[Federal Register Volume 61, Number 167 (Tuesday, August 27, 1996)]
[Proposed Rules]
[Pages 44013-44019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 880

[Docket No. 85N-0285]


Medical Devices; Reclassification of the Infant Radiant Warmer

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the infant radiant warmer from class III (premarket 
approval) into class II (special controls) based on new information 
regarding the device. The infant radiant warmer is a device consisting 
of an infrared heating element intended to maintain the infant's body 
temperature by means of radiant heat. This document summarizes the 
basis for the agency's findings that sufficient valid scientific 
evidence is available to support reclassification of the infant radiant 
warmer and to establish special controls to provide reasonable 
assurance of the safety and effectiveness of the device. This action 
implements the Medical Device Amendments of 1976 (the amendments) as 
amended by the Safe Medical Devices Act of 1990 (the SMDA).

DATES: Written comments by November 25, 1996. FDA proposes that any 
final rule based on this proposal become final 30 days after 
publication in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1287.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Classification and Reclassification of Devices Under the Medical 
Device Amendments of 1976
II. Reclassification Under the Safe Medical Devices Act of 1990
III. History of the Proceedings
IV. Device Description
V. Recommendation of the Panel
VI. Summary of the Reasons for the Recommendation
VII. Risks to Health
VIII. Summary of Data Upon Which the Recommendation is Based
IX. FDA's Tentative Findings
X. Environmental Impact
XI. Analysis of Impacts
XII. Paperwork Reduction Act of 1995
XIII. Request for Comments
XIV. References

I. Classification and Reclassification of Devices Under the Medical 
Device Amendments of 1976

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360c), as established by the amendments (Pub. L. 94-
295) and amended by the SMDA (Pub. L. 101-629), FDA must classify 
devices into one of three regulatory classes: Class I, class II, or 
class III. FDA's classification of a device is determined by the amount 
of regulation necessary to provide reasonable assurance of safety and 
effectiveness of a device. Except as provided in section 520(c) of the 
act (21 U.S.C. 360j(c)), FDA may not use confidential information 
concerning a device's safety and effectiveness as a basis for 
reclassification of the device from class III into class II or class I.
    Under the original 1976 act, devices were to be classified into 
class I (general controls) if there was information showing that the 
general controls of the act were sufficient to assure safety and 
effectiveness; into class II (performance

[[Page 44014]]

standards) if there was insufficient information showing that general 
controls themselves would ensure safety and effectiveness, but there 
was sufficient information to establish a performance standard that 
would provide such assurance; and into class III (premarket approval) 
if there was insufficient information to support classifying a device 
into class I or class II and the device was a life-sustaining or life-
supporting device or was for a use that is of substantial importance in 
preventing impairment of human health.
    Most generic types of devices that were on the market before the 
date of the original 1976 amendments (May 28, 1976) (generally referred 
to as preamendments devices) have been classified by FDA under the 
procedures set forth in section 513(c) and (d) of the act through the 
issuance of classification regulations into one of these three 
regulatory classes. Under sections 513(c) and (d) of the act, FDA 
secures expert panel recommendations on the appropriate device 
classifications for generic types of devices. FDA then considers the 
panel's recommendations and, through notice and comment rulemaking, 
issues classification regulations.
    For those devices introduced into interstate commerce for the first 
time after May 28, 1976, the device is classified through the premarket 
notification process under section 510(k) of the act (21 U.S.C. 
360(k)). Those devices that FDA finds to be substantially equivalent to 
a classified preamendments generic type of device are thereby 
classified in the same class as the predicate preamendments device.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act. This section provides that FDA may, by 
rulemaking, reclassify a device (in a proceeding that parallels the 
initial classification proceeding) based on ``new information.'' The 
reclassification can be initiated by FDA or by the petition of an 
interested person.
    The term ``new information,'' as used in section 513(e) of the act, 
includes information developed as a result of a reevaluation of the 
data before the agency when a device was originally classified, as well 
as information not presented, not available, or not developed at that 
time. (See, e.g., Holland Rantos v. United States Department of Health, 
Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); 
Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 
F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of changes in ``medical science.'' (See 
Upjohn v. Finch, supra, 422 F.2d at 951.) However, regardless of 
whether data before the agency are past or new data, the ``new 
information'' on which any reclassification is based is required to 
consist of ``valid scientific evidence,'' as defined in section 
513(a)(3) of the act and 21 CFR 860.7(c)(2). FDA relies upon ``valid 
scientific evidence'' in the classification process to determine the 
level of regulation for devices. For the purpose of reclassification, 
the valid scientific evidence upon which the agency relies must be 
publicly available. Publicly available information excludes trade 
secret and/or confidential commercial information, e.g., the contents 
of premarket approval applications (PMA's). (See section 520(c) of the 
act, (21 U.S.C. 360j(c).)

II. Reclassification Under the Safe Medical Devices Act of 1990

    The SMDA further amended the act to change the definition of a 
class II device. Under the SMDA, class II devices are those devices for 
which there is insufficient information to show that general controls 
themselves will ensure safety and effectiveness, but there is 
sufficient information to establish special controls to provide such 
assurance, including the issuance of a performance standard, postmarket 
surveillance, patient registries, development and dissemination of 
guidelines, and other appropriate actions necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Thus, the definition of a class II device was changed from 
``performance standards'' to ``special controls.''

