[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8432-8439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4719]
[[Page 8431]]
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Part V
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 880 and 890
Medical Devices; Protective Restraints; Revocation of Exemptions From
the 510(k) Premarket Notification Procedures and Current Good
Manufacturing Practice Regulations; Final Rule and 510(k) Guidance
Document; Availability; Notice
Federal Register / Vol. 61, No. 43 / Monday, March 4, 1996 / Rules
and Regulations
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[[Page 8432]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 91N-0487]
21 CFR Parts 880 and 890
Medical Devices; Protective Restraints; Revocation of Exemptions
From the 510(k) Premarket Notification Procedures and Current Good
Manufacturing Practice Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is revising the
classification regulations for protective restraints and wheelchair
accessories intended for use as restraints, by revoking the existing
exemptions for these devices from premarket notification and current
good manufacturing practices (CGMP) regulations. FDA is also modifying
the classification regulations for protective restraints and for
wheelchair accessories to clarify the definitions of these devices. FDA
is taking these actions in response to a number of recent reports of
deaths and serious injuries that may have been associated with improper
supervision of restrained patients or improper application of
protective restraints. FDA believes that these actions will have
minimal economic effect and will not disrupt the supply of these
devices. In a notice published elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a draft guidance
document for the preparation of premarket notification (510(k))
submissions for protective restraints.
DATES: Effective September 3, 1996.
FOR FURTHER INFORMATION CONTACT: Viola S. Hibbard, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1287.
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of October 21, 1980 (45 FR 69678 at 69729),
FDA published a final rule, in accordance with the procedures contained
in section 513 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360c), classifying as a device a protective restraint,
usually a wristlet, anklet, or other type of strap, that is intended
for medical purposes and that limits a patient's movement to the extent
necessary for treatment, examination, or protection of the patient. In
that regulation, FDA exempted manufacturers of protective restraints,
which are class I devices, from the premarket notification procedures
in part 807 (21 CFR part 807), and the CGMP regulations in part 820 (21
CFR part 820), with the exception of Secs. 820.180 and 820.198,
relating to general requirements concerning records and complaint
files, respectively. FDA granted these exemptions because, at that
time, FDA did not have information that caused serious concerns about
safety problems related to the use of protective restraint devices.
Since the October 1980 publication of these classifications that
exempted protective restraints from premarket notification and CGMP
requirements, FDA has become aware of numerous reports of serious
injuries and deaths that have been attributed to incorrect supervision,
handling, or application of protective restraints. In the Federal
Register of June 19, 1992 (57 FR 27397), FDA, in response to these
adverse event reports, published a proposed rule to revoke the
exemptions from premarket notification procedures and CGMP regulations
for protective restraints and wheelchair accessories intended for use
as protective restraints. FDA's proposed revocations complement the
Health Care Financing Administration (HCFA) regulations (42 CFR part
483) and HCFA's February 5, 1992 (57 FR 4516), proposed rulemaking that
address clinical indications for use of restraints that protect
individuals from inappropriate use of restraints for discipline or
convenience. The revocation of the exemption from the premarket
notification procedures will permit the agency to monitor the marketing
of these devices, and review and identify unclear labeling that may
result in incorrect application of the devices. The revocation of the
exemption from CGMP requirements will help ensure that restraints are
safe by conforming to appropriate specifications for design, materials,
performance, and labeling. A 60-day comment period, ending on August
18, 1992, was provided to allow interested persons an opportunity to
submit comments on the proposed changes.
In addition to this rule, FDA has taken other steps to ensure that
protective restraints are used safely. On July 15, 1992, FDA issued a
Safety Alert on potential hazards with restraint devices (Ref. 1) to
hospital administrators, directors of nursing, directors of emergency
room services, and long-term care facilities. FDA also issued a letter
to manufacturers in February 1992 stating that FDA considered
restraints to be prescription devices which must bear a prescription
legend as prescribed in Sec. 801.109 (21 CFR 801.109) to help ensure
appropriate medical intervention in the application and use of
restraints (Ref. 2).
