Philips Respironics provides update for the US on ongoing CPAP, BiPAP and Mechanical Ventilator field action
March 10 2022 - 7:15PM
Philips Respironics provides update for the US on ongoing CPAP,
BiPAP and Mechanical Ventilator field action
March 10, 2022
Amsterdam, the Netherlands – Royal Philips’
(NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, today
provided an update on the remediation status in the US of the
ongoing recall of certain sleep and respiratory care products in
connection with identified potential health risks related to the
polyester-based polyurethane (PE-PUR) sound abatement foam in these
devices.
Customer and patient outreach Following two
rounds of comprehensive customer and patient outreach, Philips
Respironics has reached the vast majority of the installed base in
the US resulting in the registration of approximately 2.6 million
devices in the country. Philips Respironics continues to monitor
recall awareness for affected patients [1]. Philips Respironics is
working cooperatively with the US Food and Drug Administration
(FDA) to further increase awareness for patients, consumers, and
healthcare providers of the recall. Based on feedback from the FDA,
Philips Respironics will be working with its DME customers to allow
the company to directly contact those patients and other end-users
that may not yet have received notice of the recall.
In addition, Philips Respironics continues to utilize its
current mobile application, DreamMapper, to send notifications to
patients and consumers utilizing the application with information
regarding the field action. The DreamMapper notification function
is used to direct patients/consumers back to the field action
website, which includes detailed information on the field action
and the process for registering, and maintaining such registration,
for a replacement device.
Repair and replacement programTo date, Philips
Respironics has shipped a total of more than 650,000 replacement
devices to customers in the US, and aims to complete the repair and
replacement program in the fourth quarter of 2022.
Test and research programIn December 2021,
Philips provided an update on the VOC test results to-date for the
first-generation DreamStation devices [2]. The results indicate
that the VOC concentrations are within safe exposure limits
specified in the applicable safety standard (ISO 18562).
Comprehensive particulate testing and analyses for the
first-generation DreamStation devices are expected to be completed
in the second quarter of 2022.
Initial testing results suggest that PE-PUR foam degradation in
CPAP devices is accelerated by repeated exposure to ozone cleaning.
The FDA and Philips have communicated and reiterated that ozone is
not an approved cleaning agent. For example, as directed by FDA,
Philips has prominently published information on the risk of using
ozone cleaners on the landing page of the Philips Respironics field
action website.
Philips is working cooperatively with the FDA and other
competent authorities to update them on new test data as they
become available. Philips is also working cooperatively with the
FDA to develop a consolidated summary for healthcare providers on
the available, finalized testing data, results, and conclusions,
which will be updated as new test data becomes available.
Independent of Philips Respironics, in December 2021, an
analysis was published in the American Journal of Respiratory and
Critical Care Medicine [2] that did not find a higher risk of
incident cancer among obstructive sleep apnea (OSA) patients who
used a Philips Respironics PAP device as compared to OSA patients
who used a PAP device from other manufacturers, or OSA patients
without treatment. The analysis and conclusion were based on data
from a large multicenter cohort study involving 6,900 OSA patients
on PAP devices between 2012 and 2020, including 1,200 Philips
Respironics PAP users. Philips Respironics was not involved in the
study or the analysis.
[1] Philips Respironics’ monthly surveys indicate
that nearly 80% (aggregate data) of responding Philips Respironics
CPAP users in the US confirmed they were aware of the recall. Each
study was conducted online on a national representative sample of
2,200 adults (and weighted based on age, gender, race, and
education level). Results have a margin of error of +/- 2% at a 95%
confidence level for the overall population.
[2] The vast majority of the registered affected
devices in the US to date are in the first-generation DreamStation
product family.
[3] An Association between Positive Airway Pressure
Device Manufacturer and Incident Cancer? A Secondary Data Analysis;
American Journal of Respiratory and Critical Care Medicine, 2021,
Volume 204, Issue 12 pp. 1484–1488; Tetyana Kendzerska, Richard S.
Leung, Mark I. Boulos, Daniel I. McIsaac, Brian J. Murray, Gregory
L. Bryson, Robert Talarico, Atul Malhotra, Andrea S. Gershon,
Constance Mackenzie, and Marcus Povitz. The analysis can be found
here.
For further information, please
contact:
Steve KlinkPhilips Global Press OfficeTel.: +31 6
10888824E-mail: steve.klink@philips.com
Derya GuzelPhilips Investor RelationsTel.: +31 20 59
77055E-mail: derya.guzel@philips.com
About Royal PhilipsRoyal Philips (NYSE: PHG,
AEX: PHIA) is a leading health technology company focused on
improving people's health and well-being, and enabling better
outcomes across the health continuum – from healthy living and
prevention, to diagnosis, treatment and home care. Philips
leverages advanced technology and deep clinical and consumer
insights to deliver integrated solutions. Headquartered in the
Netherlands, the company is a leader in diagnostic imaging,
image-guided therapy, patient monitoring and health informatics, as
well as in consumer health and home care. Philips generated 2021
sales of EUR 17.2 billion and employs approximately 78,000
employees with sales and services in more than 100 countries. News
about Philips can be found at www.philips.com/newscenter.
Forward-looking statementsThis statement
contains certain forward-looking statements with respect to the
financial condition, results of operations and business of Philips
and certain of the plans and objectives of Philips with respect to
these items. Examples of forward-looking statements include
statements made about the strategy, estimates of sales growth,
future EBITA, future developments in Philips’ organic business and
the completion of acquisitions and divestments. By their nature,
these statements involve risk and uncertainty because they relate
to future events and circumstances and there are many factors that
could cause actual results and developments to differ materially
from those expressed or implied by these statements.
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