III. History of the Proceedings

    In the Federal Register of August 24, 1979 (44 FR 49873), FDA 
published a proposed rule to classify the infant radiant warmer into 
class III. The preamble included the classification recommendation of 
the General Hospital and Personal Use Devices Panel (the panel). The 
panel's recommendation included a summary of the reasons why the device 
should be subject to premarket approval and identified certain risks to 
health presented by the device, including electrical shock, possible 
eye damage due to long-term exposure to infrared radiation, patient 
injury, hospital staff burns, insensible water loss, and hyperthermia 
or hypothermia. The panel also recommended that a high priority for the 
application of section 515(b) of the act (21 U.S.C. 360e)(premarket 
approval requirement) be assigned to the infant radiant warmer.
    In the Federal Register of October 21, 1980 (45 FR 69694), FDA 
published a final rule classifying the infant radiant warmer into class 
III (21 CFR 880.5130). Concern for possible long-term effects of 
infrared radiation on the skin and eyes of infants was the sole reason 
for classifying the device into class III. FDA believed that the other 
risks to health identified in the proposed rule could be addressed by 
labeling or by a standard.
    In the Federal Register of September 6, 1983 (48 FR 40272), FDA 
published a notice of intent to initiate proceedings to require 
premarket approval of 13 preamendments class III devices assigned a 
high priority by FDA for the application of premarket approval 
requirements. Among other things, the notice described the factors FDA 
considered in establishing priorities for initiating proceedings under 
section 515(b) of the act for issuing final rules requiring 
preamendments class III devices to have approved PMA's or product 
development protocols (PDP's) which have been declared completed. Using 
these factors, FDA concurred with the panel's recommendation that the 
infant radiant warmer should be subject to a high priority for 
initiating a proceeding to require premarket approval.
    In the Federal Register of January 15, 1986 (51 FR 1910), FDA 
published a proposed rule to require filing of a PMA or a notice of 
completion of a PDP for the infant radiant warmer. In accordance with 
section 515(b) of the act and 21 CFR 860.132, FDA also announced an 
opportunity for interested persons to request a change in 
classification of the device based on new information. FDA identified 
the following potential risks to health associated with the use of 
infant radiant warmers: Insensible water loss, special risk group 
infants with very low birth weight, hypothermia and hyperthermia, 
damage to the eyes and skin, increased oxygen consumption, operator 
error, and other safety risks common to many devices (e.g., electric 
shock, inadequate stability, and burns to the user).
    On January 30, 1986, the Health Industries Manufacturers 
Association submitted a petition (Ref. 1) to reclassify the infant 
radiant warmer from class III into class II. The petition was submitted 
under section 513(e) of the act. Consistent with the act and the 
regulations, FDA referred the petition to the panel for its 
recommendation on the requested change in classification.

[[Page 44015]]

    On May 21, 1986, during a meeting by teleconference, the panel 
unanimously recommended that the infant radiant warmer be reclassified 
from class III into class II and that any change in classification not 
take effect until the effective date of a performance standard for the 
generic type of device established under section 514 of the act (21 
U.S.C. 360d) (Ref. 2 at p. 75).
    In the Federal Register of May 27, 1987 (52 FR 19735), FDA 
published a notice of intent to initiate a proceeding to reclassify the 
infant radiant warmer from class III into class II. Subsequent to that 
notice, FDA determined that the deliberations of the 1986 panel were 
incomplete and that another panel meeting was necessary to allow the 
panel to address specific recommendations and issues concerning the 
reclassification of the infant radiant warmer (Ref. 2 at pp. 54 and 
65). This additional panel meeting was held on May 11, 1994. A summary 
of the panel's recommendation is set forth below.

IV. Device Description

    FDA is proposing the following device description based on the 
panel's recommendation and the agency's review.
    The infant radiant warmer is a device consisting of an infrared 
heating element intended to be placed over an infant to maintain the 
infant's body temperature by means of radiant heat. The device may also 
contain a temperature monitoring sensor, a heat output control 
mechanism, and an alarm system (infant temperature, manual mode if 
present, and failure alarms) to alert operators of a temperature 
condition over or under the set temperature, manual mode time limits, 
and device component failure, respectively. The device may be placed 
over a pediatric hospital bed or it may be built into the bed as a 
complete unit.

V. Recommendation of the Panel

    In the public meeting held on May 11, 1994, the panel unanimously 
affirmed its previous recommendation that the infant radiant warmer 
should be reclassified from class III into class II (Ref. 3), and that 
the appropriate special control is a voluntary standard. The panel 
identified the Association for the Advancement of Medical 
Instrumentation (AAMI) voluntary standard for infant radiant warmers as 
the special control for the infant radiant warmer (Ref. 4).
    The panel further recommended the following restrictions on the use 
of the device: A prescription statement in the labeling of the device 
that restricts the device to use only upon the order of a physician, 
only in health care facilities, and only by persons with specific 
training and experience in the use of the device.

