or the use of a bacterial filter were medically consulted on the potential for discontinuing therapy.
According to Dewitte, Phase 2A considered patients with chronic respiratory failure on high-level devices like a BiPAP ST or AVAPS. For these members, relevant exchanges were offered, and efficacy was closely monitored with oximetry or home apnea testing. Phase 2B was for patients on a Trilogy 100 or 200 device: For these patients, the options were an exchange for an equivalent ResMed Astral ventilator or the use of a bacterial in-line filter. However, patients who elected for a device exchange needed to first consult with their physician and perform a titration study in the sleep center to ensure appropriate settings were being applied (along with follow-up pressure support studies). Phase 3 regards legacy CPAPs that may be in use, but this phase has not yet been undertaken.
For the sleep center itself, all in-lab overnight titrations were stopped, with operations to resume once cabling for new ResMed devices is complete. Patients with low to moderate obstructive sleep apnea (OSA) and low AHI polysomnography scores were evaluated for appropriateness of alternative therapies like dental devices. Severe OSA patients were automatically ordered a ResMed APAP device.
The webinar concluded with Dr. Lee-Chiong’s recognition of the great lengths impacted centers had gone to in order to continue serving patients with excellence and safety. While the impact has certainly been significant, he praised the health care community for rising to the occasion, banding together and offering practical solutions to a challenging situation. He concluded by recommending ongoing dialogues like this webinar to support shared learnings throughout the health care community.
Nathan Costiuc, MSN, APRN, FNP-BC is a nurse practitioner in West Palm Beach, Florida. This is his first article for Sleep Lab Magazine.
This article originally appeared in the July/August issue of Sleep Lab Magazine.