Accreditation for Cone Beam Orthopaedic Imaging: Answers to 7 Questions

Providers must be accredited by a CMS-approved organizationCarestream OnSight 3D Extremity System

The process for securing accreditation for Cone Beam CT orthopaedic imaging can be a bit confusing. However, it’s a necessary process. Any facility performing CT scans must obtain accreditation prior to receiving reimbursements from Medicare and many private payers.

The process for securing accreditation is worth it. Adding the capability for in-house cone beam CT exams can have major benefits for orthopaedic practices. It can help speed your workflow, boost your productivity, and support a higher standard of care. It can even help differentiate your practice from the competition.

Read on to learn the simple answers to 7 common accreditation questions. Continue reading

Carestream OnSight 3D Extremity System Gains FDA 510(k) Clearance

Aunt Minnie Selects OnSight Product as Finalist for “Best New Radiology Device”

Editor’s note: the CARESTREAM OnSight 3D Extremity System was named the winner for Best New Radiology Device by Aunt Minnie in October!

September has been a big month for our CARESTREAM OnSight 3D Extremity System. The product received FDA 510(k) clearance and is available for order in the United States. It was also selected as a Finalist for “Best New Radiology Device”by Aunt Minnie. The publication chose the product in part because of the niche it fills – “a small CT scanner designed for extremity studies”.Carestream OnSight Aunt Minnie finalist

This affordable, compact system offers high-quality, lower-dose 3D imaging studies (compared to traditional CT) for use by orthopaedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers. The system also comes with 3D software from Carestream designed to give orthopedic specialists more information on pathology than what might be possible with 2D imaging.

The extremity imaging system can help in treating a host of orthopaedic conditions that affect the biomechanical behavior of the joints such as arthritis, meniscus loss, instability and malalignment syndromes. The system also offers less radiation than traditional CT systems while delivering excellent image quality.

A key feature of the product is its ability to capture weight-bearing images. Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo recently concluded a study, noting the benefit of weight-bearing images for orthopaedic patellofemoral diagnosis.

Orthopaedic imaging is a major focus for Carestream because of the prevalence of musculoskeletal conditions among people of all ages. Youth and adults often suffer sports-related injuries to their knees, ankles and feet while older adults experience arthritis, joint instability, meniscus loss and other conditions.

Carestream’s new extremity imaging system enables healthcare providers to capture high-quality 3D images and conduct a patient consultation in a single visit—which helps improve productivity and convenience for both specialists and patients. An additional benefit is the ability for patients to view a 3D image that illustrates their condition or injury to help them understand the reason for a treatment or surgical procedure.

The OnSight 3D Extremity System will be demonstrated at the American Society for Surgery of the Hand (ASSH) conference that begins on Sept. 29.

#NHITweek

Editor note: In Europe, the device cannot be marketed or sold until compliant with 93/42/EEC.

 

Helen Titus

Helen Titus is the worldwide X-ray & Ultrasound Solutions Marketing Director at Carestream

Research: Impact of Weight-bearing Images in Orthopaedic Imaging

Study favors weight-bearing images for orthopaedic patellofemoral diagnosis and surgery

In clinical orthopedics advanced imaging like computed axial tomography (CT) scanning, has become invaluable to the evaluation and management of patients with musculoskeletal disease. Bone detail is much better visualized with 2D and 3D CT renderings of patients with problems like glenoid fracture, failed shoulder instability surgery, and meniscal root avulsions.

Conventional CT technology requires subject in supine position

High-quality images provide multiplanar 2D and 3D visualization for practitioners who think and work in three dimensions. However, a significant limitation of CT technology has been that it forces image acquisition with the subject in a supine, relaxed position. When imaging an injured knee, for example, the leg is in full extension and the muscles relaxed.

