10 headline integral, pivotal products needed, used in healthcare delivery

If the United States of America indeed represents the highest-quality healthcare provider in the world with the most advanced products, techniques and technologies then its healthcare practitioners and citizens are spoiled.

Clinicians are conditioned to grab a readily available device or tool when a patient describes some kind of ailment or malady. Generally, the exam requires the collection of various vital signs, made easier by these tools.

But what if they didn’t have these tools? Some go back less than 100 years. Others for centuries. Clearly, it can be easy to take them for granted.

This is part of the reason why Healthcare Purchasing News launched its Healthcare Product Hall of Fame and Healthcare Product All-Stars features last year. Without these devices, products and tools – from the most basic and rudimentary to the most advanced and scientifically challenging – we likely would be experiencing much higher mortality rates, much lower population growth and perhaps less resource consumption and wastage.

For the second consecutive year, HPN surveyed readers for their suggestions about key products they thought healthcare could not succeed without having and using as potential candidates for HPN’s Healthcare Products Hall of Fame and Healthcare Products All-Stars listing.

For this follow-up feature, the themes seemed to center on accessibility and convenience with an emphasis on personal healthcare through vital signs tracking and visualization as well as supply tracking and visualization, and ways to support operations through crises and disasters.

Without further delay, here are the 10 members of HPN’s Healthcare Product Hall of Fame Class of 2021 with an approving nod to the companies that brought them to market over time, and the Healthcare Product All-Stars Class of 2021.

Blood pressure cuff

WHY IT MATTERS: When you walk into your doctor’s office for a routine health checkup you can expect the nurse to take your temperature, check your height and weight and one more necessary vital sign before the physician ever walks into the exam room – your blood pressure. Equipped with all of this data, the physician then can dive a bit deeper into your physiology. Taking your blood pressure, however, can alert the doctor about a variety of issues, including whether you’re suffering from internal pain and/or stress or may have arterial and blood vessel blockages hampering blood flow to the heart, which can cause serious damage to the aorta. Readings also can assist in determining whether medications might be needed or whether current medications being taken actually are working as they should.

With the pandemic motivating heightened interest in telemedicine, you have more opportunity than ever before to invest in your own blood pressure cuff via local retail outlet or online exchange.

WHAT IF IT DIDN’T EXIST TODAY: With heart disease continuing as one of the leading causes of death, the concept and execution of tracking blood flow and heartbeat remains paramount. It’s called a vital sign for a reason. Without this simple compression tool wrapped around your upper arm to cinch blood flow for a brief time, coupled with the use of a stethoscope (HPN Hall of Famer in 2020), doctors would be hard-pressed to determine what’s making you tick – or better yet, what’s preventing the tick.

Hearing aid 

WHY IT MATTERS: Battery-powered or electronic hearing aids, by and large, come in four types, according to Johns Hopkins Medicine. The first type is called “In-the-ear (ITE) hearing aids. They come in cases that fit in the outer ear and generally are used for mild to severe hearing loss.” The second type is called “Behind-the-ear (BTE) hearing aids. Worn behind the ear, they also come in a case that connects to a plastic ear mold inside the outer ear. They also generally are used for mild-to-severe hearing loss.” The third type, as noted by Johns Hopkins Medicine, is called “Canal aids. They fit directly in the ear and come in two sizes – in-the-canal (ITC) aid and completely-in-canal (CIC) aid. They are customized to fit the size and shape of a person’s ear canal and generally are used for mild-to-moderate hearing loss.” The fourth type, according to Johns Hopkins Medicine, is called “Body aids. They generally are reserved for profound hearing loss that other types will not accommodate and are attached to a belt or pocket, connected to the ear with a wire.” All are designed to convert sound waves to electrical signals.

WHAT IF IT DIDN’T EXIST TODAY: Silence. Or garbled/muffled sound. This would leave the hearing impaired to read lips and communicate by typing or writing as well as American Sign Language. Thankfully, today they do exist and for the first time are being considered for convenient “over-the-counter” access rather than just by prescription.

