This month's article discusses how to best investigate the benefits of new devices and testing products for your clinical practice and how to avoid the pitfalls of adopting new technologies.
Introducing new technology into a medical practice is not the same as buying a new 60-in television for a “man cave” or a crock pot for the kitchen. One must be cautious and consider the benefits and risks of being an early adopter of a new diagnostic device. Pediatricians must have confidence that their tests are accurate, and performed and interpreted correctly. In this edition of Pediatrics V2.0, we’ll discuss how to best investigate the acquisition of a new device for your practice. Also, we will take a look at several commonly used office technologies and explain how to avoid pitfalls.
All pediatricians should seek out a reputable, dependable medical supply salesperson. Fortunately, medical supply vendors have not been supplanted by Internet sales. McKesson (San Francisco, California) comes to mind as one of the large medical supply companies with a national sales force, and many smaller companies employ experienced salespersons as well. Experienced sales representatives often can give you the best price on your equipment, resolve questions, expedite repairs, and let you know when something new and exciting becomes available. Best of all, they have affiliations with medical equipment manufacturers (such as Welch Allyn; Skaneateles Falls, New York), so if you want to learn about a particular device or test, they can make a phone call and facilitate a demonstration, and perhaps even arrange an in-office trial.
Experienced pediatricians always investigate competing products before writing a check. They also seek opinions from colleagues and contact manufacturers directly when gathering information. All this effort helps them avoid some very expensive mistakes. While it’s always nice to be among the first to implement a brand new technology, sometimes patience proves to be a virtue. In some situations, it pays to wait until all the “bugs” are worked out by the manufacturer and purchase a more mature product a year or more after the inaugural release.
If you are among the first to buy a new product, get a written agreement that you will get a “free” upgrade or a guaranteed credit allowing you to trade the version 1.0 model for the next version when it becomes available. Finally, when you are close to purchase, make sure that you understand the warranty and that you have a clear understanding of what consumables need to be ordered on a regular basis. Keep in mind that some lab tests must be stored in a refrigerator and brought up to room temperature before they are performed (some lipid tests, for example). Also for CLIA-waived lab tests, understand how often controls need to be run (usually once a day for rapid tests and when you start a new box of tests). Negotiate for free on-site training for the product and on-site support if applicable.
When considering the purchase of a new technology for your practice, determine the return on investment and whether the procedure is reimbursed by insurance companies. It is always worthwhile to get the suggested billing codes from the manufacturer and contact insurance companies for reimbursement information. These days, there are few office procedures, other than wart treatments, that generate significant profit per procedure, so spend your money wisely. Some devices are worth an investment, not because they generate revenue for the office but because they will expedite office visits (otoacoustic emission hearing screeners, for example), allowing the practice to fit in a few more visits each day.
Remember that an expensive device or piece of equipment (a photoscreener, or a high-end multifunction scanner, printer, fax, and copier) often can be leased. With technologies that may be obsolete in a few short years, this may be the best way to ensure your technology stays current, and that your office is always equipped with the latest and greatest equipment to provide patients with the most cutting-edge care.
It is often helpful to contact colleagues who may have already purchased the high-end device you are investigating and seek their opinions regarding usefulness and ease of operation. I have been a member of the American Academy of Pediatrics (AAP) Section on Administration and Practice Management for many years, and its listserv is often busy with interesting discussions regarding office technologies. Another AAP section with a growing number of members is the Section on Advances in Therapeutics and Technology. This section also has a busy listserv.
Finally, it may be helpful to review catalogs from companies such as Henry Schein Medical or Medical Arts Press, because often they highlight new products and they may provide you with a good idea whether your sales representative is actually giving you competitive pricing. Remember, it is not just the expensive, high-tech items that make practicing pediatrics exciting for providers and staff. Sometimes all it takes to make your patients happy are new patient-pleasing Band-Aids, or flavored tongue blades, or table paper with cartoon characters.
Depending on the device being implemented, make sure the staff is sufficiently trained to operate the device correctly. Take advantage of the training disk, the online tutorial, or the office in-service when available. Also, put a written procedure together to include in your practice’s “Procedures and Policies” binder so that new staff members can review this information before using the device. They should be supervised by experienced staff before they are allowed to go solo. And, lest we forget the obvious, always, always read the manual!
The majority of new medical devices that come to market have been reviewed by the US Food and Drug Administration and found to be similar in function to a device that has previously been on the market (class 2 devices). A few mostly implantable devices undergo a more rigorous approval process, requiring clinical trials proving both safety and efficacy (class 3 devices). The end result is that when a new device comes to market, especially one that introduces a new technology, pediatricians must determine how accurate, reliable, and useful that device is in clinical practice. The Table provides some advice for comparing results from your devices to accepted "standards," so you can determine their reliability and measurement bias that will provide insight as to when you need to repeat a test or seek an alternate test.
