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Posts Tagged ‘regulations’


Update on FDA Policy Regarding 3D Bioprinted Material

Curator: Stephen J. Williams, Ph.D.

Last year (2015) in late October the FDA met to finalize a year long process of drafting guidances for bioprinting human tissue and/or medical devices such as orthopedic devices.  This importance of the development of these draft guidances was highlighted in a series of articles below, namely that

  • there were no standards as a manufacturing process
  • use of human tissues and materials could have certain unforseen adverse events associated with the bioprinting process

In the last section of this post a recent presentation by the FDA is given as well as an excellent  pdf here BioprintingGwinnfinal written by a student at University of Kentucky James Gwinn on regulatory concerns of bioprinting.

Bio-Printing Could Be Banned Or Regulated In Two Years

3D Printing News January 30, 2014 No Comments 3dprinterplans

organovaliver

 

 

 

 

 

Cross-section of multi-cellular bioprinted human liver tissue Credit: organovo.com

Bio-printing has been touted as the pinnacle of additive manufacturing and medical science, but what if it might be shut down before it splashes onto the medical scene. Research firm, Gartner Inc believes that the rapid development of bio-printing will spark calls to ban the technology for human and non-human tissue within two years.

A report released by Gartner predicts that the time is drawing near when 3D-bioprinted human organs will be readily available, causing widespread debate. They use an example of 3D printed liver tissue by a San Diego-based company named Organovo.

“At one university, they’re actually using cells from human and non-human organs,” said Pete Basiliere, a Gartner Research Director. “In this example, there was human amniotic fluid, canine smooth muscle cells, and bovine cells all being used. Some may feel those constructs are of concern.”

Bio-printing 

Bio-printing uses extruder needles or inkjet-like printers to lay down rows of living cells. Major challenges still face the technology, such as creating vascular structures to support tissue with oxygen and nutrients. Additionally, creating the connective tissue or scaffolding-like structures to support functional tissue is still a barrier that bio-printing will have to overcome.

Organovo has worked around a number of issues and they hope to print a fully functioning liver for pharmaceutical industry by the end of this year.  “We have achieved thicknesses of greater than 500 microns, and have maintained liver tissue in a fully functional state with native phenotypic behavior for at least 40 days,” said Mike Renard, Organovo’s executive vice president of commercial operations.

clinical trails and testing of organs could take over a decade in the U.S. This is because of the strict rules the U.S. Food and Drug Administration (FDA) places on any new technology. Bio-printing research could outplace regulatory agencies ability to keep up.

“What’s going to happen, in some respects, is the research going on worldwide is outpacing regulatory agencies ability to keep up,” Basiliere said. “3D bio-printing facilities with the ability to print human organs and tissue will advance far faster than general understanding and acceptance of the ramifications of this technology.”

Other companies have been successful with bio-printing as well. Munich-based EnvisionTEC is already selling a printer called a Bioplotter that sells for $188,000 and can print 3D pieces of human tissue. China’s Hangzhou Dianzi University has developed a printer called Regenovo, which printed a small working kidney that lasted four months.

“These initiatives are well-intentioned, but raise a number of questions that remain unanswered. What happens when complex enhanced organs involving nonhuman cells are made? Who will control the ability to produce them? Who will ensure the quality of the resulting organs?” Basiliere said.

Gartner believes demand for bio-printing will explode in 2015, due to a burgeoning population and insufficient levels of healthcare in emerging markets. “The overall success rates of 3D printing use cases in emerging regions will escalate for three main reasons: the increasing ease of access and commoditization of the technology; ROI; and because it simplifies supply chain issues with getting medical devices to these regions,” Basiliere said. “Other primary drivers are a large population base with inadequate access to healthcare in regions often marred by internal conflicts, wars or terrorism.”

It’s interesting to hear Gartner’s bold predictions for bio-printing. Some of the experts we have talked to seem to think bio-printing is further off than many expect, possibly even 20 or 30 years away for fully functioning organs used in transplants on humans. However, less complicated bio-printing procedures and tissue is only a few years away.

 

FDA examining regulations for 3‑D printed medical devices

Renee Eaton Monday, October 27, 2014

fdalogo

The official purpose of a recent FDA-sponsored workshop was “to provide a forum for FDA, medical device manufacturers, additive manufacturing companies and academia to discuss technical challenges and solutions of 3-D printing.” The FDA wants “input to help it determine technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”

Simply put, the FDA is trying to stay current with advanced manufacturing technologies that are revolutionizing patient care and, in some cases, democratizing its availability. When a next-door neighbor can print a medical device in his or her basement, it clearly has many positive and negative implications that need to be considered.

Ignoring the regulatory implications for a moment, the presentations at the workshop were fascinating.

STERIS representative Dr. Bill Brodbeck cautioned that the complex designs and materials now being created with additive manufacturing make sterilization practices challenging. For example, how will the manufacturer know if the implant is sterile or if the agent has been adequately removed? Also, some materials and designs cannot tolerate acids, heat or pressure, making sterilization more difficult.

Dr. Thomas Boland from the University of Texas at El Paso shared his team’s work on 3-D-printed tissues. Using inkjet technology, the researchers are evaluating the variables involved in successfully printing skin. Another bio-printing project being undertaken at Wake Forest by Dr. James Yoo involves constructing bladder-shaped prints using bladder cell biopsies and scaffolding.

Dr. Peter Liacouras at Walter Reed discussed his institution’s practice of using 3-D printing to create surgical guides and custom implants. In another biomedical project, work done at Children’s National Hospital by Drs. Axel Krieger and Laura Olivieri involves the physicians using printed cardiac models to “inform clinical decisions,” i.e. evaluate conditions, plan surgeries and reduce operating time.

As interesting as the presentations were, the subsequent discussions were arguably more important. In an attempt to identify and address all significant impacts of additive manufacturing on medical device production, the subject was organized into preprinting (input), printing (process) and post-printing (output) considerations. Panelists and other stakeholders shared their concerns and viewpoints on each topic in an attempt to inform and persuade FDA decision-makers.

An interesting (but expected) outcome was the relative positions of the various stakeholders. Well-established and large manufacturers proposed validation procedures: material testing, process operating guidelines, quality control, traceability programs, etc. Independent makers argued that this approach would impede, if not eliminate, their ability to provide low-cost prosthetic devices.

Comparing practices to the highly regulated food industry, one can understand and accept the need to adopt similar measures for some additively manufactured medical devices. An implant is going into someone’s body, so the manufacturer needs to evaluate and assure the quality of raw materials, processing procedures and finished product.

