In brief: Teufel’s new job, FDA’s new warning, Joerns’ new direction 

NASHVILLE, Tenn. — National Seating & Mobility has named Crispin Teufel, who served as CEO of Lincare Holding for five years, as its CEO. 

Teufel replaces Chuck Bodner, who had been serving as interim CEO. Bodner will continue in his role as CFO. 

“I am honored to take on the role of CEO at NSM,” Teufel said. “The passion and perseverance of the NSM team is evidenced by the company’s continued success. I am proud to support the NSM team in further advancing the experience and quality outcomes for clients who rely on mobility and accessibility solutions.” 

Earlier this year, Teufel left Lincare to become the CEO of AdaptHealth, but they agreed to terminate his contract following a lawsuit filed by Lincare’s parent company, The Linde Group, which alleged breach of contract, breach of duty of loyalty and misappropriation of trade secrets.

Teufel also served as CFO of Lincare and in a variety of roles at Linde, including finance director for the Engineering Division from 2011-13. He began his career in financial roles at PWC and Arthur Andersen. 

“The NSM board of directors is pleased to appoint Crispin Teufel as CEO,” said Brady Shirley, NSM chairman of the board. “Crispin is a transformational leader whose extensive background in the DME industry, strong experience and proven track record position him to guide the mission and future growth of NSM.” 

NSM named Tony Ueber CEO in April of this year and announced he was being replaced by Bodner in July. 

FDA issues warning for DreamStation 2 

Based on currently available evidence, agency does not believe safety issue is related to foam 

AMSTERDAM – The U.S. Food and Drug Administration yesterday issued a safety communication to inform users of possible thermal issues with the Philips Respironics DreamStation 2 CPAP machine and to advise them to monitor the machines for signs of overheating.  

The FDA recently received medical device reports (MDRs) associated with issues like fire, smoke, burns and other signs of overheating while using the machine. The agency is in ongoing discussions with Philips about mitigation strategies and will provide updates accordingly.   

“The FDA is committed to assuring this new safety issue is resolved expeditiously,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients. We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips. Addressing these safety concerns remains a top priority for the FDA.” 

The FDA says between August 1, 2023, and November 15, 2023, it received more than 270 reports of problems associated with the machine, compared with fewer than 30 MDRs received in the previous three years. 

Philips says the reports, while filed over the last three months, cover a three-year period following a retrospective review of possible complaints related to the DreamStation 2 since its launch. 

“Philips Respironics conducted review and analysis regarding reports of the possible thermal issues in accordance with its regulatory processes,” the company said in a statement. “The devices can continue to be used provided that the safety instructions in the instructions for use for the DreamStation 2 sleep therapy device are followed.” 

In October, the FDA requested that Philips conduct additional testing on the health risks related to the sound abatement foam in certain recalled Philips ventilators and BiPAP and CPAP devices.  

Joerns Healthcare to exit institutional settings 

‘We're following the customer's lead’ 

CHARLOTTE, N.C. – Joerns Healthcare, a provider of post-acute care medical equipment and services, plans to exit the long-term care rental business and refocus on medical equipment sales and services. 

It began notifying businesses and customers on Nov. 20, 2023. 

"(This) announcement represents the execution of the next milestone in our strategy to prioritize investments and resources on our core medical equipment sales business to better serve our customers," said CEO Taylor Smith. "Since the pandemic, there has been a noticeable shift in the preferred acquisition model away from renting. Customers are instead continuing to choose to own assets in a time of challenged census, increasing operational expenses and with changes in the reimbursement from fee-for-service to a patient-directed model. We're following the customer's lead as we've done for over a century." 

Going forward, Joerns Healthcare will continue their more than 134-year legacy as a vertically integrated, value-added manufacturer of high-quality medical equipment essential to sub-acute patients. The company has already embarked on a multimillion-dollar capital improvement project for its 300,000-square-foot manufacturing and supply chain facilities in North America. 

"This next phase of our journey further champions a focus on the core business and reinvestment in innovation," said Doug Ferguson, chief strategy officer of Joerns Healthcare. "We are dedicated to bringing the highest quality products and care-empowering technologies, driven by customer insight, to the marketplace. Exciting solutions like our Connexio IoT platform, available with our leading bed systems, are targeted at saving labor time while creating care efficiencies, improving equipment utilization and optimizing clinical practice. We believe these solutions are aligned to the key challenges of our customers now and for their future ahead." 

Earlier this year, Joerns Healthcare acquired Winncare, which offers a line of moving and handling cushions. 

Lincare, Teufel settle lawsuit 

CLEARWATER, Fla. – A federal judge in Connecticut on Nov. 29 approved a stipulated permanent injunction between Lincare and former CEO Crispin Teufel. 

