Friday, August 10, 2018

Do I need to File a 510(k) for my PACS?

Over the past several months many of our clients have asked us questions about whether their future products need a 510(k). Initially, PACS devices were generally treated as accessories to the imaging modalities with which they were used. For example, medical image digitizers, image viewing workstation or medical image printer were considered by FDA to be accessories to stationary x-ray, MRI or CT systems. However, with the significant expansion in the functionality of medical image management products, FDA realized that the identification of many of these products as accessories to specific radiological imaging modalities was no longer appropriate.

This realization led FDA to publish the “Guidance for the Submission of Pre-market Notifications for Medical Image Management Devices” in July 2000. This guidance is applicable to medical devices that provide functions related to the management of medical images after acquisition, of which PACS (as defined by the FDA), is only one of five classifications. By the way, the guidance does not address image-processing devices that utilize artificial intelligence (AI) or other techniques to identify abnormalities in medical images or assist in diagnosis. AI is currently being addressed under the FDA Guidance; Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions Document issued on: July 3, 2012.(more on that in a later blog post).

The “Classifications for Medical Image Management Devices” are;
1)     Medical Image Storage Device (892.2010) - is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. This device type is Class I and exempt from 510(k) requirements. 
2)     Medical Image Communications Device (892.2020) – is a device that provides electronic transfer of medical image data between medical devices. It may include physical communications medium, modems, interfaces, and communications protocols. This device is also Class I and exempt from 510(k) requirements.
3)     Medical Image Digitizer (892.2030) - is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners that use lasers or charge-coupled devices. This is a Class II device and a 510(k) must be submitted to FDA.
4)     Medical Image Hardcopy Device (892.2040) - produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers. These are Class II devices and a 510(k) must be submitted to FDA.
5)     Picture Archiving and Communications System (892.2050) - provide one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. Software components may provide functions for performing operations related to image manipulation, enhancement, compression, or quantification. This is a Class II device and a 510(k) must be submitted to FDA.

Classifications 892.2010 and 892.2020 are intended to include all medical image management devices whose principal functions are communications or storage. Classification 892.2050 is intended to cover devices that have not been included in the other Medical Image Management device classifications (i.e. 892.2010-2040).

The confusion regarding the applicability of 892.2050 has occurred because the term "PACS" has commonly been used by industry to refer to all types of medical image management devices. However, the FDA classification in 892.2050 is not intended to include products whose principal function is only medical image communications and/or storage. These devices are classified Class I under 892.2010 and 892.2020.

In many cases it is not clear cut if a device should be classified as a Medical Image Communications Device, a Medical Image Storage Device, or as a Picture Archiving and Communications System. In these cases, the classification is determined by reviewing the additional functions performed by the product. Simple manipulations that do not alter the image data, such as window and level, pan and zoom, and image annotation are considered to be within the scope of the communications and storage functions and no 510(k) is required. A typical image viewing workstation falls within this classification. However, image-processing functions, which are intended to alter the image data (e.g. filtering, multiplanar reconstruction, and 3D reconstruction), are considered to be outside the scope of the storage and communications functions and fall into the PACS classification where a 510(k) must be submitted.  Also, complex quantitative functions (e.g. measurements, arterial stenosis evaluation, ventricular volume calculations, and calcium scoring) are not considered to be communications and storage functions and these types of functions are treated as PACS, requiring a 510(k).

Hopefully, I have reduced some of the confusion but if you have any questions or need assistance for product classification and/or FDA clearance, don’t hesitate to contact us.

The author of this article is Carl Alletto, OTech Senior regulatory consultant. OTech filed more than 100 PACS related 510(k)'s for both US and international based companies, see list here.

PACS System Administrator: only for “geeky” Techs?

When talking with an administrator about the best qualifications for people to support the PACS
systems in radiology, he told me that he had his best experience with hiring “geeky” techs, meaning RT’s that have a knack for computers. I tend to agree with him. It would be hard to teach someone with only an IT background the ins and outs of image quality, how to map procedure codes and series descriptions to hanging protocols, and deal with issues in workflow.

At the same time, a “geeky” tech who is not afraid of computers, can take additional training and learn quickly and get the required skills to get by. As a matter of fact, in our PACS training, students with an RT background have been the largest group represented. There has been a lot of discussion on whether a PACS system administrator (SA) should have a clinical or IT background, and the consensus seems to be that either one can do a good job, with each bringing specific expertise to the table. I would argue that the best approach is to have a team with different skills, assuming you can afford more than one PACS SA to start with.

Regardless of the background, for those professionals considering a career change, here is what a “typical” PACS SA does on a day-to-day basis:

·     Data Integrity (“fix-ups”)
Data integrity refers to the information that is typically stored in the so-called “image header.” When the information is correct, an image properly shows the corresponding patient demographics on the viewing system and allows for unambiguous storage and retrieval. When this fails to happen, and one or more elements are missing – usually some part of the patient information, it results in what most users refer to as a “broken” or “unverified” study.  A broken study is when an image or set of images is not properly identified. Broken studies must be resolved or placed in a temporary folder or holding area. It is the SA’s job to implement a process to handle broken studies, and manage problems associated with them. In many institutions, this activity is done by the technologists as it is often caused by them incorrectly entering or matching studies, so the PACS SA typically only deals with complicated cases.

