Honoring products, technology that expand healthcare’s reach

Earlier this year, Healthcare Purchasing News surveyed readers for their suggestions about key products they thought healthcare could not succeed without having and using. Surprisingly, against the backdrop of the pandemic and in context of COVID-19, infection prevention products only occupied a small percentage of the suggestions.

Interestingly, information technology dominated the initial responses. HPN will share more details about that next month as it features its inaugural Medical Device All-Stars.

The HPN survey actually functioned as a litmus test for a much bigger exercise, a larger franchise designed to bring – if not rekindle – much-needed recognition and respect for products and technology long taken for granted.

The inaugural Medical Device Hall of Fame.

Honestly, this year HPN fretted that the voting would coalesce around all things pandemic-related.  Not that there’s anything wrong with that, of course, but thankfully, respondents demonstrated more open-mindedness to HPN’s project concept. While at least one or two of the 10 honorees this year is directly related to infection prevention and the pandemic, several of the remaining eight are indirectly, if not peripherally related, which demonstrates the heterogeneity surrounding homogeneous function – namely, different products and technologies geared toward a singular honorable purpose, which is patient care.

Industry support gravitated around a broad mix of genuine hall of fame-worthy products and product categories befitting the lifetime achievement recognition for their stalwart and steadfast contributions to patient care over the decades – and for several honorees this year – centuries!

Of the 10 making the first class of HPN’s Medical Device Hall of Fame, four are diagnostic imaging-related (computed tomography, ultrasound, X-ray and vein visualization), four are patient monitoring-related (glucose monitor, pulse oximeter, cardiac defibrillator/AED and stethoscope) and two are commodity-oriented and related to infection prevention (hypodermic needle and syringe  and the three veterans of PPE – personal protective equipment).

Some may contend these represent low-hanging fruit. But a new franchise must start at or near the ground floor with the opportunities for plenty more to be harvested in Hall of Fame classes to come.

Without further delay, here are the 10 members of HPN’s Medical Device Hall of Fame Class of 2020 with an approving nod to the companies that brought them to market over time.

Disposable hypodermic needle/syringe 

Earlier this year, Healthcare Purchasing News surveyed readers for their suggestions about key products they thought healthcare could not succeed without having and using. Surprisingly, against the backdrop of the pandemic and in context of COVID-19, infection prevention products only occupied a small percentage of the suggestions.

Interestingly, information technology dominated the initial responses. HPN will share more details about that next month as it features its inaugural Medical Device All-Stars.

The HPN survey actually functioned as a litmus test for a much bigger exercise, a larger franchise designed to bring – if not rekindle – much-needed recognition and respect for products and technology long taken for granted.

The inaugural Medical Device Hall of Fame.

Honestly, this year HPN fretted that the voting would coalesce around all things pandemic-related.  Not that there’s anything wrong with that, of course, but thankfully, respondents demonstrated more open-mindedness to HPN’s project concept. While at least one or two of the 10 honorees this year is directly related to infection prevention and the pandemic, several of the remaining eight are indirectly, if not peripherally related, which demonstrates the heterogeneity surrounding homogeneous function – namely, different products and technologies geared toward a singular honorable purpose, which is patient care.

Industry support gravitated around a broad mix of genuine hall of fame-worthy products and product categories befitting the lifetime achievement recognition for their stalwart and steadfast contributions to patient care over the decades – and for several honorees this year – centuries!

Of the 10 making the first class of HPN’s Medical Device Hall of Fame, four are diagnostic imaging-related (computed tomography, ultrasound, X-ray and vein visualization), four are patient monitoring-related (glucose monitor, pulse oximeter, cardiac defibrillator/AED and stethoscope) and two are commodity-oriented and related to infection prevention (hypodermic needle and syringe  and the three veterans of PPE – personal protective equipment).

Some may contend these represent low-hanging fruit. But a new franchise must start at or near the ground floor with the opportunities for plenty more to be harvested in Hall of Fame classes to come.

Without further delay, here are the 10 members of HPN’s Medical Device Hall of Fame Class of 2020 with an approving nod to the companies that brought them to market over time.

Disposable hypodermic needle/syringe 

ORIGIN (earliest known debut): The hollow metal needle reportedly debuted in 1844, invented by Irish physician Francis Rynd. Another nine years would pass until Scottish physician Alexander Wood and French surgeon Charles Gabriel Pravaz each invented his own version of the earliest type of hypodermic syringes. Some researchers, however, refer back to the second century when Galen crafted a simple piston syringe for non-invasive medical use or the 10^th century when another reported using glass tubes for suction for extracting cataracts. Others trace the “modern” syringe to Pascal’s experimental work around 1650. But the traditional, typical disposable syringe with the glass enclosures and plastic valves and different gauges emerged in the early to mid-1950s, mass produced by Becton, Dickinson and Company (BD) and Roehr Products (the Monoject).

BD is a pioneer in developing disposable syringes and needles, according to Chee Lum, Vice President, Medication Delivery at BD. “In 1954, in response to the polio epidemic, the company supplied the first sterile disposable syringes for the Salk polio vaccine field trials, helping to inoculate 1 million school children in the U.S.,” Lum noted. “In the early 1960s, BD pioneered the use of disposable needles and plastic syringes.”

