The Technology Review Site for Primary Care Providers
Advances in technology have improved healthcare providers' ability to rapidly diagnose patients at the point of care, screen for common conditions, and provide a variety of effective treatment options. Providers need to be aware of what innovations are available - or will become available in the near future. It is the purpose of Medgizmos to educate and inform healthcare providers regarding the latest and greatest technologies.
Clarius mobile Ultrasound system facilitates POC diagnoses!
As a pediatrician who wants to improve the patient experience for my young patients, I have been waiting forever for needle free injections, but I don’t see this happening anytime soon (these do exist but have very limited indications). I was thrilled when the oral rotavirus and nasal flu vaccine were introduced years ago, but most vaccines are not needle free and continue to be a painful experience for my patients. We also traumatize patients when we screen children at a year of age for lead and hemoglobin tests via finger-stick. This procedure is uncomfortable and almost always accompanied by crying (sometimes on the part of parents as well).
There is a start-up company called SeventhSense Biosystems based in Medford Massachusetts, that recently gained FDA approval to market their novel blood collection system for use in adults. As shown in the video the system consists of a cartridge that is placed on the upper arm. When actuated – 30 microneedles that are 350 microns in width and 1 mm long puncture the skin. Within minutes the device collects 100 microliters of blood that is anti-coagulated with lithium heparin. One uses a pipette to extract the sample which is then placed in a microtube and mixed before testing. The only FDA approved indication presently is for hemoglobin A1c testing.
The device is pain free! This is quite an achievement and is likely a function of the location (fewer nerve endings compared to the fingertip), and the small size and depth of penetration of the microneedles.
I’m told that the company is working on collection cartridges that use EDTA as an anticoagulant and cartridges that can collect 250 microliters of blood. Hopefully as the product evolves it will gain FDA approval for use in pediatric patients and for other indications such as CBC devices, glucose, lead etc.
Not all helpful medical gizmos survive the test of time. Such is the case of the “Acoustic Otoscope” (also called the “Spectral Gradient Angle Reflectometer”) which was introduced in the early 1980s as an alternative to tympanometry to detect the presence of fluid behind the tympanic membrane. The Acoustic Otoscope was inexpensive (hundreds of dollars) compared to tympanometry devices (thousands of dollars). Best of all it was easy to use and did not require a seal to produce a measurement (this can be problematic with tympanometry devices), and displayed results in seconds. Numerous studies showed comparable sensitivity for detection of middle ear fluid. It was particularly helpful when the tympanic membrane was obscured by cerumen. A normal reading with this device, made otitis media unlikely, and played an important role in avoiding the inappropriate prescribing of antibiotics.
While many pediatricians used the device, and it remained popular for many years, companies that manufactured the EarCheck Pro (the last incarnation of the Acoustic Otoscope) could never sell enough of them to sustain its use. Once purchased the device could be used for years. In an effort to continue to generate revenue the manufacturer sold disposable plastic tips because they said these should be replaced, but pediatricians in large measure did not replace the tips. There was also a consumer version, called the EarCheck (shown in the video), with the same internals as the more expensive professional device. Unfortunately, few parents bought this version of the acoustic otoscope.
It’s such a shame that the acoustic otoscope did not find its niche in the market as it was extremely useful, as few pediatricians have tympanometry devices in their offices these days. It would help guide management of serous otitis, and reduce referrals for myringotomy tubes.
If you have some older devices hanging around your office considering donating these to Medgizmos, so we can present a review similar to this one!
I’ve always been interested in new medical technologies. Over the years some have proven themselves indispensable and have changed medical practice. A few come to mind quickly – such as he temporal thermometer – which speeds taking of vital signs, the pulse oximeter – which helps us determine if a patient has a significant respiratory illness, and OAE hearing screeners and photo screeners which improve our ability to diagnose children with hearing and vision problems. I would add to this list the new Clia ’88 waived devices have provided the means to incorporate PCR diagnostics in the office during the visit.