Artificial heart

WHY IT MATTERS: Depending on what’s wrong with your heart, if defibrillation, drugs or stenting don’t solve the underlying problem, all that’s left is an organ transplant. Access to donor organs – particularly the heart – can be difficult and potentially a long wait. While doctors try to prolong a person’s life as much as possible through medications as he or she awaits a replacement heart, they were provided another option that can be traced in part back to the 1930s and 1940s: An artificial (mechanical) heart. The first to receive a patent for a human artificial heart were Paul Winchell and Henry Heimlich (he of the famous maneuver conceived in the mid-1970s used to prevent choking). Others would research and develop their own versions, the most famous of which was designed by a team headlined by Robert Jarvik that was implanted in a patient in 1982. This mechanical device originally wasn’t designed to be a permanent replacement for a faulty organic one (even though the concept is touted regularly in science fiction). Instead, it serves as a temporary implantable prosthesis to serve as a bridge until a donor organ could be located and implanted.

WHAT IF IT DIDN’T EXIST TODAY: Last year, HPN inducted cardiac defibrillators/AEDs into the Class of 2020. Similar to the justification for cardiac defibrillators/AEDs, the outcome likely would be more fatalities from heart disease and prolonged wait times for heart transplants due to lack of access. If anything, the artificial heart serves as just one more stopgap solution to maintaining a patient’s life.

Thermometer

WHY IT MATTERS: You can trace the concept of a thermometer back some 500 years when inventors – including Galileo – developed what became known as “thermoscopes” that used glass tubes of trapped air submerged in water. The way it worked went like this: If the tube was placed in hot water, the trapped air would expand and cause the water level to rise; if the tube was placed in cold water, the trapped air would contract and show the water level as falling. By the early 1600s, an Italian inventor added a numerical scale to the thermoscope and voila! The first thermometer was born. From there, inventors experimented with alternatives, such as switching to alcohol-filled glass tubes. In the early 1700s, however, a German physicist named Daniel Fahrenheit would use liquid mercury within the glass tubing and a standardized scale that became the standard bearer of a universal technology relied on for centuries until the advent of contact and no-contact external thermometers (2020 All-Stars).

WHAT IF IT DIDN’T EXIST TODAY: Likely, clinicians – doctors and nurses – would find it challenging to measure and treat fevers as the body’s reaction to something. The focus would remain on breaking the fever rather than understanding its roots as a bodily defense mechanism on one hand and a potential mortality threat on the other. One also wonders whether today’s more advanced and sophisticated temperature-recording devices would have seen their debuts delayed, if not eliminated, without the advent of the forerunner to the concept.

MRI scanner

WHY IT MATTERS: Last year, HPN inducted the proverbial Three Musketeers (Athos, Porthos and Aramis) of Diagnostic Imaging: X-ray, ultrasound and computed tomography. This year, just like in the fictional tale, the dashing, younger D’Artagnan joined the trio.

Magnetic resonance (MR) can trace its imaging roots to the early 1970s as an outgrowth of nuclear magnetic resonance studies dating back to the 1940s, according to Wesley Gilson, Ph.D., Senior Director, Business Development, MR, Siemens Healthineers. Healthcare started seeing commercial MRI units emerge in the 1980s. MR represents the “youngest” of the leading four diagnostic imaging modalities that include ultrasound, X-ray and CT with positron emission tomography (PET) added to the group since the 1950s. “All of these work together and build on one another, effectively defining the field of radiology,” Gilson told HPN.

Where MR makes a difference involves its interior reach and speed, and connection to surgery.

“All of us recognize certain clinical indications where MR is the preferred imaging modality,” Gilson noted. “I’m thinking of all musculoskeletal issues and traumas, including brain injury (e.g., CTE in football). MR also is helpful in diagnosing brain disorders, neurodegenerative diseases like ALS and dementia and is effective in detecting lesions for MS and other chronic diseases. MR represents a tool to prevent the need to go inside a body and to help plan and guide necessary surgical intervention.”

Technological development has facilitated visual acuity and efficient data transmission, according to Gilson.

“The progression of computerization and super-conducting magnets has enabled more clarity in the images taken and the digitization of those images for reading, diagnosis, storage and transmission,” he noted. “The image quality produced now has come a long way from the early analog days of the modality. The other development involves the speed of acquiring data for the images. In the past it took hours to acquire and process the images.

“Routine imaging exams are now being completed in 20- to 30-minute scan slots,” Gilson noted. “Innovative acceleration techniques and faster computing power have reduced individual image set acquisitions down to only a few minutes or less.”

WHAT IF IT DIDN’T EXIST TODAY: Radiologists likely would concentrate on the other modalities and adapt accordingly. However, Siemens Healthineers recognizes that MR may not exist in many places throughout the globe and has a specific vision around the MR business and that involves access, according to Gilson.

