Unsafe medical devices allowed into global markets harm patients, investigation reveals

A global investigation has found that unsafe medical devices have caused 1.7 million injuries globally and almost 83,000 deaths in the last 12 years. According to The Implant Files, a year-long investigation of the manufacturers of devices by the International Consortium of Investigative Journalists (ICIJ), unsafe medical devices have been allowed into global markets as a result of poor regulatory systems, a lack of transparency and insufficiently strict rules on testing. Some of these medical devices that have caused “adverse incidents” include pacemakers, contraceptives, artificial hips and breast implants grafted into patients’ bodies. The investigation found some devices did not complete patient trials. The report stated that some pacemakers, for example, were implanted even though their manufacturers knew of problems; other devices were approved without proper regulatory procedures.

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Healthcare Analytics

SHL Medical partners with SteriPack Group to set up final assembly service

SHL Medical | January 24, 2024

SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack facility in Poland, enhancing the overall flexibility of supply chain strategies for their customers. In addition to SHL Medical's existing final assembly, labeling, and packaging­ services in the United States, this collaboration extends high-quality CMO options to Europe. Markus Puusepp, SHL Medical's Chief Growth Officer, expressed enthusiasm about the partnership, stating "This partnership is a significant addition to the Molly® platform value proposition. We share common values with SteriPack, from focus on the customer to a commitment to quality, making the decision to collaborate straightforward." Recognizing the importance of flexibility and time-to-market, especially in clinical production, the partnership with SteriPack will offer SHL Medical's customers highly flexible and personalized final assembly and packaging solutions. This is particularly beneficial for small batch handling in clinical supply and niche markets like rare diseases. Emphasizing the comprehensive capabilities of the Molly platform, SHL Medical aims to deliver right-sized solutions that ensure improved service, faster timelines, and a more streamlined supply chain for its diverse customer base. John Ward, SteriPack Group's VP Pharmaceutical Solutions commented "SteriPack Group looks forward to supporting SHL Medical and their customers in providing quality and flexible solutions to a fast- moving market. With an emphasis on creating service solutions designed around specific customer requirements, this partnership will make the process of working with the Molly® platform an easy decision." About SHL Medical As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by its company purpose – Enabling Patients' Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. It also offers final assembly, labeling, and packaging solutions for its drug delivery systems. In response to the rising trend in home therapy, SHL Medical has increased its developmental work in the digital healthcare sector to help improve the drug delivery ecosystem. Located across Switzerland, Taiwan, Sweden, and the US, SHL Medical's global team of experts collaborate seamlessly as one team in utilizing its comprehensive in-house manufacturing capabilities. Its solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into its designs and processes to contribute to a cleaner earth. About SteriPack Group SteriPack Group is a globally renowned contract packing and manufacturing organisation serving the pharmaceutical and medical device sectors respectively. With a strong emphasis on innovation, quality and compliance, SteriPack's services to the pharmaceutical industry include device design and development, final assembly, labelling, secondary packing, serialisation and aggregation of injectable formats including vials, pre-filled syringes, and autoinjectors. SteriPack's tailored customer-focused solutions make it an ideally suited supplier for small to medium-sized batch volumes required for a growing market of targeted therapies as well as clinical trials. Its proven capabilities in cleanroom assembly and labelling as well as secondary packing services for drug delivery systems and medical devices, combined with significant investment into growing cold chain storage capacity, have helped to make it a trusted partner to top global pharmaceutical companies.

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Healthcare Analytics

Keystone Healthcare Partners Establishes Partnership with Trinity Medical to Expand Emergency Medicine Footprint into Louisiana