The conventional measures of patellofemoral alignment include the congruence angle, patellar tilt angle, and tibial tubercletrochlear groove offset distance. There are clearly defined limits of normal use for each of these measures, and they are used by surgeons to plan corrective operations on the patellofemoral joint. The degree of knee flexion and activity of the quadriceps are known to influence patellar tracking on the trochlea, but these factors are removed when images are taken with the patient supine.

Some have tried to simulate weight bearing in a CT scanner by custom designing a rig to apply longitudinal  load  through  the  patient  for  imaging  of  the  spine or  lower  extremity. These  methods  are  at worst,  a  poor depiction  of  functional  anatomy;  and  at  best , a cumbersome  and a less-than-accurate simulation of function.

Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo undertake study

Myself and other researchers from the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo are currently performing research on a new  cone  beam CT scanner,  the  CARESTREAM OnSight  3D  Extremity  System,  developed by Carestream Health. The system is designed to offer high-quality, portable,  low-dose  3D  point-of­ care imaging by orthopaedic and sports medicine practices, hospitals, imaging centers, urgent care facilities, and other healthcare providers.

We have been performing institutional IRB-approved clinical trials and basic sciences studies with the prototype model. These studies are being carried out at the Erie County Medical Center, Buffalo’s regional orthopedic tertiary care facility. Based on early data, we are convinced that many imaging studies should be acquired with subjects in positions that represent true human function, such as weight bearing on the lower extremities.

Comparing Carestream OnSight 3D Extremity System to predicate devices

We compared the 2D imaging performance of the CARESTREAM OnSight 3D  Extremity System to the predicate CARESTREAM DRX-1 Detector used with the CARESTREAM DRX-Evolution System. We compared the 3D volumetric imaging performance of the OnSight system to a multiple detector computed  tomography (MDCT) scanner  (“predicate device”). The purpose of the study was to demonstrate equivalent diagnostic  image quality between the investigational and predicate devices, using a Radlex subjective quality rating scale.

The evaluation was performed on equal numbers of knees, ankles, feet, elbows, and hands from 33 cadaveric human specimens and 13 living human subjects. Four independent, board-certified radiologists of varying general reading experience performed evaluations of the images/exams captured using both the investigational and predicate devices.

Results: OnSight 3D Extremity System produced 2D images with equivalent diagnostic image quality to predicate system

In summary, the CBCT system produced 2D images with equivalent diagnostic image quality to the predicate system for a range of exams, and 3D images were rated equal or better when compared to the predicate device for a range of exams on cadaveric specimens and human subjects.

  • More than 80% of all the 2D images were rated diagnostic or exemplary, whereas approximately 98% of all 3D images were rated diagnostic or exemplary.
  • More than 75% of all Radlex rating responses counted for all 2D images were rated equivalent or favored the investigational device.
  • Approximately 85% of the Radlex rating responses counted for the 3D images were rated equivalent or favored the investigational device.

Examples of representative scans are seen below.

2D and 3D orthopaedic renderings generated by the CBCT scanner

Figure 5: 2D and 3D renderings generated by the CBCT scanner

Our conclusion from this study is that for cases of patella instability, it may be desirable to obtain images while the patient is weight bearing on a flexed knee with their quadriceps muscles active. Improvement in objective measures of patella alignment should lead to improved clinical and surgical care of patients with this condition.

New study: comparing measures of ankle stability

A second clinical study is currently under way to take advantage of the unit’s ability to obtain images in weight bearing. The research will compare measures of ankle stability from the investigational weight-bearing cone beam computed tomography scanner to the same measures on gravity stress X-ray in patients who have supination-external rotation ankle fractures.

These and future studies may validate the value of the OnSight 3D Extremity System. Potential benefits include better quality images with a lower radiation dose than conventional computed tomography. The unit is proposed for use in orthopedic offices, but it might have applications to the operating room or at athletic competition sites. The unit is less expensive than a traditional in-hospital or radiology center CT scanner, and can be used with existing electrical systems (220V). Most important however, is the potential to acquire images while bearing weight and in more functionally relevant positions.