FDA received 24 comments in response to the proposal of June 19,
1992, from individuals, manufacturers, professional societies, and
consumer and health associations. The comments were primarily
supportive of FDA's proposed actions. Several comments, however, stated
that FDA should consider additional regulation of protective
restraints. These comments are discussed below.
II. Summary and Analysis of Comments and FDA's Response
A. General Comments
1. One comment stated that it would be helpful for FDA to recommend
that facilities use one standard brand of each type of restraint (e.g.,
vest) to provide consistency and increase the likelihood that the
restraint would be applied correctly. Another comment suggested
restraints be uniformly designed so the front and back are easily
identifiable.
Although standardization of brands in a facility may increase the
likelihood that restraints will be applied correctly, it is critical
that the correct type and size restraint be applied to maximize the
safety of these devices. Accordingly, FDA encourages standardization as
long as it can be achieved without compromising the use of the
appropriate restraint type and size. Ultimately, however, this decision
must be made by each facility. FDA cannot endorse one uniform design.
Restraints used under different circumstances must necessarily
incorporate different designs.
2. Several comments indicated support for a prescription
requirement by licensed health care practitioners, specifying the
appropriate restraint type, duration of application, and circumstances
for use. One comment stated that FDA has avoided the issue of whether
anyone other than a licensed health care worker should be permitted to
apply restraints. Another comment stated that FDA did not address the
issue of appropriate frequency of monitoring.
The determination of appropriate individuals to apply restraints or
appropriate frequency of monitoring is beyond the scope of this
regulation. However, FDA believes the use of restraints should be
limited to those circumstances when they are clearly clinically
indicated, and that they
[[Page 8433]]
should be used only for a strictly defined period of time and only
under the supervision of a licensed health care provider. For these
reasons, FDA informed protective restraint manufacturers in February
1992 that it considered these devices to be prescription devices that
may only be used under the direction of a licensed health care
practitioner. In addition, FDA strongly encourages that after
restraints are prescribed by a licensed health care practitioner, they
be applied only by adequately trained personnel, in accordance with
State licensure and Federal certification requirements for facilities.
3. While several comments were supportive of FDA's proposal to
revoke 510(k) and CGMP exemptions, three comments opposed the
revocation of the exemptions. One comment suggested withdrawing the
proposed regulations until more complete information is available.
Another comment stated that the revocations are unjustified based on
the relatively small number of associated deaths and injuries compared
to the large annual usage of restraints. Another comment by a
manufacturer stated that the revocations were unwarranted because it
was unaware of any deaths or serious injuries associated with its
restraint products.
FDA disagrees that it needs to have more complete information
before it revokes premarket notification and CGMP requirements.
Although complete information concerning the problems associated with
restraints is not available, FDA does have sufficient information about
these problems to warrant revocation of the exemptions from premarket
notification and CGMP requirements. As explained in the preamble to the
proposed rule, the revocation of these exemptions will allow FDA to
gather more information to help ensure the safety of these devices.
FDA believes that the exemption revocations are justified based on
the numbers of reports of deaths and injuries associated with
protective restraint use. FDA notes that since publication of the
proposed rule of June 19, 1992, the total numbers of deaths and serious
injuries reported under the Device Experience Network (DEN), which
includes the mandatory Medical Device Reporting Program and the
MedWatch Reporting Program, have increased from 41 deaths and 16
serious injuries to 130 deaths and 48 injuries. In addition, several
comments support FDA's belief that injuries and deaths associated with
protective restraints are seriously underreported.
FDA does not agree with the comment from one manufacturer that
revocations of the exemptions were not warranted for its restraints
because the manufacturer was not aware of any deaths or serious
injuries associated with its products. Reports of these problems
encompass many different restraint types, regardless of manufacturer or
design; various types of patient populations, regardless of clinical
indications for the use of the restraint; and various types of health
care facilities, including hospitals, home use situations, and nursing
homes. The fact that problems have been reported from a wide spectrum
of protective restraint types and situations indicates that the
problems associated with protective restraints are not specific to one
particular type of restraint. Moreover, given the probability of
underreporting of protective restraint-associated deaths and injuries,
the absence of complaints for one particular manufacturer does not
indicate that that manufacturer's devices are free of the problems
associated with other restraints.
