Saturday, January 1, 2011

Moving on to 2011 … at last

"Carefully optimistic" was the phraseemost used when reporting on U.S. consumer spending this past holiday season. I believe, along with most of the vendors I spoke with at the recent RSNA, that this also holds true for the radiology and imaging informatics market. 

The word from exhibitors at the December conference in Chicago was that there are more customers that appear willing to invest in new technologies and systems. The attendance at RSNA was up slightly from last year, a welcomed and very positive sign. In a nod to the reality of the times, I also found exuberance and extravagance of prior meetings toned down, both on and off the show floor. 

On the healthcare IT front, the most significant event of 2010 was the definition of Stage 1 requirements for the Meaningful Use of electronic health record implementations. There is no question that this will stimulate the long-awaited adoption of EHR technology in offices and clinics. The wild-card still in the deck is the role that personal health records will play. I don't think players such as Google, Microsoft, and others truly understand this market—although they are ramping up by hiring several veterans from the industry. 

Another event that might have escaped notice this past year is an increased effort by the FDA to regulate medical devices. This has shown up in an enhanced level of concern for PACS, requiring more thorough documentation when filing for FDA approval. In addition, the review process for medical devices has become significantly longer and more difficult. 

The FDA is also responding to the growing importance of manufacturing overseas. It has opened an office in China staffed nearly 100 officials. These people can visit any registered medical device manufacturer in that country and demand an audit of the quality system, as well as policies and procedures. 

In conclusion, I believe that most of us are glad to put 2010 behind and are looking forward to 2011. The signs are good, with new technology, IT, and regulatory developments and the industry—in general—is carefully optimistic in its prospects. I wish all of you a happy new year and all the best. 

Technique, Technology Aid in Driving Down Dose

As Low As Reasonably Achievable, or ALARA, has always been the mantra of technologists and radiologists when it comes to the amount of radiation to which a patient is exposed during a diagnostic imaging exam. However, due to new technology, human error, or miscommunication there have been a clutch of high-profile incidents of patient overexposure in the past few years that have received widespread press attention. These cases have served to invigorate the commitment of imaging professionals to keep the dose as low as it can go, especially for the pediatric patient.

Dose management was a hot topic at the 2010 RSNA, with several presentations offering attendees the tools and techniques to deliver low-dose exams. Physicians shared their efforts to reduce the dose to a level that provides images that are clinically acceptable, while coping with added noise and reduced resolution. 

Manufacturers of digital radiography equipment, which has suffered from a tendency of technologists to increase dose (the "dose creep" phenomena), have implemented processing technologies to improve image quality and logging tools that allow administrators to catch and coach against dose creep in their facilities. 

High-volume, multi-slice CT has also come under scrutiny, with clinicians re-examining their protocols in light of these new, powerful technologies. Proper collimation and using techniques appropriate for different areas of the body—such as varying dose from head to chest to abdomen to pelvis during a whole-body scan—are proving helpful in achieving ALARA. In addition, new solutions for dose recording and registration are rapidly being implemented in the new devices. 

The most important factors for dose reduction are the definition of policies and procedure, technique charts, training and education, as well as awareness. Healthcare IT can assist here, because an electronic health record could be used to record radiation dose events. This would allow it to be programmed to alert a physician before they order another CT scan or conventional X-ray. 

Dose reporting is critical to allow for benchmarking against yet-to-be defined national standards and good practices. The ACR is setting up several trial centers that will perform dose recording in order to establish a database from which to base to create standards. The IHE has defined the Radiation Exposure Monitoring profile that defines use cases and DICOM transactions to implement dose recording, which was demonstrated in its booth at the 2010 RSNA. 

The IHE profile uses a Dose Structured Report, which is defined by the DICOM standard and has a template for both X-ray and CT radiation dose. These templates contain information about the observer/system, date/time, and start and end of the event; the number of events that are recorded; and dose information. It also includes the method used to calculate and record the radiation event. This information can be sent to a PACS, RIS, or dose registry station, depending on the capabilities and architecture of the radiology imaging system. Dose reports can be sent, after anonymization, to an external registry. 

There are other short-term solutions to record the dose, none of which are optimal, but might provide an interim approach. One could, for example, capture a screen with the dose information, which can later be processed by an optical character recognition software package to extract the information. 

Other solutions could be the use of the DICOM MPPS dose information, which might not be as detailed and exact as the Structured Report (SR), but is better than nothing if the device does not yet support SR. Another solution, which is used by digital mammography, is to get this information from the DICOM image header. 

Both state and federal governments are taking dose management seriously—via legislation (notably in California), hearings, and FDA rule making. The MITA organization, representing imaging vendors, is also actively involved by defining guidelines and standards for dose reporting and registration. 

In conclusion, there is no question that because of regulatory and consumer pressure, X-ray radiation devices will be required to be modified, upgraded, and equipped with the capability to exchange dose information is a standard manner. Institutions will also have to store radiation events and dose details, most likely in the RIS, but also possibly in a PACS or separate application. Eventually, these events will become part of an electronic or personal health record. Imaging facilities are strongly urged to use standards for the implementation of dose management, in particular, the IHE Radiation Exposure Monitoring profile.