Planning for the Eventual: Keeping medical information secure in the handheld world

By Paul Dow, MS, RT(R)(CT)

Personal mobile devices such as smart phones and tablet computers are becoming more popular among clinicians as they look for ways to improve their daily delivery of healthcare. These devices have increasingly powerful processors and larger hard drive capacities which can be an asset when interacting with large image data sets. However, there are risks for organizations and individuals who use these devices if they are lost or stolen and there is protected health information (PHI) stored within the device. A little preparation by an organization before a loss occurs can possibly limit the scope of the damage, or at least provide a starting place for recovering from the initial shock of the event.

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Survey on Radiology Technologist job market blames imaging schools over economy

We asked 135 radiology professionals their opinions on the current job market for radiology technologists, and they sure did have a lot to say: 4,087 words to be exact. This issue is weighing heavy on the profession, and seems to be cultivating some pretty strong opinions about the politics involved in imaging schools and accreditation bodies. 53% of our survey participants attributed the main cause of job shortages in the profession to imaging schools accepting too many students per class. 17% of participants blamed the economy, and 10% identified technologists working to a later retirement age as the main cause.

According to the latest ASRT survey, the vacancy rates for all imaging modalities have dropped significantly since 2003. The modality seeing the biggest hit is Cardiovascular Intervention, dropping 11.1%, and Nuclear Medicine close behind dropping 9.5%. Our survey participants identified Radiography and Nuclear Medicine as the modalities in the lowest demand (43% and 35% respectively), while 41% felt Sonography was in the highest demand.

The statistic that speaks the loudest to the current job climate for RTs and CNMTs is that 57% of those surveyed knew more than 5 technologists that were either unemployed, or employed with limited/decreased hours, due to the inability to find work. Overall, 94% identified knowing at least 1 technologist (including themselves) that could not find full-time work in their field. While some professionals attribute this to the overall reduction in work due to the economy, others argue that this statistic of unemployment is too high to blame entirely on budget cuts.

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Catching It on the Bounce: Stanford Hospital responds to online posting of patient data

By Paul Dow, BS, RT(R)(CT)

The exposure of protected health information is always a cause for concern. There are varying degrees of exposure, and there are varying degrees of response. What separates the quality of the response from good to bad is the level of accountability and responsibility an organization takes for the loss of patient data. The best response I have seen recently from an organization has come from Stanford Hospital and Clinics.

A breach of information for approximately 20,000 emergency room patients of the Stanford Hospital and Clinics website occurred between March and August of 2009, as reported by a recent New York Times article. The breach arose from the actions of a contractor who posted patient information on a publicly accessible web site. The incident was not caused by the hospital and the contractor has assumed responsibility for the event. There will be other steps taken by the hospital as the investigation continues.

What makes this situation response remarkable to me is that Stanford Hospital and Clinics has gone the extra step to provide identity theft protection to each person who had their data exposed. Although the information exposed did not include credit card or social security numbers, Stanford is going a step further to ensure that patients feel their private information will not cause them substantial damage. It also shows that Stanford is taking steps to demonstrate that they take this event seriously and that they realize that patient/customer trust is a fragile thing.

There are choices people can make. If people do not feel their information, clinical or not, is safe, then they might take their business elsewhere. In this case, the proactive choices made by Stanford seem to be the best response an organization could provide.

According to the article, a patient discovered the breach and alerted the facility. As patients become more technologically savvy, what could your organization do to ensure that in the event of a similar situation, it could win back the trust of your valuable patients/customers? Could you convince people that your facility respects their information and treats it as if it was their own?

More on author and clinical informatics educator, Paul Dow

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Updates: Nuclear Medicine Advanced Associate (NMAA) Master Degree Program

The first NMAA exam was administered in June of this year at the SNM Annual Meeting in San Antonio, Texas. Four candidates sat for (and passed) the exam after completing an MIS (Master of Imaging Science) from the University of Arkansas for Medical Sciences (UAMS). Collaborating with UAMS in this advanced degree program are Georgia Health Sciences University, University of Missouri at Columbia, and Saint Louis University. This is the second MIS track to be offered from UAMS, the first being the better known, but still new, Radiology Assistant (RA) program.

NMAA candidates must first be graduates of an accredited Nuclear Medicine Technology program, and hold a Nuclear Medicine Technologist certification.