Keystone Healthcare Partners | February 05, 2024

Keystone Healthcare Partners a leading provider of emergency medicine, hospital medicine, critical care medicine, and telehealth staffing and management services, as well as revenue cycle management, recently announced that it has formed a partnership with Trinity Medical in Ferriday, Louisiana. Keystone's delivery of emergency medicine services at Trinity Medical will commence on February 1, 2024. This contract represents an exciting expansion of Keystone's regional influence into Louisiana; the company has managed contracts in Mississippi for decades. Glenn Adams, Keystone's CEO & Co-founder, notes, "We are excited to kick off another partnership with a client where we see opportunity for real impact. We've hit the ground running to shore up areas of frustration for the client and bring value-add and innovative solutions, such as Keystone Connect AI technology to the emergency medicine program." While the healthcare landscape has been challenging for rural and critical access hospitals, the two entities share a patient-centered ethos that will be paramount to the partnership. The two entities share a community- and patient-focus that is embodied by Trinity's motto, "People you know, caring for people you love." "We are very excited to start our partnership with Keystone Healthcare," states Keisha Smith, CEO of Trinity. "My goal for Trinity Medical has always been to provide our patients with the best healthcare and customer service possible in the Miss-Lou area. We feel that Keystone shares the same goals that we have and will be a true asset to our hospital. Henry Ford stated, 'Coming together is a beginning, staying together is progress, and working together is success.' We are looking forward to a long lasting, successful partnership with Keystone Healthcare." Trinity Medical, a 23-bed licensed facility, continues to grow and upgrade their services and facilities in addition to recruiting physicians to meet the growing needs of their expanding community. About Keystone Healthcare Keystone Healthcare™ is a leading provider of Emergency Medicine, Hospital Medicine, Critical Care Medicine and Telehealth clinical management services and staffing solutions for hospitals. We efficiently deliver high-quality, patient-centered care through strong physician leadership and involved management that drive our innovative and integrated business model. About Trinity Medical Trinity Medical is operated by Concordia Parish Hospital Service District No. 1. Trinity Medical, formerly Riverland Medical Center, opened in 1964 as Concordia Parish Hospital and has continuously served the residents of the area for more than 55 years. In addition to emergency and acute care, Trinity Medical offers surgical services, diagnostic imaging, infusion center, cardio-respiratory care, gastroenterology, lab services, otolaryngology, urology, and an in-hospital rehabilitation service as well as an extensive range of out-patient services, both diagnostic and for treatment.

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Digital Healthcare

UCI Health Reaches Definitive Agreement to Acquire Four Southern California Hospitals From Tenet Healthcare Corporation

UCI Health | February 02, 2024

The Regents of the University of California, on behalf of the University of California, Irvine, has entered into a definitive agreement with Tenet Healthcare Corporation to acquire Tenet's Pacific Coast Network. The network will become part of UCI Health, the clinical enterprise of UC Irvine. "UC Irvine has deepened its healthcare commitment to the future of Orange County, our region and California," said UC Irvine Chancellor Howard Gillman. "This journey in healthcare is deeply intertwined with the University of California's dedication to bettering our communities, expanding access to premier healthcare, and pioneering the medical innovations of tomorrow, today. Our vision will bridge gaps in regional care and reinforce UCI's place among the nation's leading academic health systems while advancing solutions to challenges facing healthcare." Pending customary regulatory approvals, clearances, and closing conditions, the proposed acquisition would bring four medical centers in Lakewood, Los Alamitos, Fountain Valley and Placentia and associated outpatient locations into the UCI Health system. UCI Health currently delivers care at UCI Medical Center in Orange and a growing network of multispecialty care centers. "At UCI Health, we are excited to add these new care sites to the UCI Health network and extend the benefits of our compassionate, high-level care, clinical innovation, and scientific discovery," said Chad Lefteris, president and chief executive officer of UCI Health. "As Orange County's only academic health system, UCI Health is unique in its ability to offer the highest level of advanced care powered by the research and innovation of a world-class public research institution." UCI Health recognizes a unique opportunity to build on the quality care already being delivered in the communities served by Tenet Healthcare's Pacific Coast Network. "These four hospitals are well-regarded in their communities for providing high-quality, compassionate care," said Saum Sutaria, M.D., chairman and chief executive officer of Tenet Healthcare. "The local communities will benefit from the nationally recognized advancements, medical knowledge, research, and community focus that UCI Health brings as an innovative academic health system. UCI Health recognizes a unique opportunity to build on the quality care already being delivered in the communities served by the Pacific Coast Network." In a region with a population greater than that of two dozen states, UCI Health operates the only Level I trauma center, locally based National Cancer Institute-designated comprehensive cancer center, high-risk perinatal-neonatal service and is the largest regional burn center and leading provider of complex tertiary and quaternary care. The system's clinical excellence has consistently placed UCI Health in the top 10 for quality and safety among the nation's leading comprehensive academic health systems. The acquisition also means more patients will have access to advanced therapies in the region's largest and most diverse portfolio of clinical trials, ranging from cancer to neurosciences, digestive diseases, orthopedics and internal medicine specialties. UCI Health and Tenet Healthcare's Pacific Coast Network patients can continue receiving care at their local facilities as they normally would from the care teams they know and trust. The transaction is expected to be completed in spring 2024, subject to customary regulatory approvals, clearances, and closing conditions. "It is a privilege to provide world-class care to Californians and we are excited to welcome the clinicians and co-workers from these Tenet Healthcare sites to UCI Health as partners in improving the health of local communities," Lefteris said. About UCI Health UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system in Orange County. Patients can access UCI Health at primary and specialty care offices across Orange County and at its main campus, UCI Medical Center in Orange, Calif. The 459-bed, acute care hospital, listed among America's Best Hospitals by U.S. News & World Report for 23 consecutive years, provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation services. UCI Medical Center is home to Orange County's only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center, gold level 1 geriatric emergency department and regional burn center. About UC Irvine About the University of California, Irvine: Founded in 1965, UCI is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 37,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. About Tenet Healthcare Tenet Healthcare Corporation is a diversified healthcare services company headquartered in Dallas. Our care delivery network includes United Surgical Partners International, the largest ambulatory platform in the country, which operates or has ownership interests in more than 480 ambulatory surgery centers and surgical hospitals. We also operate 58 acute care and specialty hospitals, approximately 110 other outpatient facilities, a network of leading employed physicians and a global business center in Manila, Philippines. Our Conifer Health Solutions subsidiary provides revenue cycle management and value-based care services to hospitals, health systems, physician practices, employers, and other clients. Across the Tenet enterprise, we are united by our mission to deliver quality, compassionate care in the communities we serve.

