Respironics

Last updated
Respironics
Company type Subsidiary
Industry Medical
Founded1976
Headquarters Murrysville, Pennsylvania
Key people
Don Spence, President and CEO
Products respiratory equipment
sleep aids
RevenueIncrease2.svg $1.05 billion USD
Number of employees
4,900 [1]
Parent Philips
Website www.respironics.com

Respironics is an American medical supply company owned by Philips that specializes in products that improve respiratory functions. It is based in the Pittsburgh suburb of Murrysville in Pennsylvania, United States.

Contents

Some of its products had hazardous foam that disintegrated and entered patients' bodies. Company officials were aware of the defect, but continued to market them while the company withheld the vast majority of reports. [2]

History

In 1976, company founder Gerald E. McGinnis opened the company's first manufacturing facility for anesthesia masks near Pittsburgh, Pennsylvania. Previous product research and manufacturing had occurred in the founder's kitchen. Other early products included endotracheal and tracheostomy products.

McGinnis developed the "Nasal CPAP Mask System," a continuous positive airway pressure (CPAP) machine for the treatment of sleep apnea, [3] based on the original 1981 design by Dr. Colin Sullivan. [4] After receiving FDA approval in 1984, Respironics began selling the first commercially available CPAP machine a year later. [5]

In 1988, the company went public under the stock ticker symbol RESP. In 1992, Respironics received a patent for bi-level technology. This technology was originally intended as an improvement on CPAP, however, its use has expanded into the treatment of other breathing disorders such as chronic obstructive pulmonary disease (COPD).

Other significant milestones were the acquisition of the ventilator company LIFECARE International in 1996, sleep apnea competitor Healthdyne Technologies in 1998, and medical monitor and sensor leader Novametrix in 2002.

On December 21, 2007, Respironics announced it entered into a merger agreement with Philips, [6] with Philips acquiring all shares of Respironics for $66 per share, for a total of approx $5.1 billion. On March 14, 2008, Philips announced completion of tender offer to acquire Respironics. [7] [8]

Hazardous foam and product recall

A redesign of the CPAP devices[ which? ] from Respironics led to over a decade of complaints to Philips, which withheld the vast majority of them from the U.S. Food and Drug Administration (FDA). Around 2010, the company added industrial foam made of polyester-based polyurethane to silence rattling in the machine. But the foam could fall apart in heat and humidity, sending it into patients' noses, mouths, throats, and lungs. Among the chemicals released was formaldehyde, a potential carcinogen. [2]

Only in 2021 did Philips recall the machines, which had been delivered across the United States and many other countries. Over 3,700 complaints across more than 11 years were held back from the FDA, which device makers are required to do so within 30 days of reports of patient injuries in addition to investigating them. The company did not begin an internal investigation until 2019. The devices were used by children, the elderly, and over 700,000 U.S. veterans. As many as 15 million devices were affected. People experienced vomiting, dizziness, headaches, and cancers in the lungs, throat, sinuses, and esophagus. Company officials knew about the dangers of the device, but continued to market and sell them. [2]

During the COVID-19 pandemic, the company ramped up production of another ventilator that also included the foam. Operating profits from the ventilators, including the CPAP devices, soared to around US$800 million. During the pandemic, Philips conducted a series of studies on the foam, showing the deteriorating foam and chemicals released by it, which could cause "serious injury, life-threatening or permanent impairment". [2]

The company said patients' health is its top priority, and regretted the "distress and concern" that the recall caused. It said complaints about the foam were limited and were evaluated on a case-by-case basis, and it was made aware of the significance in early 2021, launching the recall soon after. Months after the recall, Philips said that tests showed the chemicals released by the foam were within safe levels. [2]

The company announced a new CPAP machine in April 2021, and soon after admitted that the foam it had used previously had been breaking down in an earnings call. Then-CEO Frans van Houten, in the earnings call, pledged 250 million euros to the problem, and reassured investors that the "device is safe to be continued to use to the best of our knowledge at this time". The company alerted the FDA but not customers. Following the recall, van Houten said he regretted the impact of it on "patients, care providers, and shareholders." [2]

