New Products for pediatrics: 1999

New products for pediatrics: 1999

By Andrew J. Schuman, MD

Medical technology continues to improve the lives of pediatricians and their patients. The latest innovations include a new thermometer technology, an office-based waste-processing system, and a fully electronic stethoscope. First of two parts.

It's an exciting time to be practicing pediatrics. As we move into 21^st century, there is much to look back on and much to anticipate. I am delighted to present here the first of two articles highlighting developments in medical technology. This article offers a brief retrospective view of 1999 and introduces you to a wide array of new products that can be used in your daily practice. The second article, to be published next month, looks ahead at trends. Even if you think you have a "high tech" practice today, wait till you see what tomorrow brings.

To put past and present advances into perspective, I've constructed a time line of innovation in this century (see "A century of technology"), noting a variety of technology milestones, not just those involving medical care. As you can see, we have accumulated the majority of office-based devices in the last two decades.

A century of technology

1903 First electrocardiograph was invented by Willem Einthoven; the unit weighed 600 pounds and was not very portable.

Einthoven was awarded a Nobel Prize in 1924 for his invention.

1913 The direct vision laryngoscope was invented by Chevalier Jackson, who later developed the bronchoscope.

The zipper was marketed by Gideon Sundbach.

The first X-ray tube was patented by William D. Coolidge.

1915 First room air conditioner was produced by Carrier Engineering Corp.

1917 The first "sneaker" was introduced by US Rubber.

1924 Brain waves were discovered by Johannes Berger, using a string galvanometer.

1928 Penicillin was discovered by Alexander Fleming.

1930 Scotch brand cellulose tape was introduced.

1941 Penicillin became available for use in patients.

1945 Original Slinky toy was sold at Gimbel's in Philadelphia.

1946 Streptomycin was introduced.

1948 Polaroid Land Camera was marketed to consumers.

1949 Chloramphenicol was placed on the market.

1949 Silly Putty was produced by former General Electric employee, Peter Hodgson.

1953 Apgar Newborn Scoring System was developed by Virginia Apgar.

The Watson and Crick model of DNA structure was reported in Nature. Watson and Crick received a Nobel Prize in 1962 for their discovery.

1955 Salk vaccine was introduced.

1956 Liquid Paper was marketed by Bette Nesmith Graham, a pioneering secretary with poor typing skills.

1957 Hula Hoop, from Wham-0 Company, excited consumers so much that 25 million were sold in two months.

Abdominal ultrasound (based on sonar technology) was first used to establish pregnancy.

1959 Frisbee, a flying disk from Wham-O Company, flew off retailers' shelves.

Etch A Sketch was introduced by Ohio Art Company.

1960 The aneroid sphygmomanometer was introduced, supplanting the mercury sphygmomanometer.

1961 Scotch brand Magic Transparent Tape hit retailers' shelves.

1962 Sabin oral polio vaccine became available.

1963 First disposable diaper available for purchase.

1967 The computerized axial tomography (CT) scanner began to be used widely. G. N. Hounsfield, its inventor, received a Nobel Prize for Medicine.

1968 The first sports shoe was introduced by Nike.

A computer mouse was launched by Douglas C. Engelbart.

1969 Snugli infant carrier was developed by a pediatric nurse, Ann Moore.

1972 The first MRI scanner was produced using liquid helium to supercool magnets in a cylindrical chamber.

1976 The first wearable infusion pump was brought to market.

1977 The Apple I computer caught the eyes of consumers, priced at $666.

1984 The first issue of Contemporary Pediatrics was distributed to pediatricians. Home phototherapy first available.

1987 Microtymp, the first portable tympanometry device, was unveiled.

Latex agglutination streptococcus tests became widely available.

FirstTemp, the first ear thermometer, was introduced to the physician office.

1988 Portable home dialysis machine was produced.

The Clinical Laboratory Improvement Act of 1988 was passed, restricting office laboratory tests that could be performed on site.

First acoustic otoscope became available.

1989 Rapid enzyme immunoassays were marketed for use in testing for respiratory syncytial virus and rotavirus.

Phototherapy blankets were unveiled for home use.

Hemacue, a silent and safe hemoglobinometer, was introduced.

1991 Thermoscan ear thermometers were launched for use in offices and homes.

1992 CLIA 1988 went into effect. Occupational Safety and Health Administration mandated the adoption of universal precautions.

New thresholds for lead poisoning were adopted.