“We recognize and understand that with advanced imagery like MR, access is limited around the world – even in rural areas of the U.S. where there may be a scarcity of these systems,” he said. “For example, in the U.S., 1 in 9 citizens may have access to MR advanced imaging. In Western Africa, however, that figure is 1 in 1,000. This shows you that people around the world still don’t have access to a technology that’s been available for more than four decades now, which can negatively impact the level of care they receive.

“What separates MR from, say, CT, is the use of nonionizing contrast and the images provided from inside the body,” Gilson continued. “Thanks to MRI, we can look at soft tissue contrast without having to perform exploratory surgery and opening up a patient. We have an unrestricted ability to see soft tissue inside the body, including structures and lesions, from the brain to the spinal cord, from the heart and blood vessels for cardiac procedures to other internal organs. We are able to the measure contractile function of the heart and flow through blood vessels to enable diagnoses – imaging structure, anatomy, physiology and function with nonionizing radiation.”

While CT has worked to offer lower-dose radiation exposure in contemporary models and recently gained FDA clearance for a new CT technique called photon counting, “CT is not as versatile as MR in its ability to interrogate physiology and extract certain functional information and it has the added risk of ionizing radiation exposure,” he added.

“Our vision is to bring MR to more people – the democratization of MR, so to speak,” Gilson said. “All people deserve access to the highest level of care. Everyone everywhere deserves access to MR. We’ve benefited from it here in the western world in that our healthcare has been raised to a level above and beyond, but we’ve seen slower direct benefits to improving diagnostic and downstream care to others. We need to continue to innovate to move the clinical world forward and package it to be accessible and usable to all.”

Bar coding in healthcare

WHY IT MATTERS: Back in the early 1970s, the grocery industry sought for a way to increase speed at checkout lanes but also drive efficiency in tracking inventory and sales. So in 1973, the major grocery retailers agreed to adopt and implement the Universal Product Code (UPC), a bar code symbol that included transactional data within a series of printed vertical stripes on a label that could be scanned and sent to a computer for tracking and record keeping. The concept of bar coding wouldn’t emerge in healthcare for another two years when an enterprising hospital supply chain executive in North Dakota developed a system internally to accomplish something similar. From 1975 onward, bar coding established a beachhead in healthcare, albeit slow growing, under the intention of efficiency and safety at the point of care.

“The foundation of care delivery is patient safety,” said Rikki Jennings, Chief Nursing Informatics Officer (CNIO) at Zebra Technologies. “The development of automated data capture has transformed clinic practice at the point of care. Bar-code scanning has become the underpinning of efficiency for patient identification workflows such as medication administration and specimen collection. Scanning technologies ensure consistency and validation that the correct patient receives the designated treatment at the right time, reducing error and vastly improving patient safety.”

Jessica Bernardo, Senior Product Marketing Manager, Barcode and Label Print Solutions, Toshiba America Business Solutions, offers even higher praise.

“Thermal bar-code printers are the unsung heroes of smooth logistics and healthcare practice excellence,” Bernardo said. “No doubt, patients attribute successful medical outcomes to clinicians, facilities and thorough aftercare. Working behind the scenes for each of these are essential technology components that are often invisible but extremely critical in determining successful outcomes. 

“This is true for thermal barcode printers,” she continued. “These systems allow clinicians to track medical supplies and medications, ensuring administrative accuracy of medicines while securing and maintaining the privacy of patient data in an effective, efficient and affordable manner. Thermal bar-code printing is an integral and dependable element of healthcare delivery with oftentimes nary a thought to its existence. Printers perform in small spaces with minimal maintenance and low cost. Devices can easily accommodate various size labels or even patient wristbands and require little knowledge to print multiple labels at one time. From patient admissions to the pharmacy and more, thermal bar-code printers are the workhorses behind successful patient care.”

Angela Fernandez, Vice President Community Engagement, GS1 US, recalls the bar code’s early 1970s roots “to support price lookup at point of sale in retail to expedite the checkout process,” but adds that it has grown beyond that original mission.

“Since [then], bar codes have evolved to become an essential data carrier to provide track and traceability for products as they move through supply chains,” Fernandez said. “Today, bar codes can hold product identification and essential information such as lot and batch numbers, expiration dates and other pertinent details to assist in tracking the product’s entire life cycle. This data is essential to healthcare in an increasingly complex supply chain and patient care system, helping prevent errors and assure availability of medical products when and where they are needed.”