But, as in the food industry, this means the producer needs to know the composition of materials. Suppliers cannot hide behind proprietary formulations. If manufacturers are expected to certify that a device is safe, they need to know what ingredients are in the materials they are using.

Many in the industry are also lobbying the FDA to agree that manufacturers should be expected to certify the components and not the additive manufacturing process itself. They argue that what matters is whether the device is safe, not what process was used to make it.

Another distinction should be the product’s risk level. Devices should continue to be classified as I, II or III and that classification, not the process used, should determine its level of regulation.

 

 

Will the FDA Regulate Bioprinting?

Published by Sandra Helsel, May 21, 2014 10:20 am

(3DPrintingChannel) The FDA currently assesses 3D printed medical devices and conventionally made products under the same guidelines, despite the different manufacturing methods involved. To receive device approval, manufacturers must prove that the device is equivalent to a product already on the market for the same use, or the device must undergo the process of attaining pre-market approval. However, the approval process for 3D printed devices could become complicated because the devices are manufactured differently and can be customizable. Two teams at the agency are now trying to determine how approval process should be tweaked to account for the changes.

3D Printing and 3D Bioprinting – Will the FDA Regulate Bioprinting?

This entry was posted by Bill Decker on May 20, 2014 at 8:52 am

3dprintedskin

 

 

 

 

 

VIEW VIDEO

https://www.youtube.com/watch?v=5KY-JZCXKXQ#action=share

 

The 3d printing revolution came to medicine and is making people happy while scaring them at the same time!

3-D printing—the process of making a solid object of any shape from a digital model—has grown increasingly common in recent years, allowing doctors to craft customized devices like hearing aids, dental implants, and surgical instruments. For example, University of Michigan researchers last year used a 3-D laser printer to create an airway splint out of plastic particles. In another case, a patient had 75% of his skull replaced with a 3-D printed implant customized to fit his head. The 3d printing revolution came to medicine and is making people happy while scaring them at the same time!

Printed hearts? Doctors are getting there
FDA currently treats assesses 3-D printed medical devices and conventionally made products under the same guidelines, despite the different manufacturing methods involved. To receive device approval, manufacturers must prove that the device is equivalent to a product already on the market for the same use, or the device must undergo the process of attaining pre-market approval.

“We evaluate all devices, including any that utilize 3-D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used,” FDA spokesperson Susan Laine said.
However, the approval process for 3-D printed devices could become complicated because the devices are manufactured differently and can be customizable. Two teams at the agency now are trying to determine how approval process should be tweaked to account for the changes:

http://product-liability.weil.com/news/the-stuff-of-innovation-3d-bioprinting-and-fdas-possible-reorganization/

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The Stuff of Innovation – 3D Bioprinting and FDA’s Possible Reorganization

Weil Product Liability Monitor on September 10, 2013 ·

Posted in News

Contributing Author: Meghan A. McCaffrey

With 3D printers, what used to exist only in the realm of science fiction — who doesn’t remember the Star Trek food replicator that could materialize a drink or meal with the mere press of a button — is now becoming more widely available with  food on demand, prosthetic devices, tracheal splintsskull implants, and even liver tissue all having recently been printed, used, implanted or consumed.  3D printing, while exciting, also presents a unique hybrid of technology and biology, making it a potentially unique and difficult area to regulate and oversee.  With all of the recent technological advances surround 3D printer technology, the FDA recently announced in a blog post that it too was going 3D, using it to “expand our research efforts and expand our capabilities to review innovative medical products.”  In addition, the agency will be investigating how 3D printing technology impacts medical devices and manufacturing processes.  This will, in turn, raise the additional question of how such technology — one of the goals of which, at least in the medical world,  is to create unique and custom printed devices, tissue and other living organs for use in medical procedures — can be properly evaluated, regulated and monitored.
In medicine, 3D printing is known as “bioprinting,” where so-called bioprinters print cells in liquid or gel format in an attempt to engineer cartilage, bone, skin, blood vessels, and even small pieces of liver and other human tissues [see a recent New York Times article here].  Not to overstate the obvious, but this is truly cutting edge science that could have significant health and safety ramifications for end users.  And more importantly for regulatory purposes, such bioprinting does not fit within the traditional category of a “device” or a “biologic.”  As was noted in Forbes, “more of the products that FDA is tasked with regulating don’t fit into the traditional categories in which FDA has historically divided its work.  Many new medical products transcend boundaries between drugs, devices, and biologics…In such a world, the boundaries between FDA’s different centers may no longer make as much sense.”  To that end, Forbes reported that FDA Commissioner Peggy Hamburg announced Friday the formation of a “Program Alignment Group” at the FDA whose goal is to identify and develop plans “to best adapt to the ongoing rapid changes in the regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs.”

It will be interesting to see if the FDA can retool the agency to make it a more flexible, responsive, and function-specific organization.  In the short term, the FDA has tasked two laboratories in the Office of Science and Engineering Laboratories with investigating how the new 3D technology can impact the safety and efficacy of devices and materials manufactured using the technology.  The Functional Performance and Device Use Laboratory is evaluating “the effect of design changes on the safety and performance of devices when used in different patient populations” while the Laboratory for Solid Mechanics is assessing “how different printing techniques and processes affect the strength and durability of the materials used in medical devices.”  Presumably, all of this information will help the FDA evaluate at some point in the future whether a 3D printed heart is safe and effective for use in the patient population.

In any case, this type of hybrid technology can present a risk for companies and manufacturers creating and using such devices.  It remains to be seen what sort of regulations will be put in place to determine, for example, what types of clinical trials and information will have to be provided before a 3D printer capable of printing a human heart is approved for use by the FDA.  Or even on a different scale, what regulatory hurdles (and on-going monitoring, reporting, and studies) will be required before bioprinted cartilage can be implanted in a patient’s knee.  Are food replicators and holodecks far behind?

http://www.raps.org/regulatory-focus/news/2014/05/19000/FDA-3D-Printing-Guidance-and-Meeting/

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FDA Plans Meeting to Explore Regulation, Medical Uses of 3D Printing Technology

Posted 16 May 2014 By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) plans to soon hold a meeting to discuss the future of regulating medical products made using 3D printing techniques, it has announced.

fdaplanstomeetbioprinting

Background

3D printing is a manufacturing process which layers printed materials on top of one another, creating three-dimensional parts (as opposed to injection molding or routing materials).