VI. Summary of the Reasons for the Recommendation

    The panel gave the following reasons in support of its 
recommendation to reclassify the infant radiant warmer from class III 
into class II:
    1. General controls by themselves are insufficient to provide 
reasonable assurances of the safety and effectiveness of the device.
    2. There is sufficient publicly available information to establish 
special controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use.
    3. An existing voluntary standard (Ref. 4) is the special control 
recommended by the panel.
    4. There is sufficient publicly available information to 
demonstrate that the device is not potentially hazardous to the life, 
health, or well-being of the infant. The panel identified no new risks 
to health associated with the use of the device and determined that 
some of the previously identified potential risks to health are no 
longer risks or are no longer serious risks (Ref. 3 at p. 225). Thus, 
the probable benefits to health of the device outweigh any probable 
risks to health.
    The panel believes that the current and any subsequent 
manufacturers of the infant radiant warmer can comply with this 
voluntary standard, that FDA can ensure the safety and effectiveness of 
the device made by new manufacturers through the premarket notification 
procedures under section 510(k) of the act, and that a regulatory level 
of class III is unnecessary.

VII. Risks to Health

    When the infant radiant warmer was proposed for classification into 
class III in 1979, the panel identified certain risks to health that 
they believed the device presented. The risks to health were identified 
as electrical shock, possible eye damage, patient injury, hospital 
staff burns, insensible water loss, and hyperthermia or hypothermia (44 
FR 49873 at 49874). When the device was classified into class III in 
1980, FDA identified concern for possible delayed long-term effects of 
infrared radiation on the skin and eyes of infants as the only risk to 
health presented by the device. FDA also determined that the other 
risks to health identified in the proposed rule could be addressed by 
labeling or by a standard (45 FR 69694). Subsequently, in 1986, the 
agency identified increased oxygen consumption as another potential 
risk to health associated with the use of the device (51 FR 1910).
    Based on the review of the new data and information contained in 
the petition and the panel members' personal knowledge of and 
experience with the device, the panel on May 11, 1994, agreed that all 
the potential risks to health (insensible water loss; special risk 
group, very low birth weight infants; hyperthermia and hypothermia; 
possible eye and skin damage; and increased oxygen consumption) 
associated with the use of the infant radiant warmer could be 
controlled by special controls (Ref. 3). The panel also believed that 
the general risks to health (operator error, electric shock, inadequate 
device stability, and burns to operators) could also be addressed by 
special controls.
    On the basis of its review and the panel's recommendation, FDA now 
believes that the use of the infant radiant warmer for maintaining an 
infant's body temperature does not present a potential unreasonable 
risk of illness and injury, and that special controls would provide 
reasonable assurance of the safety and effectiveness of the device. In 
addition to the AAMI standard, FDA has also incorporated the panel's 
labeling recommendation as special controls for this device.

VIII. Summary of the Data Upon Which the Proposed Recommendation is 
Based

A. Insensible Water Loss

    An increased rate of insensible water loss is the principle, well-
documented risk to health associated with the use of infant radiant 
warmers (Refs. 5 and 6). Insensible water loss is the continuous and 
usually imperceptible loss of water, mainly from the skin, that occurs 
to some extent in all newborn infants. It is a well recognized 
condition of prematurity, its severity being inversely related to birth 
weight (Ref. 7). Other factors that contribute to insensible water loss 
in neonates include: Illness; environmental temperature and humidity; 
and other therapies, especially phototherapy and respiratory support 
(Ref. 5). Insensible water loss is also associated with the use of 
incubators (Refs. 5 through 7).
    Bell (Ref. 6) evaluated four studies (Refs. 8 through 11), which 
reported increased rates of insensible water loss of 40 to 190 percent 
during the use of radiant warmers compared to the use of incubators. He 
determined that the variations in the increased rates of insensible 
water loss are related to the experimental conditions of the 
investigations (mainly the different

[[Page 44016]]

weighing methods used in the studies). Bell concluded that insensible 
water loss in infants under infant radiant warmers without phototherapy 
is 40 to 100 percent higher than in infants in incubators.
    Increased insensible water loss places an infant at a risk of 
dehydration and electrolyte imbalance and potentially interferes with 
the infant's thermoregulation. Because both underestimation and 
overestimation of fluid and electrolyte requirements can have serious 
consequences to infants, especially to low birth weight infants, 
guidance for parenteral fluid and electrolyte administration was 
needed. Since the infant radiant warmer was classified in 1980, several 
guidances which include recommendations for parenteral fluid and 
electrolyte administration have been developed for premature and term 
infants (Refs. 6, 12, and 13).
    The use of plastic heat shielding with infant radiant warmers has 
been reported to reduce insensible water loss (Refs. 14 through 17). 
However, this practice is not without risks, including both 
underheating and overheating of infants (Refs. 2 and 18). The panel 
agreed that the use of heat shielding should be at the discretion of 
the informed physician (Ref. 2).
    Although an increased rate of insensible water loss is a risk to 
health in the use of the infant radiant warmer, it can be managed by 
careful monitoring of the infant and administration of parenteral or 
oral electrolyte therapy when necessary. The new parenteral fluid and 
electrolyte therapy guidances minimize this risk to health and support 
the use of infant radiant warmers in the management of critically ill 
infants to whom continual access by health professionals is essential.
    The panel believed that this risk to health is a well-understood 
risk associated with the use of the infant radiant warmer and that it 
is related to both the prematurity of the infant and the open bed 
design of the device (Ref. 3). The panel agreed that this risk to 
health is clinically manageable and that it could be controlled by 
special controls.