Editor’s note: The CARESTREAM OnSight 3D Extremity System received FDA 510(k) clearance in September 2016 and is available for order in the United States.

Dr. John Marzo, UBMD

Dr. John Marzo is a physician with UBMD Orthopaedics & Sports Medicine, Associate Professor of Clinical Orthopaedics, Jacobs School  of  Medicine  and  Biomedical  Sciences,  University at Buffalo and  former  Medical  Director,  Buffalo Bills. He is also a member of Carestream’s Advisory Group, a collective of medical professionals that advises the company on healthcare IT trends.

Diagnostic Reading #33: Five “Must Read” Articles on HIT and Radiology

The role of imaging in stress tests and MTBI; and the cost of health IT are in the news

Articles include: zero-gravity treadmills beneficial for stress tests; plans that don’t require pre-authorization for radiology imaging are a worst-case scenario; a type of MRI might be effective in assessing mild traumatic brain injury (MTBI); healthcare IT systems and technology cost physicians anRunning on treadmill average of $32,000 a year; and seniors are not embracing digital technology for healthcare management.

Study uses NASA technology for heart health tests – Health Imaging

A new study could give physicians a better understanding of patients’ cardiac health. To combat the burden that traditional treadmill exercise places on patients, physicians are using zero-gravity treadmills in stress tests. The treadmills can reduce patients’ weight by 25 to 50 percent, making it much more comfortable for them to walk for the amount of time necessary to reach a stress test-level heart rate. Then doctors can use normal imaging techniques to take pictures of the heart and its blood supply to determine the patient’s condition.

How to improve patient care and get paid for it too – Health Imaging

It’s a paradox. Procedures listed by payers as “no pre-authorization required” are among the most commonly denied for payment after they’ve been completed. Part of the problem is the general unwillingness of payers to authorize procedures they’ve listed this way. The radiology stakeholders on the short end of this stick include referring physicians along with patients and radiology services providers.

Imaging Predicts Long-Term Effects in Veterans With Brain Injury – Radiology Today

A type of MRI – diffusion tensor imaging (DTI) – might be able to predict post-deployment outcomes for veterans who sustained mild traumatic brain injury (MTBI) or a concussion during combat, according to a study. Current assessment of MTBI remains challenging due to the difficulties in separating the effects of MTBI from other conditions like post-traumatic stress disorder. DTI uses measurements of water movement in the brain to detect abnormalities, particularly in white matter. Previous studies have linked DTI metrics to neurocognitive function and short-term functional outcomes in groups of patients

Health IT now costs $32,000 per doctor, annually – DotMed Healthcare Business News

A new survey reveals that the move to digitization costs more than $32,000 per doctor per year. Physician-owned multispecialty practices spent more than $32,500 per full-time physician on information technology equipment, staff, maintenance and other related expenses in 2015. That’s a whopping 40 percent bump up for IT costs for doctors since 2009 – the last year before new regulations ushered healthcare into the digital era.

Digital health technology not popular among seniors – Health Data Management

Seniors might be the sickest, most expensive and fastest growing segment of the U.S. healthcare population, but they are not embracing digital technology for healthcare management. A new study of Medicare beneficiaries over age 65 is underway to gather data about how seniors are using digital health.

#HIT #Radres

Diagnostic Reading #17: Five “Must Read” Articles

Health imaging, contact sports and patient engagement are in the spotlight

This week’s articles include: a radiologist spearheads improvements at a Texas hospital; measurable changes can occur inside young athletes’ brains in a single season of contact sports; patient engagement is becoming essential to getting maximum payment for services; a study reports that one-third of radiology recommendations went unacknowledged at a Boston facility; and admissions growth for U.S. hospitals is unlikely to be repeated in 2016.

