May 2016

Operating Room

Outpatient Connection

FDA proposes ban on most powdered medical gloves

The U.S. Food and Drug Administration has announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to healthcare providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.

The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.

Powder is sometimes added to gloves to help make it easier to put them on and take them off; however, powdered gloves are dangerous for a variety of reasons. In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions.

Although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.

As these risks cannot be corrected through new or updated labeling, the FDA is moving forward with the proposal to ban these products, which – if finalized – would ultimately remove them from the marketplace completely.The proposed rule is available online at for public comment for 90 days.

Patients carry superbugs on their hands, study finds

Hospitals may be cracking down on handwashing for doctors, nurses and other staffers, but they’re missing a big source of superbug spread, a new study finds: Patients.

Researchers at the University of Michigan found close to a quarter of the patients they tested had some sort of drug-resistant germ on their hands when they were discharged from the hospital to a post-acute care facility such as a nursing home, rehabilitation center or hospice.

The finding, publishing in JAMA Internal Medicine, supports what many healthcare experts have been arguing for years: that patients are a major source of the spread of "superbug" infections.

"We swabbed the palm, fingers, and around nails of patients’ hands," they wrote. The tests were done when patients were admitted, two weeks later and then once a month for the next six months.

They tested for a number of bugs, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and resistant gram-negative bacilli.

Efficient, effective patient monitoring is vital

by Kara Nadeau

As the healthcare industry works to become more efficient and effective in its delivery of care, patient monitoring has grown in importance. The ability to intervene more quickly to patients in distress — with greater knowledge of their conditions — helps minimize the risk for dangerous and costly complications and adverse events.

In this article, HPN examines the latest technological developments in patient monitoring devices for the surgical suite and the patient’s bedside. We explore trends including wearable sensors, data collection and transmission, electronic health record (EHR) integration, alarm management, solutions for non-acute care environments, patient tracking, multiple monitor management and remote monitoring. The article features insights from manufacturers of monitors, sensors and related equipment, as well as some of the latest products to hit the marketplace.

Monitoring in today’s healthcare environment

With the passing of the Affordable Care Act (ACA), there are more patients seeking medical care and a greater burden on clinical staff to treat them. In a 2014 TIME Magazine article, Registered Nurse Amy Dertz provided a real-world perspective on our changing healthcare environment. Dertz notes how she is not only caring for more patients since the passing of the ACA, but also treating previously uninsured patients with chronic conditions, many of whom have neglected their health for years. She stated:

"With the ACA, there are more patients entering hospital infrastructures that have been diminished. Patients visit the emergency room and wait longer before being admitted. When they do get admitted, rather than being sent home and told to follow up with their primary care physician, they are often much sicker and require more care. This new burden is falling heavy on the hospitals and staff. Nurses are working harder than ever with fewer resources."1

Veffa Devers

According to Veffa Devers RN, BSN, MS, CCRN-A, Vice President, Clinical Excellence Programs, Nihon Kohden America, today’s patient monitors have evolved to address this growing burden on healthcare, with features that enable nurses and other clinicians to do their jobs more effectively and efficiently.

"No one expects nurses and other care providers to do less," said Devers. "It’s really the other way around. Hospitals must equip clinicians with tools that enable them to do what they need to do in real time with as few steps as possible. To meet this need, we’ve enhanced our monitoring technology with advanced features that enable clinicians to make an accurate, rapid assessment of a patient’s condition at the bedside."

Identifying issues sooner - and smarter

Carla Kriwet

According to Carla Kriwet, CEO, Patient Care and Monitoring Solutions for Philips, another way monitors have evolved to meet changing needs is by allowing patients to be monitored unobtrusively, continuously, and in a way that provides valuable data and actionable insights to clinicians and caregivers.

"Technologies are evolving in such a way that they can help caregivers detect early signs of patient deterioration for early intervention, which in turn helps to reduce costly adverse events, complications, unplanned transfers back to the ICU and longer lengths of hospitalization," said Kriwet. "Additionally, alarms are becoming smarter and more meaningful to clinicians by only alerting them to clinically significant issues through easy-to-use interfaces and dashboards that highlight the most at-risk patients and provide clinicians with smart, actionable information and communication tools to support enhanced workflows."

Philips’ next-generation, medical grade wearable biosensor

Philips’ next-generation, medical grade wearable biosensor automatically and continuously measures clinically relevant vital signs including heart rate, respiratory rate, skin temperature and more. The biosensor then transmits the data it collects to a connected clinical decision support software application, where the software can be configured to promptly notify the appropriate caregiver or clinician when preset limits are exceeded. The wearable biosensor is designed to help patients in low-acuity areas of the hospital, such as the general ward, helping to reduce readmissions and costs.