The manufacturing method has recently come into vogue with hobbyists, who have been driven by several factors only likely to accelerate in the near future:

  • The cost of 3D printers has come down considerably.
  • Electronic files which automate the printing process are shareable over the Internet, allowing anyone with the sufficient raw materials to build a part.
  • The technology behind 3D printing is becoming more advanced, allowing for the manufacture of increasingly durable parts.

While the technology has some alarming components—the manufacture of untraceable weapons, for example—it’s increasingly being looked at as the future source of medical product innovation, and in particular for medical devices like prosthetics.

Promise and Problems

But while 3D printing holds promise for patients, it poses immense challenges for regulators, who must assess how to—or whether to—regulate the burgeoning sector.

In a recent FDA Voice blog posting, FDA regulators noted that 3D-printed medical devices have already been used in FDA-cleared clinical interventions, and that it expects more devices to emerge in the future.

Already, FDA’s Office of Science and Engineering laboratories are working to investigate how the technology will affect the future of device manufacturing, and CDRH’s Functional Performance and Device Use Laboratory is developing and adapting computer modeling methods to help determine how small design changes could affect the safety of a device. And at the Laboratory for Solid Mechanics, FDA said it is investigating the materials used in the printing process and how those might affect durability and strength of building materials.

And as Focus noted in August 2013, there are myriad regulatory challenges to confront as well. For example: If a 3D printer makes a medical device, will that device be considered adulterated since it was not manufactured under Quality System Regulation-compliant conditions? Would each device be required to be registered with FDA? And would FDA treat shared design files as unauthorized promotion if they failed to make proper note of the device’s benefits and risks? What happens if a device was never cleared or approved by FDA?

The difficulties for FDA are seemingly endless.

Plans for a Guidance Document

But there have been indications that FDA has been thinking about this issue extensively.

In September 2013, Focus first reported that CDRH Director Jeffery Shuren was planning to release a guidance on 3D printing in “less than two years.”

Responding to Focus, Shuren said the guidance would be primarily focused on the “manufacturing side,” and probably on how 3D printing occurs and the materials used rather than some of the loftier questions posed above.

“What you’re making, and how you’re making it, may have implications for how safe and effective that device is,” he said, explaining how various methods of building materials can lead to various weaknesses or problems.

“Those are the kinds of things we’re working through. ‘What are the considerations to take into account?'”

“We’re not looking to get in the way of 3D printing,” Shuren continued, noting the parallel between 3D printing and personalized medicine. “We’d love to see that.”

Guidance Coming ‘Soon’

In recent weeks there have been indications that the guidance could soon see a public release. Plastics News reported that CDRH’s Benita Dair, deputy director of the Division of Chemistry and Materials Science, said the 3D printing guidance would be announced “soon.”

“In terms of 3-D printing, I think we will soon put out a communication to the public about FDA’s thoughts,” Dair said, according to Plastics News. “We hope to help the market bring new devices to patients and bring them to the United States first. And we hope to play an integral part in that.”

Public Meeting

But FDA has now announced that it may be awaiting public input before it puts out that guidance document. In a 16 May 2014 Federal Register announcement, the agency said it will hold a meeting in October 2014 on the “technical considerations of 3D printing.”

“The purpose of this workshop is to provide a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. The Agency would like input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”

That language—”transparent evaluation process for future submissions”—indicates that at least one level, FDA plans to treat 3D printing no differently than any other medical device, subjecting the products to the same rigorous premarket assessments that many devices now undergo.

FDA’s notice seems to focus on industrial applications for the technology—not individual ones. The agency notes that it has already “begun to receive submissions using additive manufacturing for both traditional and patient-matched devices,” and says it sees “many more on the horizon.”

Among FDA’s chief concerns, it said, are process verification and validation, which are both key parts of the medical device quality manufacturing regulations.

But the notice also indicates that existing guidance documents, such as those specific to medical device types, will still be in effect regardless of the 3D printing guidance.

Discussion Points

FDA’s proposed list of discussion topics include:

  • Preprinting considerations, including but not limited to:
    • material chemistry
    • physical properties
    • recyclability
    • part reproducibility
    • process validation
  • Printing considerations, including but not limited to:
    • printing process characterization
    • software used in the process
    • post-processing steps (hot isostatic pressing, curing)
    • additional machining
  • Post-printing considerations, including but not limited to:
    • cleaning/excess material removal
    • effect of complexity on sterilization and biocompatibility
    • final device mechanics
    • design envelope
    • verification

– See more at: http://www.raps.org/regulatory-focus/news/2014/05/19000/FDA-3D-Printing-Guidance-and-Meeting/#sthash.cDg4Utln.dpuf

 

FDA examining regulations for 3‑D printed medical devices

 

Renee Eaton Monday, October 27, 2014

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The official purpose of a recent FDA-sponsored workshop was “to provide a forum for FDA, medical device manufacturers, additive manufacturing companies and academia to discuss technical challenges and solutions of 3-D printing.” The FDA wants “input to help it determine technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”

Simply put, the FDA is trying to stay current with advanced manufacturing technologies that are revolutionizing patient care and, in some cases, democratizing its availability. When a next-door neighbor can print a medical device in his or her basement, it clearly has many positive and negative implications that need to be considered.

Ignoring the regulatory implications for a moment, the presentations at the workshop were fascinating.

STERIS representative Dr. Bill Brodbeck cautioned that the complex designs and materials now being created with additive manufacturing make sterilization practices challenging. For example, how will the manufacturer know if the implant is sterile or if the agent has been adequately removed? Also, some materials and designs cannot tolerate acids, heat or pressure, making sterilization more difficult.

Dr. Thomas Boland from the University of Texas at El Paso shared his team’s work on 3-D-printed tissues. Using inkjet technology, the researchers are evaluating the variables involved in successfully printing skin. Another bio-printing project being undertaken at Wake Forest by Dr. James Yoo involves constructing bladder-shaped prints using bladder cell biopsies and scaffolding.

Dr. Peter Liacouras at Walter Reed discussed his institution’s practice of using 3-D printing to create surgical guides and custom implants. In another biomedical project, work done at Children’s National Hospital by Drs. Axel Krieger and Laura Olivieri involves the physicians using printed cardiac models to “inform clinical decisions,” i.e. evaluate conditions, plan surgeries and reduce operating time.

As interesting as the presentations were, the subsequent discussions were arguably more important. In an attempt to identify and address all significant impacts of additive manufacturing on medical device production, the subject was organized into preprinting (input), printing (process) and post-printing (output) considerations. Panelists and other stakeholders shared their concerns and viewpoints on each topic in an attempt to inform and persuade FDA decision-makers.