When rapid strep tests first became available, we obtained double swabs and ran office throat culture plates along with rapid strep tests to determine the limitations of the new technology. We discovered that when rapid strep tests were positive, most of the time our traditional throat cultures were positive as well. Unfortunately, a substantial number of negative rapid strep tests proved to be false negatives, and subsequently we backed up negative rapid strep tests with throat culture, as is still recommended by the Report of the Committee on Infectious Diseases, aka the Red Book.
Such office-based validation of new technology taught us a valuable lesson. Sensitivities and specificities as reported by manufacturers are performed under “ideal” lab conditions, and often do not reflect real-world practice. It is not an easy chore to obtain a throat swab from an uncooperative child. Each of us has developed our own methodology to obtain an optimum specimen (“say ah” just doesn’t cut it for most). Some pediatricians won’t permit support staff to obtain swabs until they can consistently demonstrate an ability to obtain good specimens. Bottom line, if you don’t have enough streptococcal antigen on the swab, you are likely to get a negative rapid test. Most pediatricians also know they are more likely to get false negatives early in the course of a strep infection when the numbers of bacteria in the throat have not reached levels that are seen several days into the illness.
This healthy level of skepticism also proved valuable when ear thermometers were introduced to office practice. Before clinical studies were published that detailed the accuracy and limitations of what were initially called tympanic thermometers, pediatricians interested in purchasing devices from competing manufacturers would convince the vendor to let them trial the device prior to purchase. Prudent pediatricians compared the measurements these devices produced to their standard glass or digital thermometers and came to 1 of 2 decisions: Either the device was not ready for “prime time,” or it was, in fact, worth integrating into practice because it would speed the taking of vital signs and could be used in children in whom detection of fever was not critical. Today most pediatricians have confidence in the utility of forehead temperature scanning thermometers, so they are routinely used in most pediatric practices.
Most technologies improve over time (and get less expensive). These days, our strep tests are easier to perform and more accurate than they’ve ever been. Some pediatricians have discovered that when they compare rapid strep tests to throat culture, the false negative rate is so low that they choose not to back up rapid strep tests unless the patient has not been ill long or they have a strong clinical suspicion of a strep infection. It is always a good idea to run 25 to 50 rapid strep tests with backup culture periodically to determine what your practice’s false negative rate is and whether it is significant enough to warrant performing backup throat cultures regularly. This is a good example of how we should continue to keep an open mind regarding using technologies and examining ways to define and implement “best practices.”
By now we have had extensive experience using transcutaneous bilirubinometers in the hospital setting in screening newborns prior to discharge for rising bilirubin levels, or for levels that warrant a more accurate serum bilirubin level to determine whether phototherapy is indicated or whether we can closely monitor a baby on an outpatient basis. When using these devices in the office, it would be wise to remember their limitations. These are screening devices whose measurements correlate well with total serum measurements. In my own experience, there is usually only a 1-mg/dL to 2-mg/dL difference between the 2 measurements. It has been well documented that the accuracy of transcutaneous bilirubin measurements diminishes with serum levels over 15 mg/dL. It is recommended that decisions regarding initiating phototherapy should be made based on serum levels only. Additionally, once phototherapy has been initiated, then serum levels should be followed rather than transcutaneous measurements.
We have become dependent on pulse oximeter measurements to help make important clinical decisions, and it can be frustrating when it is difficult to obtain these important readings when we evaluate a child in respiratory distress. Oximeter measurements are reassuring when they are normal and worrisome when they are low, so it would be wise for practices to trial different brands prior to purchase and not to err on the side of buying a less expensive device. Pulse oximeters are a good example of “you get what you pay for.” Some can acquire a signal more quickly than others, and provide information about pulse rate and quality of pulse/signal. As you are aware, there are many different sensor types that can facilitate taking these measurements, so it is well worth your investment to trial a variety of finger clip as well as reusable and disposable wraparound sensors so your office staff have a variety from which to choose. It is important that they have the opportunity to gain experience with all sensor types. Purchase from companies that are willing to provide “in-service” demonstrations following purchase and that will check back on their use from time to time.
Remember, no test is perfect. In clinical practice, we may be dealing with false-positive as well as false-negative tests. Devices are only as good as the people performing the tests and interpreting results. As clinicians we should always be prepared to retest or to use alternative methods to rule in or rule out a suspected diagnosis. When in doubt, clinical judgment always should prevail over technology.
DR SCHUMAN is adjunct associate professor of pediatrics at the Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire. He is also section editor for Pediatrics V2.0 and an editorial advisory board member for Contemporary Pediatrics. He has nothing to disclose in regard to affiliations with or financial interests in any organizations that may have an interest in any part of this article.
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