What is the FDA Approval Process for Medical Devices?

FDA approval process for medical imaging devices helps ensure safety and efficacy of products

Image of FDA approval on Carestream products

FDA review helps ensure safety and efficacy of medical imaging devices

Carolyn L. Wagner, Carestream Health

As we introduce new solutions for radiology and health IT, we are often asked, “What is the FDA approval process for medical devices?”

The purpose of the US Food and Drug Administration (FDA) is to ensure the safety and efficacy of products that are used in the diagnosis and treatment of a wide variety of medical conditions, including products for diagnostic medical imaging.

The US FDA has three different classifications for medical devices based on the level of control deemed necessary to assure the safety and effectiveness of a device. Class 1 devices require the least amount of oversight by the FDA.  Class 3 devices are held to the strictest controls that the FDA has defined. Only Class 2 and Class 3 medical devices require FDA clearance or approval (respectively) prior to being marketed in the US. Continue reading

Baystate Health’s Regional HIE Invites Outside Providers to Participate to Help Enhance Patient Care

Integrating clinical information supports the needs of the community

Neil R. Kudler, MD,  Baystate Health

Baystate Health is an integrated delivery network (IDN) that includes five hospitals and more than 90 primary and specialty care practices serving a region of western Massachusetts with 800,000 residents. We know that patients who are coming to our facilities are also visiting other facilities outside of our network. As a result, they might be at risk of receiving duplicate procedures and imaging exams.Exchanging information to enhance patient care

To address these concerns and to enhance patient care, we spent several million dollars to expand our electronic health record (EHR) into a regional health information exchange (HIE). We then invited hospitals and physician groups outside our network to participate at no cost to make our HIE both attractive and more effective.

Starting with an electronic medical record (EMR) and associated applications that provide demographic, claim and coding data, we built a clinical data repository that integrates and aggregates clinical information from Baystate entities and facilitates interfaces with disparate data sources from other organizations and their EMRs. Our platform addresses the challenge of standardizing the proprietary code language and data sets from the various EMR platforms to create a comprehensive view of patient health information.

Continue reading

A New Ultrasound System Design to Support HAI Reduction Programs and Infection Control

Carestream Touch Prime and XE Systems offer sealed control panel for easy cleaning

Jack Rozner , Carestream Health


Healthcare-associated infections (HAIs) are once again grabbing headlines.  In December Kaiser Health News image_Touch_Prime_PIU_10_hiresreported, “Medicare Penalizes 758 Hospitals For Safety Incidents.” The following month, The Osgood File on CBS Radio News aired a segment on “Preventing Infections in Hospitals” urging patients to be more proactive and advocate for themselves during hospital stays. And the CDC Vital Signs March report called on healthcare providers to focus efforts to prevent HAIs in three areas: prevent spread of bacteria between patients; improve antibiotic use; and prevent infections related to surgery or placement of a catheter.

However, it’s not media attention that makes the reduction of HAIs a priority for hospital administrators and staff – it’s the threat to patients and the hospital’s financial health.

Continue reading

Diagnostic Reading #9: Five Must-Read Articles From the Past Week

This week’s articles include: the limitations and applications of mobile devices in radiology; three things CIOs can learn from radiology analytics; how vendor neutral archives can reduce duplicate imaging exams; patients increased trust in the security of EHRs; and a study on communication errors within the radiology department.Doctors in Radiology Department

Analytics can illustrate radiology’s value to the healthcare enterprise. Radiology has a meaningful contribution to make within the context of value-based care. And artificial intelligence may transform the practice of radiology in the future. CIOs also need to understand the workflow of radiologists, and varying amounts of time required to read different types of exams. Continue reading

Diagnostic Reading #21: Five Must Read Articles from the Past Week

Carestream logoIt’s Friday, which means it is time for a new Diagnostic Reading. This weeks edition includes cybersecurity, ethics in radiology, patient safety, Meaningful Use and EHRs and tips on reading ultrasounds.

1) 6 Steps Healthcare Groups Must Take in Response to a Security Hack– Fierce Health

This article discusses the importance of security when it comes to big data. The author gives tips on how to handle a security breach if it does happen. The steps are to establish a response team, investigate the event, stop the harm, know if it’s a breach, notify those impacted and go back to risk analysis.