Fernandez acknowledges the slower pace of bar code progress in healthcare versus grocery and retail.

“The healthcare industry did not begin broadly adopting bar codes until the early 2000s,” she noted. “Recognizing the need for better, more reliable and more robust data to help manage pharmaceutical and medical device supplies, healthcare stakeholders are now widely using global standards and barcodes in their daily operations. Today, even the patients are identified by bar codes on the bracelets they wear in a hospital – helping to increase safety, ensure they receive the right medication or product, and to populate health records with details about the products that are used in their care.”

In fact, the bar code has been much more widely applied across healthcare to improve operational efficiencies, accuracy and patient safety, according to Fernandez, in that It is used to carry data that uniquely identifies pharmaceutical products and medical devices and to provide additional details about them. “The bar codes can be scanned throughout the supply chain to enhance track and traceability, simplify and expedite recalls where necessary, help identify expired product for removal and more,” she continued. “When the bar codes are also scanned into patients’ electronic health records, follow-up monitoring can be extended to offer better tracking of outcomes, side effects and other information that helps providers understand their efficacy and make more informed purchasing decisions for the future.”

Government regulations, such as the FDA’s Drug Supply Chain Security Act, or DSCSA and Unique Device Identification Rule, or UDI, are driving momentum because they now require standardized bar codes on packaging for prescription medications and medical devices, respectively, she added.

The emergence, adoption and implementation of global data standards for unique identification of products, locations and services underpin bar coding’s growth, according to Fernandez. Globally recognized standards ensure information contained in a bar code can be scanned, captured and incorporated into diverse data systems utilized by supply chain stakeholders, and understood by all as a common language for organizations to communicate vital information about the products they manufacture, distribute, and use, she added.

“Using these standards, the captured data can be shared between organizations throughout the supply chain to help ensure the right product (medication or device) reaches the right patient, at the right time, in the right location and in the right dose or use. We refer to these crucial parameters as the 5 Patient Rights,” Fernandez said. “The use of GS1 Standards continues to increase in healthcare partly to support legislative requirements, and overall, to help improve the entire healthcare system’s ability to continually provide the best possible patient care and safety.

WHAT IF IT DIDN’T EXIST TODAY: Paper and pencil or pen and typewriters to record inventory levels and transactional data in printed ledgers that date from the 1960s backward for centuries.

“Without this vital advancement in automation and safety gate, clinicians would need to revert to using manual processes,” Zebra’s Jennings noted. “These manual processes add time and risk to each workflow, as well as prevent the ability to collect and analyze data that is needed at the point of care. By providing clinicians with automated data capture solutions, healthcare providers are helping ensure patients receive the best possible care.”

Toshiba’s Bernardo emphasizes bar coding’s enduring impact on healthcare.

“Not many of us were born yet when the first adhesive labels were created in the 1930s,” she indicated. “Such labels are now essential for healthcare and myriad other sectors. It is hard to imagine doctors, pharmacists and logistics companies being able to perform their jobs without the existence of thermal bar-code labels.”

GS1’s Fernandez contemplates the effect on efficiencies that a lack of bar coding would reveal.

“Without these standards, the bar code’s usefulness would be very limited,” she said. “Without standards, proprietary data systems would be incapable of interoperating with one another, errors would be far more common and manual recording of product information would consume unsustainable levels of staff time at the point of care.”

The adoption and implementation of bar code use and data standards also could have played a more significant role in the pandemic, according to Fernandez.

“Based on dialogue with their respective industry members, the Association for Health Care Resource & Materials Management (AHRMM), Healthcare Supply Chain Association (HSCA), Strategic Marketplace Initiative (SMI) and GS1 US believe that much of the supply chain upheaval experienced during the COVID-19 crisis could have been avoided if globally unique identification standards had been more broadly adopted across the healthcare supply chain to support exchange and synchronization of reliable, trusted quality data,” Fernandez insisted. “They agree, and are advising their members, that full adoption of global standards could help improve product transparency and data-driven demand planning and forecasting – two critical issues that have been shown to adversely impact patient care as well as patient and clinician safety.

“In addition, healthcare providers have demonstrated that using GS1 Standards to quickly and accurately identify and track medical devices and pharmaceuticals enables increased patient safety, and internally improves staff productivity, inventory management, precise and inclusive capture of costs, and eliminates human error from manual data entry,” she added.