In addition to regular technologist duties, NMAAs could be responsible for:

  • ordering and administering testing agents
  • administering sedation (under supervision of a physician)
  • assessing and monitoring patients, monitor exercise and pharmaceutical stress testing procedures
  • performing therapeutic procedures (under supervision of a physician)
  • assessing patient images
  • requesting further imaging and/or ordering additional diagnostic procedures to compliment nuclear medicine findings
  • preparing preliminary reports and readings on tests
  • communicating report findings to ordering physician

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Review of the FDA’s 510(k) approval process for medical devices

By Ryan Hamilton, PhD

The process by which the FDA reviews medical devices has recently come under increasing criticism. Both consumer and manufacturing groups are frustrated with the slow pace and nature of the medical device review process.

In 1938, Congress first regulated medical products for safety and effectiveness, although at the time these were mainly drugs and not medical devices. In 1976 the FDA took sole responsibility to regulate the medical device industry in the US; two competing goals were the focus: to provide the public reasonable assurances of safe and effective medical devices and to avoid overregulation of the industry. The most recent reorganization of medical device regulation came in 2002 as the Medical Device Fee and Modernization Act (MDUFMA), which was interpreted by the FDA as a shift towards the least burdensome approach to medical device approval. The FDA, and more specifically, the Center for Radiological Health (CDRH), offers two paths to approval. First, is the Premarket Approval Process (PMA), typically used for products which support or sustain human life. This process is lengthy and intensive. The second path is the 510(k) approval process, which was designed for use with lower risk products as well as changes made to existing products, or those that are substantially equivalent to previously approved products. Regardless of the approval process, the federal Food Drug and Cosmetic Act requires reasonable assurance of safety and effectiveness before a product reaches the market.

Recently, the 510(k) process has become burdened beyond its design. In 2009, 90% of new medical devices were approved through 510(k) and the FDA received 4,000 submissions for approval. A 2011 Archives of Internal Medicine article, by Diana Zuckerman et al., reported that of the 113 Class I recalls of medical devices (Class I is the strictest recall of a product which has the potential to cause serious health problems), 71% were approved through 510(k) while only 19% through PMA.

Concerns about the 510(k) process, its evaluation of new devices, and increased prevalence of recalls led the FDA to take a two-pronged approach in September of 2009. The FDA conducted its own internal review of 510(k) to analyze what changes could be made to improve consistency in the program, and commissioned an independent study by the Institute of Medicine (IOM).

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Seeking Moby Dick Mo-99: Coping with the Tc99m shortage and what’s ahead

By: Ajay K Malik, PhD

Technetium-99m (Tc-99m) is the most used radioactive tracer with over 30 million tests per year done all over the world. When tagged to a pharmaceutical or biological marker, it helps evaluate, diagnose or manage cancer spread, blood flow and cardiac function; brain activity and thyroid disease; and detect osseous metastasis, fractures and infections (bone scan). Radiology professionals inject this radioisotope to gauge blood flow to the organs and detect cancer spread much earlier and with greater precision than many other methods, including PET or CT scan. Tc-99m, with a half-life of just 6 hours, is the most preferred radioactive tracer—it emits high energy 142.7 keV gamma rays, allowing very high resolution imaging without posing any danger of long-term radiation damage to the internal organs. Lately, Tc-99m supply chain has come under stress. In the January 21, 2011 issue of Science, Robert F. Service wrote that due to the 2009 temporary closure of NRU and Petten reactors and resulting shortage of Tc-99m, “physicians were forced to use less Tc-99m for many procedures, ration what scant supplies remained, and find less desirable substitutes.”

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Google announces the end of Google Health

By Paul Dow, BS, RT(R)(CT)

The Good and Bad of the Situation

Google has announced in their official blog that their Personal Health Record (PHR) experiment is coming to an end on January 1, 2013. If you have data entered on their site there will be enough time to safely export the data to another application. However, this announcement, like many events in life, is not all good or all bad for the average healthcare consumer. There are still many useful, and free, options for the empowered patient. Microsoft’s HealthVault is available, as well as an AHIMA version, MyPHR which can cover the needs of most, if not all, consumers. What then is lost, really, from this announcement? Not as much as you might initially think.

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A glass of CABERNET or MERLOT for a leaky case of AMD

By Ajay Malik, PhD

Age-related macular degeneration (AMD) is the leading cause of vision loss and blindness in adults over 50 years age. While 90% of AMD patients have the dry-type AMD (atrophic), it is the wet AMD (exudative), driven by choroidal neovascularization (CNV), which is responsible for severe and acute vision loss in over 90% of the patients. Famous people, like the artist Georgia O’Keefe, entertainer Bob Hope and the author Henry Grunwald have coped with AMD. There are over 1.6 million people with AMD in the United States and about 200,000 people are diagnosed with wet AMD every year.