Multiple federal lawsuits have been levied against the company. One settled with the company for US$479 million to reimburse customers. [9] [2]

Today

Philips Respironics's products include devices for the diagnosis and treatment of sleep apnea including CPAP and bi-level (BiPAP) non-invasive ventilation machines, oxygen concentrators for patients requiring supplemental oxygen, infant apnea monitors for infants at risk of SIDS, asthma treatment solutions and hospital ventilators.

Related Research Articles

<span class="mw-page-title-main">Philips</span> Dutch multinational conglomerate corporation

Koninklijke Philips N.V., commonly shortened to Philips, is a Dutch multinational conglomerate corporation that was founded in Eindhoven in 1891. Since 1997, its world headquarters have been situated in Amsterdam, though the Benelux headquarters is still in Eindhoven. Philips was formerly one of the largest electronics companies in the world, but is currently focused on the area of health technology, having divested its other divisions.

<span class="mw-page-title-main">Sleep apnea</span> Disorder involving pauses in breathing during sleep

Sleep apnea, also spelled sleep apnoea, is a sleep disorder in which pauses in breathing or periods of shallow breathing during sleep occur more often than normal. Each pause can last for a few seconds to a few minutes and they happen many times a night. In the most common form, this follows loud snoring. A choking or snorting sound may occur as breathing resumes. Because the disorder disrupts normal sleep, those affected may experience sleepiness or feel tired during the day. In children, it may cause hyperactivity or problems in school.

<span class="mw-page-title-main">Snoring</span> Vibratory sound made while asleep

Snoring is the vibration of respiratory structures and the resulting sound due to obstructed air movement during breathing while sleeping. The sound may be soft or loud and unpleasant. Snoring during sleep may be a sign, or first alarm, of obstructive sleep apnea (OSA). Research suggests that snoring is one of the factors of sleep deprivation.

<span class="mw-page-title-main">Ventilator</span> Device that provides mechanical ventilation to the lungs

A ventilator is a type of breathing apparatus, a class of medical technology that provides mechanical ventilation by moving breathable air into and out of the lungs, to deliver breaths to a patient who is physically unable to breathe, or breathing insufficiently. Ventilators may be computerized microprocessor-controlled machines, but patients can also be ventilated with a simple, hand-operated bag valve mask. Ventilators are chiefly used in intensive-care medicine, home care, and emergency medicine and in anesthesiology.

<span class="mw-page-title-main">Obesity hypoventilation syndrome</span> Condition in which severely overweight people fail to breathe rapidly or deeply enough

Obesity hypoventilation syndrome (OHS) is a condition in which severely overweight people fail to breathe rapidly or deeply enough, resulting in low oxygen levels and high blood carbon dioxide (CO2) levels. The syndrome is often associated with obstructive sleep apnea (OSA), which causes periods of absent or reduced breathing in sleep, resulting in many partial awakenings during the night and sleepiness during the day. The disease puts strain on the heart, which may lead to heart failure and leg swelling.

<span class="mw-page-title-main">Positive airway pressure</span> Mechanical ventilation in which airway pressure is always above atmospheric pressure

Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea. PAP ventilation is also commonly used for those who are critically ill in hospital with respiratory failure, in newborn infants (neonates), and for the prevention and treatment of atelectasis in patients with difficulty taking deep breaths. In these patients, PAP ventilation can prevent the need for tracheal intubation, or allow earlier extubation. Sometimes patients with neuromuscular diseases use this variety of ventilation as well. CPAP is an acronym for "continuous positive airway pressure", which was developed by Dr. George Gregory and colleagues in the neonatal intensive care unit at the University of California, San Francisco. A variation of the PAP system was developed by Professor Colin Sullivan at Royal Prince Alfred Hospital in Sydney, Australia, in 1981.