2) The Ethical Radiologist– Diagnostic Imaging

In the evolving field of radiology, ethical practice is becoming a higher priority. The author of this article talks about the importance of ethics and how to implement ethical behavior in your practice, touching on establishing a code of ethics, what to do when facing challenges, and how ethics are policed in radiology.

3) Patients Want Information About Radiation Risk– Aunt Minnie

A study conducted by Radiology indicated that patients would like information on the health risks of radiation. The study found that these patients would rather hear this information from physicians than radiologists. This article talks about the importance of communicating with physicians about these risks in order to insure better patient care.

4) Stage 3 Proposal Embraces Open API Movement– Healthcare Informatics

This article touches on the new standards of Meaningful Use Stage 3. In the proposal, the CMS stated that application programming interfaces (API) would be an effective gateway to interoperability. These APIs can be third party applications and may be seen as more accessible than typical patient portals.

5) Ultrasound Exams Present Interpretation Challenges– Aunt Minnie

Sonography is rapidly growing due to its versatility and real-time imaging. With the growth of the ultrasound field, it is important to accurately read images, as well as learn how to read difficult images.

Diagnostic Reading #17: Five Must Read Articles from the Past Week

Carestream logoThis Friday’s Diagnostic Reading includes articles from a busy week in radiology and health IT news. Topics this week include, the FDA and electronic medical records, improving patient safety, radiology IT downtime, outpatient imaging quality, and data security.

1) FDA Calls it Quits on Regulating Medical Device Data Systems– Radiology Business

The FDA has determined that technologies that receive, store or display data from medical devices do not need to be regulated. These medical device data systems are classified as Class I, which means they are low risk devices. The FDA noted that these devices are more important than ever and lifting regulations would be beneficial to achieving interoperability in healthcare systems.

2) Competing Hospitals Work Together to Share Data, Improve Patient Safety– FierceHealthcare

This article highlights the success that hospitals have had when collaborating to improve patient safety. From 2012 until 2015, a network of over 80 hospitals reduced serious safety occurrences in children by 70%. Hospital administrators note that safety is not a point of competition, but a necessity for every healthcare system.

3) Radiology IT Downtimes are Common, but Not Usually Serious– AuntMinnie

A study by the Journal of the American College of Radiology found that the use of several disparate machines and systems can cause downtime due to losing connection with each other. However, the study found that most IT issues can be dealt with in a timely manner and only 3% were considered to have a severe impact.

4) Outpatient imaging: Assessing the Performance of U.S. Hospitals– Health Imaging

Quality and efficiency are becoming points of emphasis in the imaging field. This article addresses the Hospital Outpatient Quality Reporting Program (OQR). The OQR is an incentive program that looks at the efficiency of healthcare systems when ordering certain imaging procedures. The author argues that it might be time for a new metric system—one that is better able to determine the quality of imaging.

5) Data Breach: What’s at Stake for Hospitals-Radiology Today

Thirty million patient records have been exposed through data breaches since 2009. While it is of utmost concern to eliminate data breaches, this article discusses important information for hospitals after experiencing a breach. Topics include notification requirements, financial repercussions and regaining patient trust.

Diagnostic Reading #5: Five Must-Read Articles from the Past Week

Carestream Booth at RSNA 2014

Carestream booth at RSNA 2014 in Chicago.

This week’s Diagnostic Readings include findings that were presented at the RSNA conference over the past week. Ultrasound training, radiation safety and health technology are some topics that were prevalent at RSNA.

1) Radiologists Must Play Central Role in Point-of-Care Ultrasound Training

With the adoption of ultrasound technology across the radiology industry, it is becoming a necessity to train medical professionals. David Bahner, MD, and Brian D. Coley, MD, discuss how radiologists need to step up and ensure that patients are getting proper care. Additionally, the presenters express the need to provide better ultrasound training in medical schools.

2) Radiologists Across the World Need to Lead the Way in Radiation Safety

With few new technologies in the radiology field, imaging safety has become a point of emphasis. Radiologists from across the world met at RSNA to talk about ways to make radiology a safer field. Dose reduction, education and appropriate use are a few of the topics that are addressed.