1993 An optical immunoassay streptococcus test was launched.

1994 Giardia-specific antigen rapid assay reached the market.

Speech recognition audiometry was introduced to pediatric practice.

1996 First office rapid streptococcus test was waived under CLIA '88.

EMLA cream became available for preinjection anesthesia.

1997 Second generation acoustic otoscopes were introduced for office and home use.

1998 The first blood lead screener was available for use by physicians in the office. Dermabond glue became available in the US for laceration repair.

AuDx, the first office distortion product otoacoustic emissions hearing screener, was unveiled.

1999 Temporal artery thermography was introduced.

The same advances that are responsible for improvements in business and home electronics—computers, compact disk players, fax machines, and dedicated video disk players—have helped create many of the tools pediatricians use daily. The time line also shows other trends. There has been a transition from time-consuming, latex agglutination office diagnostic tests to the speedier and easier-to-interpret enzyme immunoassay technologies. However, the Clinical Laboratory Improvement Act of 1988 markedly reduced the number of new diagnostic devices and laboratory tests that could be developed and used in the average office.

New devices have met with varying degrees of success. The Hemacue hemoglobin analyzer is now found in the majority of medical practices, while other products, such as the original acoustic otoscope, are no longer in use.

Today's technologies

While it's easy to become nostalgic about the way things were (see "Looking back"), we need to remember that medical science thrives on change and builds on previous inventions and discoveries. This year's introductions include a new thermometer technology, an office-based system for processing medical waste, and a fully electronic stethoscope.

Looking back

When I started my pediatric residency some 20 years ago, I recall being impressed by the number of antibiotics that were introduced each year, and by the wonderful diagnostic capabilities of CT scans and MRIs that had just become available. Transcutaneous oxygen and carbon dioxide monitors were in wide use in our neonatal intensive care unit, but the pulse oximeter was not yet available. Temperatures were taken rectally with digital thermometers, and theophylline was the drug of choice for treating the asthmatic child. In our overcrowded children's hospital, "iron lungs" were stored in hallways, and there were several four-bed, tile-walled patient rooms used as "croup rooms" for decades before I started my training. These artifacts of ancient pediatrics were a constant reminder to me and my fellow residents of how sophisticated pediatric medicine was becoming.

Even 20 years ago, though, pediatrics was technologically sophisticated compared to the 1950s and 1960s, when a good part of patient care was supportive. We have come a long way in understanding diseases and their cures. Many senior pediatricians can remember when penicillin came into widespread use in the 1940s, changing the role of the pediatrician from passive bystander to active participant in disease management. Since that time the introduction of a variety of antibiotics, vaccines, asthma and allergy medications, and diagnostic tools has enabled pediatricians to effectively detect, prevent, and combat many childhood diseases.

At this century's end, pediatric care continues to develop and change. Less phototherapy is being done, hospital stays for sick children are shorter, our legislators are advocating laws to protect patients' rights, and we are using antibiotics more conservatively in an attempt to preserve their efficacy in years to come.

From hospital to office to home

It is easy to take for granted the medical tools we have at our disposal to speed our exams, screen for common pediatric conditions, or expedite an accurate diagnosis. In any pediatrician's office today, a variety of well-designed products are in daily use, such as rapid streptococcus tests, ear thermometers, silent and safe hemoglobin analyzers, tympanometers, pulse oximeters, vision screeners, hearing screening devices, nebulizers, and peak flow meters. We must remind ourselves that this equipment has been in existence for less than 15 years.

Advances in biotechnology and a shift in emphasis from hospital-to office-based medical care together account for the development of the high-tech office. Sophisticated and expensive devices are usually launched first in hospitals, particularly in pediatric and neonatal intensive care units. As technology advances and becomes more affordable, the new instruments eventually migrate to the office.

Over the past two decades, medical technology first used in hospitals and offices has found a place in our patients' homes, assisting in the management of complex medical conditions. Blood glucose monitors with digital memory, apnea monitors, infusion pumps, peak flow meters, home phototherapy blankets, ventilators, ear thermometers, pregnancy and cholesterol tests, and home spectral gradient acoustic reflectometers are all available today for home use by patients.