B. Special Risk Group--Very Low Birth Weight Infants

    To survive, very low birth weight infants, weighing 1,500 grams or 
less, require aggressive diagnostic and therapeutic procedures, such as 
emergency resuscitation, tracheal intubation, placement of catheters 
and needles, and blood sampling (Ref. 1). The use of infant radiant 
warmers has allowed essential access to the infants for the performance 
of these necessary procedures while providing effective warming. This 
is particularly important immediately after birth, during the first 
days of life, and for the care of critically ill premature infants.
    Very low birth weight infants are especially susceptible to 
increased rates of insensible water loss because of their larger 
surface area to mass ratio, higher body water content, and the thinner 
epidermal barrier of their skin (Refs. 2 (at pp. 56 and 57), 5, and 
13). The advances in parenteral fluid and electrolyte therapy since 
1980 provide specific guidance to minimize this risk for very low birth 
weight infants (Refs. 6, 12, and 13).
    The panel believed that this potential risk to health is not a risk 
related to the device, but that it is related to the prematurity of the 
infants (Ref. 3). The panel stated that the use of the infant radiant 
warmer has made the care of these infants more manageable, and the 
panel commented that now even smaller premature infants than in 1986 
are successfully treated in infant radiant warmers. The panel believed 
that this risk can be controlled through special controls.

C. Damage to the Eyes

    Infant radiant warmers operate by directing invisible infrared 
radiation (IR) from an overhead heater to the infant's body. The 
magnitude and spectral characteristics of the IR are controlled by the 
design of the device and are important in assessing the potential risk 
of exposure to IR.
    During its classification deliberations in 1979, the panel 
considered infant radiant warmer performance data developed for FDA 
under a contract (Ref. 19). However, that data did not sufficiently 
address the panel's concern about the possibility of adverse effects on 
the eyes of infants resulting from long-term exposure to IR. The 
petition reported new performance data on five radiant warmers (Ref. 
1). The new data provided measurements for individual wavelength 
regions of the electromagnetic spectrum, including the ultraviolet (200 
to 400 nanometers (nm)), visible (400 to 760 nm), and IR-A (760 to 
1,400 nm) wavelength regions, and for the 1,400 to 4,500 nm wavelength 
region which includes the IR-B (1,400 to 3,000 nm) wavelength region 
and the 3,000 to 4,500 nm portion of the IR-C wavelength region (the 
IR-C wavelength region extends from 3,000 to 100,000 nm). The petition 
also reported total irradiance, including irradiance for wavelengths 
extending beyond 4500 nm obtained by another measurement method. The 
IR-A wavelength region is associated with the potential for damage to 
the lens and retina of the eye. The IR-B and IR-C wavelength regions 
are associated with the potential for thermal damage to the cornea of 
the eye.
    All the infant radiant warmers emitted IR primarily in the IR-B and 
IR-C wavelength regions (Ref. 1). No ultraviolet radiation and 
negligible visible radiation (nondetectable to 0.026 milliwatt per 
square centimeter (mW/cm2)) was detected. The range of maximum IR-
A irradiance was 0.103 to 3.463 mW/cm2, and the range of maximum 
total irradiance was 39.2 to 60.3 mW/cm2. These maximum 
irradiances were obtained at full power and at high line voltage (130 
volts). At lower heater power levels, proportionately more of the IR is 
from the IR-C wavelength region.
    In clinical use, however, infant radiant warmers are rarely 
operated at full power and at high line voltage (Ref. 1). The total 
irradiances necessary to maintain the desired infant skin temperature 
typically range from 12 to 25 mW/cm2, and typical IR-A irradiances 
are less than 1.0 mW/cm2. Engel et al. reported mean total 
irradiances of less than 10 mW/cm2 and 17.1 mW/cm2 for the 
warming of two groups of critically ill premature infants (Refs. 20 and 
21); in general, the smaller infants required higher irradiances. In 
addition, the necessarily more frequent handling of critically ill 
neonates, which may be as often as once every 10 minutes, may interrupt 
delivery of a portion of the radiant heat to the infant and thus 
increase the amount of radiant power required for heating (Ref. 2).
    The petition also summarized published information that was not 
reviewed by the classification panel when the infant radiant warmer was 
classified. Both Sliney and Freasier (Ref. 22) and Sliney and Wolbarsht 
(Ref. 23) reported that a safe chronic ocular exposure level to IR-A 
was 10 mW/cm2. The petition reported that the maximum amount of 
IR-A of the tested infant radiant warmers ranged from 0.24 to 3.5 mW/
cm2, and that in actual use, infant radiant warmers emit typically 
less than 1 mW/cm2 of IR-A (Ref. 1). Thus, the potentials for 
chronic injury to the lens and the retina are low because infant 
radiant warmers emit significantly less IR-A radiation than the level 
of IR-A radiation believed to be associated with injuries of the lens 
and retina.
    The cornea and aqueous humor absorb almost all of the IR from 1,400 
to 1,900 nm; the cornea absorbs all the IR above 1,900 nm (Ref. 23). 
Thus, most IR emitted by infant radiant warmers is absorbed by the 
anterior structures of