A variety of safety-engineered models designed to prevent needlesticks debuted in the late 1990s, spurred in large part by the burgeoning movement to prevent occupational exposure to blood-borne pathogens, alongside the passage of several state needle-safety laws and in advance of the federal Needlestick Safety and Prevention Act in late 2000.

WHY IT MATTERS: Hypodermic needles and syringes, by and large, serve to deliver accurately measured drug doses for disease and sickness treatment and vaccinations as well as to extract blood and other body fluids with minimal contamination, discomfort and pain. Larger bore needles and syringes also are used for surgical biopsies to take tissue samples from lesions and tumors to determine whether they are benign or malignant.

“With the development of these products, clinicians have the ability to deliver medications, advance therapies and deliver immunizations while avoiding cross-contamination among patients due to sharing devices,” BD’s Lum indicated.

WHAT IF IT DIDN’T EXIST TODAY: Patients would have to receive medicine in myriad other ways, which largely and likely would delay their distribution until such alternatives (e.g, patches, etc.) were developed. Needles and syringes enabled the injection of medications directly into the bloodstream via veins so without the existence of these products patients would have to chew or swallow medications or topically apply them, which might delay their effectiveness, if not reaction speed. And don’t forget about blood draws, testing and donations, all of which would be made more challenging and potentially painful and prone to infection without them. In addition, the latest models of safety-engineered devices, by such companies as Retractable Technologies (RTI), that cover, sheathe or otherwise blunt the exposed needle to prevent needlesticks and disease transmission, elevate and justify the use of these essential devices.

“Without these innovations, treatment and immunization would be delayed, and potentially less safe and effective, due to the laborious efforts to prepare for the reuse of the devices,” BD’s Lum said. “Disposables syringes and needles are ubiquitous in healthcare today and it’s hard to imagine not having them in our toolbox for delivery of healthcare.”

With its VanishPoint automated retractable syringes, RTI set a new standard for needle safety, according to Kathryn Duesman, Vice President of Clinical Affairs.

“In 1997, when VanishPoint retractable syringes were made commercially available, almost all safety syringes were manually activated after removal from the patient, resulting in 100 percent exposure to contaminated needles and high needlestick injury risk,” Duesman indicated. “VanishPoint retractable syringes allow for pre-removal activation, virtually eliminating exposure.

“Without the advent of VanishPoint syringes, the realization of clinicians, healthcare organizations and regulators that occupational risk can be reduced to the lowest possible level through effective technology might not have occurred,” Duesman continued. “Prior to the 1998 passage of the nation's first law mandating the use of safety needles, California nurses, working on the frontlines of the AIDS epidemic, activated VanishPoint syringes on the steps of their Capitol Building to bring attention to the need for effective safety-engineered devices. Other states passed similar laws and, in 2000, the Federal Needlestick Safety and Prevention Act was signed into law. VanishPoint syringes made eliminating exposure — the goal of bloodborne pathogens regulations — a working reality for injections. In light of COVID-19 and an impending mass vaccination campaign, safe and effective syringes are critical for the protection of clinicians.”

Stethoscope

ORIGIN (earliest known debut): French physician and musician René Laennec played the flute, carving his own wooden models, and used that interest to invent what became the earliest known stethoscope, which in 1816, started off as a wooden tube with brass fittings. He fashioned it to listen to the heartbeat of a rather weighty female patient who was exhibiting symptoms of heart disease. Until the stethoscope, doctors would listen to a patient’s heartbeat by placing his or her ear directly against the chest of the patient. The concept generated mixed reception among doctors until Irish physician Arthur Leared developed the binaural stethoscope with the dual earpieces in 1851, and a year later the design more recognizable today was improved for commercial production.

WHY IT MATTERS: Arguably, the heart represents the engine/motor of the human (and animal) body. Skilled and talented automobile mechanics and engineers can discern what may be wrong with a motor simply by hearing it run and listening to the sound it makes. The same holds true for the heartbeat.

“The human body produces a symphony of sounds that reveal much about our state of health,” observed David Tufenkijian, Global Welch Allyn Product Manager, Hillrom. “There are normal sounds caused by the beating of a healthy heart. Breath sounds as healthy lungs fill with air and then exhale. The rumbling of our bowels as peristalsis propels matter through our intestines. The reassuring sounds of a fetal heartbeat.

“Then there is the lack of normal sounds or the presence of other sounds that are diagnostically significant,” Tufenkijian continued. “A subtle whoosh between the normal ‘lub-dub’ sounds of a beating heart, the absence of breath sounds, a wheezing sound upon exhalation or a crackling sound upon inspiration, a lack of bowel sounds, the telltale sounds of carotid stenosis. Listening to the sounds made by the body is called auscultation.”

Tufenkijian likens the sounds produced by the human body to a “symphony” with each organ as instrument contributing to the “opus.

“Dr. W. Proctor Harvey, a famous and distinguished cardiologist, introduced his students to the art of auscultation by impressing upon them that the sounds produced by a beating heart are composed of many different components, each with its own timbre,” Tufenkijian noted. For more than 50 years until his death in 2007 Harvey worked with engineers at Welch Allyn, which manufactured his stethoscopes.

