You joined Philips Respironics at the start of the recall. How would you characterize the progress you’ve seen? From your perspective, what are some of the significant changes Philips Respironics has made in that time?

It was certainly an interesting time to join the company. The relentless focus on patient safety and quality while ensuring completion of the remediation remains our top priority. To that end, we are transforming our processes and the way we operate so we can deliver what matters most to our patients – safe and effective therapy.

Accountability in making the right decisions, especially tough decisions, and being guided by science are two of the most important parts of patient safety. 

We’ve put a new training and awareness program in place to ensure that every Philips employee is trained on their role in quality and patient safety. While this was in place prior to the recall, we strengthened it, so everyone understands the impact of their work on patient care. Philips also recently appointed a new Patient Safety and Quality Officer, Steve C. De Baca, to drive patient safety and quality across all of Philips and Steve has been a great partner in our transformation in the Sleep and Respiratory Care business. Our goal is to constantly elevate the quality of our products, so patients feel confident they are receiving the best care possible, and I think these changes reinforce that.

In May, Philips Respironics reported that the test and research program found that the issues around recalled CPAP/BiPAP sleep therapy devices were unlikely to cause an appreciable harm to health. In addition to being the Business Leader for Sleep & Respiratory Care, you also have a PhD in chemistry. Looking at the results through the lens of scientific study, what makes you feel confident in these results and why are they important?

The comprehensive test and research program has been conducted together with five independent, certified testing laboratories, and the results have been reviewed and assessed by third-party qualified experts and Philips Respironics, as well as an external medical panel – meaning they have been reviewed and assessed by organizations outside of Philips. In May, we announced that the risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices, including the first-generation DreamStation, System One and DreamStation GO devices. These devices represent approximately 95% of affected devices registered globally. 

There's a statement in the report that I think captures why the research is so important. It explains that at the time the recall we relied on an initial, limited data set and toxicological risk assessment. The results of that assessment were then extrapolated across all device platforms, and out of an abundance of caution, a reasonable worst‐case scenario was considered. 'Limited data set' are the key words I'd highlight. With the completion of the home sleep therapy devices portion of the test and research program, patients and their physicians can have much needed clarity on the potential health impact of their affected devices.

How is Philips Respironics helping patients who are still waiting for a remediated device?

Many patients have been waiting a long time for their replacement device, and they've been waiting because getting them a device has required navigating unique and largely unprecedented circumstances. I want these patients to know that we regret the frustrations caused by the delays. Getting them safe and effective therapy will continue to be our top priority. We have devices ready for patients, and we are making every effort to ensure they get into the hands of those who are waiting for them. To do that, we've dedicated staff to call and email patients for needed information. We are also reaching out to their doctors for their prescriptions. We're providing alternative replacement device options and in some cases, financial payment. We will continue to work through options for DreamStation Go users and will be providing specific information for those devices once those options are available. 

What can patients expect from Philips Respironics moving forward?

We remain fully focused on completing the remediation program, and patients can expect us to keep them informed with regular updates on progress. They can also expect that future decisions relating to our products will continue to be made with patient safety as the top priority. 

Lastly and importantly, they can expect us to continue to create more accountability internally while looking externally to independent third parties to validate our efforts to support patients with sleep and respiratory conditions. We’re continuing with testing on remaining devices, including Trilogy 100/200 and OmniLab Advanced Plus devices, and expect to provide an update in the coming months. We will also continue to work alongside industry organizations, care providers and customers to make sure we’re best supporting patients with sleep and respiratory conditions.

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