How radiologists can lead the way in healthcare quality improvement – Health Imaging

When quality improvement efforts at the Baylor College of Medicine stalled out due to multiple staffing disruptions and a general lack of coordination, it was a radiologist who took the challenge head-on, according to Emily Sedgwick, MD, an assistant professor and author of a recent article in the Journal of the American College of Radiology.

Changes to brain cells measurable after one season of high school football – Health Imaging Carestream-head-trauma

A single season spent playing contact sports is all it takes for measurable changes to occur inside young athletes’ brains, according to results of a study recently published in the Journal of Neurotrauma. Researchers from the University of Texas Southwestern Medical Center in Dallas used helmets capable of recording data related to head impacts, then used MRI and diffusional kurtosis imaging to measure changes in neural cellular structures. They found that even when no concussion occurs, athletes experience neurological changes at the cellular level after just one season. Continue reading

Overcoming Limitations of CT for Orthopaedic Imaging of Extremities

Weight-bearing images show pathologies more clearly

Musculoskeletal and orthopaedic disorders are without prejudice. They plague the sports professional, the weekend athlete and even sedentary office workers.

According to the United States Bone and Joint Initiative, 77% (65.8 million) of all injury health care visits are for musculoskeletal injuries. And OSHA estimates that work-related musculoskeletal disorders in the United States account for over 600,000 injuries and illnesses. The injuries can cause pain, limit activities and require surgical repair and/or physical therapy.

Imaging the extent of these injuries, ranging from carpal tunnel to meniscus loss, has been challenging. The reason: traditional computed tomography (CT) has a significant limitation. It requires multiple rotations –and it cannot capture a weight-bearinCarestream OnSight 3D Extremity Systemg image. However, new cone beam CT (CBCT) technology from Carestream removes these restrictions. The CARESTREAM OnSight 3D Extremity System, designed to offer high-quality, low-dose 3D point-of-care imaging  by orthopedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers.CBCT, first described in the late 1970s, is a variant of traditional computed tomography. The main difference between the two approaches is the volume of the object that is imaged at one time. In traditional CT, a narrow slice of the patient is imaged with a “fan beam” of X-rays. For an extended volume of the anatomy via CT, the patient must be imaged multiple times through the fan of X-rays as it rotates. In contrast, in CBCT, a large-area detector images an extended volume of the patient in a single rotation, reducing the complexity of the mechanical design of the system.

Continue reading

Diagnostic Reading #15: Five “Must Read” Articles on Brain Injuries in the NFL and Healthcare Data from the Past Week

Unstructured data and radiologists’ adoption of technology are in the news

 

This week’s articles on #healthcare data and #radiology include: more than 40% of retired #NFL players might have traumatic brain injuries; 80% of big health data is unstructured and “invisible” to healthcare organizations; scientists are gaining unprecedented tools for understanding the genetic roots of cancer; engaging radiologists is key to a successful standardized structured reporting program; and efforts are underway to make customer relationship management a central component in the population health ecosystem.

Imaging study: More than 40% of retired NFL players may have traumatic brain injuries – HealthBrain injuries Imaging

Nearly half of retired National Football League players might suffer from traumatic brain injuries, according to re
sults of a diffusion tensor imaging study scheduled to be presented at the annual meeting of the American Academy of Neurology in Vancouver, Canada.

Providers need new tools to make sense of unstructured data – Health Data Management

Healthcare is being inundated with a deluge of big health data, 80 percent of which are invisible to current computing systems because the data are unstructured, according to IBM. Unstructured data includes doctors’ notes, wearables, X-rays, social media, the weather, sensors and sound.

Continue reading

X-rays and Mom — Case Study into the State of Imaging Technology

Reposted from Imaging Technology News (ITN) with permission.

While I write a lot about medical imaging technology and how new technology can and should work, it is not often that I get to experience how things actually work in the real world. This past Thanksgiving I received a call from a paramedic explaining that my mom had fractured her leg and I should stop working on the turkey and fixings and rush to the emergency department (ED) at Edward Hospital in Naperville, Ill. She had been walking her dog on wet grass and leaves in a park when her dog took off after another dog and pulled her down. She was whipped around and the change in weight caused her to dislocate her ankle (the bottom of her shoe was facing her when she looked at her feet) and caused a spiral fracture to her fibula.