“Dr. Harvey required a stethoscope that would detect and transmit the full spectrum of subtle, diagnostically significant sounds produced by a beating heart,” Tufenkijian said. “At Hillrom, we are honored by our long association with Dr. Harvey and proud to offer the Harvey DLX Double Head, Triple Head, and the more compact Harvey Elite Stethoscopes as part of our comprehensive Welch Allyn portfolio of stethoscopes.” 

WHAT IF IT DIDN’T EXIST TODAY: If you can’t accurately and discernably hear the distinct sound a heartbeat, you likely miss a fundamental understanding of patient physiology. “To imagine even the most rudimentary patient examination being conducted without the use of a stethoscope would be inconceivable,” Tufenkijian added.

Cardiac defibrillator/AED

ORIGIN (earliest known debut): In 1899, two physiologists in Switzerland, Jean-Louis Prévost and Frédéric Batelli, applied small electrical shocks in dogs to induce ventricular fibrillation. More than three decades later, a New York heart specialist and an electrical engineer, Dr. Albert Hyman and C. Henry Hyman, respectively, wanted to find a way to deliver an electrical shock to the heart in lieu of injecting drugs. They developed a hollow needle device through which they threaded an insulated wire to deliver the shock. The cardiac defibrillator device/automated external defibrillator recognized today was invented by electrical engineer William Kouwenhoven in 1930 who studied the concept in college, created the device and tested it successfully on a dog. Seventeen years later, a surgery professor would test the device on a human for the first time.

WHY IT MATTERS: Imagine being in a public place and witnessing someone suddenly experiencing cardiac arrest. Until the advent and convenient availability of AEDs, much like fire extinguishers and public telephones (in the pre-mobile communications era) calling 9-1-1 for an ambulance was the common sense reaction by reasonable people. While emergency vehicles might arrive within minutes, accessing and activating a conveniently located AED might take seconds to a minute, which could delineate between life and death of the patient.

WHAT IF IT DIDN’T EXIST TODAY: In short, arguably more fatalities from heart attacks.

“Today’s technology is changing how we respond to time-sensitive emergencies,” said Anne Mullally, Vice President and General Manager, Emergency Care, Stryker. “Stryker works in partnership with EMS, hospitals and local communities to develop and evolve groundbreaking devices that help rescuers of all skill levels safely deliver definitive, time-critical therapy— saving a life every 15 minutes.”

Vein identifier/locator/visualization

ORIGIN (earliest known debut): The technology that helps nurses and phlebotomists find veins in which to insert needles, syringes and catheters accurately, effectively, efficiently and safely represents the youngest honoree in the 2020 class with a lifespan rooted in the 21^st century. The technology, which resembles an articulating arm on wheels that projects a near-infrared light reflection onto the patient’s skin, debuted in 2006 by a company called Luminetx, followed two years later by its first competitor, AccuVein. Today, there are several prominent and well-known brands used in many healthcare facilities and about a half-dozen other products.

WHY IT MATTERS: Ask a nurse or phlebotomist about of the frequent, repetitive tasks they train for and do every day and he or she likely will mention needle injections on patients. They practice their techniques on fruit – typically oranges – so that they can learn to minimize, if not eliminate, causing pain to the patient from poor technique or frequent attempts, which only add to the fears and discomfort of the patient. In fact, for more than a decade you’ll find a “Vein Viewer” on display in the healthcare exhibit of Chicago’s Museum of Science & Industry. (See “From sci-fi to sci-fact, healthcare supply chain spies Star Trek wonder,” April 2013, HPN).

 You’ll also find one in the St. Louis Science Center & Planetarium, the Terry Lee Wells Nevada Discover Museum, Reno, NV, and in the Discovery Place, Charlotte, NC, among others.

WHAT IF IT DIDN’T EXIST TODAY: Nurses and phlebotomists would have to pinch and squeeze patient skin to find useful blood vessels and veins for accessibility by simple eyesight, thereby increasing the potential for more needlesticks than necessary.

CT scanner

ORIGIN (earliest known debut): Back in the early 1900s, Italian radiologist Alessandro Vallebona started experimenting with what was known as tomography. He used radiographic film to view a slice of the body. But “conventional tomography” still struggled to capture images of soft tissue. Then in the 1960s, researchers started exploring how to use computers to generate tomographic images. In 1967, British enginner Sir Godfrey Hounsfield used X-ray technology to craft what is regarded as the first CT – as in “computed tomography” – scanner at EMI Central Research Laboratories. Six years later, the first CT scanners emerged in the United States. Back then the term “computed axial tomography” or CAT scan was considered synonymous. By the 1980s, CT scanners were more widely available in hospitals. Those early “single-slice” CTs now have evolved into multi-slice models that can exceed 512 slices in a single scan, demonstrating improvements in speed, radiation dose (exposure) and image quality.

WHY IT MATTERS: Until the advent of CT, clinicians and engineers used ultrasound and X-ray for internal views of the body, the latter involving considerable exposure to radiation to generate clearly visible images of hard tissue like bone and the former using sound waves to generate images. Before CT, generating clear images of soft tissue remained a goal.

“Imaging as a field has given us tremendous insight into understanding the human body without having to dissect it,” Matthew Fuld, Ph.D., Clinical Excellence Segment Product Manager for CT, Siemens Healthineers North America, told HPN. “It is one thing to understand what happened after death via an autopsy, but another to understand it when someone is living. When X-ray debuted in 1895 it was just the beginning of the diagnostic imaging journey that expanded to CT in the early 1970s. CT gives us much more in details than did the early views from X-ray, specifically due to speed and quality level of the image.”