4. One comment from a restraint manufacturer disagreed with the
economic impact analysis of the proposed rule and stated that
revocations of the exemptions would result in substantial economic
costs. To avoid incurring the costs associated with compliance with the
regulation, the manufacturer stated that their company may disavow the
``medical device'' classification of their product line and continue to
sell their restraint devices to interested members of the health care
industry.
FDA advises that protective restraints, within the meaning of
section 201(h) of the act (21 U.S.C. 321(h)), are medical devices
because they are intended for use in the cure, mitigation, treatment,
or prevention of disease. Therefore, on or after the effective date of
this final rule, any manufacturer distributing a restraint device not
meeting the provisions of this final rule would violate the act by
distributing devices that are: (1) Misbranded, in that no premarket
notification submission has been filed pursuant to section 510(k) of
the act (21 U.S.C. 360(k)); and (2) adulterated, if CGMP requirements
are not met under section 520(f) of the act (21 U.S.C. 360j(f)). FDA
strongly discourages any noncompliance with this regulation and is
prepared to take enforcement actions against persons who violate this
regulation. Such actions may include seizure, injunction, civil
penalties, and criminal prosecution.
Furthermore, FDA disagrees that a substantial economic impact would
result from these regulations. The comment estimated that the company
would incur costs of $200,000 for 100 510(k) applications and as much
as $500,000 to attain compliance with CGMP's, which could force the
company out of business. The comment did not present any data to
support claims of substantially higher costs for complying with CGMP's.
FDA has reconsidered its economic analysis and believes that the
costs of premarket notification submissions and compliance with CGMP's
are considerably lower than suggested in this comment. Also, FDA
expects to allow some grouping by product category in a 510(k)
submission as discussed in comment 10 of this document, which should
limit the number of 510(k)'s that have to be submitted by any
particular manufacturer.
5. One comment questioned the benefit of simply revoking the
exemptions, but believed that the revocations were necessary as an
interim measure while reclassification of the devices to a more
stringent regulatory category is considered. Three comments believed
the proposed revocations to be a totally inadequate response to
problems with restraints and inconsistent with requirements issued by
HCFA. These comments stated that FDA should convene a device
classification panel to determine whether restraint devices should be
reclassified to class II or III.
FDA is continuing to evaluate the need for reclassification of
these devices. However, FDA believes that revocation of the premarket
notification exemption will facilitate more immediate improvements in
the labeling of restraint devices that quickly will provide increased
safety and effectiveness in the use of restraints, and that revocation
of CGMP exemptions will facilitate improvements in the manufacture of
restraint devices. FDA believes that these measures will greatly reduce
the risk associated with use of protective restraints. FDA retains the
option to reclassify the devices at a later time, if such additional
action is believed necessary to protect the public health.
FDA disagrees that its actions are inconsistent with those of HCFA.
As stated in the preamble to FDA's June 19, 1992, proposed rule, the
intent of HCFA's requirements on use of restraints in nursing homes is
to protect nursing home residents from use of restraints for purposes
of convenience or discipline. FDA's actions complement these
requirements by ensuring that for those instances where
[[Page 8434]]
restraints are clinically indicated, the labeling and instructions for
use of the restraints will facilitate correct application by health
care providers.
6. One comment requested immediate recall action on restraints that
have a higher association with death and serious injury than others.
The comment believed that criss-crossed vests were the most dangerous,
although the comment acknowledged that the higher number of death
reports associated with vest restraints may be due to more frequent use
of those devices.