Radiofrequency identification (RFID) in healthcare

WHY IT MATTERS: Bar coding may have emerged in healthcare in the mid-1970s, but its “more advanced” younger sibling RFID needed at least another 15 years to place its flag in the sand alongside bar coding among the most forward-thinking of hospital supply chain leaders.

“Bar-code scanning and/or RFID serves as the foundation of any modern point-of-use technology,” observed Mike Ferrazzo, Product Manager, Jump Technologies. “It has allowed for a fast, simple and accurate means of recording supply consumption in a hospital. It also has helped improve patient care and safety by reducing the time clinicians have hands on keyboards, while providing more accurate identification of staff, patients, equipment, medications and implants used in a procedure.”

Joe Pleshek, President and CEO, Terso Solutions, envisions a bright future for RFID in healthcare.

“RFID has been and will continue to be rapidly adopted in the healthcare market to improve inventory visibility across the supply chain,” Pleshek said. “Enhanced visibility to critical supplies enables each stakeholder to be more efficient, lower costs and ensure patient safety. Traditionally, the management of inventory has been very manual, requiring clinicians to take stock counts, check expiration dates and update software systems as products are being consumed throughout a procedure.

“I believe life for clinicians and patient care already looks a lot different on the other side of RFID inventory management systems,” he continued. “With this technology, the management of inventory is automated, allowing clinicians to spend their time on providing patient care instead of searching for inventory.”

Today, automation such as RFID are helping to relieve workplace pressure as hospitals deal with labor shortages across the country, according to Pleshek.

“From a patient safety perspective, RFID is ensuring product integrity and chain-of-custody,” he indicated. “Many therapies, specialty pharmaceuticals, and biologics need to be consistently stored at a certain temperature. Terso Solutions’ RFID enabled freezers, refrigerators and cabinets automatically track when a product or pharmaceutical has been removed from the device, who removed it and if the temperature of the product has been compromised in any way.  We are just scratching the surface of the value RFID can bring to our healthcare system.”

Regardless of automated tracking modality, adoption and implementation remains a long slow climb.

“Hospitals always seem to us an advanced place – it’s true when it comes to clinical innovation,” said Or Lomnitz, Head of Marketing and Strategic Partnerships, IDENTI Medical (formerly LogiTag). “But when it comes to operational processes today there are still administrative tasks that are done manually or with outdated technics that consume time away from patient care and fail to give a full business view to the hospital management.

“One of the most prominent areas is the management and documentation of medical implants and consumables in operating and procedural rooms,” Lomnitz continued. “Today’s solutions do not provide a satisfactory solution to those unique and stressful environments. As a result, the hospital is exposed to risks of patient safety, waste and burnout of the nurses. The core reason is because hospitals find it difficult to capture inventory utilization and trace stock at point of use.

“It leads to uncertainty in inventory available on core areas` shelves,” she said. “For example, it has often happened that expired products have found themselves transplanted into a patient. Or a case of a recalled product that because no digital tracking was done, it was not possible to locate those transplanted people. This is the reason why data-capture regulations as the FDA’s UDI rule is being forced in the past 10 years. Today hospitals management realize they must invest in data integrity in point of care.”

Lomnitz promotes that IDENTI Medical “cracked the system” and developed an easy-to-use platform that provides complete visibility in operating and procedural rooms.

“While the other solutions concentrate on resolving the symptoms, the IDENTI platform addresses the problem itself.  By combining UHF-RFID Smart Cabinet with Snap & Go image-based charge-capture, we deliver a clear and safe view of the current stock and usage. When all items and costs are documented, accurate management is made possible.”

Arnold Chazal, CEO, VUEMED, identifies and outlines seven ways RFID makes a difference in the healthcare supply chain, spanning accuracy of documentation and item tracking, reliable data to guide decision-making, increased productivity and substantial savings and revenue generation. For Chazal, RFID enables the following:

1. Makes the monitoring, documenting, and accounting of items efficient, accurate and easy – it’s hands free, cabinet free and virtually error-proof;

2. Provides an item’s location and chain of custody in the hospital at any moment, and can track assets, patients and personnel with equal agility using the same light, inexpensive overhead infrastructure;

3. Enables UDI regulatory compliance by embedding the item’s unique ID and all pedigree data like lot/serial number and expiration date on its tags;

4. Reports in real time on product availability and low par levels, automates replenishment, and optimizes inventory size and composition by providing the data visibility needed to be proactive and take action;

5. Increases billed revenue and patient record accuracy through automated, accurate clinical documentation at the point of care;

6. Reduces waste by automating expiration tracking so that items no longer expire on the shelves, and protects patients by preventing expired and recalled items from reaching them;

7. Guarantees swift and easy recall management by being able to report instantly on usage of recalled products in completed patient procedures, which saves time for clinicians and identifies the concerned patients for proper follow-up care.