3) Integrating Radiology, Pathology Would Improve Diagnostics, Aid Patients

Developing channels for radiologists and pathologists to exchange patient information could lead to better patient care. Professionals from both fields have begun to discuss the most efficient ways to exchange templates. Radiology has been moving towards implementing standardized templates that mirror those of pathologists.

4) Many Chest Radiographs in Children Unnecessary

A study presented by Mayo Clinic at RSNA found that 88% of chest x-rays performed on children did not alter patient care. Reducing the amount of unnecessary x-rays could also reduce dose and cost.

5) Patients Like Accessing Imaging Records

According to a study presented by Mount Sinai School of Medicine, 96% of patients responded positively to receiving their images through a web-based interoperable system. This shows the benefit that comes from having available patient portals and enhancing patient engagement in medical care.

FDA Regulations Benefit the Medical Profession and Improve Patient Care

The U.S. Food and Drug Administration (FDA) branch named the “Center for Devices and Radiologic Health” regulates manufacturers, distributors and importers of medical devices.  Carestream Health follows FDA regulations and guidance relating to the design, manufacture, distribution, servicing and maintenance of its products. In addition, many of Carestream’s products are subject to FDA review for safety and effectiveness prior to receiving permission to market those products in the United States.

FDA  “Center for Devices and Radiologic Health”

The FDA’s “Center for Devices and Radiologic Health” branch regulates manufacturers, distributors and importers of medical devices.

Premarket submissions to the FDA include:

  • Various administrative documents.
  • Evidence that the product performs in a safe and effective manner.
  • In most cases, clinical evidence of the product’s performance must be gathered, analyzed and submitted to demonstrate safety and effectiveness of the device to the FDA reviewer.
  • Evidence that the product was designed and validated for proper performance against its specifications.
  • User documentation to ensure that users of the product are provided with adequate instructions for operating the device.
  • Depending on the level of regulatory control for a particular product, inspection of the manufacturing operation by the FDA may also be required prior to gaining approval to market a device.

Compliance with FDA regulation and guidance is a benefit to our customers and ultimately to the patients whose medical care is aided by the use of our products. Carestream has established and maintains a quality system for the medical devices it manufactures. This quality system consists of procedures and guidelines that are in accordance with the requirements put in place by the FDA. Some requirements apply generally to all devices and some are specific to the types of devices we produce (i.e. radiation emitting devices). The purpose of these requirements is to ensure that every stage of product design, manufacture, distribution, installation and servicing is structured and completed in compliance with processes proven to result in high-quality, safe and effective products.

FDA requirements are not limited to the design, production and sale of the medical device to the customer. As a manufacturer of medical devices, Carestream also maintains established procedures for installing and servicing its products at customer sites. These procedures must be documented, validated and controlled to ensure that the products are properly serviced and maintained.

Procedures are in place to ensure that any complaints or issues reported to us about our products are properly addressed and corrected in a timely manner. Any issues that could impact safety or effectiveness of the device are documented and considered in the ongoing analysis and mitigation of any risks associated with the device.

Carestream is dedicated to ensuring customer satisfaction and improving patient care.  Embracing FDA regulations is one way we continue to provide the medical profession with innovative, well-designed, high-quality products that benefit healthcare providers and the patients they serve.

Do Carestream medical imaging systems aid in the delivery of care at your facility? Are you satisfied with Carestream’s level of service and support? 

Carolyn L. Wagner Regulatory Affairs Manager, X-ray Solutions, CarestreamCarolyn L. Wagner is the Regulatory Affairs Manager for the X-ray Solutions business at Carestream.

Dose Efficiency and Reduction Remain Vital Issues in 2014

Helen Titus

Helen Titus, Marketing Director, X-ray Solutions, Carestream

In 2014, the phrase “safe imaging” means more now than ever. Across the world we are seeing organizations and governments working to ensure that patients are kept safe while simultaneously ensuring that imaging quality is not compromised.

