In brief: Philips update, Essity expansion, Kubat recognition

AMSTERDAM – Philips Respironics has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. 

The announcement comes after an assessment by an outside medical panel and Philips and is intended to give healthcare providers the most recent data. Overall guidance for physicians and patients in the recall notification remains unchanged. 

At the time of the recall, Philips relied on an initial, limited data set and toxicological risk assessment. Since then, using ISO 18562 guidance, VOC toxicological risk assessments were performed by certified testing laboratories and a qualified third-party expert based on the initial and new VOC testing performed to date. Philips has made this data available to the Food and Drug Administration and other authorities. 

Philips notes that the tested DreamStation devices were not exposed to ozone cleaning, in accordance with the instructions for use. Additionally, this new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. Further health risk assessments are ongoing. 

Philips recently asked HME providers to return to the company any recalled DreamStation 1 devices that patients return to them.  

Comprehensive particulate testing and analyses are expected to be completed in the second quarter of 2022, as testing protocols in compliance with the full extent of the relevant ISO standards for all affected product platforms require long lead times of multiple months. Philips will continue to provide updates on findings from these assessments. 

‘COVID-somnia’ impacting sleep 

ARLINGTON, Va. – More than half of Americans (56%) say they have experienced an increase in sleep disturbances since the onset of the COVID-19 pandemic, according a survey commissioned by the American Academy of Sleep Medicine. 

Of the reported sleep disturbances, or “COVID-somnia,” most common was trouble falling or staying asleep (57%). Others included sleeping less (46%), experiencing worse quality sleep (45%) and having more disturbing dreams (36%). 

“COVID-somnia can be brought on by multiple stressors: fears about the pandemic, concern for loved ones, financial worries, and limited socialization,” said Jennifer Martin, licensed clinical psychologist and president-elect of the AASM board of directors. “The best way to get healthy sleep during these unprecedented times is to be intentional about your sleep habits and routines.” 

Men (59%) were more likely than women (54%) to report COVID-somnia sleep disturbances. Those 35-44 had the highest rate of COVID-somnia at 70%. Those 55 and older were most likely to report trouble falling or staying asleep. 

 It makes sense that so many people are having sleep problems, since insomnia is often caused by stress or lifestyle factors, which have likely changed greatly during the pandemic, says AASM. Among its recommendations: maintain a consistent sleep schedule, turn off electronics, follow a relaxing evening routine, and create a peaceful sleeping environment. 

Essity expands wound care portfolio 

STOCKHOLM – Essity has acquired Hydrofera, a manufacturer and developer of advanced wound care technology and products for approximately $116 million USD. The acquisition supports Essity's strategic priority to grow through acquisitions in Medical Solutions. "The acquisition of Hydrofera is yet another great strategic fit for Essity further strengthening our innovation capacity and expanding our offering within advanced wound care,” said Ulrika Kolsrud, president, health and medical solutions at Essity. “The company has innovations that significantly accelerate healing and reduce the patient's discomfort.” Hydrofera has a direct sales force and maintains agreements and preferred provider status with the major national medical/surgical distributors and buying groups in the US and Canadian healthcare markets. Products are used across the entire care range such as hospitals, wound clinics, long term care facilities and homecare. In July, Essity finalized its acquisition of ABIGO. 

Kubat recognized as Best of Omaha 

OMAHA, Neb. – Kubat HealthCare received first-place honors in Omaha Magazine’s Best of Omaha 2022 contest. Kubat HealthCare placed first in the Local Pharmacy and Physical Therapy Equipment categories. “Winning Best of Omaha is directly connected to the fantastic team we have at Kubat HealthCare,” said Tony Schmid, vice president of pharmacy operations, “I am very proud of the team, their success and their dedication to our customers every day.” Omaha Magazine’s Best of Omaha is an advertisement free, blank ballot system that allows only one vote per verified email. In addition, voting selections are solely determined by the community. “Kubat HealthCare has been dedicated to this community as a local pharmacy since 1935,” said Jim Rich, CEO of Kubat HealthCare, “We are honored to be the first-place winners of the Local Pharmacy and Physical Therapy Equipment categories and are grateful to continue to serve a community we adore.” 

Dispensing new COVID-19 treatment quickly is critical, says NCPA 

ALEXANDRIA, Va. – The National Community Pharmacists Association and other pharmacy stakeholders says the Food and Drug Administration’s decision to prevent pharmacists from prescribing a new COVID-19 antiviral medication from Pfizer wastes time and money and puts patients at risk. “Pharmacists are educated, trained, and able to assess patients in accordance with clinical guidelines for appropriate use of these more convenient COVID-19 treatment options,” say stakeholders. “The oral antivirals are most effective when taken early in the infection. Time is of the essence. Requiring patients to make an appointment with another prescriber just to get a prescription that their pharmacist will fill adds time, cost, and inconvenience but most concerning of all, it could cause hospitalizations and even deaths.” The NCPA was joined on the statement by American Pharmacists Association (APhA), American Society of Consulting Pharmacists (ASCP), American Society of Health System Pharmacists (ASHP), and the National Alliance of State Pharmacy Associations (NASPA). The FDA approved the Pfizer pill Dec. 22. It is not a substitution for vaccines, says the agency. 

NHIA releases recommendations on managing supply shortages 

ARLINGTON, Va. – The National Home Infusion Association has issued guidance for members that are experiencing shortages of administration sets for ambulatory infusion pumps due to an ongoing supply chain crisis. The association is working with manufacturers and suppliers to get more information about when these issues might be resolved and if they can offer alternatives. In the meantime, NHIA reminds providers that the decision to use an infusion pump—and which pump to use—is a clinical one. To assist in assessing patient needs and considering alternatives, NHIA has developed a few recommendations for managing current shortages, including considerations for selecting an appropriate infusion device. 

Quality Biomedical moves into larger Florida location 

BOULDER, Colo. – Quality Biomedical, a national provider of respiratory equipment management solutions has moved into a 30,000-square-foot facility in Pinellas Park, Florida, tripling the size of its previous service facility in Largo, Florida. “Our business in Florida continues to grow at an increasing rate” said Jim Worrell, chief commercial officer. “We have added several new OEM partners, including 3B Medical, Dynarex Medical and Rhythm Healthcare, all which require more space and staff to support their equipment and our mutual customers. Additionally, the demand from our providers to support their COVID patients has been an element in our rapid growth.” Established in 2004, Quality Biomedical now has eight service centers across the country specializing in the repair of respiratory equipment, including ventilators, oxygen concentrators, POCs and apnea monitors.  

Quality Biomedical promotes Bianca Neri 

BOULDER, Colo. – Quality Biomedical has promoted Bianca Neri to vice president, sales, where she will oversee a team of regional directors servicing customers in all 50 states. Neri has been with the company for more than five years and is a “natural” to step into the new position, say company execs. “We are thrilled to have her join our senior management team”, said PK Bala, CEO. “She is a true professional and has been an integral part of our significant growth in the past five years.”