WHAT IF IT DIDN’T EXIST TODAY: As the third-generation modality behind ultrasound and X-ray, diagnostic imaging and radiology might not be quite as advanced and sophisticated in visual acuity without CT, which most likely would further postpone the development of CT’s next of kin, magnetic resonance imaging (MRI). But X-ray experts counter that the progress of diagnostic imaging and radiology would not be so far behind due to the ongoing development and innovation within X-ray.

“When X-ray discoverer [Wilhelm] Roentgen X-rayed his wife’s hand the event took about 15 minutes and likely gave her cancer because of the exposure to radiation,” Fuld opined. “With CT today, clinicians can image a beating heart in seconds and obtain a clear image of the coronaries. As a result, without the CT scanner we would treat patients very differently, particularly in cardiology, the emergency department (ED) and oncology.”

While radiation exposure remains a key concern even as both CT and X-ray pursue and deliver lower-dose models, speed seems to distinguish between the two, according to Fuld.

“Every ED has a CT because it allows you to see things in great detail as you’re capturing images at such a high rate of speed,” he said. “You can see if someone is bleeding internally, if bones are broken or if organs are displaced without having to cut open the body. This enables virtual views but also gives ED doctors the one thing they want in new technology – speed, speed, speed – as in a clear, detailed image quickly so that they can make the best clinical decisions for the patient. Our latest dual-source CT, Somatom Force, can scan 74 cm/second with submillimeter detail. So in the ED speed is what matters for cardiac, emergency and imaging procedures.”

One key difference with CT shows up in cardiology, according to Fuld.

“In cardiology, for example, if you only used X-rays to image the heart you would receive a blurry picture of the organ without being able to visualize the coronaries,” he said. “With CT you can image a patient with coronary heart disease and see the blockage that likely indicates the risk of a heart attack. This would complicate structural heart disease planning, aortic valve repair, mitral valve repair and even repairing hearts in children (congenital SHD). With CT you can see the motion of valves opening and closing. You would not be able to do that without CT. Without the surgical planning provided by CT there would potentially be too high levels of morbidity and mortality during the invasive transcatheter procedures.”

The advent of multislice CT in the late 1990s afforded clinicians with something more dramatic.

“With multislice CT, clinicians were able to generate a stop-motion image of a heart between beats,” Fuld noted. “To do something like this you had to scan faster than the heart could beat. With CT, you can tell whether someone is having a heart attack or suffering from a pulmonary embolism because the technology allows you to stop motion the beating and breathing. Without CT, we would be blind. We would not have the foresight to know how to treat patients and whether that treatment is working.”

Controlling radiation dose remains a pillar of CT development and growth.

“The year 2005, with the introduction of Dual Source CT, saw the advent of low-dose CT scanning, designed to reduce the risk of radiation exposure, particularly to sensitive and vulnerable patients such as children,” Fuld said. “In recent years, CT has seen progress in reducing radiation dose exposure to ultra low-dose CT as well as the incorporation of A.I. to identify elements within an image and feed that data through a CAD algorithm to help with image interpretation that can drive diagnosis and treatment decision-making.”

CT also allows clinicians to see how the human body develops over time.

“You can’t dissect a person 20 times during their life to see how his or her body changes during growth,” Fuld said. “You only can see those developments after death. One of the things we have seen within the last 10 years with Siemens is the growth of Dual Energy spectral imaging that allows us to measure the energy in two levels providing insight into materials and function. With traditional CT we can see the normal and abnormal structure of something, but Dual Energy CT can help us understand the functional nature of a lesion or tissue. CT gives you the knowledge of what something is and how it functions without having to do invasive testing. This is why CT is such a great modality/technology for screening.

“With X-rays you may be able to see the shadow of something possibly abnormal in a lung, for example, but nothing more,” he continued. “With CT, you gain incredible detail of the abnormality.

Fuld fully anticipates CT becoming an integral part of a patient’s overall lifetime health cycle.

“You need to be able to look into the body without incision for screening, diagnosis and follow-up,” he said. “This represents the entire healthcare pathway of a patient. Using the 3-D information from a CT scanner allows the clinician to bring the patient through the medical pipeline to get the treatment and outcome both want. We expect in the very near future that standard health guidelines for heart patients will include a CT heart scan to determine risk of heart disease. Detecting disease early using the appropriate device for screening at lower doses of radiation will become the norm.”

X-ray machine

ORIGIN (earliest known debut): In 1895 Bavarian physics professor Wilhelm Roentgen actually discovered X-rays by accident as he tested whether cathode rays could pass through glass. Roentgen removed the air from the glass tube, filled it with a special gas and then passed a high electric voltage through the tube that emitted a fluorescent glow. Then he covered the tube with some heavy black paper and did the same thing. He saw a barium-coated screen in his lab begin to glow, which led him to experiment with other substances, learning that the glow or “ray” would cast shadows of solid objects on film.

WHY IT MATTERS: Despite the emergence of CT and MR, X-ray remains prevalent and useful, certainly as a baseline, according to Laurie Falk, Clinical Product Manager, X-ray, Siemens Healthineers North America. And with low-dose capabilities, the modality retains its staying power.