FDA does not believe that the criteria for requiring the recall of
any particular protective restraint have been met. Under section 518(e)
of the act (21 U.S.C. 360h(e)), FDA may order a recall of a device only
after finding that the device would cause serious adverse health
consequences or death. FDA does not have information that any type of
restraint, including criss-crossed vests if used properly, would cause
serious adverse health consequences or death. Furthermore, restraints
can provide benefits that outweigh the risks for some patients, for
example, by preventing patients with medically related cognitive
deficits from involuntarily discontinuing life-support or other needed
medical interventions, by temporarily reducing the mobility of agitated
patients who may otherwise hurt themselves or others, or by helping
patients feel safer in a bed or wheelchair. FDA does not believe that
recalling these restraints where the benefits outweigh the risks would
be in the best interest of the public health. Furthermore, FDA believes
that the risks associated with restraints will be further reduced by
the measures taken in this regulation. FDA, however, will certainly
initiate 518(e) recall action in the future if the agency determines
that individual circumstances warrant such action.
7. Four comments requested that FDA resume plans to conduct
clinical and human factors engineering tests on restraining devices to
assess their safety and effectiveness. Several comments stated that FDA
should gather and study information from other sources besides DEN,
including the Consumer Product Safety Commission, HCFA, State and local
agencies that regulate nursing homes, the courts, review of patient
records, review of the literature, and consultation with experts in the
field.
FDA notes that in developing its course of action regarding
protective restraints, the agency gathered considerable information
from many other sources besides DEN, including literature reviews,
interviews with health care professionals and professional
organizations, visits to user facilities, and discussions with
manufacturers of restraints. It is the manufacturers' responsibility to
conduct testing to assess safety and effectiveness. FDA, however, would
welcome any additional research information regarding restraint use
from health and consumer groups and encourages research by such groups
that would promote safer use of restraints. By revoking the premarket
notification and CGMP exemptions, FDA will gain further information
that will enable the agency to ensure safe use of these devices. FDA
will continue to evaluate information received from other available
sources.
8. One comment stated that FDA has ``exhibited confusion'' about
the appropriate circumstances for use of restraints. The comment noted
that the proposed rule states that restraints may be needed to keep
agitated patients from hurting themselves, but an FDA Medical Alert
warned that restraints may only add to this agitation and confusion and
therefore may place the patient in jeopardy.
Whether restraints should be used may vary depending on the
circumstances presented by the individual patient. While FDA realizes
that restraints can adversely affect a patient by increasing agitation,
they may sometimes be necessary under certain circumstances to restrain
agitated patients from harming themselves. The determination of whether
restraint use is appropriate should be made by clinicians for each
patient individually, after assessing the risks and benefits of
restraint use.
9. Several comments that supported the revocations suggested that
manufacturers who fail to submit a 510(k) or fail to adhere to CGMP's
should not only be prohibited from future sales of restraints, but
should be compelled to remove from use (at the manufacturers' expense)
all previously sold restraint products.
FDA disagrees that recalling devices is necessarily an appropriate
remedy for failure to comply with CGMP or premarket notification
requirements. As explained in comment 6 of this document, FDA will
initiate recalls only if the statutory criteria under section 518(e) of
the act are met, and will decide whether those criteria are met on a
case-by-case basis. As stated in FDA's response to comment 4 of this
document, manufacturers who fail to comply with CGMP and premarket
notification requirements are subject to various enforcement actions by
FDA.
10. Five comments requested that manufacturers be allowed to submit
510(k)'s by product category (e.g., vests, limb holders etc.), rather
than for each individual product, because some products differ only in
minor design aspects, while their function, application, and use is
identical.
FDA agrees that grouping of similar devices in a 510(k) submission
would be acceptable to a limited extent. For example, vests of similar
design but composed of different fabrics might be grouped into one
510(k). However, submissions for devices differing substantially in
design (and therefore risk) should not be grouped in a single 510(k).
FDA will review this issue on a case-by-case basis.
11. One comment expressed concern regarding what criteria FDA is
using to determine safety and effectiveness, and whether manufacturers
could be assured that 510(k)'s will not be delayed on the basis of
individual reviewers' perceptions of what constitutes safe and
effective.
