Philips-Respironics CPAP and Ventilator Device Recall, What to Know

 Philips-Respironics, a medical device manufacturer for home ventilator and CPAP/BIPAP machines used to treat sleep apnea, recently announced a recall for many of their medical devices due to concerns that a sound reducing foam may degrade over time and enter into a patient's airway and lungs, posing severe medical risk.

Philips Respironics announced a voluntary recall notification (U.S. only) / field safety notice (International Markets) for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life.

Advice for Patients and Customers

Philips advises patients and customers to take the following actions:

• For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or durable medical equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.
• For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.

Patients, physicians and DME suppliers can call Philips at 877-907-7508 for additional support.

Read article here.

Recall letter here.

Treating Sleep Apnea without CPAP

We care about the adults too.  Not all sleep apnea is the same, join us to learn about a treatment alternative.

Click HERE to register

COVID 19 Vaccination - Why, When, and Where?

 

The SARS-COV2 virus is known to be very dangerous if not deadly to high risk populations.  Common severe complications from this virus include a life threatening pneumonia requiring hospital care.  

Two highly effective mRNA vaccines are now available (Pfizer and Moderna) in limited quantities and should become increasingly available to high risk individuals before it becomes generally available to the public.  These vaccinations DO NOT contain live virus and therefore CANNOT cause infection.  They are primarily approved for prevention of a severe COVID 19 related illness.  The Pfizer vaccination is approved for 16 and up and the Moderna vaccine is approved for 18 and up.  Both vaccination require 2 doses to be effective. We are currently in phased 1A and 1B in Texas.

Because of limited vaccine availability, CDC and many public health agencies and hospital systems are providing vaccine in a phased manner as indicated below:

Healthcare personnel and residents of long-term care facilities should be offered the first doses of COVID-19 vaccines (1a)

CDC recommends that initial supplies of COVID-19 vaccine be allocated to healthcare personnel and long-term care facility residents. This is referred to as Phase 1a. Phases may overlap. CDC made this recommendation on December 3, 2020.

Groups who should be offered vaccination next (1b and 1c)

CDC recommends that in Phase 1b and Phase 1c, which may overlap, vaccination should be offered to people in the following groups. CDC made this recommendation on December 22, 2020.

Phase 1b

• Frontline essential workers such as fire fighters, police officers, corrections officers, food and agricultural workers, United States Postal Service workers, manufacturing workers, grocery store workers, public transit workers, and those who work in the educational sector (teachers, support staff, and daycare workers.)
• People aged 75 years and older because they are at high risk of hospitalization, illness, and death from COVID-19. People aged 75 years and older who are also residents of long-term care facilities should be offered vaccination in Phase 1a.

Phase 1c

• People aged 65—74 years because they are at high risk of hospitalization, illness, and death from COVID-19. People aged 65—74 years who are also residents of long-term care facilities should be offered vaccination in Phase 1a.
• People aged 16—64 years with underlying medical conditions which increase the risk of serious, life-threatening complications from COVID-19.
• Other essential workers, such as people who work in transportation and logistics, food service, housing construction and finance, information technology, communications, energy, law, media, public safety, and public health.

Texas Department of State Health Services has provided state specific guidance about who is eligible for vaccination now.  

It includes peoples age 16 and above who may have certain underlying conditions.  Those recommendations are listed here:

Texas DSHS recommendations

People 16 years of age and older with at least one chronic medical condition that puts them at increased risk for severe illness from the virus that causes COVID-19, such as but not limited to:

• Cancer
• Chronic kidney disease
• COPD (chronic obstructive pulmonary disease)
• Heart conditions, such as heart failure, coronary artery disease or cardiomyopathies
• Solid organ transplantation
• Obesity and severe obesity (body mass index of 30 kg/m2 or higher)
• Pregnancy
• Sickle cell disease
• Type 2 diabetes mellitus

There are a variety of other chronic medical conditions that are considered possibly higher risk that may be indication for vaccination as well. That comprehensive list is here:

CDC recommendations about chronic medical conditions

Below is a link from the Texas DSHS website to help identify a vaccine provider here you:

Vaccine provider locations can be found here

It's Here! Home Monitoring For Asthma

 During a period where office visits are reduced when possible and safe, and when some lung function testing maneuvers are avoided (spirometry) because of increased risk for asymptomatic infection spread, it is a great advantage to have quality home monitoring options.  The Capmedic device does this and provides the additional benefit of coaching asthma patients through proper lung function and allowing your asthma doctor to monitor compliance.  Dr. Susarla

CapMedic Measures Lung Function, Makes Sure Inhalers Used Correctly

The FDA has cleared the CapMedic device that helps to make sure that metered dose inhalers (MDIs) are properly used, even by young patients.

MDIs are most commonly employed to deliver asthma medications deep into the lungs, but to work effectively they have to be used correctly and on a consistent schedule.