“X-rays can be transmitted at a lower radiation dose than CT, which makes X-ray an effective baseline or precursor to more advanced modality imaging when necessary. X-ray is the backbone of imaging modality. You can detect a lot with X-rays but you also can use X-rays to determine if additional diagnostic imaging tests are needed.

Falk praises the scientific minds over the decades that developed X-ray’s ongoing potential.

“If we didn’t really have those medical engineers thinking of new technology like this we wouldn’t be where we are today,” she noted. “We went from basic X-ray in their time to what we have now, from fluoroscopy to radiography. Now we can do 3-D cone beam X-ray imaging, and we’re adding artificial intelligence (A.I.) to help technologists in the control room via touchscreen to maneuver the system to open up the collimation to detect the lung fields in the chest. These types of advancements increase the imaging quality, reduce the need for repeat exams and radiation dose exposure. From moving equipment around to dedicated X-ray rooms – bringing the equipment to patients or the patients to equipment – the speed at which you can treat patients now is amazing. The progress of getting from there to here is phenomenal.”

Falk remains an avid fan of the X-ray modality, noting that five days after her interview with HPN that Siemens and everyone in diagnostic imaging/radiology would be celebrating the 125^th anniversary of the discovery of X-rays.

Siemens also maintains a close connection with X-ray’s roots, according to Falk. When Roentgen discovered X-rays in 1895 he asked for scientific reviews and for people and companies to submit ideas and products for further research, she recalled. Within three days of Roentgen making that call, executives from the company Reiniger, Gebbert & Schall (RGS) reached out to him and shared its prototype of X-ray tubes. RGS later would become part of the company founded by Werner von Siemens. [In fact, the original RGS factory on the outskirts of Erlangen, Germany, today serves as the official site of the Siemens Healthineers MedMuseum that welcomes visitors from all over the globe.] RGS didn’t meet with Roentgen directly at first but with his assistant, and when Roentgen actually worked with the RGS product he was impressed, Falk noted. Four months later in March 1896, RGS patented the X-ray tube that became the foundation of Siemens’ diagnostic imaging business.

Carestream emphasizes access, convenience and utility as key attributes of X-ray popularity.

“Carestream developed the industry’s first mobile X-ray system with a collapsible column and by doing so, we offered healthcare providers and radiologists improved workflow and easier access to high-quality images at the patient’s bedside,” said Sarah K. Verna, World Wide Marketing Manager, X-ray Solutions. Verna cites the user-friendliness of Carestream’s DRX-Revolution Mobile X-ray System that contributes to the speed of exams and higher productivity. “High-quality images with low-radiation dose capabilities enable accurate diagnoses and planning of effective treatment and in turn, improved patient care,” she added. “Without the images necessary to make a diagnosis, treatments could be delayed, and patients may take longer to recover.”

Carestream relied on customer feedback to create and improve products, such as the DRX-Revolution, according to Verna. “We redesigned the unit with a smaller and lighter tube head and collimator for easier use and faster positioning. It helps support quicker exams and increased workflow and productivity. Additionally, the DRX-Revolution’s display screens are more responsive, with improved functionality to boost speed and efficiency. The screens also are redesigned with flush mounting to better protect the system against fluid ingress, which helps support maximum uptime and may decrease maintenance and service calls and costs.”

Once customers told them that the mobile X-ray systems can be noisy during transport, Carestream worked to make the brakes and driver motors quieter, according to Verna. Storage bins also were expanded to accommodate large and small detectors.

Mobility drives access, which is something Carestream pursues, Verna indicated. “Radiologists are focused on capturing high-quality images that facilitate accurate diagnoses. In the past, mobile units were not used as frequently as they are now, because of low image quality,” she said.

WHAT IF IT DIDN’T EXIST TODAY: Doctors would have to examine the location of broken bones, bullets, coins, food and other objects and tumors by sight and touch and then make educated guesses on how to proceed with a diagnosis and treatment.

Siemens’ Falk remains passionate about X-ray, emphasizing that the healthcare industry would be “nowhere” without it.

“It all started with X-ray,” she insisted. “It was the first modality. We’re the basis for all imaging there is in all healthcare facilities – from hospitals to clinics to imaging centers. In 1897, X-rays were first used during wartime (Balkan War) to spot bone fractures and embedded shrapnel. Yet, even though the use of X-rays started with imaging bones, it quickly expanded to imaging the lungs, chest cavity, thorax and abdomen. From there it started to expand out to fluoroscopy whereby you injected contrast media into a patient to see the colon and stomach, then interventional imaging, CT and the change from film to digital imaging.”

Falk doubts X-ray machines ever will outlive their usefulness, but will continue to evolve with more functionality and newer applications.

Carestream’s Verna points to the benefits that mobile X-ray systems offer during a pandemic.

“Without mobile systems, especially during a pandemic, it would be difficult to maintain the isolation that a COVID-19 infection demands,” Verna said. “An X-ray room on wheels allows both technicians and healthcare facilities to conduct the necessary chest exams, whenever and wherever needed.