Temporal artery thermometry

Eleven years ago pediatricians began using tympanic thermometers in their offices, and clinical thermometry hasn't been the same since. Speed, ease of use, and acceptance by patients have made ear thermometers virtually ubiquitous in medical practice, and several inexpensive models are commonly used at home. Exergen Corp., based in Watertown, MA, has long been an innovator in the development of infrared thermometry technologies. This year the firm introduced a family of clinical thermometers that measures temperature not in the ear canal, but from the temporal artery as it perfuses the skin of the forehead and nearby tissues. Exergen's SensorTouch temporal artery thermometers use dual scanners, one that measures ambient environmental temperature and another that gauges the arterial temperature of the patient's skin (Figure 1). The SensorTouch thermometers record over 2,000 readings per second. An internal "heat balance" algorithm determines the arterial temperature, which is displayed in the unit's LED screen. Clinical studies have shown that the devices are extremely accurate. To use the thermometer, one presses a button on the device, sweeps the thermometer across the temple, and then touches the sensor behind the child's ear. The reason for this last maneuver is to avoid inaccurate readings that may result if there is perspiration on the child's forehead.

Many new SensorTouch models are now available, including a home version (developed with Philips Electronics North America Corp.) that sells for less than $100 and a miniature neonatal model for use in nursery incubators. The neonatal model is designed for storage in an incubator, where the generally uniform temperatures of newborns can be monitored from any accessible exposed area (temporal artery, axilla, neck, or chin). It is priced at $399.

Pediatricians might consider either the hospital or professional model. The hospital version of the SensorTouch is designed to be extremely durable. It has a list price of $599 and a lifetime warranty. The professional model (price not set at the time of publication), looks like the home version but has a two-year warranty. The home version requires no sensor covers, but the office version has inexpensive plastic covers used to prevent cross contamination between patients.

Many products have been introduced first in hospitals. As costs come down, these products move into physicians' offices and finally appear in the homes of patients. For more on this trend, see "From hospital to office to home."

Waste not!

Medical waste disposal is a significant problem for pediatric offices. In most practices, when disposable needle bins are full they are replaced with a new container, and when the bins accumulate, they are collected by a medical waste disposal service. Medical Innovations Inc. provides an alternative to the traditional means of disposal with an on-site medical waste-processing system (see Figure 2). Their Medical Waste Machine system includes reusable stainless steel needle disposal bins that are mounted in each examination room. When a bin is full, it is placed into a processing unit, along with a plastic disk that looks like a shuffleboard puck. The processing unit heats the waste to extremely high temperatures during a four-hour cycle, sterilizing it (50 minutes of sterilization and the rest a cooling down period) and rendering it both nonreusable and nonrecognizable, as required by Occupational Safety and Health Administration.

The plastic disk liquefies at temperatures above sterilization levels. Then it melts down, around, and through the waste. When the process is complete, only a black, circular plastic block remains, which can be discarded as nonregulated waste. The cost of the system depends on the number of needle bins required and the frequency with which waste is processed. Overall, the system can provide significant cost savings, and may be more efficient than traditional ways of disposing of medical waste.

An electronic stethoscope

The first stethoscope, invented by French physician R. T. H. Laënnec in 1816, consisted of a hollow wooden tube that was held to a patient's chest in order to study sounds. Laënnec's stethoscope was a huge improvement on the traditional technique of auscultation—pressing one's ear against a patient's chest wall. Wooden stethoscopes were used until the middle of the 19^th century. At that time, design changes included earpieces, tubing for binaural sound, and a diaphragm for amplification. Not much changed in the 20^th century until several manufacturers added electronic amplification.

New this year is the HP Stethos, the first fully electronic stethoscope, introduced by Hewlett- Packard. While the device looks similar to traditional acoustic stethoscopes, it has an electronic design that delivers sound amplification up to 14 times greater than standard stethoscopes. The design also includes electronic filters for ambient and hand tremor noise, assuring high quality audio even in noisy environments. Another nice feature is one-button control, which enables the operator to switch from diaphragm to bell to extended diaphragm modes with one hand without interrupting auscultation. Priced at about $350, the HP Stethos is powered by three small button batteries that last approximately one year (see Figure 3).

Blowing the whistle on asthma

Peak flow meters have long been available to improve the at-home monitoring of children with asthma. Unfortunately, though, peak flow meters can be difficult for young children to use.

Launched this year by Harwill Medical is the WhistleWatch Asmalert, designed to warn parents when a young asthmatic child requires a change in his or her drug regimen (Figure 4). The whistle/peak flow device is set at a child's expected peak flow reading. When the child blows through the device, a whistle sounds when at least 80% of the child's desired peak flow is achieved. Much easier to use than a standard peak flow meter and considered a fun toy by young children, the WhistleWatch Asmalert can significantly improve the care of the young asthmatic. It is priced at $14.95 for one device or $299 for a case of 20.