An interesting (but expected) outcome was the relative positions of the various stakeholders. Well-established and large manufacturers proposed validation procedures: material testing, process operating guidelines, quality control, traceability programs, etc. Independent makers argued that this approach would impede, if not eliminate, their ability to provide low-cost prosthetic devices.

Comparing practices to the highly regulated food industry, one can understand and accept the need to adopt similar measures for some additively manufactured medical devices. An implant is going into someone’s body, so the manufacturer needs to evaluate and assure the quality of raw materials, processing procedures and finished product.

But, as in the food industry, this means the producer needs to know the composition of materials. Suppliers cannot hide behind proprietary formulations. If manufacturers are expected to certify that a device is safe, they need to know what ingredients are in the materials they are using.

Many in the industry are also lobbying the FDA to agree that manufacturers should be expected to certify the components and not the additive manufacturing process itself. They argue that what matters is whether the device is safe, not what process was used to make it.

Another distinction should be the product’s risk level. Devices should continue to be classified as I, II or III and that classification, not the process used, should determine its level of regulation.

If you are interested in submitting comments to the FDA on this topic, post them by Nov. 10.

FDA Guidance Summary on 3D BioPrinting

fdaregulationguidelinesfor3dbioprinting_1 fdaregulationguidelinesfor3dbioprinting_2 fdaregulationguidelinesfor3dbioprinting_3 fdaregulationguidelinesfor3dbioprinting_4 fdaregulationguidelinesfor3dbioprinting_5 fdaregulationguidelinesfor3dbioprinting_6 fdaregulationguidelinesfor3dbioprinting_7 fdaregulationguidelinesfor3dbioprinting_8 fdaregulationguidelinesfor3dbioprinting_9 fdaregulationguidelinesfor3dbioprinting_10 fdaregulationguidelinesfor3dbioprinting_11

 

 

 

 

 

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Why should Quality Assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)


Why should Quality Assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)

 Reporter: Dror Nir, PhD

Converting life-science innovations into useful products involves allocation of significant resources to handling of regulatory processes. A typical approach that makes the management of these processes difficult and awkward is starting your project and later patching it with a QA system. It then becomes a source of sever headaches to many people who need to live and operate according to such patch.
I hope that the following post by Rina will inspire you all.
It is all too easy to dive into the list of requirements contained within the ISO 13485 and achieve compliance by just ticking the boxes: looking at one requirement or one area at a time and making sure you have put in place something to address that requirement. This may easily result in a quality system that feels like a patchwork. Compliant, perhaps, but most certainly awkward and difficult to sustain.
The second most common mistake is to not ask yourself how software tools can help in setting up the quality system. “We already have MS Word, MS Excel, email, and we can always print a document and have it signed.” This is only a solution if you think that the quality system is a one-off activity. In the longer run, the system turns out to be a constant struggle with non-integrated elements that have no cohesion.
A better way to address compliance is to:
  1. Accept the fact that the quality system is a long term commitment and that it is very demanding.
  2. Assume that the right software tools do help.
  3. Think strategically, reviewing the whole standard, and try to identify the different areas, in respect to what type of software would help address those.

Real life example: A company maintains an Excel list of all corrective actions. The date of effectiveness check is filled in manually. A QA engineer needs to review the Excel spreadsheet once a week to identify which effectiveness checks are due. Last audit revealed that in most cases, effectiveness checks were not followed up.
Real life question: Meetings and other events are registered in a calendar and you are reminded when they are due. Wouldn’t it be easier if effectiveness checks due dates were also linked to a calendar? Putting those dates in Excel does not make more sense than putting your meetings in Excel…..

What follows is how we can divide the ISO-13485:2003 in regard to the type of software features which can help us. You do not need to be an IT expert to follow the logic or the explanation – if you know the standard and see my examples hopefully you will get the idea.
In any case, I put here the complete mapping of the ISO into the different categories I describe. I also mention the main Atlassian tools we use to address each area. In future posts we will dive deeper into each of those categories and provide more details on exactly how we achieve easy and sustainable, compliance.
So, as promised, these are the various categories that appear in the ISO 13485:2003:
  1. Document management: These are the various requirements relating to the procedures, manuals, and device related documents you need to have, and how they should be handled within the organization. The ISO elaborates in quite a detailed manner about how the controlled documents needs to be approved, who should access them, etc. Confluence is the key tool we use to handle all these requirements.
  2. Procedures and records are the evidence that the organization lives up to its quality system: The various procedures and work instructions should be followed consistently on a daily basis, forms or other records should be collected as evidence. Some examples (with reference to the standard section):
    • Training( 6.2.2).
    • Customer complaints: (8.5.1).
    • Corrective and preventive actions: (8.5.2, 8.5.3)
    • Subcontractor approvals( 7.4.1)
    • Purchasing forms( 7.4.1).

Those records may be created as electronic or physical paper forms which need to be completed by the authorized person. However, a much better way is to implement an automatic workflow that makes it easier for the team to create, follow, and document all the various tasks they need to do. Such a workflow can automatically schedule tasks, remind and alert, thus triggering better compliance to the quality system and at the same time automatically creating the required records. This is a double win. JIRA® is our tool of choice and it provides a state-of-the-art solution to everything related to forms and workflows.