“What the pandemic has shown us, however, is the versatility of the DRX-Revolution,” she continued. “Not only does the system provide critical bedside imaging, it also aims to reduce contamination with flush-mounted displays that provide a smooth surface for easier disinfecting. Shelves are located in each of the detector slots, within the bin, that allow users to safely place protective bags on detectors, and wristband barcode scanners provide smoother workflow and limited equipment interaction.”

The pandemic reinforced the capabilities of mobile X-ray, according to Verna.

“Healthcare providers have had to isolate patients and use rooms in their facilities where they may not have typically deployed a mobile system,” she said. “With its compact footprint, the DRX-Revolution is able to navigate crowded spaces, and responsive display screens located at both the tube head and main display offers technologists another point of visibility. Our systems are being transported across hospital departments, conducting exams on the go. It would be a challenge to perform these diagnostic imaging exams amid a pandemic and mitigate transmission of the disease without a mobile unit at work.”

Ultrasound machine

ORIGIN (earliest known debut): 1794 by Italian biologist, physiologist, professor and priest named Lazzaro Spallanzani who studied the movement of bats and how they navigated by sound instead of sight. He found they would emit sound waves that would bounce back from or reflect off objects they hit. This concept became known as echolocation. Similarly, ultrasound used frequencies higher than what is audible to the human ear in short bursts to reflect off hard and soft organic tissue. In 1942, Austrian neurologist Karl Dussik first applied Spallanzani’s research on ultrasonic waves as a diagnostic tool for use on humans. To detect brain tumors, Dussik transmitted an ultrasound beam through a skull. Dussik previously had been researching the concept of radar or sonography, which was used to detect objects atop and under water and even was used as a form of physical therapy for athletes. He called the diagnostic method of using ultrasound on humans for diagnostic purposes hyperphonography. Within the next two decades, ultrasound would be used to deter gallstones, breast tumors and become integral to obstetrics and gynecology by 1960.

WHY IT MATTERS: By and large, it’s safe and effective on patients for its intended applications as it relies on high-frequency sound waves to form images, according to Nikki Troiano Gainey, Senior Vice President, Strategy & Business Development, Global Ultrasound, Siemens Healthineers, and unlike other imaging tests, ultrasound imaging does not utilize radiation, offering an alternative clinical imaging option to patients.

“Exams with ultrasound are generally painless and offer a low stress procedure for patients,” Gainey indicated. “With ultrasound real-time needle guidance, clinicians are able to conduct procedures with more precision. And, in some cases, elastography tissue assessment (definition) can potentially help to avoid biopsies.

Gainey also stressed its accessibility, cost effectiveness and overall utility to reinforce its workhorse nature.

“Ultrasound is the most widely used and fastest growing imaging modality used, widely accessible and offers high-quality imaging that is less expensive than other imaging,” she noted. “Clinicians and [healthcare practitioners] often rely on ultrasound testing as the first-line imaging modality. For example, high-quality ultrasound imaging addresses increasing cost of healthcare by providing imaging at the primary care level with systems like our ACUSON Redwood. This is particularly important with the fast-growing aging global population.

Additional developments include mobility and portability.

“Due to its small form factor, ultrasound systems are mobile, able to be moved to a patient’s bedside,” Gainey said. “With portable ultrasound, imaging is possible on sports fields. With the COVID-19 pandemic, easily movable ultrasound systems were available for pop-up stations to quickly scan and assess patients. With little to no special preparation required, ultrasound procedures are rapidly performed and usually last only a few minutes, providing a comfortable and low stress patient experience. Additionally, ultrasound captures real-time images of soft tissues – images that do not show up well on X-rays.”

WHAT IF IT DIDN’T EXIST TODAY: Expectant mothers likely would experience more uncertainty during their routine checkups without any audio or visual points of view of the embryo and later the fetus, as well as updated information on their own internal organs as the pregnancy progresses. Other modalities simply emit radiation, which would be harmful for this purpose, making ultrasound the optimal modality. Further, computer-directed and image-guided surgery relies to an extent on ultrasound to guide and place instruments, including cameras for direct visual feeds.

“Without ultrasound clinical imaging, clinicians, as well as their patients would have fewer options for diagnosis, therapy and follow-up,” Gainey added.

Glucose monitor

ORIGIN (earliest known debut): Clinicians and researchers worked to find glucose in urine as far back as the mid-1800s, but it wasn’t until the early 1900s with the commercial availability of urine glucose testing, followed some four decades later with the “Clinitest” product that made testing a bit more convenient. By the mid-1960s, the blood glucose test strip called Dextrostix was used for testing. The first glucose meters using the Dextrostix product emerged during the 1970s. Glucose testing at home by diabetes patients surfaced in the 1980s, pairing a Dextrostix with a small digital display. From there, device manufacturers improved the products such that diabetes patients could test their own glucose levels using less blood and less painful ways of doing it, such as needles, to small sticks to skin-attached monitors that can be recorded by mobile telephone apps.

WHY IT MATTERS: Diabetes patients must consistently monitor their blood glucose levels for their ongoing health record trending data but also to determine the frequency of taking medication, insulin and other remedies to manage the disease effectively and efficiently.

WHAT IF IT DIDN’T EXIST TODAY: The old adage of “what you don’t know can hurt you” applies here. But the real developments in glucose monitoring involved convenience and portability as manufacturers developed ways for people to collect and test samples using fewer steps, involving less discomfort and in their own environmental choice, such as their home, instead of at a clinic, doctor’s office or hospital.