“When used in combination with smart key performance indicators (KPIs), optimization software and Cloud analytics, RFID technology can lead to dramatic improvements,” Chazal continued. “In one of our case studies involving a large academic medical center in California, expired items have been maintained at less than 0.5% of total inventory value; unused inventory and inventory above recommended PAR levels have been reduced by more than 60%; and billing accuracy is now more than 90%, just to name a few key results.”

VUEMED uses RAIN RFID technology to power its clinical inventory management and supply chain optimization solutions in hospitals – a type of advanced RFID distinguished by its use of the GS1 UHF Gen2 protocol, according to Chazal.

“RAIN RFID isn’t new,” he noted. “The adoption of RAIN RFID is broad and deep, spreading across many industries around the globe. It is new to healthcare, however, and we are seeing a growing level of interest in this set of capabilities as providers are looking for ways to gain more visibility and control over their operations in a world where they are continuously under pressure to control costs and juggle labor shortages, while simultaneously delivering high quality patient care.

“With RFID, we now have the Internet of Things (IoT) for medical devices and supplies. From application of the tag to their use at the point of care, each individual item is recorded in the Cloud, as well as every event and location associated with it,” he continued. “Providers can now identify the exact location and usage of all medical supplies and products at all times, thereby dramatically improving clinical documentation, integration of key supply data into other systems, and ultimately patient outcomes.”

Todd Stewart, Vice President, Enterprise Workflow Solutions at CenTrak, emphasizes the necessary productivity gains that automated location technologies provide healthcare organizations.

“The demand for care has increased exponentially over the past decade, and there is no sign of it slowing down,” he said. “Powered by CenTrak RTLS (real-time location systems), RFID tags are crucial resources for healthcare facilities, patients and staff. Health systems need operational workflow automation to help them work smarter, not harder. This approach improves outcomes while simultaneously reducing the operational cost of care delivery in a scalable, repeatable manner.”

WHAT IF IT DIDN’T EXIST TODAY: From VUEMED’s Chazal, think the status quo. Of course, this reasons that bar coding wasn’t accepted either. It’s entirely possible that bar coding would be the preferred transactional modality within healthcare after becoming standard operating procedure within the retail, grocery and food service realms.

“Although the FDA UDI Rule, in conjunction with scanning a GS1 bar code or other UDI, provides accurate traceability of items consumed or implanted in a patient, a large portion of operating rooms in hospitals do not leverage these technologies,” lamented JumpTech’s Ferrazzo. “In fact, many hospitals still rely on either recording consumption on paper or by hand keying consumption into EHRs. Decades of embedded processes can be a difficult thing to change, but it is incumbent on all of us to assist with making that change easier. Not only for patient care, but for the well-being of our healthcare workers.”

For CenTrak’s Stewart the lack of any type of automated location technology would affect priorities and operational efficiencies.

“Without the use of location-based solutions to deliver real-time situational awareness, clinicians and health systems would never have seen the advancements in workflow efficiencies, time savings, cost avoidance and a better overall experience for the patients they serve,” Stewart noted. “Prior to a health system embarking on their RTLS journey, they were left to conduct searches for assets the old-fashioned way by walking around and looking, instead of simply going to a designated location to retrieve what they need, knowing with confidence that the asset will always be there.”

Stewart cites one media outlet that reported that 30% of nurses surveyed spent at least an hour searching for equipment such as IV pumps, drip stands and patient monitoring devices during an average shift, totaling 6,000 hours a month.

“With the implementation of RTLS, if someone does need to search for mobile medical equipment, whether it is to provide care to a patient, conduct routine maintenance or quickly manage a device recall, this task is now accomplished within minutes – reducing the need for valuable resources to conduct non-value-added activities,” he said.

Mobile clinical/medical/reprocessing facilities

WHY IT MATTERS: Whether dealing with over-capacity service demands or the aftermath of some crisis or disaster, hospitals and other healthcare facilities have appreciated and relied on mobile units to provide a variety of services, including diagnostic imaging, laboratory testing, sterile processing, standard medical care and during the last year or two, COVID-19 testing and vaccine distribution and injection.