<span class="mw-page-title-main">Polysomnography</span> Multi-parameter study of sleep and sleep disorders

Polysomnography (PSG), a type of sleep study, is a multi-parameter study of sleep and a diagnostic tool in sleep medicine. The test result is called a polysomnogram, also abbreviated PSG. The name is derived from Greek and Latin roots: the Greek πολύς, the Latin somnus ("sleep"), and the Greek γράφειν.

<span class="mw-page-title-main">Mandibular advancement splint</span>

A mandibi splint or mandibi advancement splint is a prescription custom-made medical device worn in the mouth used to treat sleep-related breathing disorders including: obstructive sleep apnea (OSA), snoring, and TMJ disorders. These devices are also known as mandibular advancement devices, sleep apnea oral appliances, oral airway dilators, and sleep apnea mouth guards.

<span class="mw-page-title-main">Non-invasive ventilation</span> Breathing support administered through a face mask

Non-invasive ventilation (NIV) is the use of breathing support administered through a face mask, nasal mask, or a helmet. Air, usually with added oxygen, is given through the mask under positive pressure; generally the amount of pressure is alternated depending on whether someone is breathing in or out. It is termed "non-invasive" because it is delivered with a mask that is tightly fitted to the face or around the head, but without a need for tracheal intubation. While there are similarities with regard to the interface, NIV is not the same as continuous positive airway pressure (CPAP), which applies a single level of positive airway pressure throughout the whole respiratory cycle; CPAP does not deliver ventilation but is occasionally used in conditions also treated with NIV.

<span class="mw-page-title-main">Obstructive sleep apnea</span> Sleeping and breathing disorder

Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder and is characterized by recurrent episodes of complete or partial obstruction of the upper airway leading to reduced or absent breathing during sleep. These episodes are termed "apneas" with complete or near-complete cessation of breathing, or "hypopneas" when the reduction in breathing is partial. In either case, a fall in blood oxygen saturation, a disruption in sleep, or both, may result. A high frequency of apneas or hypopneas during sleep may interfere with the quality of sleep, which – in combination with disturbances in blood oxygenation – is thought to contribute to negative consequences to health and quality of life. The terms obstructive sleep apnea syndrome (OSAS) or obstructive sleep apnea–hypopnea syndrome (OSAHS) may be used to refer to OSA when it is associated with symptoms during the daytime.

<span class="mw-page-title-main">ResMed</span> American medical equipment company

ResMed Inc. is a San Diego, California-based medical equipment company. It primarily provides cloud-connectable medical devices for the treatment of sleep apnea, chronic obstructive pulmonary disease (COPD), and other respiratory conditions. ResMed produced hundreds of thousands of ventilators and bilevel devices to help treat the respiratory symptoms of patients with COVID-19. ResMed also provides software to out-of-hospital care agencies to streamline transitions of care into and between these care settings for seniors and their care providers.

Hypopnea is overly shallow breathing or an abnormally low respiratory rate. Hypopnea is defined by some to be less severe than apnea, while other researchers have discovered hypopnea to have a "similar if not indistinguishable impact" on the negative outcomes of sleep breathing disorders. In sleep clinics, obstructive sleep apnea syndrome or obstructive sleep apnea–hypopnea syndrome is normally diagnosed based on the frequent presence of apneas and/or hypopneas rather than differentiating between the two phenomena. Hypopnea is typically defined by a decreased amount of air movement into the lungs and can cause oxygen levels in the blood to drop. It commonly is due to partial obstruction of the upper airway.

<span class="mw-page-title-main">Continuous positive airway pressure</span> Form of ventilator which applies mild air pressure continuously to keep airways open

Continuous positive airway pressure (CPAP) is a form of positive airway pressure (PAP) ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of a person. The application of positive pressure may be intended to prevent upper airway collapse, as occurs in obstructive sleep apnea, or to reduce the work of breathing in conditions such as acute decompensated heart failure. CPAP therapy is highly effective for managing obstructive sleep apnea. Compliance and acceptance of use of CPAP therapy can be a limiting factor, with 8% of people stopping use after the first night and 50% within the first year.