At ECR 2014, we saw the launch of EuroSafe Imaging, which works to improve safe imaging practices across Europe. In the U.S., the Image Gently campaign created by the Society of Pediatric Radiology has been a powerful movement in the U.S.’s pediatric medical imaging sector.

Now as we move toward the halfway point of 2014 we are about to see updated standards for diagnostic imaging. The Joint Commission announced these new standards at the end of 2013 and they will go into effect on July 1, 2014. Additionally, a second round of accreditation announcements will be phased in by 2015.

According to the Joint Commission, new areas addressed in the standards are:

Society of Pediatric Radiology official logo

The Society of Pediatric Radiology (SPR) has taken great measures to educate the medical imaging industry about the importance of safe imaging.

  • Minimum competency for radiology technologists, including registration and certification by July 1, 2015
  • Annual performance evaluations of imaging equipment by a medical physicist
  • Documentation of CT radiation dose in the patient’s clinical record
  • Meeting the needs of the pediatric population through imaging protocols and considering patient size or body habitus when establishing imaging protocols
  • Management of safety risks in the MRI environment
  • Collection of data on incidents where pre-identified radiation dose limits have been exceeded

Even with these updates to standards and creation of mission-oriented organizations there are those arguing that there is not enough being done for radiation safety.

This study conducted at Emory University’s School of Medicine says it all:

“Even though the residents believed there to be a link between radiation exposure and cancer, many of them–including radiology residents–couldn’t demonstrate knowledge related to specific estimated dose effects. For example, just 22 percent of the residents surveyed (and only 29 percent of radiology residents) could estimate the lifetime risk of cancer mortality from a single abdominal CT scan in pediatric patients.” – April 19, 2014, Mike Bassett, FierceMedicalImaging

If we are to see improvements made in radiation safety, while also providing quality imaging service to patients for the most effective care, then it all starts with education—both current and tomorrow’s radiologists. As we move forward in 2014, we must embrace the standards put in place that keep patients safe and work to stay up-to-date about why safe imaging is so valuable to our profession. It improves the radiology profession, the technologies used in medical facilities, and the care provided to the patient.

ESR’S EuroSafe Imaging: Supporting & Strengthening Medical Radiation Protection

Rich Pulvino, Digital Media Specialist, Carestream

Rich Pulvino, Digital Media Specialist, Carestream

ECR 2014 is hardly a day old and ESR has already made a splash with its new initiative, EuroSafe Imaging–a mission “to support and strengthen medical radiation protection across Europe following a holistic, inclusive approach.”

The necessity for this organization stems from the fact that cumulative patient radiation doses have reached levels never seen before, and these levels have resulted in cases of overexposure. Much of this exposure has come from computed tomography (CT) and its overuse in the medical imaging environment. Thanks to the evolution of technology, CT is now heading in the direction of becoming a simple radiograph, such as a chest X-ray.

With its mission in place, EuroSafe Imaging is currently in the process of creating a steering committee and has already taken part in projects in the area of medical radiation protection. The ESR has already worked with numerous organizations around the world on this topic. Projects with organizations such as the World Health Organization (WHO), the United Nations Scientific Commission on the Effects of Atomic Radiation (UNSCEAR), and the International Commission on Radiological Protection, has resulted in motivating countries to translate guidelines into their own languages, and creating methods to soliciting feedback and providing certification.EuroSafe

Another mission behind Euro Safe Imaging is to educate patients about medical radiation and how it affects them. This accomplished by explaining how everyone is exposed to small levels of radiation on a daily basis. ESR breaks this information down by providing details on how many months/years worth of everyday radiation is included in medical imaging procedures such as chest X-rays, CT, PET/CT, etc.

From these charts, patients can understand the relative harmlessness of a single exam. It becomes the mission of the radiologist to provide the patient with the right medicating imaging procedure, at the appropriate dosage (as low as possible without compromising image quality), while producing the best image possible for proper diagnoses.

Dose efficiency and patient safety have become increasingly common in the medical imaging industry and for good reasons. It is the role of medical professionals to keep patients safe while providing them with excellent care. EuroSafe Imaging from ESR is another excellent example of a professional association taking action to increase awareness and find solutions to this important issue.