But these facilities extend far beyond “pop-up” service providers. They can amplify or reinforce existing service, particularly during construction and renovations.

“Sterile Processing Services (SPS) have been notoriously ignored until recent problems, traced to a lack of understanding [of] properly sterilized instruments used for surgery,” said Janet Lumbra, Director of Business Development, MMIC Medical Systems, which manufactures and markets temporary facilities to ensure business/service continuity. “These problems awakened hospitals to the importance of the SPS role in reducing the risks associated with hospital acquired infections (HAIs). As a result, many hospitals are upgrading, updating, and totally overhauling outdated SPS departments to be effective in their role as the first line of defense against HAIs. These renovations receive top priority with facilities as their implementation maintains a good reputation of the facility well into the future.”

To facilitate a code-compliant on-site solution for hospitals to use during renovations is one of the primary reasons MMIC Medical Systems designed its Mobile Sterile Processing System, according to Lumbra. “Now clinicians have a solution that retains staff, ensures proper processing protocols are preserved during the renovation while also providing the assurance of code compliance, perhaps even to a greater degree than the space they are renovating,” she noted.

STERIS Corp. offers its STERIS Mobile Sterile Processing Unit as a one to three expandable semitruck platform that “allows for a turnkey solution and process to continually support the SPD and Surgical department delivered to the hospital site to support clinicians without disruption during hospital construction, renovation, or emergency situation,” said Nicholas Shelton, Director of Mobile Solutions.

“Turnkey Mobile SPD solutions enable hospitals to maintain 100% surgical volume and a high level of infection control during construction renovations and emergent situations,” Shelton indicated. “A Mobile Sterile Processing Unit is a fully integrated, Mobile SPD that allows for a turnkey process to continually support the OR without disruption during times of construction, renovation, or emergent situations. The Mobile SPD solution creates value for hospitals by decreasing down-time, lowering costs, and creating an environment for continual effective sterilization.”

STERIS maintains a large fleet of mobile SPD units that has responded to facility renovations that have lasted months to years, surgical capacity demand increases and emergencies, including floods from hurricanes and rivers, fires, sewage backups, HVAC issues and compliance issues, according to Shelton.

“The STERIS Mobile SPD has supported hundreds of projects over the years and continues to allow clinicians, SPD and Surgical departments to maintain a high level of care for patient populations and is truly an innovative product and solution that is unique in the marketplace,” he added.

WHAT IF IT DIDN’T EXIST TODAY: Think service delays, which neither Sterile Processing nor its Surgical Services customers can afford or would welcome.

“Practices – in hospitals and ASCs – would require longer periods of time to renovate as they would need to either ‘phase’ the renovation, which extends the renovation process and increases the overall cost,” indicated MMIC’s Lumbra. “Procedures may have to be re-scheduled or cancelled due to the impact of construction on the ability of the SPS department to process instruments. With delays or cancelled surgeries, patients do not receive the level of care they need to live a fulfilling life.

“Without the Mobile Sterile Processing System, which is an SPS configured on a mobile platform, clinicians would not have a tool they have come to rely on to keep SPS services up and running so their patients can be safely cared for,” Lumbra continued. “Patients would be negatively impacted by either delayed or cancelled surgeries impacting their ability to live their lives fully without the worry of when or if they will receive the surgery their physician has recommended. Patient safety would also be impacted without a mobile solution if that caused facilities to continue operating with sub-par SPS services making patients vulnerable to possible HAIs.”

Think diversion, too, which can impact community access to care and an organization’s financial ability to remain in operation.

“Without a Mobile SPD interim solution, hospitals would have to divert surgical procedures to other facilities,” said STERIS’ Shelton. “This can cause whole patient populations to lose their local surgical services and a loss in revenue for the hospital. By using a Mobile SPD, surgical procedures can take place during construction, renovation and emergent situations, which can help keep a hospital operating at full capacity.

Capsule endoscopy, a.k.a. pill camera

WHY IT MATTERS: By using a small wireless camera that can be swallowed by the patient a doctor can see inside that patient’s digestive tract, including the esophogas and small intestine. This enables doctors to diagnose cancer, gastrointestinal ailments and bleeding as well as see polyps more quickly. Capsule endoscopy provides faster access to internal visualization without the need for invasive surgery. Where the diagnostic imaging modalities provide views inside the body from outside the body, capsule endoscopy provides views inside the body from inside the body.