Central sleep apnea (CSA) or central sleep apnea syndrome (CSAS) is a sleep-related disorder in which the effort to breathe is diminished or absent, typically for 10 to 30 seconds either intermittently or in cycles, and is usually associated with a reduction in blood oxygen saturation. CSA is usually due to an instability in the body's feedback mechanisms that control respiration. Central sleep apnea can also be an indicator of Arnold–Chiari malformation.

Colin Sullivan is an Australian physician, professor, and inventor known for his invention of the nasal continuous positive airway pressure (CPAP) machine for the treatment of sleep apnea.

Modes of mechanical ventilation are one of the most important aspects of the usage of mechanical ventilation. The mode refers to the method of inspiratory support. In general, mode selection is based on clinician familiarity and institutional preferences, since there is a paucity of evidence indicating that the mode affects clinical outcome. The most frequently used forms of volume-limited mechanical ventilation are intermittent mandatory ventilation (IMV) and continuous mandatory ventilation (CMV). There have been substantial changes in the nomenclature of mechanical ventilation over the years, but more recently it has become standardized by many respirology and pulmonology groups. Writing a mode is most proper in all capital letters with a dash between the control variable and the strategy.

Nasal expiratory positive airway pressure is a treatment for obstructive sleep apnea (OSA) and snoring.

A sleep-related breathing disorder is a sleep disorder in which abnormalities in breathing occur during sleep that may or may not be present while awake. According to the International Classification of Sleep Disorders, sleep-related breathing disorders are classified as follows:

Sleep surgery is a surgery performed to treat sleep disordered breathing. Sleep disordered breathing is a spectrum of disorders that includes snoring, upper airway resistance syndrome, and obstructive sleep apnea. These surgeries are performed by surgeons trained in otolaryngology, oral maxillofacial surgery, and craniofacial surgery.

Gerald Edward McGinnis was an American inventor and businessman who founded Respironics, a medical device company which the sold first mass-produced CPAP machines.

References

  1. ↑ "Company Profile for Respironics, Inc (RESP)". Zenobank.com. Archived from the original on July 20, 2010. Retrieved 2008-10-02.
  2. 1 2 3 4 5 6 7 Cenziper, Debbie; D. Sallah, Michael; Korsh, Michael; Robinson-Johnson, Evan; Sager, Monica (September 27, 2023). "Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared". ProPublica . Retrieved October 14, 2023.
  3. ↑ "Philips kept complaints about dangerous breathing machines secret while company profits soared". Pittsburgh Post-Gazette Interactive. Pittsburgh Post-Gazette. 27 September 2023. Retrieved 2 February 2024.
  4. ↑ "How the CPAP machine beats deadly sleep apnoea". The University of Sydney. Retrieved 2 February 2024.
  5. ↑ "Philips recall crisis casts shadow over legacy of Respironics founder". Pittsburgh Post-Gazette. 30 December 2023. Retrieved 2 February 2024.
  6. ↑ "ROYAL PHILIPS ELECTRONICS TO ACQUIRE RESPIRONICS FOR USD $66.00 PER SHARE". Respironics. Archived from the original on 10 June 2008.
  7. ↑ "PHILIPS ANNOUNCES COMPLETION OF TENDER OFFER TO ACQUIRE RESPIRONICS (EX-99.A.2.I)". www.sec.gov (Press release). 14 March 2008.
  8. ↑ Foo Yun Chee; Niclas Mika (2007-12-21). "Philips in $5 billion Respironics deal". Reuters.
  9. ↑ Jewett, Christina (September 7, 2023). "CPAP Maker Reaches $479 Million Settlement on Breathing Device Defects". The New York Times . ISSN   0362-4331 . Retrieved November 28, 2023.
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