An eye on vision screening

Although pediatricians should routinely screen infants and children for astigmatism, strabismus, cataracts, and refractive errors, less than 40% of children under 4 years of age receive an adequate visual exam. Two new devices are now available to facilitate eye exams in young children.

The EyeDx Digital Vision Screening System consists of a specially designed digital camera and computer software (see Figure 5). The EyeDx camera takes two digital images of the child's face, which are then downloaded into a computer system using proprietary software. The software analyzes the images of the eyes and issues a one-page printable report. The report indicates that the patient either has passed the screening or should be referred for further testing. A complete exam of both eyes takes three minutes. The price of the system including the camera and software for the first 500 "pass" or "refer" exams is approximately $2,100. After the initial purchase, the procedure fee is between $2 and $3 per completed examination, depending on usage. Tests must be purchased in groups of 500. Keep in mind that the EyeDx must be connected to a computer, which is not included in the price of the system.

Another new vision screening device is the SureSight from Welch Allyn Inc. Priced at $4,195, SureSight is a portable autorefractor that can be used to detect amblyopia or refractive errors in infants and children of all ages. Each eye is tested separately. The examiner holds the SureSight 14 inches from the child's face while a series of beeps indicates the correct camera position and distance and position from the eye being examined. A sequence of five to eight readings is obtained from each eye. After both eyes have been tested, a pass or refer result is displayed on the LCD screen. The SureSight is stored on a charger base and can be attached to a $199 printer from Hewlett-Packard so that results can be included in the patient record (Figure 6).

A path to better audio testing

Welch Allyn, which has a comprehensive line of pediatric diagnostic devices, has also introduced the AudioPath Home Screening Platform (Figure 7). Using evoked otoacoustic emissions technology, the AudioPath screener tests hearing at 2 kHz, 3 kHz and 4 kHz, and reports a simple pass or refer result on an LCD screen. The test takes about 30 to 60 seconds for each ear, and unlike traditional tests does not require an active patient response. A variety of reusable eartips for infants and children of all ages are included with the device. AudioPath, priced at $3,500, is battery operated and completely portable. Following a series of measurements, the AudioPath can be returned to its printer charger base, so that results can be printed for inclusion in the patient's chart. Even newborns can be tested with the AudioPath at their initial office visit, if your hospital doesn't have a newborn screening program. According to Welch Allyn, the AudioPath system will soon have add-on audiometry and tympanometry modules available, so that it can serve as a complete hearing diagnostic device.

Keep it simple

Most of the most impressive devices we rely on are simple in design and use. Such is the case with the cones and buds used in cryosurgery and a new disposable speculum.

Cerumen frequently obscures our inspection of the tympanic membrane. To improve our view, we may resort to using metal or plastic curettes to remove cerumen. The KleenScoop disposable speculum from Welch Allyn has an attached curette that extends about a centimeter beyond the tip of the speculum (Figure 8). Soft cerumen can usually be removed under direct visualization, avoiding blind curettage of the ear canal and the trauma associated with this procedure. Note that the reach of the KleenScoop extends only to the anterior prominence of the ear canal in patients over 10 years of age, so deep wax may need to be removed using other techniques. KleenScoop specula sell for about $40 per box of 100, and can only be used with Welch Allyn otoscopes.

In my practice, I seem to be doing a booming business in cryosurgery for removing warts and molluscum contagiosum. CryoSurgery Inc, suppliers of Verruca-Freeze cryogen, has made this process a bit easier this year with the introduction of transparent limiting cones in six sizes ($50 for the set). The cones, placed over the wart to limit the area frozen by the cryogen spray, make it easy to observe the freezing process and to target the wart being treated (see Figure 9). CryoSurgery has also recently introduced disposable CryoBuds in three sizes for treating lesions in hard-to-reach places or on bony surfaces. A pack of 50 buds costs $12.

Treating seizures

When a child has a seizure in a pediatric office, treatment has typically been to administer anticonvulsant medication intravenously. A new gel preparation of diazepam, combined with a "quick dose," prefilled, rectal delivery system, permits fast treatment without starting an intravenous line (Figure 10). Elan Pharmaceuticals markets diazepam rectal gel (Diastat) in fixed doses of 2.5, 5, and 10 mg with a 4.4 cm pediatric tip. They come two in a package. A dose of 0.5 mg/kg (rounded to the nearest available dose) generally results in cessation of seizures within minutes. Diastat is usually not associated with respiratory depression, produces peak levels in 1.5 hours, and can continue to suppress seizure activity for several hours. You can give a repeat dose four to 12 hours after the initial dose. In addition to improving the office management of seizures, Diastat is worth considering for home use by children in your practice who have chronic or refractory seizure disorders.