FDA advises that there will be uniformity in the criteria that
reviewers consider to determine the safety and effectiveness of these
devices. Section 513(i) of the act (21 U.S.C. 360c(i)) and its
implementing regulations in part 807 (21 CFR part 807) describe the
criteria used by FDA to determine substantial equivalence. FDA provided
guidance that described labeling for restraints at an October 1991
meeting with a medical device trade organization. This guidance has
been incorporated into a draft 510(k) submission guidance that will be
used by FDA reviewers to assist in evaluating 510(k) submissions.
Additional general labeling guidance is available in the Human Health
Services (HHS) publication ``Labeling: Regulatory Requirements for
Medical Devices'' (Ref. 3), the Office of Device Evaluation's labeling
guidance document (Ref. 4), and the publication ``Write It Right,'' a
guidance on labeling for home use products (Ref. 5). The draft 510(k)
submission guidance recommends that manufacturers' 510(k) submissions
for restraints address the following: (1) Specific intended use of the
device; (2) ease of release of the device in the event of emergencies;
(3) tear strength of the materials; (4) potential for injury (e.g.,
whether there are abrasive materials, such as metal fasteners, that
would come in contact with the patient's skin, and similar
considerations); (5) ease of identification of size; (6) completeness,
conspicuousness, and simplicity of directions and labeling; (7) care/
cleaning instructions; (8) whether the material is biocompatible; and
(9) any safety testing data available for the device, including an
analysis of bench simulation testing data; and for certain
circumstances, (10) patient testing data.
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Manufacturers may contact the reviewing division to discuss the
appropriate content of their submissions on a case-by-case basis. FDA,
elsewhere in this issue of the Federal Register, is publishing a notice
of availability of this draft guidance and requesting comments on it.
12. Five comments stated that to ensure that protective restraints
continue to be available for medical use, manufacturers need to be able
to continue to market their products during the interim period between
the effective date of the final rule revoking the 510(k) exemptions and
the date that products are cleared by FDA. The comments also stated
that manufacturers need to be given a reasonable amount of time (at
least 6 months) after their final labeling is approved to exhaust the
remaining existing supplies of their products and phase in products
with the new labeling. Additionally, three comments stated that
manufacturers need to be given a reasonable amount of time (for
example, 2 years) to attain compliance with CGMP's.
FDA realizes that there will be a time period between the filing of
a 510(k) submission required by this regulation, and FDA's
determination, based on that submission, of whether the device has
marketing clearance. During the time period between the filing of a
510(k) and the FDA's substantial equivalence decision, FDA, in
exercising its enforcement discretion, does not intend to initiate
enforcement action relating to the distribution of protective restraint
devices that are adulterated under 21 U.S.C. 351(f)(1)(B) because they
fail to have FDA marketing clearance if: (1) The devices were initially
introduced into interstate commerce prior to September 3, 1996; and (2)
the sponsor has filed a 510(k) submission as of September 3, 1996.
FDA, however, intends to exercise its enforcement discretion to
initiate regulatory action against protective restraint devices that
have not received marketing clearance after June 4, 1997 if FDA has
been unable to reach a decision determining substantial equivalence
because the 510(k) submission fails to contain sufficient information.
FDA will notify the sponsor if such additional information is
necessary.
FDA has extended the effective date of the final rule requiring
submission of 510(k)s and compliance with CGMP's from 90 days to 180
days. FDA believes this time period is appropriate.
FDA first informed restraint manufacturers about FDA's planned
actions regarding 510(k) and CGMP requirements at a meeting with a
medical device trade organization in October 1991. FDA again notified
manufacturers in FDA's June 19, 1992, proposed rule, that the agency
intended to revoke these exemptions. Given the fact that industry has
been on notice since 1991 of FDA's plans to revoke these exemptions,
FDA does not believe manufacturers need an additional 2 years to comply
with CGMP's or 6 months after their labeling is approved to exhaust
supplies of labeling.
