This webinar is focused on catheter shaft componentry with a deeper dive into polytetrafluoroethylene (PTFE) liners and fluorinated ethylene propylene (FEP). Information provided will contain a mix of polymer material science, specifications of extruded fluoropolymers, engineering considerations for fluoropolymer use and processing of those. We will also cover new developments for PTFE as well as FEP heat shrink including the ultrathin (less than .001” wall thickness) extruded liners and peelable heat shrink.

An overview of radiation dosimetry will be given with emphasis on dosimetry principles and calibration methods in order to maintain measurement traceability. The importance of estimating measurement uncertainty is discussed, including how uncertainty can be applied to the radiation process, and to assess new product process capability for new products. An introduction to the mathematical model is also given with emphasis on how it can be used to complement radiation dosimetry, and assist with the validation of an irradiator change.

WASHINGTON – While healthcare has made great strides in recent years with the proliferation of electronic health records (EHRs), establishment of regional health information exchanges, and development of data exchange standards and interfaces, interoperability among healthcare technologies remains very limited, says a new National Academy of Medicine (NAM) special publication. The lack of interoperability results in waste, inefficiency, and clinician burnout, which can contribute to patient safety risk.

Digital interoperability across clinicians, care units, facilities, and systems has become more essential because of increasing complexity in healthcare, the need for more seamless interfaces among clinicians, patients and families, and the growing number of clinicians across disparate specialties that a typical patient sees. Authored by leading national experts on health information technology, clinical operations, and healthcare delivery, the publication outlines steps for health systems to establish comprehensive, ongoing procurement strategies with system-wide interoperability by moving away from serial purchases of individual software and hardware with proprietary interfaces toward those that will interoperate with others through a vendor-neutral open platform.

Interoperability is the ability to seamlessly and automatically deliver data across time and space from and to multiple devices and organizations. As of 2016, 96 percent of hospitals and 78 percent of physicians’ offices were using EHRs, the publication says. However, due to lack of interoperability, information from multiple sources, devices, and organizations across the care continuum are unable to flow at the right time, to the right party, and for the right patient. For example, less than one in three hospitals is able to electronically find, send, receive, and integrate patient information from another provider, leaving most providers relying on paper or fax when sending a care summary for patient discharges or referrals.

Unlike in other industries where computerization has made work easier, deployment of EHRs in their current state — coupled with growing requirements for high-quality reporting and regulatory compliance — create additional work and exacerbate clinician burnout, the publication says. In addition to staff time spent manually entering readings, such as vital signs, from a device onto paper or electronic charts, another common source of inefficiency is time spent manually programming devices such as infusion pumps. A 2013 report by West Health Institute estimated that widespread medical device interoperability could eliminate at least $36 billion of waste in inpatient settings alone by, for example, reducing redundant testing, reducing clinician time spent manually entering information, and shortening length of stay through more timely transmission of critical information, such as lab tests.

Suboptimal system acquisition processes in the current marketplace contribute to data silos, hoarding, and blocking, the publication says. Hospitals and other health care providers purchase systems and equipment from a variety of different manufacturers, and frequently, each comes with its own proprietary interface technology. As a result, most health care providers spend time and money setting up each technology in a different way, instead of being able to rely on a consistent means of connectivity. Healthcare providers also purchase technology that will work for their system, without considering the systems that interact with their own, or the systems that their patients are connected with. These technologies often cannot transfer data to one another, resulting in the need for patients and clinicians to expend energy collecting and collating multiple sets of data.

Although the proportion of patient harm that is directly attributable to the lack of interoperability is unknown, several common causes of medical errors, including drug errors, diagnostic errors, and failure to prevent injury, can partially be addressed by better data exchange among patients, medical devices, EHRs, and other health technologies.

“To ensure that healthcare dollars are spent in pursuit of healthcare delivery systems reaching desired levels of care quality, safety, and efficiency, interoperability must be a top priority,” says Victor J. Dzau, president of the National Academy of Medicine. “Only then will the healthcare industry begin to create truly integrated care systems that continuously provide better experiences for clinicians and patients while achieving better health and healthcare at a lower cost. The time is now to realize the true potential of health information technology, and all health care organizations have an obligation to see this through so that future generations will lead better, healthier lives.”

The publication contains a technical supplement that details approaches for health care organizations to ensure interoperability, including creating an organization-wide steering group, a long-range road map, an interoperability needs identification process, and a procurement specification process.

