Safe Medical Devices for Children (2006) / Chapter Skim
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2 Medical Devices for Infants, Children, and Adolescents
2 Medical Devices for Infants, Children, and Adolescents
Pages 46-72
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From page 46... ...
`It's unlikely that we would ever have got the pediatric catheters built if there hadn't been an adult market -- which we had to invent.'" Jerome Groopman, 2005, p. 361 This saga of medical device innovation illustrates both the special needs of children and the challenges of getting to the market a device that meets those needs.
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From page 47... ...
This chapter provides a specific pediatric context for the consideration of postmarket surveillance of medical devices used with children. It reviews definitions of pediatric subgroups (infant, child, adolescent)
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From page 48... ...
The definitions serve primarily as general guides that encourage attention by clinicians, researchers, policymakers, and others to developmental differences -- physical, cognitive, and psychological -- within young populations and between younger and older populations. In guidance documents on pediatric drug testing and assessment of pediatric medical devices, the FDA has defined infants as those younger than 2 years of age (FDA, 1994, 2004p; ICH, 2000)
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From page 49... ...
. For certain conditions and medical products, differences within this age group in cognitive and emotional development may be significant, particularly with respect to the use of medical devices that normally require user set-up steps, user programming, or other patient-initiated control.
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From page 50... ...
. To cite yet another kind of developmental consideration, clinicians and researchers have identified tactile, visual, and auditory overstimulation as a concern for ill infants who depend on ventilators and other medical devices to assist their breathing, nutrition, and other functions (ATS, 2003)
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From page 51... ...
. Eventually, we found a valve that would drain the fluid quick enough." Ben Harder, 2004 Another question considered in this report is whether postmarket surveillance studies are adequate to evaluate how children's active lifestyles may affect failure rates and longevity for implanted devices (see Chapter 6)
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From page 52... ...
The adolescent can, however, be expected to have more awareness of and control over movements such as rolling over that might dislodge or otherwise impair the functioning of a medical device such as a catheter or a breathing tube. Likewise, a 5-year-old and a 25-yearold who have had a cardiac pacemaker implanted may each know that they need to protect the device, but developmental differences in the understanding of risk and causation and in the control of impulses increase the probability of risky behavior by the child, for example, jumping off a porch (see, e.g., Giedd, 2004)
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From page 53... ...
Some complications associated with pediatric use of medical devices may result from patient activities that have a realistic potential for harm, given the inherent limitations or characteristics of the device. A continuing interest of clinicians, parents, and device manufacturers is strategies for "child-proofing" devices by changing their design or use.
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From page 54... ...
107250) , FDA recently provided guidance on the premarket assessment of pediatric medical devices.
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From page 55... ...
In addition to the guidance on premarket assessment, the agency issued guidance on procedures to ensure that advisory panels that review documents such as applications for premarket approval of medical devices appropriately include or consult with pediatric experts. This guidance, which responds to another provision in the Medical Device User Fee and Modernization Act (21 USC 360(e)
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From page 56... ...
Box 2.1 summarizes some of the developmental considerations for drugs compared to medical devices. To the extent that pediatric considerations are known for a medical device, the labeling of the device should reflect that knowledge.
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From page 57... ...
. To cite another example, FDA recently granted limited approval (through a Humanitarian Device Exemption, as discussed in Chapter 4)
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From page 58... ...
· Newborn hearing screener Devices developed primarily for children but also used with adults · Atrial septal defect occluder · Cerebrospinal fluid shunt Same core device, different accessories for pediatric use · Pulse oximeter with different sensor attachment for infants · Automated external defibrillator with paddles that deliver attenuated charge based on pediatric-specific algorithms Variations in device use or technique to accommodate developmental differences · Adjustment in radiation dose and frequency for computed tomography · Shift in implantation site for pacemakers used with young children · Use in pediatric cardiac procedures of adult bile duct stents Devices that vary in size for use with small patients · Baclofen infusion pump · Bronchoscopes · Heart valves · Testicular prosthesis · Intravenous catheters and needles Same Device for All Patients Sometimes the same monitoring, diagnostic, or therapeutic medical device is used for adults and all or most children without requiring pediatric modifications in size, design, or key accessories. For example, ear thermometers do not vary in size for adults and children nor do syringes, although needle sizes vary.
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From page 59... ...
.) Same Core Device, Different Accessories For some technologies, the core medical device may be the same, but the accessory devices that connect the patient to the device may differ based on patient size or other characteristics.
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From page 60... ...
Gross, M.D., Director, Division of Postmarket Surveillance, CDRH, November 7, 2004)
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From page 61... ...
Adjustments in Device Size Sometimes the physical size of a medical device is the main issue with pediatric use. Infant or child versions exist for many common medical devices such as hospital beds, bandages, and scales.
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From page 62... ...
(The mean axial length of a newborn's eye is 17 mm, whereas that of an adult is 23 to 24 mm.) In addition, the surgical procedure must accommodate developmental considerations such as lower scleral rigidity, greater elasticity of the anterior capsule, and higher vitreous pressure (see, e.g., Dahan, 2000; Ahmadieh and Javadi, 2001; Good, 2001; Pandey et al., 2001)
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From page 63... ...
For example, in intracardiac echocardiography (an imaging technique used to guide certain cardiac procedures) , the size of the catheter used in the procedure has limited use with very young patients.
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From page 64... ...
Efforts to shrink left ventricular assist devices (which have been used to support patients awaiting heart transplants) have encountered problems because "blood flow in the smaller version is completely different than in the larger adult heart devices.
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From page 65... ...
. Devices That Accommodate Children's Growth A unique pediatric problem with the use of certain implanted medical devices is that they either interfere with growth or do not grow as children grow.
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From page 66... ...
. They found a lower rate of devicerelated complications requiring reoperation than for metal devices and low rates of adverse events (e.g., infections, instability, and foreign-body reaction)
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From page 67... ...
As noted above, some medical devices that are critically important for certain conditions require cooperation from the patient that may not be possible for infants and very young children. The options in such situations may involve adaptations in the device, development of an alternative device, or foregoing use of the device until the child has matured.
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From page 68... ...
. As in this example, workarounds may involve "off-label" or unlabeled uses of medical devices.
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From page 69... ...
Now, newer connectors have been designed to reduce the dead space to less than a milliliter. IDENTIFYING PROBLEMS OR CONCERNS WITH MEDICAL DEVICES USED WITH CHILDREN Problems with the potential or actual performance of devices in infants, children, and adolescents may be identified in at least three different ways (Box 2.3)
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From page 70... ...
.To cite another example, because children require higher heart rates than adults (approximately 140 beats per minute for infants versus 70 beats per minute for adults) , it is anticipated that battery life may be shorter in certain cardiac devices, which makes the prospect of battery exhaustion and planned, serial replacement of devices a reasonable expectation in the pediatric population rather than an unanticipated adverse event (ACC, 2004)
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From page 71... ...
. Based on a review of the adverse event reports, FDA worked with CDC and health departments in many states and three cities on an epidemiologic study that attempted to assess risk factors for meningitis among implant recipients compared to a control group (Reefhuis et al., 2003)
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From page 72... ...
Thus, FDA provides guidance on device design and testing and evaluates information on safety prior to approval or clearance of devices. Through the agency's adverse event reporting program and requirements for postmarket studies of certain devices, it focuses on safety after devices are marketed.
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