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Health Technology

Axxess Launches New Axxess Connect Solution to Accelerate Health Information Exchange

Axxess | January 23, 2024

Axxess, the leading global technology innovator for healthcare at home, launched a new product called Axxess Connect, a groundbreaking interoperability solution. This new product will revolutionize the way Axxess users connect and share data with healthcare providers and specialists, further enhancing care coordination, improving patient outcomes and driving the future by enabling new care models and value-based care. "Axxess Connect is a new benchmark for interoperability in healthcare," says Tim Ingram, Executive Vice President of Interoperability at Axxess. "By working with our partner Kno2 we can now connect our solutions to help accelerate the exchange of health information securely across any network. This means our clients will have easier access to a broader range of providers and specialists, making data sharing and referrals more efficient." By being Kno2 Connected™, Axxess Connect, enables the secure, effortless, and maximized exchange of patient information across patients, providers, payers and HIT vendors. ­­­­The solution meets data security and compliance requirements in accordance with HITRUST and HIPAA regulation for privacy, data sharing and healthcare communication standards supported by national and regional frameworks including Direct Trust, Carequality and most recently, TEFCA. This ensures that patient data is interoperable, secured and protected when shared across systems. "Our collaboration with Kno2 not only improves the overall experience for our users, but it also reduces the administrative load on healthcare providers," said Ingram. "By minimizing time spent on administrative tasks, our clients can focus more on providing quality patient care." Added Theresa Bell, Co-founder, President and Chief Technology Officer of Kno2: "By seamlessly connecting Axxess users with healthcare providers and specialists, we are breaking down barriers and revolutionizing the way data is shared in every care setting. Axxess Connect represents the power of the partnership and the value of being Kno2 Connected. Together, we are revolutionizing care delivery and thoughtfully solving healthcare's biggest problems." Axxess Connect will first be available to Axxess Palliative Care clients before eventually being rolled out to the entire Axxess suite of solutions for home health, hospice and home care. About Axxess Axxess is the leading global technology innovator for healthcare at home, focused on solving the most complex industry challenges. Trusted by more than 9,000 organizations that serve more than 5 million patients worldwide, Axxess offers a complete suite of easy-to-use software solutions that empower home health, home care, hospice, and palliative providers to make healthcare in the home human again. Multiple independent certifications have confirmed that Axxess has the most secure and industry-compliant software available for providers. The company's collaborative culture focused on innovation and excellence is recognized nationally as a "Best Place to Work."

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