ImagingTechnologyNews December-2015 X-ray_Fractured_fibula_with_permission_of_patient_MF

A bedside screen shot of a Carestream DRX mobile X-ray in the ED of the fractured fibula.

When I got there my mom was already heavily sedated due to the pain and because the ED staff had already put her ankle back in place. The ED doctor ordered a digital radiograph (DR) of her leg to see the extent of damage. They wheeled in a new Carestream DRX mobile X-ray system and I had a live demonstration of how fast these types of systems can snap the pictures. It called up the images immediately on the machine’s screen. The image of the Pott’s fracture with fragments was really interesting as someone who covers radiology, but I also realized from a non-clinical standpoint she was really messed up and in pain. Additionally, she would need reconstructive surgery to put her Humpty Dumpty leg back together again. She was way up the creek without a paddle with it being Thanksgiving and there were no orthopedic surgeons in staff due to the holiday. The day after Thanksgiving was not much better, as we found, since most physicians were out through the following Monday. So the ER splinted the leg, wrapped it in ace bandages and sent her home with heavy pain killers.

Compounding her mobility issues was the fact that she has bilateral knee replacements. Due to the trauma, broken bone and knowing she had these implants that further limited her ability to move around, she was prescribed a prophylactic anticoagulant.

Knowing we would need the images for a surgeon to review, I had the ED burn a CD. However, I was happy to find

ITN NEWS Orthopedic_Surgery_repair_of_Broken_fibula_with_permission_of_patient_MF_0

The post-surgical X-ray showing the bone repair, which was accessed and copied by the patient using a patient portal.

Edward is among the growing number of hospitals to grant patients access to their health records via a DR Systems Internet image/results distribution system. This technology pulls images and reports from the hospitals’ Epic EMR (electronic medical record) system and makes them available for remote viewing by clinicians outside of the hospital’s picture archiving and communication system (PACS). She also was given login instructions at discharge for a patient portal so she could access her records and images herself on a home computer or smartphone.

We managed to find one orthopedic surgeon in their office on the Friday after Thanksgiving. They thought it was great that we had a CD, but before attempting to open it, they asked which hospital she had been at. Edward was already in a health information exchange, so outlying offices such as this one from a different medical group could access her records remotely in less than a minute. They were able to call up her images and see what meds she was prescribed, which made the office visit go much faster.

She had surgery on Dec. 1, the Tuesday of RSNA 2015. The orthopedic surgeon practiced at Elmhurst Hospital in Elmhurst, Ill., across the county from Naperville. But, thanks to the remote image viewing system, they could get the ED images for reference and planning. The surgeon’s post-surgery DR image showing the reconstruction of the fibula also was available via my mom’s patient portal.

She did what most patients today do with this type of access and posted her X-rays on Facebook. Leveraging the Facebook form of patient engagement, the result was lots of sympathy, flowers and friends volunteering to help her with things around the house and groceries since she cannot walk or drive for at least two months.

While an unfortunate incident and a horrible thing to have happen to my mom, from a professional standpoint, I was happy to see the technology I cover working in the real world as it was intended. The speed in workflow efficiency, speed and ease of access to her imaging at the point of care and remotely, and access to a patient portal are all examples of how the healthcare system should work. In this case, the technology and imaging integration was flawless.

David_FDave Fornell, ITN Editor

Dave Fornell is the editor of Diagnostic & Interventional Cardiology magazine and assistant editor for Imaging Technology News magazine.

 


Imaging Case Study: Carestream Mobile DRX-Revolution

 

To learn more about the CARESTREAM DRX-Revolution, click here.