Pulse oximeter

ORIGIN (earliest known debut): The first device created to measure oxygen levels in the blood was invented by Japanese bioengineer Dr. Takuo Aoyagi in 1974. Clinicians, engineers and researchers first became aware of the need to measure blood oxygen levels in the late 1800s through the first World War when early aircraft elevated humans to oxygen-deficient and depleted heights with drastic life-threatening consequences. Aoyagi was motivated by a newspaper interview with the founder of Nihon Kohden Corp. where he worked at the time. He started experimenting with the waveform produced by the arterial pulse to measure and calculate SpO2, according to the National Center for Biotechnology Information (NCBI). Aoyagi’s groundbreaking work attracted enough competition, leading to the development and growth of an important product segment for patient safety. “In 2007, the World Health Organization (WHO) included pulse oximetry as an essential component of its surgical safety checklist for reducing complications,” according to the NCBI report.

WHY IT MATTERS: By the late 1980s, some clinicians saw pulse oximetry as so important that they chose to graft it in as the fifth vital sign to join the traditional four of blood pressure, pulse rate, respiratory rate and temperature.

WHAT IF IT DIDN’T EXIST TODAY: Measuring arterial blood oxygen saturation would require a more painful alternative, an invasive arterial puncture using a needle and cannula, instead of a convenient and small device non-invasively clipped to a finger. Some clinicians contend, however, that the pulse oximeter’s availability does not totally obviate the need for more invasive blood gas measurement.

PPE family (gloves, masks, scrubs only)

ORIGIN (earliest known debut): Doctors, nurses, clinicians and technicians started dressing the part, protecting themselves with necessary garb – scrubs, masks and gloves – as far back as the mid-to- late 1800s as an outgrowth of an early understanding of rudimentary aseptic technique that can be traced through to hand-washing advocate Paul Revere as the first President of colonial era Boston’s Board of Health in the late 1700s. Certainly, the concept of personal protective equipment exists outside of healthcare and predates the last few hundred years to encompass construction workers, firefighters and even soldiers.

But here’s the rub in healthcare. Until the Occupational Safety and Health Act of 1970, and the debut of the Occupational Safety and Health Administration (OSHA), wearing PPE was optional. So five decades ago, it became mandatory for people in the workplace to protect themselves from exposure to illness and injury that could result in death, healthcare being no exception due to exposure to blood, other bodily fluids and other visible and microbial materials. Within two decades, clinicians and other healthcare workers would see their PPE reliance ramped up as they navigated through the HIV era, glove shortages, latex allergy era, needlestick safety era and beyond. In the early 1980s companies rolled out alternatives and upgrades to PPE products to solve the particular challenges of the day.

Corinne Schmid, Director of Marketing, Biogel, Mölnlycke Health Care, recalls 1983 as a pivotal year for the glove segment of PPE. That’s when the Biogel powder-free glove came to market using a proprietary polymer coating with hydrophilic properties to make donning easy and to conform to the hand like a second skin, she explained. Biogel products stressed safety with tactile sensitivity, she added.

WHY IT MATTERS: Imagine if Batman didn’t have access to his cape, cowl, uniform … and all of his “bat tools.” How could he engage evil-doers and fight crime effectively without all of that and protect himself from harm? Now apply similar common sense and logic to healthcare workers – clinicians and administrators – clad in PPE – primarily scrubs, masks and gloves as they may be exposed to all kinds of dangerous solid, liquid and gaseous (aerosolized) materials in the surgical suites, patient rooms, sterile processing areas or even the hallways.

Healthmark Industries offers a broad line of PPE that is intended for use in the decontamination area of healthcare facilities.

“Wearing the proper PPE and wearing it correctly is vital to the safety of healthcare workers responsible for the cleaning and decontamination of surgical instruments, endoscopes and other clinically used medical devices,” said Ralph Basile, Vice President, Healthmark. “There is no doubt that their jobs are hazardous, and PPE, along with proper training, is their first line of defense against injury and infection.”

Basile describes the environment from which clinicians protect themselves by wearing PPE. The milieu involves surgical instruments arriving in the decontamination area “grossly soiled with human secretions, including blood, mucus, feces, urine, and other potentially infectious materials.” If the instruments weren’t pre-cleaned or soaked in the OR, then sterile processing technicians typically will rinse the instruments with water to remove the gross soil before manually cleaning them. “This involves directly handling the contaminated devices – often devices that have sharp edges, points, etc. The most common specific hazards include splashing, puncture, aerosolization of contaminants, exposure to irritating chemicals found in cleaning agents and disinfectants,” he said. The dangers include getting contaminants or chemicals in the eye, mouth, hair and other areas of the body and on clothing; puncture of the skin leading to blood-borne infection by contaminants, including blood and microbial agents; rash or other skin irritation.”

Basile points to comfort as another concern.

“By its nature, PPE does not breathe well,” he noted. “So the wearer gets hot. The tasks in decontam are physically demanding, so that further exacerbates the discomfort of the wearer. Also, often there are heat sources within decontam – washer-disinfectors, ultrasonic machines, hot water, etc. that are also a factor in creating discomfort. We know that if someone is unconformable in their PPE, they are more likely not to wear the PPE correctly.”

