Since April 2021, the FDA has received more than 69,000 medical device reports, including 168 reports of death, related to sound abatement foam breaking down in CPAP and BiPAP ventilators and other respiratory devices. (Note: The FDA’s MDR system is a passive system with limitations.)
In a recent statement to stakeholders, Jakobs recognized the serious recalls, which involve millions of devices. He said the Dutch medtech giant is taking steps to realign itself with its “people-centered” ideology.
“Delivering on this is what matters most, and that will require us to double down on what we do best, continuing to innovate, but also urgently fixing things where we have disappointed patients and customers. This will, of course, also help to restore our financial health,” he said in the statement shared on Philips’ website.
Philips’ new CEO was already handling the massive respiratory devices recall
Jakobs became CEO on October 15 after former CEO Frans van Houten agreed to step down from the corner office amid the recall of millions of devices.
Jakobs served as the company’s chief business leader of connected care before becoming the face of Philips. The company had already made him responsible for handling the voluntary recall notification and field safety notices for Respironics devices. He says the company has made progress in the execution of a comprehensive program. The program’s goal is to deliver resolution to affected patients as quickly as possible in consultation with relevant authorities.
“I’m also mindful of the pain caused when expected levels of care fall short. The product recall of our Respironics sleep apnea devices let down the many patients who relied on them, as well as the doctors and nurses caring for those patients, for which I am deeply sorry. While I can point to many great ways Philips is helping to improve people’s health and well-being, any quality issue across the company hurts,” Philips’ new CEO said in the statement.
Philips Respironics has held talks with federal prosecutors over its handling of the recall. Respiratory device problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a device’s air pathway and cause a range of potential health problems and toxic, carcinogenic effects for the use
On October 19, the FDA labeled the company’s most recent recall as Class 1, the most serious kind. Philips Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps. The magnets could negatively interact with implantable, metallic medical devices.
Jakobs’ plan to restore assurance in Philips’ customers
As one of the largest medical device companies in the world, Jakobs said the company will partner with care providers and customers to ensure the company is helping all patients. This includes collaborating with doctors, nurses and leaders in the healthcare systems to understand the issues they are facing.
Philips’ new CEO noted that the medical device industry is facing rising costs, staff shortages and strained resources, which have impacted the morale of employees.
“I look forward to strengthening ties with you and working together to co-innovate and co-create solutions that drive impact for patients, staff and health systems,” he said. “At the same time, I want to empower people everywhere to better manage their health and well-being. Philips’ personal health solutions support self-care and help individuals and families embrace care routines that promote healthy living and disease prevention.”
His plan to empower patients includes:
- Providing innovations that help people take care of their oral health and personal hygiene;
- Giving mothers and fathers access to personalized guidance before, during, and after a newborn enters the world;
- Offering more sustainable and convenient care by improving health outcomes through precision diagnosis, monitoring and therapies;
- Making healthcare systems smarter and more resilient, more productive and less energy-intensive to enable greater access to care;
- Improving the patient and staff experience through the patient journey;
- Workflow optimization and value-adding informatics solutions that scale and provide doctors with actionable insights to improve the delivery of care.
“For me, getting things right for patients and providing reliable support to the doctors and nurses treating them is what makes working in healthcare so deeply rewarding. It is also a great responsibility, and the technological innovation that Philips brings to the world of health is critical.”
Original story updated to clarify that the FDA has received reports of deaths — and that the agency’s Medical Device Reporting (MDR) system is a passive surveillance system with limitations.