  1. Design control: Some of the issues covered by section 7 of the ISO 13485 require quite advanced control along several phases of design and development. The risk mitigation measures and the product requirements should be, for example, verified in the product verification stage. This verification, or the test file, could be written as a simple Word or Excel document, but a far better implementation is to create it within JIRA. The advantage of JIRA here is the various reporting that it allows once the data is in and the fact that it can connect directly into the work scheduling of the various team members. JIRA is the principal tool we use for design control. Confluence can be used in some advanced implementations. If the medical device involves software, then the development suite from Atlassian can be implemented to provide a complete software life cycle management suite.
  2. Manufacturing and product traceability: Some requirements relate to your manufacturing setup. Depending on the scale and type of manufacturing, specialized ERP may be the best option. When manufacturing is more basic and does not call for a full blown manufacturing facility, JIRA can handle the requirements of the standard.
  3. Monitoring and improving: A key theme of the standard is the need of the organization to measure and improve (for example, section 8.2.3). The nice thing is that the framework we have put in place to support the other categories, if done correctly, should provide us with the reports, alerts, and statistics we need. Indeed, all the processes we have implemented in JIRA, as well as the various elements we have implemented in Confluence, may easily be collected and displayed in practically endless variations of reports and dashboards.
Requirement (Article) Requirement type
4.Quality management system – 1.General requirements Non specific
4.Quality management system – 2.Documentation requirements – 1.General Document management
4.Quality management system – 2.Documentation requirements – 2.Quality manual Document management
4.Quality management system – 2.Documentation requirements – 3.Control of documents Document management
4.Quality management system – 2.Documentation requirements – 4.Control of records Procedures and records
5.Management responsibility – 1.Management commitment Document management
5.Management responsibility – 2.Customer focus Non specific
5.Management responsibility – 3.Quality policy Monitoring and ongoing improvement
5.Management responsibility – 4.Planning – 1.Quality objectives Monitoring and ongoing improvement
5.Management responsibility – 4.Planning – 2.Quality management system planning Monitoring and ongoing improvement
5.Management responsibility – 5.Responsibility, authority and communication – 1.Responsibility and authority Document management
5.Management responsibility – 5.Responsibility, authority and communication – 2.Management representative Monitoring and ongoing improvement
5.Management responsibility – 5.Responsibility, authority and communication – 3.Internal communication Monitoring and ongoing improvement
5.Management responsibility – 6.Management review – 1.General Monitoring and ongoing improvement
5.Management responsibility – 6.Management review – 2.Review input Monitoring and ongoing improvement
5.Management responsibility – 6.Management review – 3.Review output Monitoring and ongoing improvement
6.Resource management – 1.Provision of resources Non specific
6.Resource management – 2.Human resources – 1.General Procedures and records
6.Resource management – 2.Human resources – 2.Competence, awareness and training Procedures and records
6.Resource management – 3.Infrastructure Manufacturing and product traceability
6.Resource management – 4.Work environment Non specific
7.Product realization – 1.Planning of product realization Design control
7.Product realization – 2.Customer-related processes – 1.Determination of requirements related to the product Design control
7.Product realization – 2.Customer-related processes – 2.Review of requirements related to the product Design control
7.Product realization – 2.Customer-related processes – 3.Customer communication Design control
7.Product realization – 3.Design and development – 1.Design and development planning Design control
7.Product realization – 3.Design and development – 1.Design and development input Design control
7.Product realization – 3.Design and development – 3.Design and development outputs Design control
7.Product realization – 3.Design and development – 4.Design and development review Design control
7.Product realization – 3.Design and development – 5.Design and development verification Design control
7.Product realization – 3.Design and development – 6.Design and development validation Design control
7.Product realization – 3.Design and development – 7.Control of design and development changes Design control
7.Product realization – 4.Purchasing – 1.Purchasing process Procedures and records
7.Product realization – 4.Purchasing – 2.Purchasing information Procedures and records
7.Product realization – 4.Purchasing – 3.Verification of purchased product Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 1.General requirements Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 2.Control of production and service provision: Specific requirements – 1.Cleanliness of product and contamination control Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 2.Control of production and service provision: Specific requirements – 2.Installation ativities Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 2. – 3.Servicing activities Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 3.Particular requirements for sterile medical devices Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 2.Validation of processes for production and service provision – 1.General requirements Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 2.Validation of processes for production and service provision – 2.Particular requirements for sterile medical devices Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 1.Identification Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 2.Traceability – 1.General Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 2.Particular requirements for active implantable medical devices and implantable medical devices Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 3.Status identification Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 4.Customer property Non specific
7.Product realization – 5.Production and service provision – 5.Preservation of product Procedures and records
7.Product realization – 6.Control of monitoring and measuring devices Manufacturing and product traceability
8.Measurement, analysis and improvement – 1.General Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 1.Feedback Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 2.Internal audit Procedures and records
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 3.Monitoring and measurement of processes Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 4.Monitoring and measurement of product – 1. General requirements Design control
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 4.Monitoring and measurement of product – 2.Particular requirement for active implantable medical devices and implantable medical devices Procedures and records
8.Measurement, analysis and improvement – 3.Control of nonconforming product Procedures and records
8.Measurement, analysis and improvement – 4.Aalysis of data Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 5.Improvement – 1.General Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 5.Improvement – 2.Corrective action Procedures and records
8.Measurement, analysis and improvement – 5.Improvement – 3.Preventive action Procedures and records

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Ultrasound in Radiology – Results of a European Survey

Reporter and Curator; Dror Nir, PhD

Ultrasound is by far, the most frequently used imaging modality in patient’s pathway being used by office-based clinicians and in most of hospitals’ departments. This is also true for cancer patients. As the contribution of imaging to the clinical assessment of patients becomes more substantial, the argument around “who is qualified” to perform such assessment is becoming louder and definitely more relevant!

Both the European and the North America Radiology societies are pushing towards establishment of centralized ultrasound services within the hospitals radiology department, still most ultrasound machines are spread between the different departments and being used by all practitioners. ESR’s working group on ultrasound published a report on the status of ultrasound-practice in European hospitals. Quite a shame; only 13% of the hospital addressed for participation in the survey reacted positively. I would like to highlight the most relevant conclusion from this survey, which is valid no matter which hand is holding the probe: Technique-oriented teaching, time and examinations are necessary to learn how to use Ultrasound properly within the framework of organ-oriented and disease training. Personally, I would support the idea that when it comes to management of cancer patients, this will become a “quality requirement” by law, similar to rules applicable to using radio-active substances.

 Here below is the full report:

Organisation and practice of radiological ultrasound in Europe: a survey by the ESR Working Group on Ultrasound

European Society of Radiology (ESR) 

Neutorgasse 9/2, AT-1010 Vienna, Austria

European Society of Radiology (ESR)

Email: communications@myesr.org

URL: http://www.myESR.org

Received: 25 April 2013Accepted: 26 April 2013Published online: 29 May 2013

Abstract

Objectives

To gather information from radiological departments in Europe assessing the organisation and practice of radiological ultrasound and the diagnostic practice and training in ultrasound.

Methods

A survey containing 38 questions and divided into four groups was developed and made available online. The questionnaire was sent to over 1,000 heads of radiology departments in Europe.

Results

Of the 1,038 radiologists asked to participate in this survey, 123 responded. Excluding the 125 invitations to the survey that could not be delivered, the response rate was 13 %.

Conclusion

Although there was a low response rate, the results of this survey show that ultrasound still plays a major role in radiology departments in Europe: most departments have the technical capabilities to provide patients with up-to-date ultrasound examinations. Although having a centralised ultrasound laboratory seems to be the way forward, most ultrasound machines are spread between different departments. Ninety-one per cent of answers came from teaching hospitals reporting that training is regarded as an art and is needed in order to learn the basics of scanning techniques, after which working in an organ-oriented manner is the best way to learn how to integrate diagnostic US within the clinical context and with all other imaging techniques.