Improved alarm management

An estimated 72 percent to 99 percent of clinical alarms are false2, which can interfere with patient care and compromise safety. When clinical staff members are bombarded by numerous alarms, it can be difficult to discern which device is sounding or which patient’s condition is deteriorating. Clinicians often become desensitized to the alerts, ignore them or even disable the monitors’ alarm functions.

The Joint Commission created the National Patient Safety Goal (NPSG) NPSG.06.01.01 to improve the safety of clinical alarm systems by requiring hospitals to prioritize alarm system management, better identify the most important alarm signals, establish policies and procedures and educate staff about the systems for which they are responsible. As of January 2016, all U.S. hospitals accredited by the Joint Commission must have established policies and procedures for managing clinical alarms.

"The high volume of alarms generated by patient monitors and devices presents significant challenges for hospitals," said Anne Crammond, Director of Marketing, Monitoring Systems & IT, North America, Dräger. "When critical-care professionals are consistently exposed to the alarms of every patient within a unit, they spend time and effort assessing their need to respond. This strain, which is dubbed ‘alarm fatigue,’ drains resources and adds stress to an already demanding environment."

The Dräger Alarm Management Solution

She added: "Hospitals are creating new alarm-management plans and workflows and adopting new technologies and strategies to not only meet NPSG mandates, but to also ensure the wellbeing of their workers and patients."

Designed to help hospitals meet NPSG mandates and improve workflow and patient safety, the Dräger Alarm Management Solution provides contextual knowledge needed to develop an alarm management plan. It is a source for alarm auditing and reporting, workflow consulting and alarm management plan development and implementation.

Using advanced analytics and alarm-auditing software, Dräger provides hospitals with detailed reports on alarms and responses to critical events and helps evaluate the effectiveness of current alarm policies and procedures. Dräger’s team of experts use those findings to work with hospital alarm committees to ensure they make evidence-based decisions to meet NPSG mandates and reduce adverse events related to alarms.

In March 2016, Nihon Kohden America launched its new Aware Alarm Management and Reporting system. The system allows hospitals to quickly aggregate alarm data by time, date and care setting, helping them to identify alarms with the highest frequency. Hospitals can then use the Aware data to educate staff on the importance of alarm management while also developing and executing protocols for alarm reporting and data management policies.

As part of the Aware offering, Nihon Kohden’s Nurse Executives are available to assist nursing leadership and other key stakeholders identify ways to reduce nuisance alarms, perform patient touch-point assessments and review alarm settings for goal-based optimization.

Nihon Kohden’s Aware Alarm Management and Reporting

Solutions to fit your environment

Tim O’Malley, President of EarlySense, explains how many of the monitoring products on the market today were developed for use in acute care areas, such as the intensive care unit (ICU), operating room (OR) and post-anesthesia care environments, where there are low clinician-to-patient ratios. With these products, patients are typically tethered to the monitor with a lead. According to O’Malley, when healthcare facilities attempt to use these monitors in non-acute patient care areas where clinician-to-patient ratios are much higher, clinical staff members are often burdened by false alarms due to poor patient-to-lead/sensor interfaces, or sensors/leads detaching from the patients.

"Hospitals are looking for ways to increase safety for their patients, by continuously monitoring all patients and obtaining actionable information which will support the clinicians in detecting early signs of patient deterioration, act quickly and ultimately save lives," said O’Malley. "However, an environment in which low acuity-level patients reside requires much different technology than the post-operative or ICU units of a hospital. An effective technology for monitoring these lower-risk patients must be easy to use by the staff, place few limitations on patients and their family, have low alarm rates in an effort to avoid alarm fatigue and be cost effective."

The EarlySense All-in-One System

The EarlySense All-in-One System is a contact-free, continuous patient monitoring solution to assist in early detection of adverse events, including code blues, preventable ICU transfers, patient falls and pressure ulcers. It is comprised on a sensor placed under the patient’s bed mattress that measures heart rate, respiration rate and movement without touching the patient; a bedside monitor that displays the patient’s data; and a central display unit at the nurses’ station that presents real-time information on up to 40 patients at a time and transmits information and alerts to handheld devices.

"With The EarlySense System, the alarm frequency in a typical 12 hour shift will only be two or three alarms, compared to the hundreds of alarms per shift experienced when using devices such as telemetry and oximetry, which were initially intended for the acute care environment," explains O’Malley. "This allows nurses to respond to the pertinent needs of patients, instead of checking in routinely due to the sound of an often unwarranted alarm."