One promising approach in late-stage clinical development is the use of beta-radiation to selectively target the proliferating cells in the macular lesion. A small company 40-miles south of San Francisco called NeoVista in Newark, Calif., is at the forefront of testing an epimacular brachytherapy device in the pivotal CABERNET (CNV Secondary AMD Treated with BEta RadiatioN Epiretinal Therapy) Study. The results of this trial are expected in October 2011 (read here). The CABERNET trial is a multicenter randomized controlled study with two arms in which 495 treatment-naive patients will be randomized into a control group who will receive a regular schedule of ranibizumab (anti-VEGF Fab; Lucentis; Genentech, South San Francisco) injections (the standard of care); the patients in the second arm will receive strontium-90 beta radiation and Lucentis as needed.

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F18 FLT: Imaging cell proliferation in contrast to cell metabolism in PET tumor imaging

Investigational radioisotope, F-18 FLT (fluorothymidine), is showing promise in clinical trials in it’s ability to assess response to cancer treatment. Research into the clinical applications of the FLT radiotracer has been underway for over 10 years. After FDA approval for the use in clinical trials, the molecular imaging community is holding much promise in the use of this tracer for the assessment of cancer treatments.

While the most widely used PET tracer, F-18 FDG, exhibits glucose metabolism in cellular tissue, F-18 FLT is retained only in proliferating tissues. This difference in uptake can mean quite a lot when examining some applications of tumor assessment, such as brain imaging. Due to the high glucose metabolism in the brain, some lesions of the brain can be hard to assess using F-18 FDG imaging.

When using FLT imaging to assess chemotherapy response, serial imaging is indicated. Cell proliferation is expected to decrease after the first course of treatment. A baseline FLT study would be performed, and then a post-treatment study after the first course of treatment. The amount of uptake, and more importantly, the differences in the amount of uptake, will determine the effectiveness and response of the treatment.

Method of Uptake: How and why does F18 FLT incorporate itself into proliferating cells?

In order to understand the method of uptake of F18 FLT, it is important to understand a few simple biochemical aspects:

1) Fluorothymidine is a thymidine (also called deoxythymidine) analogue

2) Thymidine is the nucleoside ‘T’ of DNA (composed of thymine and deoxyribose)

3) Every time a cell divides it synthesizes its DNA to create a new cell: thymidine is used to create new DNA

4) This is why the thymidine analogue exhibits itself in proliferating cells and is retained: the radiolabeled thymidine analogue incorporates itself in the DNA of the newly created cells and remains there

In contrast to using F18 FDG, where we see the metabolic state of the cells, we are able to use this application to see if the cells are growing (or if growth is being slowed down due to therapy).

 

By Jennifer Lilly Gutiérrez, CNMT, RT(N)(CT)

 

Also read: Can a New PET Imaging Technique More Quickly Predict Response to Ongoing Cancer? : Newswise

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Taking the bite out of second cancer risk attributable to radiotherapy of primary first cancer

By Ajay K Malik, PhD

Over the last forty years, we have made great strides in the diagnosis and treatment of cancer. According to the Centre for Disease Control and Prevention (CDC), the number of cancer survivors have steadily increased from three million in 1971 to over eleven million today; one in twenty Americans is a cancer survivor.  The increasing ranks of cancer survivors have brought new concerns into focus—second primary cancers now account for 18% of all cancer diagnosis and are the third most common cancer diagnosis in US.  Similar data is also emerging from other countries.  Second primary cancers (a.k.a. second cancers) are new cancers that arise after the first incidence of any cancer.  Second cancer may be in the same, surrounding or distant organs, and differ from metastatic cancer which is a result of primary first cancer cells disseminating to a distant organs (see a definition here).

Genetics and lifestyle behaviors, for instance, smoking, alcohol or poor diet, are partly responsible for second cancer, the treatment modalities during first cancer may also have a role.  Both chemotherapy and radiotherapy can increase predisposition of other cells to cancer.  Radiotherapy, while a highly effective cancer treatment option, has long been considered to increase the risk of subsequent cancers, but convincing data had been lacking.  Now, an epidemiological study published by the National Cancer Institute in the April 2011 issue of Lancet Oncology journal shows that 92% of all second cancers are due to causes other than the radiation treatment of previous cancer.

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