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Experts Urge Federal Government and FDA to Adopt Stricter Oversight for Medical Devices Used for Children

Jul 20, 2005 |

A recent report by the Institute of Medicine (IOM), a group that advises the government on health, advocates more vigilant monitoring of medical devices sold for children.

Increased attention to potential consequences associated with such devices could uncover harmful side-effects and improve safety for these most vulnerable patients.

The report concluded that the biggest problem was a lack of data on the impact of medical devices on children’s growth and development. Frequently doctors must adapt products designed for adults to children’s needs because fewer devices are designed specifically for children, who represent a smaller market.

This is especially true in the case of very small children and newborns where some types of devices are actually adapted from those used on small animals. Dr. Henry Chugani of Hutzel Hospital in Detroit, Michigan, has found that using micro positron emissions tomography (PET) equipment on small infants weighing less than 2 pounds is possible when using a scanner designed for small animals.

Larger scanners used for adults and older children are imprecise when it comes to very small infants and so Dr. Chugani used his years of conducting animal research at the University of California-Los Angeles to introduce the smaller scanner into the nursery.

After receiving FDA approval last year, the doctor acquired one of the small refrigerator-sized scanners and has used it to conduct tests on some 30 infants. Dr. Chugani has found he is able to pinpoint problems that can reveal the source of epileptic seizures and other brain diseases.

The use of the small scanner is seen as a possible way to discover new forms of infant brain disease and detection methods. At least one epileptic baby has had surgery based on the results of the PET scan.  

Unfortunately, this is not always the case. All too often, children simply do not receive medical devices which are specifically designed with their special needs in mind. 

The IOM report concluded that a lack of data on how devices affect children's growth and development presents a serious problem. In addition, children’s active lifestyle or hormonal changes in puberty can affect the way a device functions.

One example the IMO cited was a pre-school girl, whose defibrillator, used to treat a rare irregular heartbeat, broke due to her rapid growth. The defibrillator misfired, causing her to collapse with severe chest pain.

In another instance, a medication syringe intended for babies posed a choking hazard because parents failed to remove its difficult to see plastic cap.

Such problems can only be corrected and prevented if parents and health care professionals report them.  The panel recommended the government take the following actions:
•    Congress should give FDA the authority to require postmarket studies of any device; today, it can force them to perform such studies only for certain products.
•    Congress should require FDA to establish a public database showing those studies' status and findings.
•    Congress should fund improved postmarket surveillance for device-related problems in both adults and children.
•    FDA should collaborate with the National Institutes of Health to prioritize research on devices used on children despite a lack of manufacturers' studies.
•    FDA should work with parents, patient advocates, health organizations and the industry to increase reporting of side effects or potential device flaws.

The importance of instituting these measures and ensuring children’s safety was confirmed by professionals. Mark Isaac of the Elizabeth Glaser Pediatric AIDS Foundation remarked "We must raise the level of vigilance for devices used in children or we risk causing serious problems for the young patients we are trying to help." The Foundation is encouraging Congress to institute the requests.

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