Philip Doyle, Executive Director of Marketing for Endoscopy at Olympus Corporation of the Americas, traces the roots of this technology to the early 1950s when the first gastrocamera was developed to allow doctors to see all parts of the gastrointestinal (GI) tract. But there were limits.

“As technologies evolved through the end of the 20^th century, the endoscope allowed doctors to reach to the end of the colon and into the stomach,” Doyle said. “But most of the small intestine remained off limits to endoscopic technology due to its tortuous anatomy that includes 20 feet of loops and turns and a very compact lumen.”

Not all parts of the GI tract were able to be seen without surgery until the advent of the capsule endoscope, which means that diagnosis and treatment of digestive diseases and disorders, such as Crohn’s disease, GI bleeding and small bowel tumors were very challenging, according to Doyle. Doctors were able to see inside the small bowel, courtesy of the capsule endoscope in 2001.

“With this pill-sized, wireless capsule endoscope, the small intestine is fully scanned while the patient is at home, and physicians can process and access imagery without the need for lengthy hospital procedures,” Doyle noted. “Patients wear an antenna belt and a recorder. The pill takes about 8 hours to travel through the digestive tract, and once it’s done, the patient gives the equipment back to the physician, who downloads the exam into processing software and reads the exam. There are risks associated with this type of procedure, including potential interference with implanted electronic devices and possible retention of the capsule endoscope, which may require open surgery.”

Endoscopic technologies continued to advance enough to allow physicians access to the small bowel for non-surgical treatment, according to Doyle. “With the introduction of balloon-assisted enteroscopy, physicians were able to move the endoscope deep within the small bowel, and now it is possible to perform many minimally invasive treatments of the small bowel, such as removing polyps, opening blockages, sampling tissue, and stopping bleeding, without the need for surgery.” ^{1, 2}

WHAT IF IT DIDN’T EXIST TODAY: Without Given Imaging pioneering the field of capsule endoscopy two decades ago, physicians either would have to rely on the diagnostic imaging modalities such as MR that allow views of organs and soft tissue or at the very least more invasive surgical techniques.

Surgical staple

WHY IT MATTERS: Questions might be raised about why the surgical staple makes it into the Hall of Fame earlier than its predecessor, the suture. Fair question. The challenge for the suture is that, by and large, it’s nothing more than “medical/surgical-grade thread” that is part of a much-larger family of products that include rope, string, twine, etc., and is used in multiple industries and markets. But then some might counter with the fact that staples are used in packaging (think corrugated cardboard boxes and containers) and form/paper groupings as well as serving as the brand name for a famous office supply store. Again, fair enough. But surgical staples represent a noteworthy advancement and alternative to suture in how they function within the anatomy and affect the healing process.

The surgical staple, by and large, offer a number of benefits that differ from traditional suture, which is why it tends to be the tissue closure of choice for minimally invasive surgical procedures. Benefits include convenience and portability in that the surgical stapler can be inserted into the body cavity quickly and activated to connect tissue after an organ has been removed (resection) or sealed (transection). Until absorbable staples were manufactured (like absorbable suture), the surgeon could remove them rather easily and quickly compared to suture. This also meant that the patient spent less time in surgery and under anesthesia, compared to when suture was used. Finally, because of their durability and strength, surgical staples tend to be used on the skin to close skin “under high tension,” such as the scalp for cranial and neurosurgery.

During the last decade, the U.S. Food and Drug Administration has received reports of problems and data involving device malfunctions that led to several major product recalls. The FDA also held public meetings that led to a final guidance on labeling as well as reclassifying surgical staplers for internal use as a Class II (moderate risk) medical device from a Class I (low risk) medical device.

WHAT IF IT DIDN’T EXIST TODAY: Doctors and surgeons still would have access to suture and thread, but that would be the extent of it. One wonders also that if staples weren’t conceived, developed and used as an upgrade to suture would the industry innovate to the point of developing surgical glue, which has been an All-Star nominee for two years?

References:

1.  Balloon Assisted or “Deep” Enteroscopy. ASGE.org. https://www.asge.org/home/about-asge/newsroom/media-backgrounders-detail/balloon-assisted-enteroscopy. Last Reviewed August 2014. Accessed October 25, 2021.

2.  Voelkel J, Di Palma JA, South Med J. 2010;103(10):1045-1048.