I’ve long been intrigued by portable ultrasound devices. Clarius Mobile systems has sold thousands of these to medical specialists who routinely use diagnostic ultrasounds in their practice. But what about primary care specialists???
As shown and discussed in the video the Clarius Wireless Portable Ultrasound is affordable, and connects wirelessly to a user-friendly application on an android or IOS smartphone or tablet. Images or ultrasound recordings are then uploaded to the “Clarius Cloud”, for later review by providers. The application simplifies the process of performing an ultrasound by integrating presets, so few adjustments are needed.
The review article “Lung ultrasound for the diagnosis of community acquired pneumonia in children” 1 looked at several studies where ultrasounds were compared to x-rays and CT studies to diagnosis pneumonia in children. The authors concluded that ultrasound could diagnosis pneumonia in pediatric patients with the same accuracy, less radiation exposure, quicker, and at lower cost compared to the other modalities.
How much training and support would a physician need to become facile with a portable ultrasound device? It would be wonderful if primary care physicians could have a new diagnostic tool! In the primary care setting ultrasound could be used for bladder scans, lung scans, abdominal scans, and joint scans . It could be used to determine whether suspected abscesses are drainable, and guide joint injections, lumbar punctures etc.
Stay Tuned! I will update Medgizmos viewers as I learn more about this exciting technology!.
Stadler JA, Savvas A, Heather J. Zar, HJ: Lung ultrasound for the diagnosis of community-acquired pneumonia in children Pediatr Radiol (2017) 47:1412–1419
Amblyopia is one of the most common visual problems of childhood, occurring in as many as 1% to 4% of children. It is defined as poor vision caused by abnormal development of visual areas of the brain; if undetected and untreated it can lead to permanent vision impairment.
Unfortunately, less than 21% of children are screened for this condition. Causes of amblyopia include strabismus (misalignment of eyes), anisometropia (inequality of vision of both eyes because of refractive errors or astigmatism), cataracts, ptosis, or other factors. Because children do not complain of problems with visual acuity, and affected eyes often appear normal, amblyopia can easily go undetected unless a child has vision screening done routinely at health maintenance examinations.
Vision screening in children aged younger than 3 years in a medical office can be challenging because few children this age can be screened with a vision chart. From age 3 to 5 years, screening is possible with Snellen charts, Tumbling E charts, or picture tests such as Allen Visual Acuity Cards, but this is time consuming and can lead to inconsistent or erroneous results. According to the latest 2017 guidelines Screening instruments detect risk factors for amblyopia, including high refractive error and strabismus. I recommend that Instrument-based screening be performed at age one and repeated at each annual preventive medicine encounter through 5 years of age.
Amblyopia remains treatable until age 60 months, with rapid decline of effective treatment after age 5 years. The goal of vision screening in infants and young children, therefore, must be the early detection of high severity (magnitude) amblyopia risk factors (ARFs), including moderate or severe astigmatism, anisometropic myopia, high hyperopia, severe strabismus, and opacities in the visual axis, including retinoblastoma or other ocular entities that cause opacities that interfere with transmission of light to and from the retina.
In the Vision in Preschoolers Study, published in 2004, it was found that visual acuity testing (using eye charts) of more than 2,500 preschool children had a 77% sensitivity for detecting conditions associated with amblyopia, while photoscreener devices had a sensitivity of 81% to 88%. Note that the use of photoscreeners not only improves detection of eye pathology but also does so in a fraction of the time required to perform testing with eye charts.
I’ve been using the PlusoptiX S12C mobile vision screener for years and picked up hundreds of children with amblyopia risk factors that have been referred to our community pediatric ophthalmologists. As noted in the video it is important to discuss setting the parameters preferred by your ophthalmologists (which correlate with sensitivity and specificity for detection of risk factors) to minimize over-referrals in young children while avoiding missing children at risk as they approach the age at which amblyopia is not correctable!