Main Messages

• Hospitals should introduce centralised ultrasound laboratories to allow for different competencies in US under the same roof, share human and technological resources and reduce the amount of equipment needed within the hospital.

• Technique-oriented teaching, time and examinations are necessary to learn how to use US properly within the framework of organ-oriented training.

• A time period of about 6 months dedicated solely to learning US scanning techniques is deemed sufficient in most cases.

INTRODUCTION

The Working Group on ultrasound (US) of the European Society of Radiology was founded in 2009 with the aim of supporting increased quality and visibility of US within radiological departments as well as strengthening the position of US within the radiology community.

Among the many practical goals assigned to the group, one of the most important has been to gather information about the organisation and practice of radiological US in Europe.

This article reports the results of a survey assessing how diagnostic US is practiced and how training in US is organised in radiological departments of European hospitals. Questions were also aimed at evaluating the practice of US within both radiology and other hospital departments in order to understand the relationships among the different users of this technique. A comparison with the results of a previous survey on the US activities within 17 academic radiological departments throughout Europe published in 1999 by Schnyder et al. [1] was also attempted.

MATERIALS AND METHODS

A questionnaire was developed to obtain data about the practice of diagnostic US within radiology departments in Europe.

The survey contained 38 questions that were divided into four groups:

(1)

Related to the hospital: location; dimensions; presence or absence of teaching duties.

(2)

Related to the workload of US: number of US examinations/year, amount of US equipment available; state of available technology; types of most frequent examinations; organisation of the US laboratory; presence of sonographers; methods of reporting and archiving US examinations.

(3)

Related to the teaching of US to radiology residents: organisation and duration of training programmes; number of examinations to be performed before completion of the training period; presence of training programmes dedicated to sonographers or other non-radiology residents.

(4)

Related to the US examinations performed outside radiology in each hospital; clinical specialists most often involved in performing directly US; availability of special techniques, such as contrast-enhanced ultrasound (CEUS); methods of reporting and archiving US examinations.

The questionnaire was made available online and an invitation to fill it in was sent to all 1,038 heads of radiology departments throughout Europe within the database of the European Society of Radiology. The invitation was repeated three times over a period of 3 months, between June and August 2011.

RESULTS

There were 123 responses to the questionnaire. Considering that 125/1,038 e-mail messages were reported as “undelivered”, the response rate to the invitation was 13 %. Many responders did not answer all the questions presented in the questionnaire, and some answers and comments were somewhat difficult to understand and evaluate.

First group of questions

Answers were gathered from different parts of Europe; 63.4 % were from five nations (Germany, Austria, France, Spain and Italy). The distribution according to countries is presented in Table 1.

Table 1

Nationality of responders

Germany (DE)

19

Austria (AT)

18

France (FR)

16

Spain (ES)

14

Italy (IT)

11

Hungary (HU)

7

Switzerland (CH)

5

The Netherlands (NL)

4

Turkey (TR)

3

UUK

3

Czech Rep (CZ)

3

Poland (PL)

2

Denmark (DK)

2

Romania (RO)

2

Norway (NO)

2

Croatia (HR)

2

Portugal (PT)

2

Belgium (BE)

2

Greece (GR)

1

Montenegro (ME)

1

Lithuania (LT)

1

Ireland (IE)

1

Serbia (RS)

1

Sweden (SE)

1

There were 25 responses (20.3 %) from hospitals with fewer than 400 beds, 52 (42.3 %) from hospitals with between 400 and 1,000 beds and 46 (37.4 %) from hospitals with more than 1,000 beds. Most answers were from teaching hospitals (91.1 %).

Second group of questions

Most radiology departments (77 %) have fewer than 10 working US units; 22 % have between 10 and 20 US machines; only 0.8 % have more than 20 machines. Small, portable units are available in 64.5 % of departments, 3D/4D capabilities are present in 52 % and elastography in 48.2 %, and 67.3 % have the possibility to perform CEUS examinations.

Up to 57.6 % of radiology departments perform more than 10,000 examinations per year; between 3,000 and 10,000 examinations per year are performed in 33.1 % of cases; only 9.3 % of departments perform fewer than 3,000 examinations.

Abdominal US is the most frequent exam (51.51 %), followed by breast (14.46 %), musculoskeletal (11.59 %), pelvic (10.88 %) and vascular (10.42 %) US examinations. Contrast-enhanced US (CEUS) studies constitute about 4.39 %. US is used by radiologists in emergency in 96.6 % of cases and in paediatrics in 74.6 %. Comments indicate that most of those who answered “no” did not have a paediatric section in their hospital.

Transvaginal US is used in obstetric examinations by 15.8 % of responders and in gynaecological studies by 50.7 %. Endoscopic US is used by radiologists in 13.4 % and intravascular US in 14.6 %; radiologists are called by surgeons for intraoperative US in 64.2 % of cases.

There were 49 responders who indicated the actual number of US examinations performed/year. The characteristics of hospitals in which the radiology department performs more than 20,000 ultrasound examinations/year are presented in Table 2.

Table 2

Characteristics of the hospitals in which the radiology department performs more than 20,000 US examinations/year (nationality, presence/absence of teaching duties, number of inpatients, number of US machines available, ratio between number of US examinations performed by non-radiology specialists vs. radiologists)

t2

Those who reported fewer than 5,000 US examinations/year are reported in Table 3.

Table 3

Characteristics of the hospitals in which the radiology department performs less than 5,000 US examinations/year (nationality, presence/absence of teaching duties, number of inpatients, number of US machines available, ratio between number of US examinations performed by non-radiology specialists vs. radiologists)

t3

Third group of questions

The first question in this group was whether the hospital was organised with a centralised US laboratory where physicians from all specialties work together.

There were 13/110 positive answers (11.8 %) from Germany (5), Spain (3), Austria (2), Hungary (2) and Croatia (1). All other hospitals have US machines scattered throughout the different radiological and non-radiological departments. The centralised US laboratory is organised together by the radiology and the internal medicine departments in three cases; it is truly multidisciplinary, with all specialties concurring, in three others; it is run by radiology in two. The remaining two positive answers did not provide further detail about their organisation.

The second question related to the role of sonographers. Only 15/110 (13.6 %) department heads stated they work with sonographers. They are located in Spain (3), Germany (2), UK (2), The Netherlands (2), Austria (1), Belgium (1), Ireland (1), Lithuania (1) and Montenegro (1). In all others, US examinations are done directly by the radiologists. There were 12 comments describing how the work of sonographers is organised. Sonographers do both the examination and the report, with the radiologist checking difficult cases only in four hospitals; sonographers do the studies and the radiologist takes a final look and writes the reports in six; two departments state they use sonographers for vascular examinations only.