[[Page 44017]]

the eye and is not transmitted to the lens and retina. Sliney and 
Freasier (Ref. 22) and Sliney and Wolbarsht (Ref. 23) also reported 
that the irradiance of 100 mW/cm2 was ``well below'' the threshold 
irradiance level to prevent corneal injury. Thus, the potentials for 
injury to the cornea and aqueous humor from exposure to IR emitted by 
infant radiant warmers are low because the maximum irradiances of 
infant radiant warmers range from 36.8 to 60.3 mW/cm2 and their 
typical total use irradiances range from 12 to 25 mW/cm2 (Ref. 1). 
For both the total irradiance and the IR-A irradiance, the margins for 
safety are significant.
    To put this irradiance information in perspective, it should be 
noted that premature infants' eyes are rarely opened and that blinking 
of the eyes when opened keeps the corneal epithelium from drying out 
(Ref. 24). Thus, there is a low probability that a significant amount 
of IR actually enters the eyes of premature infants.
    There are two studies on the effects of IR on the eyes of neonates. 
Johns et al. detected no adverse eye effects in infants warmed under 
radiant warmers after followup times of up to 45 days (Ref. 25). This 
study now has increased significance since Pitts and Cullen reported 
that corneal damage heals rapidly (usually within 24 hours) and that 
lens opacities formed within 24 hours after exposure heal earlier than 
expected (usually within 1 month) (Ref. 26). Thus, any corneal or lens 
effects, if present, would have been detected by Johns et al.
    In 1993, Baumgart et al. (Ref. 27) reported a retrospective study 
of critically ill premature infants treated under radiant warmers and 
incubators with longer followup times of 30 days to 6 years. The mean 
followup time for the radiant warmer group was 29 months, and the mean 
IR irradiance of the infant radiant warmer group was less than 30 mW/
cm2. They found no long-term or short-term corneal or lens effects 
in either group. The incidence of retinopathy of prematurity was higher 
in the radiant warmer group, but this higher incidence was attributed 
to prematurity and to the hospital's policy of placing the more 
critically ill premature infants receiving oxygen in infant radiant 
warmers rather than in incubators. It is noted that the incidence of 
retinopathy of prematurity is associated with prolonged oxygen therapy 
(Ref. 28).
    There are few recommended IR exposure levels specifically intended 
for infants under infant radiant warmers. The Emergency Care Research 
Institute proposed that 0.3 W/cm2 (300 mW/cm2) was a 
reasonable total irradiance limit for an infant under an infant radiant 
warmer in 1973 and 1984 (Refs. 24 and 18, respectively) and that the 
near IR range between 700 to 1,200 nm should be limited to 40 mW/
cm2. The 1994 International Electrotechnical Commission standard 
for infant radiant warmers has irradiance limits of 100 mW/cm2 for 
total IR irradiance and 10 mW/cm2 for IR-A (Ref. 29). The 1995 
AAMI voluntary standard special control has irradiance limits of 60 mW/
cm2 for total IR irradiance and 10 mW/cm2 for IR-A (Ref. 4). 
The maximum irradiances of currently marketed infant radiant warmers 
meet the AAMI voluntary standard special control irradiance limits 
(Ref. 3).
    This new information concerning the IR irradiance characteristics 
of infant radiant warmers and the irradiance levels associated with 
acute and chronic injuries to the eyes have addressed the safety 
concerns previously held about the unknown potential for IR-induced 
long-term effects to the eyes of infants under infant radiant warmers. 
The panel stated that in over 20 years of clinical use, there are no 
reports in the literature of any adverse long-term effects to the eyes 
of infants attributed to the IR radiation emitted by infant radiant 
warmers (Ref. 3). They further commented that long-term developmental 
health assessments of infants cared for in infant radiant warmers do 
not mention any delayed eye conditions (Ref. 3, pp. 190 and 191). The 
panel agreed that the potential risk to health of long-term damage from 
overexposure of the eyes to total IR and IR-A could be controlled by 
special controls.

D. Damage to the Skin

    The IR emitted by infant radiant warmers is designed to be below 
the threshold for thermal injury to the infant's skin (Ref. 24). The IR 
is not of sufficient energy to cause photochemical reactions in the 
skin. Most of the IR-A irradiance is reflected from the skin while IR-B 
and IR-C irradiance are absorbed by the outer 1 millimeter of the skin 
to accomplish the desired warming effect.
    The panel commented that there are no published reports of skin 
damage in infants attributed to the use of radiant warmers and that 
long-term developmental health assessments of infants cared for in 
infant radiant warmers do not mention skin conditions (Ref. 3). The 
panel believed that the potential risk of overexposure of the skin to 
IR could be controlled by special controls.