Point and click

Computer technology has come a long way since the Apple II, the first home computer, was introduced in 1977. It is unusual these days to find practices that haven't computerized billing, and many physicians use a variety of medical software to improve patient care. Two new software products are worth your consideration.

Medifor Inc. has recently released version 3.0 of their Patient Ed Provider Productivity Suite (see Figure 11). Patient Ed is a comprehensive system for preparing patient prescriptions and instruction sheets. With just a few clicks of a mouse, a pediatrician can easily navigate through the Patient Ed screens. The first step is to select a patient's name and the assigned provider from two pull-down menus, and indicate a diagnosis. A series of screens guides you through writing the prescription and selecting an instruction sheet for the patient. The instruction sheet includes answers to common questions and detailed instructions for treatment and follow-up. All this can be accomplished in less than a minute. New to the current version are a pop-up warning of potential drug interactions and the ability to store patient information in a database that can be accessed during return visits. The software is very affordable at $700 per year for the first physician in an office and $395 per year for additional providers.

Medifor recently acquired CMC Research, a prominent medical publishing company that produces dozens of CD-ROM titles for physicians and other medical professionals. CMC's latest, and perhaps best, pediatric software offering is PediaStat. With contributions by over 150 authors, PediaStat presents a quick review of the course, differential diagnosis, pathophysiology, and therapies for hundreds of pediatric diseases and conditions. One enters a symptom or diagnosis as a key word, and the software retrieves and organizes the relevant information for review. PediaStat also includes a full version of Lexi-Comp's Pediatric Dosage Handbook, which lists all currently available pediatric medications, complete with dosage and drug interaction information. A bargain at $150, the software runs on both Macintosh and Windows-based systems.

What's ahead

I hope this year's product review has piqued your curiosity and perhaps convinced you to try some of the devices I've discussed. For information on how to reach their manufacturers, see "For more information."

If you think you've seen everything, just wait till next month, when we will turn your attention toward the future of pediatric office technologies. As you ponder what future technologies have in store for our profession, perhaps you should also take the opportunity to do your last minute Y2K preparation—buy those batteries and flashlights, plug in the generator, and buy some bottled water . . . just in case! See you in the year 2000.

For more information

SensorTouch temporal artery thermometers
Exergen Corp.
51 Water Street
Watertown, MA 02472
617-923-9900
www.exergen.com

Medical Waste Machine
Medical Innovations
PO Box 148
Wayland, MA
508-358-8099

HP Stethos electronic stethoscope
Hewlett-Packard Co.
Medical Products Group
3000 Minuteman Road
Andover, MA 01810
800-225-0230
www.hp.com/go/hpstethos

WhistleWatch Asmalert peak flow device
Harwill Medical Ltd
Mallinckrodt (US distributor)
3 Missouri Research Park Drive
St. Charles, MO 63304-5685
314-939-5434
www.harmed.co.za

EyeDx vision screener
EyeDx Inc.
4370 La Jolla Village Dr., Suite 400
San Diego, CA 92122
877-323-9339
www.eyedx.com

SureSight vision screenerAudioPath EOAE screenerKleenScoop speculum tip
Welch Allyn
4341 State Street Road
Skaneateles Falls, NY 13153
800-535-6663
www.welchallyn.com

Verruca-Freeze CryoBuds and limiting cones
CryoSurgery, Inc.
PO Box 50035
Nashville, TN 37205-0035
800-729-1624
www.cryosurgeryinc.com

Diastat diazepam rectal gel
Elan Pharma, division of Elan Pharmaceuticals
800 Gateway Blvd
South San Francisco, CA 94080
888-272-3526
www.athenaneuro.com

Patient Ed and Pediastat
Medifor Inc.
647 Washington Street
Port Townsend, WA 98368
800-366-3710
www.medifor.com

As always the author would like to thank Virginia A. Mason for her invaluable assistance. This article is Y2K compliant, and no pediatricians or medical devices were damaged in its preparation.

THE AUTHOR is Adjunct Professor of Pediatrics at Dartmouth Medical School, Lebanon, NH, and practices pediatrics at Hampshire Pediatrics, Manchester, NH. He is a Contributing Editor for Contemporary Pediatrics.



Andrew Schuman. New Products for pediatrics: 1999. Contemporary Pediatrics 1999;12:36.