The CapMedic snaps onto the top of many inhalers and, using built-in lights and a tiny speaker, it works to nudge users to inhale the medication correctly and at the right time. When a person is ready, the device talks them through all the steps, like shaking the inhaler, properly squeezing it while keeping it upright, and timing the inhalation just right.

The same device can snap onto an accompanying plastic adapter to turn it into an accurate at-home spirometer for lung function measurement. It can now measure FEV1, the maximum amount of air that the patient can push in a second, and PEF, the maximum flow one can generate at a steady rate.

Readings about usage and spirometer data are stored on an accompanying smartphone, helping patients, parents, and caretakers, make sure that the inhaled medication regimen is adhered to.

“Decades of studies have shown that almost 90% of patients are unable to use MDIs correctly – a result of their complex, multi-step usage requirements. The Cognita team has conducted drug deposition studies showing a tenfold improvement in the delivery of medication from just 4-5% to 45% when inhalers are used correctly,” said Rajoshi Biswas, Ph.D., Chief Scientific Officer and co-founder at Cognita Labs, in the announcement. “Getting an effective daily dose means patients are more likely to avoid costly, life-threatening hospitalizations.”

Read article here.

COVID-19 Infection and Transmission in Children

Are children at significant risk for a COVID-19 infection?  Although there may certainly be high risk groups, the data do not seem to support this.

Age-dependent effects in the transmission and control of COVID-19 epidemics

The COVID-19 pandemic has shown a markedly low proportion of cases among children1,2,3,4. Age disparities in observed cases could be explained by children having lower susceptibility to infection, lower propensity to show clinical symptoms or both. We evaluate these possibilities by fitting an age-structured mathematical model to epidemic data from China, Italy, Japan, Singapore, Canada and South Korea. We estimate that susceptibility to infection in individuals under 20 years of age is approximately half that of adults aged over 20 years, and that clinical symptoms manifest in 21% (95% credible interval: 12–31%) of infections in 10- to 19-year-olds, rising to 69% (57–82%) of infections in people aged over 70 years. Accordingly, we find that interventions aimed at children might have a relatively small impact on reducing SARS-CoV-2 transmission, particularly if the transmissibility of subclinical infections is low. Our age-specific clinical fraction and susceptibility estimates have implications for the expected global burden of COVID-19, as a result of demographic differences across settings. In countries with younger population structures—such as many low-income countries—the expected per capita incidence of clinical cases would be lower than in countries with older population structures, although it is likely that comorbidities in low-income countries will also influence disease severity. Without effective control measures, regions with relatively older populations could see disproportionally more cases of COVID-19, particularly in the later stages of an unmitigated epidemic.

Read article here.

Severe COVID 19 In Children and Young Adults

Here is a look at pediatric and young adult cases of COVID 19 from Washington, DC.  Note the higher percentage of cases in infants and older teenagers, in addition to asthma as the most common comorbidity.  Other chronic conditions more likely to be associated with ICU admission.

Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.

“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.

In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.

Read article here.

What About COVID 19 and Asthma?

As data continues to stream in regarding possible risk factors for COVID 19, one missing population besides children in general seems to be .... asthma.  COVID 19 and other SARS type viruses are known to enter lung cells (type 2 pneumocytes) through a cell surface receptor known as ACE2.  According to this study, there appears to be reduced cell surface expression in people with allergic diseases.  This is of course, not enough to clear children with asthma from significant risk, but warrants investigation.  Incidentally, nonatopic individuals did NOT have reduced ACE2 expression.

  

Viral respiratory infections are the most common trigger of severe asthma exacerbations in children and adults. Unexpectedly, large epidemiological studies of the COVID-19 pandemic in China did not identify asthma as a risk factor of severe COVID19 related illnesses.(2) Here, we report that respiratory allergy and controlled allergen exposures are each associated with significant reductions in ACE2 expression. ACE2 expression was lowest in those with both high levels of allergic sensitization and asthma. Importantly, non-atopic asthma was not associated with reduced ACE2 expression. Given that ACE2 serves as the receptor for SARS-CoV-2, our findings suggest a potential mechanism of reduced COVID-19 severity in patients with respiratory allergies. However, it is likely that additional factors beyond ACE2 expression modulate the response to COVID-19 in allergic individuals, and elucidation of these factors may also provide important insights into COVID-19 disease pathogenesis. Strengths of our study include carefully phenotyped cohorts of children and adults. Further, the allergen challenge studies included both upper and lower airway samples, with each demonstrating a consistent impact on ACE2 expression. Limitations include lack of clinical information to directly link ACE2 expression to SARS-CoV-2 infection and illness severity in our study populations. In addition, we do not have data on the ACE2 protein levels to confirm the gene expression data, though previous work suggests a direct association between ACE2 mRNA levels and ACE2 protein levels in the lung.(8)

 Read article here.