The injunction bans Teufel, who left the company in June to become the CEO of AdaptHealth, and any associates from neither using, distributing nor relying upon confidential data or trade secrets he may have obtained from Lincare or Linde in any future endeavors.   

The deal was entered into "without any admission of fault or liability," according to the injunction. 

Teufel and AdapHealth agreed to terminate his contract following a lawsuit filed by Lincare’s parent company, The Linde Group, which alleged breach of contract, breach of duty of loyalty and misappropriation of trade secrets. 

National Seating & Mobility announced on Nov. 29 that it had hired Teufel as its new CEO. 

FDA clears Vivos device for OSA 

LITTLETON, Colo. – Vivos Therapeutics has received 510(k) clearance from the U.S. Food and Drug Administration for treating severe obstructive sleep apnea in adults using its removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance. “This achievement is a pivotal milestone for Vivos and elevates our proven treatment options right into the mainstream of sleep medicine,” said Kirk Huntsman, chairman and CEO of Vivos. “It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention.” This latest clearance comes just 11 months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA, and represents the first time the agency has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older, along with positive airway pressure (PAP) and/or myofunctional therapy, as needed. 

Motion gives back 

TORONTO – Motion made a number of donations to organizations that support its clients in honor of Giving Tuesday, International Day of Persons with Disabilities (Dec. 3) and its upcoming 5 Days of Caring event (Dec. 4-8). It donated: 

• $10,000 to Spinal Cord Injury Ontario's Independence Initiative 

• $5,000 to Sunny Hill Health Centre at the BC Children's Hospital 

• $1,000 to Kinsmen TeleMiracle (SK) 

• $1,000 to Manitoba League of Persons with Disabilities 

• $1,500 to Variety - the Children's Charity of Alberta 

Motion has also announced a new sponsorship for the Shine Foundation in 2024. The Shine Foundation, formerly The Sunshine Foundation of Canada, changes lives of children and youth ages 11-21 living with severe physical disabilities acorss Canada by ensuring they live out their dreams. 

AmeriCare Medical named Top Workplace 

DETROIT, Mich. – AmeriCare Medical has been named one of the Top Workplace 2023 by the Detroit Free Press. The list is based on employee feedback gathered through a third-party survey that evaluates factors like alignment, execution and connection. “AmeriCare’s competitive advantage is spawned by our employees,” said Greg Jamian, president and CEO. “They have supported our innovation and growth throughout the years. The strength of our company lies in the collective abilities of our employees.” AmeriCare Medical, which offers integrated health care services, including durable medical equipment, medical staffing and specialized pharmacy services, is the parent company of Sun Medical Equipment & Supplies, AmeriStaff Nursing Services, Rx iV Infusion Pharmacy and QCN Home Health Care. AmeriCare has been named a Top Workplace since 2021. “We are honored to have been nominated and recognized for this award for the third consecutive year, confirming our dedication to our team members and the workplace culture at AmeriCare Medical,” said Joshua Schacht, human resources generalist.  

Product launches: Liviliti Health, NikoHealth, Withings Health, Wynne Systems 

Liviliti Health has launched CPAP Soap, a retail add-on for CPAP providers to increase the margins of their resupply businesses. The company says the soap allows patients to follow manufacturer guidelines and U.S. Food and Drug Administration processes for daily and weekly cleaning. The soap is non-allergenic and SLS and alcohol free. FMI: www.cpapsoap.com.  

NikoHealth has launched “Electronic Medical Attachments,” a new functionality that allows DME providers to submit essential attachments, along with claims to insurance payers, ensuring a seamless and efficient claims process. "We are thrilled to introduce the 'Electronic Medical Attachments' feature, underscoring our commitment to simplifying health care processes," said Michael Kutsak, CEO at NikoHealth. "This innovation not only enhances efficiency for DME suppliers but also contributes to a more streamlined and accurate claims process, benefiting both providers and patients." FMI: www.nikohealth.com. 

Withings Health has launched Body Pro 2, a cellular-connected smart scale that allows care teams to capture advanced health metrics, such as weight and body composition. The company also offers a prescription-only module for the scale that can monitor electrochemical skin conductance (ESC) to help detect early signs of diabetic peripheral neuropathies and assess the risk for diabetic foot ulcers. FMI: www.withingshealthsolutions.com. 

Wynne Systems has launched EquipFlows, a platform specifically engineered to focus on DME management, tracking and ordering. The company realized the potential impact of EquipFlows on the health care industry after working with the nation's largest hospice provider, VITAS Healthcare, on developing a solution to fit the unique DME management needs of an organization their size. FMI: wynnesystems.com/equipflows/medical-equipment-management-software/.