The third question related to the organisation of training programmes in US. Radiology residents are trained in 91.1 % of responders. Some centres organise a theoretical course on basic principles of US before starting practical activity. Then, clinical practice is usually performed according to organ/systems training schemes. Residents work under close supervision of a senior radiologist: they approach the patient, perform a preliminary examination and issue a first report, which is then checked by the expert. The aim is to obtain progressive growth of competences: from scanning capabilities, to reporting capabilities, to complete independence.

The length of the period of training within the US laboratory in the various teaching hospitals and the minimum number of US examinations required before the end of the residency period are summarised in Tables 4 and5.

Table 4

Length of the period of training within the US laboratory in the 84 teaching hospitals that reported it

No. of teaching hospitals

Length of training

13

<4 months

38

4–6 months

26

6–12 months

7

>1 year

Table 5

Minimum number of US examinations to be performed before the end of the residency period in the 75 teaching hospitals that reported it

No. of teaching hospitals

Minimum no. of US examination

20

<500

16

500–1,000

17

1,000–2,000

22

>2,000

There was a direct correlation between the number of US exams performed in the department and the depth of US involvement during training: training programmes in the two hospitals where the lowest number of US examinations/year is performed indicate a period of 3 months and 250 and 500 examinations. However, a hospital with a workload of 45,000 US studies per year (in which, however, the examinations are performed by sonographers) suggested only 2–3 months of training and 100 exams before the end of the residency period.

Training is also provided for non-radiology residents in 37 hospitals. It is most frequently offered to internal medicine, gastroenterology, surgery, anesthesiology, vascular surgery and paediatrics. Comments indicate that these radiology courses allow only theoretical teaching, since observation, but not direct contact with patient, is provided for non-radiologists.

All 15 departments working with sonographers provide, or are planning to provide, starting in 2012, training courses for these professionals. These include both theory and practice; the theoretical part is done, in some cases, together with radiology residents.

As an important technical point, it must be noted that US images performed by radiologists are recorded into PACS systems in 85.6 % of cases. Comments on this question indicated that not all equipment is linked to PACS and that only selected images or videos are often archived; furthermore, technical problems in archiving videos have been reported.

A final group of questions pertained to the US examinations performed outside the radiology department in each hospital.

One question asked about the proportion of US examinations performed by radiologists vs. those performed by non-radiologists. European radiologists, as a whole, still perform a higher number of examinations (61.27 %) than non-radiologists (38.32 %). Differences in the percentage of studies performed in the different hospitals are presented in Table 6.

Table 6

Proportion of US examinations performed by radiologists vs. non-radiologists. Although radiologists, as a whole, perform more US examinations than non-radiologists, the table shows there are differences among different departments, with slightly more than 50 % performing more than 70 % of the studies

% of hospital US exams performed by radiologists

No. of radiology departments

≥90 %

25 (20.32 %)

70–90 %

37 (30.08 %)

10–70 %

57 (46.35 %)

<10 %

4 (3.25 %)

Comments indicate that most OB/GYN, neurology, vascular, urology, internal medicine, anaesthesiology and gastroenterology departments run their own US units in their wards. CEUS is used in 35.1 % of gastroenterology departments, in 15.1 % of internal medicine, in 10.6 % of transplant units and in 10.4 % of nephrology departments.

The examinations performed out of the radiology department are formally reported in 64.4 % of cases only. Comments indicate that reports are fully stored within the Hospital Information System (HIS) in 31 cases; storage is only partial in 24; no HIS storage is used in 5 cases.

US images obtained outside of the radiology department are recorded into the PACS system of the hospital in 18.3 % of cases only.

DISCUSSION

Several considerations are raised from the results of this survey.

First, there was a low response rate to the survey itself. There were only 123 answers to the 913 received messages asking for information from radiology department heads (a mere 13 %). It is hoped that this low response rate relates to the many committments on their side and not to low interest in the role of US within radiology [23].

Second, most responders indicated that US is still an important part of the activities of the radiology department. Only 9.3 % report fewer than 3,000 examinations/year. It must be noted that there may be a bias in these figures, since it is conceivable that responders were more interested in US than those who did not answer the questionnaire (even if there were responders who indicated that, in their hospital, US is done mostly outside of the radiology department). Most of the workload is due to abdomino-pelvic exams, followed by breast, musculoskeletal and vascular applications. Furthermore, state-of-the-art equipment is used in about 50 % and CEUS can be performed in 64.2 %. Portable machines are available in 64.5 %, transvaginal US examinations of the pelvis are used in 50.7 %, and radiologists are still involved in intraoperative US examinations in 64.2 % of cases. Most departments still have the technical capabilities to provide up-to-date US answers to the requests they receive.

Another consideration relates to the organisation of US within the hospital. In most cases US machines are scattered throughout the different departments, and only 13 hospitals have organised a centralised US laboratory where all physicians from different specialities come to examine their patients. Although centralisation seems the best way to run a US service, there are several factors that can explain why this is not the case, many of which stem from tradition. US laboratories, in fact, commonly arose separately from one another, following the initiatives of the different specialists who started introducing this technique in their practice. Then, there is a disposition to maintain independence and separate departmental income from the activities as well as the desire to control all aspects of patients’ care.

Only 15 departments reported they are working with sonographers. Although it is known that in Europe most radiologists perform US examinations directly, it is believed that this figure underestimates the real contribution of these professionals. A possible explanation is that only three hospitals from the UK answered the questionnaire; in the UK sonographers play a major role in dealing with the US workload.

Most answers to the questionnaire came from teaching hospitals (91.1 %). Comments on how training is organised state that US scanning is commonly regarded as an art, taught from maestro to pupil, with progressive growth in scanning and reporting capabilities. In addition, most report that US is taught within an organ-/system-oriented training system. The “art” of US is highly dependent on the operator’s dedication and technical ability, and this has to be properly taught. Additionally, a period of training within a dedicated US laboratory is probably needed to learn the basics of scanning techniques. After learning the technique, working in an organ-oriented manner is surely the best way to learn how to integrate diagnostic US within the clinical context and with all other imaging techniques.

There were 13 teaching hospitals in which fewer than 4 months is deemed sufficient, and in 20 cases having fewer than 500 examinations before the end of the residency is regarded as complete training.