The special publication was sponsored by the Gordon and Betty Moore Foundation. The National Academy of Medicine, established in 1970 as the Institute of Medicine, is an independent organization of eminent professionals from diverse fields including health and medicine; the natural, social, and behavioral sciences; and beyond. It serves alongside the National Academy of Sciences and the National Academy of Engineering as an adviser to the nation and the international community. Through its domestic and global initiatives, the NAM works to address critical issues in health, medicine, and related policy and inspire positive action across sectors. The NAM collaborates closely with its peer academies and other divisions within the National Academies of Sciences, Engineering, and Medicine. The views presented in this special publication – “Procuring Interoperability: Achieving High-Quality, Connected, and Person-Centered Care” – are those of the authors and do not represent formal consensus positions of the NAM; the National Academies of Sciences, Engineering, and Medicine; or the authors’ organizations.

On October 10, 2018, FDA will host a webinar to share information and answer questions about the Quality in 510(k) (“Quik”) Review Program pilot. More information about the webinar is available here. On September 6, FDA launched the “Quik” Review Program pilot. The goal of this pilot is to simplify how manufacturers of certain moderate risk medical devices complete a premarket notification (510(k)) submission, and to evaluate whether use of the FDA’s free eSubmitter software will result in well-organized submissions that can be reviewed more efficiently.

Researchers have created the first flat lens capable of correctly focusing a large range of colors of any polarization to the same focal spot without the need for any additional elements. Only a micron thick, their revolutionary “flat” lens is much thinner than a sheet of paper and offers performance comparable to top-of-the-line compound lens systems.

Using their expertise in optical metasurfaces — engineered two-dimensional structures — to control light propagation in free space, the researchers built flat lenses made of pixels, or “meta-atoms.” Each meta-atom has a size that is just a fraction of the wavelength of light and delays the light passing through it by a different amount. By patterning a very thin flat layer of nanostructures on a substrate as thin as a human hair, the researchers were able to achieve the same function as a much thicker and heavier conventional lens system. Looking to the future, they anticipate that the meta-lenses could replace bulky lens systems.

A low-cost, easy-to-replicate test for tuberculosis might help developing nations better identify and treat the infectious and sometimes deadly disease, new research suggests. A study of the $2 test in rural Malawi in southeastern Africa found that it was reliable and could be easily employed in areas with a high incidence of tuberculosis, says study author Jesse Kwiek, an associate professor of microbiology at The Ohio State University.

The TB CX-test is designed to not only detect tuberculosis, but to determine whether the infecting strain is resistant to any of a handful of antibiotics used to treat it. In this study of 96 people at high risk of TB, however, drug-resistant forms of the disease were not detected, and further studies are under way to assess the role the inexpensive test could play in identifying the best route of treatment, Kwiek says.

A team has developed a wearable blood pressure monitor, designed to continuously monitor his blood pressure at home. The Tactile Blood Pressure Imager (TBPI) is worn on the wrist, over the radial artery, and uses a sensor to capture skin-surface forces affected by blood in the artery, respiratory rhythm, and pulse rate.

The TBPI’s proprietary algorithms incorporating these markers then provide a continuous estimate of heartbeat-to-heartbeat blood pressure. The TBPI is also worn overnight, and can be integrated with a mobile phone for remote monitoring by health-care professionals.

Children’s Healthcare of Atlanta has performed Georgia’s first-ever procedure to place 3D-printed tracheal splints in a pediatric patient. Biomedical engineers at the Georgia Institute of Technology helped create three custom splints using an innovative and experimental 3D printing technology.

Scott Hollister, PhD, developed the process for creating the tracheal splint using 3D printing technology at University of Michigan C.S. Mott Children’s Hospital prior to joining Georgia Tech.The splints were created using reconstructions of the patient’s air ways from CT scans. Hollister and his team of biomedical engineers collaborated with the Global Center for Medical Innovation (GCMI) so that GCMI could create multiple versions of the splint, of varying sizes, to ensure the perfect fit was available for the surgical team to select and place around the patient’s airways during surgery. GCMI will also support the ongoing development and commercialization of the technology.

A special event at MD&M Minneapolis will demonstrate ultrasonic welding technology. The lunch-and-learn event, which will be held October 31, will begin with an introduction and overview presented by Tom Hoover, Emerson’s business development segment manager (medical), who will will detail the full range of Branson technology and products — including ultrasonic and clean laser technology — as well as support and service offerings for customers across the medical industry.

In September, FDA granted de novo classification to two apps offered in the new Apple Watch Series 4, which the tech giant says have been “redesigned and re-engineered to help users stay connected, be more active, and manage their health in powerful new ways.”