E. Increased Oxygen Consumption

    Bell reviewed five studies (Ref. 6) that reported conflicting 
results of statistically significant increased oxygen consumption rates 
(Refs. 30 and 31) and unchanged oxygen or slightly increased 
consumption rates (Refs. 11, 28, 32, and 33) in infants warmed under 
radiant warmers compared to infants warmed in incubators. Because 
increased oxygen consumption may be an indicator of a stress-related 
increase in metabolism, these reports caused concern that the use of 
infant radiant warmers stress the metabolism of infants.
    Bell evaluated these studies taking into account differences in the 
various study parameters used, including differences in the 
servocontrol skin temperatures and the humidity in the neonatal 
nurseries (Ref. 6). He determined that only a small increase in oxygen 
consumption (4 kilocalories per kilogram per 24 hours additional energy 
expenditure) occurs in the infants under infant radiant warmers 
compared to infants in incubators. Bell agreed with Wheldon and Rutter 
(Ref. 31) that the net total heat loss of infants under radiant warmers 
to the environment due to evaporation, convection, radiation, and 
conduction does not exceed that of infants in incubators. He concluded 
that the increased oxygen consumption of infants in infant radiant 
warmers is of unknown clinical significance. Subsequently, Marks et al. 
reported that premature infants under infant radiant warmers 
experienced no short-term metabolic complications or adverse effects on 
growth even though they had a 10 percent higher oxygen consumption 
compared to infants in incubators (Ref. 34).
    The panel acknowledged that although oxygen consumption may be 
greater in infants cared for in infant radiant warmers than in 
incubators, the clinical significance of this, if any, is unknown (Ref. 
3). They noted that other factors unrelated to the device can also 
cause increased oxygen consumption. The panel agreed this potential 
risk could be controlled by special controls.

F. Hypothermia and Hyperthermia

    The risks to health of hypothermia and hyperthermia are low during 
proper use of the device (Ref. 1). Infant radiant warmers are used to 
treat and to prevent hypothermia. Both hypothermia and hyperthermia can 
result from malfunctioning alarms and radiant heater components, and 
hyperthermia can result from detachment of the skin temperature probe 
from the infant. The device's temperature and failure alarm system is 
designed to prevent

[[Page 44018]]

hypothermia and hyperthermia by alerting operators of unsafe 
temperature conditions, skin temperature probe detachment from the 
skin, probe failure and device failure. The petition (Ref. 1), current 
device labeling (Ref. 3), the AAMI voluntary standard special control 
(Ref. 4), and accepted medical practice (Refs. 1 and 3) all recommend 
frequent monitoring of infants under infant radiant warmers. They also 
recommend that infant radiant warmers should be operated in the skin 
temperature servocontrol mode rather than the manual mode to further 
reduce the risks of both hypothermia and hyperthermia (Refs. 1 and 4). 
The panel agreed that this risk to health could be controlled by 
special controls.

G. Other Risks

    Four other potential risks associated with the use of infant 
radiant warmers are electrical shock due to improper design or 
construction of the device, injury due to instability of the device, 
burns to the operator if the device is constructed of materials that 
absorb radiant heat, and operator error. Operator error can be 
minimized by appropriate training and comprehensive device labeling. 
The panel agreed that these are well-known risks that are generic to 
many neonatal devices and that they can be controlled by special 
controls (Ref. 3).

H. Benefits of the Device

    The infant radiant warmer has the unique benefit of providing 
greater accessibility to the infant than do incubators during routine 
nursing and intensive care procedures without interrupting the delivery 
of heat. Infant radiant warmers can also heat an infant faster than an 
incubator. Ahlgren reported that only 5 to 10 minutes are required to 
warm the infant's skin to the preset skin temperature with the infant 
radiant warmer as compared to 45 to 50 minutes for the incubator (Ref. 
35). Infant radiant warmers are recommended for the care of newborn 
infants who lose large amounts of heat through evaporation of amniotic 
fluid from their skin in the delivery room (Ref. 27). It is estimated 
that 80 percent of all infants are placed under infant radiant warmers 
at some time during their hospital stay (Ref. 1). Many practitioners 
consider infant radiant warmers to be the only way of warming some very 
low birth weight and critically ill infants (Refs. 3 and 6).
    The panel believes, based on publicly available, valid scientific 
evidence, that the infant radiant warmer can be regulated as a class II 
device (general and special controls) to reasonably assure the device's 
safety and effectiveness (Ref. 3).

IX. FDA's Tentative Findings

    FDA tentatively concurs with the recommendation of the panel that 
infant radiant warmers should be reclassified into class II. The agency 
believes that ``new information'' in the form of publicly available, 
valid scientific evidence exists to establish special controls to 
provide reasonable assurance of safety and effectiveness of the infant 
radiant warmer for its intended use. The agency further identifies the 
AAMI voluntary standard and labeling as the special controls. Moreover, 
existing devices, within the generic type, have established a 
reasonable record of safe and effective use. Consistent with the 
purpose of the act, class II controls as defined by section 
513(a)(1)(B) of the SMDA would provide the least amount of regulation 
necessary to reasonably assure that current and future infant warmers 
are safe and effective.

X. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

XI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because of the potential costs to comply with the 
provisions of premarket approval (class III) by each manufacturer, the 
agency believes that the economic impact to comply with special 
controls (class II) would likely be less. Therefore, the agency 
certifies that the proposed rule will not have a significant economic 
impact on a substantial number of small entities. Therefore, under the 
Regulatory Flexibility Act, no further analysis is required.

XII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that the labeling requirements in this 
proposed rule are not subject to review by the Office of Management and 
Budget because they do not constitute a ``collection of information'' 
under the Paperwork Reduction Act of 1995 (Pub. L. 104-13). Rather, the 
proposed labeling statements are ``public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)).

XIII. Request for Comments

    Interested persons may, on or before November 25, 1996, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be submitted 
except that individuals may submit one copy. Comments are to be 
identified with the name of the device and the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.

XIV. References

    The following information has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Health Industry Manufacturers Association Petition with 
incorporated errata, volumes 1 to 5, Washington, DC, 1986 (submitted 
January 30, 1986; revised April 15, 1986).
    2. Transcript, General Hospital and Personal Use Devices Panel 
(telephone conference call), May 21, 1986.
    3. Transcript, General Hospital and Personal Use Devices Panel 
with the attached general device classification questionnaire and 
supplemental data sheet, May 11, 1994.
    4. Association for the Advancement of Medical Instrumentation, 
Infant Radiant Warmers (draft standard), May 1995.
    5. Baumgart, S., ``Radiant Energy and Insensible Water Loss in 
the Premature Newborn Infant Nursed under a Radiant Warmer,'' 
Clinics in Perinatology, 9:483-503, 1982.
    6. Bell, E. F., ``Infant Incubators and Radiant Warmers, Early 
Human Development,'' 8:351-375, 1983 (included in Ref. 1).

[[Page 44019]]