The CLIA’ 88 regulations, were published in 1992 and phased in through 1994. Over the years they’ve had a dramatic impact on primary care medical practice. Before their implementation primary care physicians could perform urine and throat cultures in their office, spin hematocrits, and perform a modified CBC using a neat device called the QBC Star. CLIA’ 88 took all this away as most small practices could not afford to maintain a “moderately” complex lab. Eventually, devices began to emerge that gained FDA approved CLIA ’88 waived status. The first in my memory was the Hemacue for determining Hemoglobin levels, and then rapid diagnostic tests for strep A detection followed shortly thereafter.
We’ve had no point of care, waived CBC device in the US until this year! Sysmex corporation based in Japan and world leader in hematology analyzers modified their highly successful PocH-100i tabletop analyzer and introduced the Clia’88 waived XW-100 hematology analyzer several months ago.
Having a CBC test in office can help physicians make important decisions regarding the need for antibiotics or further testing. In the setting of treating febrile patients, especially children, a normal or a CBC which a predominance of lymphocytes can be reassuring,. In contrast, an elevated CBC may suggest that more attention need to be taken when a source of infection is not evident.
As shown in the video the XW-100 is easy to setup and use. Effectively it is fully automated, and users simply follow on screen instructions. The machine attaches to reagents and an exhaust reservoir. The device requires 3 controls be run every 8 hours, a process which takes about 20 to 30 minutes. Venous specimens take just 3 minutes to run, and results are printed on a thermal printout with normal values for age accompanying the results.
It is slightly noisy during operation, but it is nice to be able to run CBCs in the office rather than send patients to the local hospital for testing, and then calling with results after they have left the office.
The FDA has approved the XW-100 device for “non-critically” ill patients 2 years and above and can only be run on venous (not finger stick) samples. The FDA also limits the XW-100 device in that results are suppressed if the platelet count is below 100,000 , the hemoglobin is below 10, or when the white blood count is below 3000, requiring a physician to obtain a specimen at a hospital lab. Hopefully as more waived CBC devices become available, the FDA will relax their restrictions.
For many years primary care physicians have been using lateral flow assays to diagnose strep A, Influenza A and B and RSV infections at the time of an office visit. These have the advantage of being inexpensive and relatively fast. When positive they expedite diagnosis. Their disadvantage is that negative tests do not necessarily rule out infection as their sensitivity ie their ability to detect a positive when the antigen is present can be low. In the case of strep A lateral flow rapid antigen detection tests the sensitivity may be 85% or less. In the case of flu tests sensitivities may be 60% or less, and some RSV tests have sensitivities only around 70%.
Point of Care (POC) PCR tests have improved significantly upon the accuracy of rapid detection of strep A, influenza A and B as well as RSV. Please see Medgizmos review of the Alere I System here for a full discussion. The downside is that the tests are much more expensive than traditional lateral flow assays, and not all insurances will reimburse for these more accurate tests. The Sophia 2 analyzer from Quidel, represents an “enhanced” lateral flow assay. It provides much improved sensitivity for detecting the pathogen being screened for compared to traditional lateral flow assays – but is much less expensive than POC PCR assays. Keep in mind that with the Sophia 2 system, negative rapid strep tests still need to be backed up with culture in children, with negative PCR tests they do not. So, if one were to factor in the cost of the rapid test and the culture, the point of care PCR strep A test is the most cost-effective assay.
The Sophia 2 is an elegant device to say the least. It has a touchscreen display, and it is very easy to run monthly controls for all test kits. It features 1) a “test now” mode where you insert a cartridge into the device for testing once you run the test for the necessary time, or 2) a walk away mode, where the cartridge is inserted once the test solution is deposited.
New this year is the first ClIA ‘88 waived fingerstick blood assay for Lyme IgG and IgM antibodies, providing results in 15 minutes. Positive tests require confirmation with a Western Blot analysis as you are aware.
Check out the video above for an overview of this analyzer. If you agree to use a reasonable number of assays per month Quidel will provide the analyzer at no cost to your practice.