The low number of US examinations performed in some training centres can jeopardise teaching. The recruitment of patients for adequate training can be impossibile to obtain in low-volume practices, leading to a further decrease of radiological US for future generations of radiologists. Furthermore, the use of sonographers can make teaching the practical skills of US scanning difficult. In a hospital with high-volume US practice (45,000 cases/year) in which the examinations are performed by sonographers, residents are asked to remain in the US laboratory only for 2–3 months and to perform only 100 examinations before the end of training. When in clinical practice in a hospital without sonographers, these radiologists would not be able to carry out even routine diagnostic US examinations. On the contrary, the role of expert sonographers as a resource to provide practical training to radiology residents has not been considered and can be explored.

The results of this survey show a large heterogeneity in the use of US within radiology throughout Europe. There are hospitals in which the majority of US examinations are still performed by radiologists, and others in which radiologists are left with only a small proportions of studies.

Similar findings were observed by Schnyder et al. in 1999 [1]. From their survey in 17 academic radiology departments throughout Europe, these authors reported that in some nations radiologists had full control of US, while this was not the case in Germany, Austria and Switzerland. The situation seems somewhat worse today, since there are 22 hospitals (18.2 %) in different nations (Austria, Poland, Germany, France, UK, Norway, Switzerland and Italy) in which radiologists perform less than 70 % of all US examinations and 5 (4 %) who answered they do less than 10 % of the studies. Since the answers to the questionnaire were provided by radiology departments, the figures for radiological activity can be considered as precise. On the contrary, it is possible that those answers on the US activities out of radiology can be regarded as an estimate. However, to the best of our knowledge, the data in the survey of Schnyder et al. were also obtained in a similar way, and a comparison can thus be made.

The percent decrease in the number of US examinations done in radiology vs. those performed outside radiology is probably related to a marked increase of the use of US by non-radiology clinicians rather than to a decreased attention to this technique by radiologists. In fact, new specialists, such as emergency physicians and anesthesiologists, are now using this technique as a complement to their visit or as a guide to therapeutic manoeuvres, and the so-called “point-of-care US” philosophy, in which US equipment accompanies the physician at the patient’s bedside to guide his/her therapeutic decision making, is gaining popularity.

An additional point to be considered relates to the recording of US reports and images into the hospital informations system and PACS. US examinations performed by radiologists are archived within the PACS system in 85.6 %, while those performed by non-radiologists are stored in only 18.3 % of cases. Furthermore, radiologists provide a formal report in virtually all cases, while examinations performed out of radiology are formally reported in 64.4 %. Costs and technical difficulties in connecting all equipment to PACS and RIS are described as reasons for not recording US images, and this is especially the case for recording of video clips. The use of “point-of-care US” is a further difficulty for connecting equipment to PACS, and, within this framework, the US exam is not regarded as a separate study but as part of the physician visit. However, to have all US images and reports of the patient recorded and available for consultation could greatly help during subsequent studies, and efforts have to be made to develop consensus with clinical colleagues to increase connectivity and to report all US studies, at least as a description within the patients’ charts. Within the framework of the relationships established by the ESR WG in US with the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB), it has been agreed to prepare and publish a recommendation about the necessity, for all US examinations, of a formal report and proper archiving of both report and images.

ACTION POINTS

Two points of action can be suggested.

The first relates to the centralisation of the US laboratory. Although at the moment only a small number of hospitals are working according to this model, radiologists should take the lead in proposing such organisation [4]. This would allow the gathering of all the different competencies in US under the same roof, to share human and technological resources and to reduce the amount of equipment needed within the hospital. In an era of cost containments, a centralised US laboratory can allow each US scanner operate for longer hours and with higher numbers of examinations, resulting in an optimisation of resources. Furthermore, requests to upgrade and/or renovate equipment would possibly be easier if coming from a large laboratory and shared by different hospital departments. Another advantage would be having people with different backgrounds work in the same environment, thus promoting exchange and integration of their knowledge and possibly resulting in better patient care. It would be easier, in this respect, to prepare institutional guidelines and protocols that place US in the correct perspective towards all other imaging modalities and, most importantly, towards patients’ needs. It is not clear from the survey how this way of working is organised on a day-to-day basis, and especially how emergency services are provided (i.e. if all specialists concur in the emergency or if this is left to radiologists only), but an integrated management and organisational infrastructure bears numerous advantages for cost containment, quality standards and efficiency.

The second point of action relates to training in US within radiology residency programmes. In the opinion of the ESR Working Group on US, radiologists need to develop consensus on how many examinations under tutorship residents have to perform and on how much time they have to spend in ultrasound before the end of the training period. The results of the survey vary widely. However, out of 75 training centres that reported on the number of examinations, there were 39 (52 %) providing figures between 1,000 and 2,000 or higher. Therefore, approximately 2,000 seems to be a figure on which consensus can be reached. This figure also complies with what is suggested by the EFSUMB [5]. This federation provides recommendations about the number of examinations for training in the different subspeciality areas of US: the sum of studies for abdomen, breast, musculoskeletal and vascular training is 1,500, while figures for head and neck are not provided. The length of training is more complex to decide. A distinction has to be made here between the time needed to learn the technique of US scanning and the time needed to learn how to use US properly, to integrate it with other imaging techniques and to provide useful reports. In order to perform US, both approaches are needed. Technique-oriented teaching is necessary to learn how to perform the studies and to identify anatomy and pathology. Time and exams are needed to learn how to use US properly within the framework of organ-oriented training. A period of time of about 6 months dedicated solely to learning the US scanning technique can possibly be considered sufficient, as suggested by 76.2 % of responders. The capabilities of residents to perform US examinations have to be assessed during the training period, especially during and at the end of the technique-oriented part. It is known that the learning curve can vary widely among trainees, and longer times and higher numbers of examinations may be needed in some cases [6]. Additional time should be spent, and exams taken, during organ-oriented training. It must be underlined that organ-oriented teaching needs to include the proper role of US in each subspeciality and also take into account technical advances such as CEUS, 3D/4D and elastography and to use them when needed.

Acknowledgment

This article was kindly prepared by the ESR Working Group on US (M. Bachmann-Nielsen, M. Claudon, L. E. Derchi, S. Elliott, G. Mostbeck, C. Nicolau, S. Yarmenitis, A. Zubarev, Y. Menu–Chair of the ESR Professional Organisation Committee and J.A. Reekers–Chair of the ESR Subspecialty Societies Committee) on behalf of the European Society of Radiology. It was approved by the ESR Executive Council in April 2013.

Open Access This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

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