    7. Baumgart, S., W. D. Engel, W. W. Fox, and R. A. Polin, 
``Radiant Warmer Power and Body Size as Determinants of Insensible 
Water Loss in the Critically Ill Neonate,'' Pediatric Research, 
15:1495-1499, 1981 (included in Ref. 1).
    8. Williams, P. R., and W. Oh, ``Effects of Radiant Warmers on 
Insensible Water Loss in Newborn Infants,'' American Journal of 
Diseases in Childhood, 128:511-514, 1974 (included in Ref. 1).
    9. Wu, P. Y. K., and J. E. Hodgemen, ``Insensible Water Loss in 
Preterm Infants. Changes with Postnatal Development and Non-Ionizing 
Radiant Energy,'' Pediatrics, 54:704-711, 1974 (included in Ref. 1).
    10. Bell, W. F., M. R. Weinstein, and W. Oh, ``Heat Balance in 
Premature Infants: Comparative Effects of Convectively Heated 
Incubator and Infant Radiant Warmer, with and without Heatshield,'' 
Journal of Pediatrics, 96:460-465, 1980 (included in Ref. 1).
    11. Jones, R. W. A., M. J. Rochefort, and J. D. Baum, 
``Increased Insensible Water Loss in New Born Infants Nursed under 
Radiant Heaters,'' British Medical Journal, 1:1347-1350, 1976 
(included in Ref. 1).
    12. Baumgart, S., C. B. Langman, W. W. Fox, and R. A. Polin, 
``Fluid, Electrolyte, and Glucose Maintenance in the Very Low Birth 
Weight Infant,'' Clinical Pediatrics, 32:199-206, 1982 (included in 
Ref. 1).
    13. Costarino, A. T., and S. Baumgart, ``Controversies in Fluid 
and Electrolyte Therapy for the Premature Infant,'' Clinical 
Perinatology, 15:863-878, 1988.
    14. Marks, K. H., Z. Freidman, and M. B. Maisels, ``A Simple 
Device for Reducing Insensible Water Loss in Low-Birth Weight 
Infants,'' Pediatrics, 60:223-226, 1980 (included in Ref. 1).
    15. Baumgart, S., W. D. Engel, W. W. Fox, and R. A. Polin, 
``Effect of Heat Shielding on Convective and Evaporative Heat Losses 
and on Radiant Heat Transfer in the Premature Infant,'' Journal of 
Pediatrics, 99:948-956, 1981 (included in Ref. 1).
    16. Baumgart, S., W. W. Fox, and R. A. Polin, ``Physiologic 
Implications of Two Heat Shields for Infants under Infant Radiant 
Warmers,'' Journal of Pediatrics, 100:787-790, 1982 (included in 
Ref. 1).
    17. Fitch, C. W., and S. B. Korones, ``Heat Shield Reduces Water 
Loss,'' Archives Disease in Childhood, 59:886-888, 1984 (included in 
Ref. 1).
    18. Emergency Care Research Institute, ``Evaluation: Infant 
Warmers,'' Health Devices, 13:119-145, 1984.
    19. Emergency Care Research Institute, ``The Development of a 
Standard for Infant Warmers and Incubators,'' final report, FDA 
Contract No. 223-75-5012, Plymouth Meeting, PA, 1976.
    20. Engel, W. D., S. Baumgart, W. W. Fox, and R. A. Polin, 
``Effect of Increased Radiant Power Output on State of Hydration in 
the Critically Ill Neonate,'' Critical Care Medicine, 10:673-676, 
1982 (included in Ref. 1).
    21. Engel, W. D., S. Baumgart, J. G. Schwartz, W. W. Fox, and R. 
A. Polin, ``Insensible Water Loss in the Critically Ill Neonate,'' 
American Journal of Diseases in Children, 135:516-520, 1981 
(included in Ref. 1).
    22. Sliney, D. H., and B. C. Freasier, ``Evaluation of Optical 
Radiation Hazards,'' Applied Optics, 12:1-24, 1973 (included in Ref. 
1).
    23. Sliney, D., and M. Wolbarsht, ``Safety with Lasers and Other 
Optical Sources,'' Plenum Press, New York, 1980, pp. 144-149.
    24. Emergency Care Research Institute, ``Evaluation: Infant 
Warmers,'' Health Devices, 3:4-25, 1973.
    25. Johns, R., D. Schaffer, and G. Peckham, ``Evaluation of the 
Effects of Infrared Radiation on the Eyes of Infants under Radiant 
Warmers,'' Unpublished, 1977 (included in Ref. 1).
    26. Pitts, D. G., and A. P. Cullen, ``Determination of Infrared 
Radiation Levels for Acute Ocular Cataractogenesis,'' Albrecht von 
Graefes Archives Klinische Ophthalmologie, 217:285-297, 1981 
(included in Ref. 1).
    27. Baumgart, S., A. Knauth, F. X. Casey, and G. E. Quinn, 
``Infrared Eye Injury Not Due to Radiant Warmer Use in Infants,'' 
American Journal of Diseases in Childhood, 147:565-569, 1993.
    28. American Academy of Pediatrics and American College of 
Obstetricians and Gynecologists, Guidelines for Perinatal Care, 
Evanston and Washington, DC, respectively, 1983 (included in Ref. 
1).
    29. International Electrotechnical Commission, ``Medical 
Electrical Equipment, Part 2: Particular requirements for the safety 
of infant radiant warmers'', 1994.
    30. LeBlanc, M., ``Relative Efficacy of Radiant and Convective 
Heat in Incubators in Producing Thermoneutrality for the 
Premature,'' Pediatric Research, 18:426-428, 1984 (included in Ref. 
1).
    31. Wheldon, A. E., and N. Rutter, ``The Heat Balance of Small 
Babies Nursed in Incubators and under Radiant Warmers,'' Early Human 
Development, 6:131-143, 1982 (included in Ref. 1).
    32. Marks, K. H., R. C. Gunther, J. A. Rossi, and M. J. Maisels, 
``Oxygen Consumption and Insensible Water Loss in Premature Infants 
under Radiant Heaters,'' Pediatrics, 66:228-232, 1980 (included in 
Ref. 1).
    33. Darnall Jr., R. A., and R. L. Ariagno, ``Minimal Oxygen 
Consumption in Infants Cared for under Overhead Radiant Warmers 
Compared with Conventional Incubators,'' Journal of Pediatrics, 
93:283-287, 1978 (included in Ref. 1).
    34. Marks, K. H., E. E. Nardis, and M. N. Momin, ``Energy 
Metabolism and Substrate Utilization in Low Birth Weight Neonates 
under Radiant Warmers,'' Pediatrics, 78:465-472, 1986.
    35. Ahlgren, E. W., ``Environmental Control of the Neonate 
Receiving Intensive Care,'' International Anesthesiology Clinic, 
12:173-215, 1974 (included in Ref. 1).

List of Subjects in 21 CFR Part 880

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 880 be amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

    1. The authority citation for 21 CFR part 880 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    2. Section Sec. 880.5130 is revised to read as follows:


Sec. 880.5130  Infant radiant warmer.

    (a) Identification. The infant radiant warmer is a device 
consisting of an infrared heating element intended to be placed over an 
infant to maintain the infant's body temperature by means of radiant 
heat. The device may also contain a temperature monitoring sensor, a 
heat output control mechanism, and an alarm system (infant temperature, 
manual mode if present, and failure alarms) to alert operators of a 
temperature condition over or under the set temperature, manual mode 
time limits, and device component failure, respectively. The device may 
be placed over a pediatric hospital bed or it may be built into the bed 
as a complete unit.
    (b) Classification. Class II (Special Controls). (1) Association 
for the Advancement of Medical Instrumentation (AAMI) Voluntary 
Standard for Infant Radiant Warmers; (2) prescription statement in 
accordance with 21 CFR 801.109 (restricted to use by or upon the order 
of qualified practitioners as determined by the States); (3) labeling 
for use only in health care facilities and only by persons with 
specific training and experience in the use of the device.

    Dated: August 1, 1996.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 96-21846 Filed 8-26-96; 8:45 am]
BILLING CODE 4160-01-F