As a result, Healthmark makes a line of PPE to address these concerns, including its thick “Lined Sleeve Glove” that extends all the way up to the end of the arm, its “Decontam Gown” that sports an impervious “strike-through” zone while enabling breathability and a host of additional products such as shoe and boot covers, aprons with thumb loop, bouffants, scrub hats, domestically produced face shields with attached draping and neck-worn evaporative Cool Aid packs.

The pandemic sounded the alarm on access to PPE, according to Don Lowe, spokesperson, ProTEC-USA, a Cadillac Products Inc. company..

“Our healthcare professionals and front-line workers have bravely faced innumerable obstacles since the start of the COVID-19 pandemic,” Lowe indicated. “The thought of them facing this virus head-on with sub-standard PPE—or even lacking the proper amount of protection at all—immediately shed light on the critical nature of having reliable equipment that can be delivered on-time. As we all know, unfortunately, this was the case across the country. Beyond COVID, there are too many instances where sub-standard products are dumped in the [United States], failing advertised performance requirements, carrying poor delivery reliability, etc. This 100 percent domestic product alleviates all concern for the healthcare industry. PPE demand was forecast to grow at 13 percent per year over the next six years. This is prior to the COVID pandemic. The need for reliable PPE is a long-term need.”

ProTEC-USA emphasizes the convenience of domestic availability.

“ProTEC-USA set out to resolve these issues and provide distributors and healthcare supply chains with reliable medical gowns made entirely in the United States using our proprietary materials and processes,” Lowe noted. “Our company has set out to be a domestic supply chain resource, on-shoring the production and distribution of medical equipment for industries in need.

“For patients, our products provide peace of mind that their clinicians are protected during a time when we’re learning and battling the coronavirus,” Lowe continued. “Even more important, clinicians and healthcare professionals can enter their workplaces and serve their patients while knowing they’re protected by equipment that meets or exceeds industry standards. EZDoff gowns were placed in healthcare facilities around the country when no other gowns were readily available.”

Medline Industries reiterates the need for availability, too, and now is ramping up domestic production of masks.

“To help shorten the supply chain so healthcare providers can have access to crucial PPE, Medline is announcing plans to manufacture face masks in North America for the first time,” said Stacy Rubenstein, Public Relations Manager. We are modifying our Lithia Springs, GA, plant and anticipate production on level-1 ear loop procedure masks to begin in January, with an anticipated second production line launching later in 2021. When the two lines are fully operational, we estimate to produce 36 million face masks per month.” Rubenstein noted that this is the second manufacturing expansion by Medline in the U.S. in 2020. Back in April, the company launched hand sanitizer production at its Hartland, WI, plant to help meet a nationwide shortage.

“Throughout the pandemic, Medline has been laser-focused on implementing new ideas to combat the national shortage of medical supplies,” stated Charlie Mills, Medline CEO, in a prepared release. “In particular, our customers have a critical need for readily available face masks. This is a significant capital investment in one of our largest manufacturing facilities that will increase the number of face masks Medline can offer to healthcare facilities and diversifies our PPE supply chain.”

Gloves play a key role, too.

“Surgical gloves are an integral part of the prevention measures in the [operating room],” said Mölnlycke’s Schmid. “Glove breaches or barrier failures can pose an increased risk of surgical site infections (SSIs) for patients and expose healthcare workers to blood-borne pathogens. At least 60 different blood-borne pathogens can be transmitted to healthcare workers due to accidental exposures with HIV, Hep B and Hep C accounting for most of the risk.”

O&M Halyard concurs with the importance of glove production and availability.

“At O&M Halyard we understand the unique needs of healthcare workers when it comes to personal protective equipment,” indicated Greg Metcalf, Global Director of Gloves & Apparel, O&M Halyard. “That’s why we continue to make investments to produce PPE, like HALYARD STERLING Nitrile Exam Gloves, that meet high quality standards for protection and performance, while providing optimal comfort and fit for those on the frontlines of healthcare.” 

WHAT IF IT DIDN’T EXIST TODAY: Clinicians and healthcare workers simply would be exposing themselves to danger – contact with and inhaling of bacterial and viral microbes, lacerations and punctures from rough or sharp objects and they likely would be bringing that home with them. They would have to wear throwaway street clothes or even some kind of uniform or sheet that would need to be disposed or laundered at least daily.

The lack of gloves would call for an accelerated frequency of hand washing unless clinicians wore plastic bags as makeshift “paw pads” that an amateur MacGyver might love. And depending on the material of the bag, doubling up on the product might be warranted.

Schmid singles out double-gloving as an accepted practice that blossomed during the HIV era of the 1980s forward overlapping with the needlestick safety era from the 1990s forward.

“Double gloving systems are an evidence-based solution to effectively decrease pathogen transmission that are proven to reduce risks of sharps injuries and exposure to blood-borne infections by 71 percent,” she said. “Biogel developed the first patented puncture indication system in the world that increased the safety and effectiveness of double-gloving. Data research reveals that on average, only 10 percent of glove punctures are noticed during surgery. Biogel Indicator undergloves are engineered to work together with a variety of Biogel overgloves to create customized double-gloving system that delivers clear, fast and large perforation detection when the glove is punctured to ensure breaches are spotted quickly.”