Sports Medicine Enhancing Care for Amateur and Professional Athletes

Carestream Sports MedicineMany young football players dream of playing in the NFL. My dream was to work for an NFL team and care for the medical needs of these skilled athletes.

Anyone who has watched an NFL game has seen the elite athleticism—and its potential for injuries. Our job as athletic trainers is to help prevent, evaluate and treat conditions ranging from concussions to soft tissue sprains and strains, fractures/dislocations and internal injuries. We also care for our share of chronic conditions.

A Carestream digital X-ray system at Lambeau Field can deliver excellent images in seconds. Our staff provides these images to our team physicians and other specialists who diagnose the injury and determine whether a player can return to the “action” or is in need of further evaluation or urgent care.

Many spectators don’t realize the medical expertise that is available on the sideline for every game—which includes orthopaedists, internal medicine specialists, neurosurgeons, emergency room physicians and neuropsychologists. These experts can view images on the sideline using their iPads and make critically important medical treatment decisions in seconds.

As athletic trainers, game days are just a small aspect of our weekly routine. We monitor our players’ healthcare all year—from the last whistle of the season through the off-season program and back through another long season. We work closely with our physicians to provide optimal and personalized care for each player. Using baseline concussion testing, body composition and multiple physical exams, we are always on the lookout for conditions and injuries that may not present immediate symptoms.

Every year athletic training and physical therapy professionals are exposed to the latest imaging, diagnostic and treatment technologies that can help enhance patient care. We are seeing a tremendous growth in the number of individuals who pursue these careers, which will help enhance the health of amateur to professional athletes for years to come.

Pepper Burress, Green Bay PackersPepper Burruss was named Director of Sports Medicine Administration for the Green Bay Packers in June. He was the team’s Head Athletic Trainer for 22 years and is a Certified Athletic Trainer and Physical Therapist. He also worked for 16 seasons with the New York Jets as an Assistant Athletic Trainer. Burruss has won several awards during his career, including being honored as the NFL Physicians Society’s Outstanding NFL Athletic Trainer for the 2012 season. In 2011, he and his staff were named the NFL’s Athletic Training Staff of the Year.

A Medical Imaging Revolution at Okinawa Churaumi Aquarium

By Tomoki Oka, Manager, X-ray Systems Business, Japan, Carestream

日本語版はここで読むことができます。

The DRX-Revolution has been visiting and capturing images of some new patients in Japan at Ocean Expo Park, Okinawa Churaumi Aquarium.

Ocean Expo Park houses the aquarium and is a national government park located on the site of the Okinawa International  Ocean Exposition held in 1975. The aquarium, located within the park, is one of the most popular tourist spots in Okinawa. It is home to approximately 740 different species and 21,000 marine life that inhabit the sea around Okinawa.

Animal Management Team Sub-Leader Keiichi Ueda, is one of two veterinarians at the aquarium, and is responsible for the health and physical status of the animals. In an interview,  Vet Ueda explains the differences of human care in a hospital versus animal care in the aquarium—particularly that they have to take the animals out of the water for an extended period of time, and in the case of x-rays, the exposure dose is different and time must also be considered.

With some animals being quite large, the facility required x-ray equipment that would be able to capture high-quality images of the animals, capture multiple images without using different cassettes, and also provide enough radiation dose so image quality would not be compromised.

In the interview, Fish Team Chief Technician Makio Yanagisawa, says, “Because the Revolution can be used to expose continuous radiographic images of dolphins without having to place and change the cassettes under them each time, it is much easier to use when compared with the previous types of analog film that had to be developed after each exposure.”

Additionally, their work environment is much different than that of a hospital. There are no hallways, several small hills, and rougher terrain that can make pushing and pulling equipment more difficult.  Vet Yanagisawa found the ease of use with the DRX-Revolution to be valuable in helping to move and maneuver around the facility.

The video below shows the DRX-Revolution in action at Okinawa Churaumi Aquarium, and includes in-depth interviews with the aquarium’s medical staff.