Tracking your most important asset

"Patients, while being the most important hospital asset, are notoriously the most difficult to track," said Ari Naim, CEO of CenTrak. "The technology exists today to help monitor where a patient is at all times, how long they have been there, and where they are moving. This can help increase response times, optimize patient flow and enhance patient safety if they wander into restricted areas."

CenTrak’s 31-day disposable patient tag

According to Naim, use of Real-Time Locating Systems (RTLS) for monitoring patients, via active-RFID, Wi-Fi, Bluetooth Low Energy (BLE) and other technologies, is increasingly recognized as a pivotal component to improving patient satisfaction and maximizing reimbursement. A RTLS solution can provide a hospital visibility into which patients have checked-in, how long they have been waiting, as well as their current status and location. He points out how greater visibility in this area helps hospitals meet patient needs in a timely manner, improving the patient experience and, in turn, Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores.

Centrak’s RTLS solution integrates with a hospital’s EHR so that the movements of each patient — from entry/hospital admittance, to their progress and treatments administered within ancillary departments, up until their departure — are automatically updated in the EHR and time-stamped for hands-free documentation. Hospitals can also use this integrated solution to record patient-provider interactions, as well as associated equipment to provide hospital administrators with contact-tracing information should there be an infectious outbreak.

Managing multiple monitoring solutions

As patient monitoring technology evolves and expands, healthcare facilities must find ways to manage all of the various solutions they use at a patient’s bedside. Numerous monitors and their associated stands and cables can cause clutter if not well managed, and potentially interfere with the delivery of care. GCX Vice President of Sales and Product Development Cris Daugbjerg points out how patient monitors are becoming even more critical to data and decision support as they are integrated with EHRs and other technology systems. Healthcare facilities must carefully consider where and how monitoring solutions are positioned in a room so that clinicians can more easily access and interact with them.

The VHM-PL medical-grade, adjustable arm

"A patient monitor is no longer just a static device placed on a wall for viewing," said Daugbjerg. "Today, caregivers must have greater physical interaction with monitors. As a result, ergonomics is a higher priority."

GCX, which develops medical device mounting solutions, recently introduced two new adjustable arms, the VHM-P and VHM-PL, to make it easier for hospitals to manage the myriad medical equipment cables in patient rooms. The medical-grade arms feature seamless, unibody construction, can accommodate up to eight cables, conceal approximately 80 percent of cabling, facilitate one-handed positioning and provide swivel/tilt and pivot-tension adjustments and parallel linkage for consistent viewing angle. The VHM-P and VHM-PL also offer durability and ease of cleaning to fight the spread of infection, and are designed to allow easy removal/replacement of covers. Additionally, the VHM-PL locking version provides quick and safe vertical repositioning of the mounted device without interrupting workflow.

"As monitoring and electronic health records converge, there are a variety of possible bedside workstation configurations that combine monitoring and IT hardware such as additional screens and keyboards," added Daugbjerg. "Such a workstation may also need to be reconfigured as the hospital’s approach evolves. GCX’s modular design and flexibility accommodate this variety of needs and facilitates technology updates. The mounting hardware can often be upgraded or reconfigured down the road rather than replaced."

Accessing patients remotely

As the healthcare industry seeks out ways to care for more patients in an effective and affordable manner, the use of telemedicine has rapidly expanded. According to the American Telemedicine Association (ATA), nearly 1 million Americans are currently using remote cardiac monitors, and over half of all U.S. hospitals now use some form of telemedicine.3

During late November and December 2015, REACH Health conducted its 2016 U.S. Telemedicine Industry Benchmark Survey among 390 healthcare executives, physicians, nurses and other professionals throughout the United States. Roughly two-thirds of respondents indicated that telemedicine was the top priority or one of the highest priorities for their healthcare organization – a 10 percent increase from the 2015 survey results.4

"Telemedicine decision-making is rapidly moving from individual departments and specialties to an enterprise initiative," said Steve McGraw, President and CEO of REACH Health. "Both hospitals and health systems reported significant increases in the average number of telemedicine service lines which are active or being implemented in concert."

McGraw further noted that the top three telemedicine program objectives identified by survey participants all related to patient benefits: improving patient outcomes, improving patient convenience, and increasing patient engagement and satisfaction. The fourth most common objective was providing rural or remote patients access to specialists. HPN


1. Obamacare’s Killer Burden on Nurses, TIME Magazine,

2. Alarm Fatigue: A Patient Safety Concern,

3. Telemedicine Frequently Asked Questions (FAQs), American Telemedicine Association (ATA),

4. 2016 U.S. Telemedicine Industry Benchmark Survey Report, REACH Health,