·     Project Management
Comprehensive coordination of a new PACS or upgrade installation is a big undertaking. Understanding the workflow directly impacts successful project management. Creating a map of information flow, and thoroughly understanding the interaction, as well as information storage and retrieval will help define system placement, configuration, routing, testing, and maintenance. Mapping should commence with collecting the patient information, going through the examination process, and ending with image viewing, storage, and diagnostic report generation.

Post-installation management includes software upgrades, adding new modalities, workstations, interfaces, or users to the system. Successful management of these jobs involves anticipating cause and effect relationships. For example, if a software upgrade is scheduled at noon on Sunday, will all users be trained on the new features within an acceptable timeframe?

·     Training
Training is important for the smooth daily operations and management of a PACS system. SA’s will work with vendors to train users on new releases and upgrades, as well as develop materials and curricula for the staff. They will create “cheat-sheets” to replace often bulky and unreadable manuals or on-line help. A vendor will typically “train a trainer,” which is most cases the PACS SA.

·     Support
Support follows training. Hardware and software issues, operator questions and errors, system bugs or failures, and emergency situations all require hands-on, immediate support. The SA must be available “on-call” in the event of a support need. Most support activities fall under the job description category of system maintenance; be prepared to have to be available 24/7 and get compensated for it.

·     Managing Software and Hardware Configurations
Documenting and physically mapping the system prevents potential compatibility issues whenever making a change to the system i.e. adding a new CT or upgrading ultrasound software.  Recording new installations and upgrades of software releases goes hand-in-hand with this process. It’s important to know which devices run with which software for future upgrade purposes. Lastly, hardware configuration, and changes should be documented as well.

·     Configuration Control Board
The PACS system typically interfaces with a Radiology Information System (RIS), Voice Recognition System (VR), the Electronic Health Record system (EMR) and acquisition modalities. As such, it is important that the people managing these systems and devices communicate regularly. These groups of people make up a “configuration control board,” and are responsible for planning events that will collectively affect their system(s), or device(s). They discuss the potential impact of any new addition or change to their system (or device), and how it may result in a functionality issue with another system (or device).

·     Preventive Maintenance
Preventive maintenance drastically reduces problems and issues with the PACS system. Several components comprise preventive maintenance and can be managed with a simple checklist. Monitoring image quality among modalities, workstations, and printers; checking unresolved study queues; making sure the network is up and running; and checking critical processes such as the database, are functions commonly found on a preventive maintenance checklist.

·     General System Maintenance
This task can be described as cataloguing users, and assigning them appropriate security access. It goes hand-in-hand with the Health Insurance Portability and Accountability Act (HIPAA), which deals with patient privacy and security. Hospital employees are provided with varying degrees of access based upon their authorization level, which depends on the role in the healthcare process.

·     Modality Acceptance Testing
This activity is performed with every new piece of equipment that is added to the system. The best way to execute acceptance testing is to maintain a “shadow system” that reflects the same characteristics as the main PACS system and is basically a “mini” or test PACS. Having a fully duplicated system with reduced storage capability is critical.

·     Image Quality
Proper acquisition of an image is the first step in achieving good image quality. The skill level of an RT, whether they over- or under-expose a patient, impacts how the image appears. The patient, unbeknownst to them, also affects image quality.  Movement during an exam can contribute to “fuzziness” of an image. It is critical to be able to identify whether a “noisy” image represents a bone, tissue or organ with disease, or whether it is due to a quality issue. In this specific example, a noisy image could very well be caused by under-exposing a patient, or an image processing error. When troubleshooting an image quality issue, a PACS SA must consider all of these factors.

·     Image communication
Digital images can be transferred from a hospital to a doctor’s home or from a clinic to the main hospital using compression. Common types of compression include lossy, in which the image may lose some of it’s detail, and lossless which maintains the integrity of the image. Managing image quality through this process is important, and if a problem occurs, it needs to be determined whether it lies with the compression, or the image acquisition. The ability to determine the root of the problem is essential for a PACS SA.

·     Manage Off-line storage
Short-, mid- and long-term storage solutions, e.g. to archive images that are a few months old for immediate access, or for up to more than e.g. seven years old for access within minutes, are an essential part of the PACS system. In case an institution decides to have certain studies off-line, or in the cloud, the SA typically “mounts” the specific media on a reader or makes sure the images can be fetched from the remote storage depending on whether the images have to be used as comparison for a new study.

The challenging work of a PACS System Administrator has numerous and varied tasks. A PACS SA is often someone with interdisciplinary skills, the ability to multi-task, be a forward thinker, and handle crisis management well. It requires clinical, technical, training and people skills, and can be a fun and challenging job for those who are up to it.