B. Restraint Identification
13. Two comments agreed with FDA's identification of a protective
restraint as it was published in the proposed rule. Several comments
stated that the identification of restraint used in the proposed rule
is too narrow, leaving major gaps in the coverage of a growing list of
potentially dangerous devices that are routinely used to restrain
patients or residents and that are ``falsely marketed'' as alternatives
to restraints. To alleviate these concerns, several comments suggested
using the broader definition of restraint proposed by HCFA in order to
include the concept of a method of restriction of movement.
FDA disagrees that the identification of protective restraints is
too narrow and leaves major gaps that do not cover devices that are
``falsely marketed'' as alternatives to restraints. Although the
identification gives examples of protective restraints, such as
wristlets, vests, and straps, the identification of protective
restraints is not limited to those examples. The identification is
based on the product's intended use. Under Sec. 801.4, evidence of a
device's intended use is not limited to labeling claims or to verbal
representations. It may be shown by the circumstances that the device
is offered and used for a purpose for which it is neither labeled nor
advertised. FDA considers any actions that otherwise represent a
device's intended use, as well as labeling, to determine a device's
intended use. Therefore, even devices that are ``falsely marketed'' as
alternatives to restraints will fall under the identification of
protective restraint if their intended use is to function as a
protective restraint. If a manufacturer intends a device to be used as
a restraint or is aware that the device is used as a restraint, that
manufacturer must comply with requirements for protective restraints.
FDA encourages consumers or health care workers to report instances
where manufacturers of such products are not complying with the
requirements for protective restraints.
Other comments suggested that the identification should state that
a restraint is any device which a resident cannot remove easily and
which restricts freedom of movement or easy access to their body. FDA
does not agree that the protective restraint identification should be
this broad. FDA may only regulate as devices products that fall within
the definition under section 201(h) of the act. Many products that
restrict freedom of movement or easy access to the body do not fall
under FDA's jurisdiction (e.g., safety belts, car seats). Also, even if
products that restrict freedom or access are medical devices (e.g.,
geriatric chairs), FDA believes it is inappropriate to identify all
such devices as protective restraints where that is not the intended
use of such devices.
14. One comment objected to the use of ``or others'' after
``protection of the patient'' at the end of Sec. 880.6760 (21 CFR
880.6760) because it is an established rule that restraints may only be
used to ``ensure the physical safety of the resident or other
residents'' (Social Security Act, section 1919 (42 U.S.C. 1396q)). The
comment also objected to the use of the term ``patients'' in the
restraint identification, because it is not appropriate in many non-
hospital settings. The term ``patients or other residents'' was
suggested as a substitute.
FDA disagrees with the comments. Restraints are sometimes used in
situations to protect individuals other than the person in restraints.
For example, hospitals may use restraints in emergency rooms to protect
staff, or other patients/residents from harm (e.g., due to patient drug
abuse or comparable circumstances). With regard to the objection to the
term ``patients'' in the context of non-hospital settings, FDA believes
that since restraints are medical devices, any resident who is
restrained constitutes a patient within the broad meaning of the term
in this section while wearing the restraint. Therefore, FDA rejects
these comments.
15. One comment stated that FDA should define bedrails and
geriatric chairs as restraints.
FDA notes that bedrails and geriatric chairs are currently
classified under Secs. 880.5100, 880.5110, 880.5120, and 880.5140
(bedrails); and Secs. 890.3100 and 890.3110 (21 CFR 890.3100 and
890.3110) (geriatric chairs). For the reasons stated in response to
comment 13 of this document, FDA believes that the current definition
of restraints is appropriate.
16. One comment requested that FDA modify the restraint
identification to exclude from the regulation those restraints that are
used with radiotherapy linear accelerators and simulators, because of
the controlled
[[Page 8436]]
conditions under which such restraints are used and the benefit they
provide. The comment requested that the identification of a restraint
be modified as follows:
A protective restraint is a device * * * that is intended for
medical purposes and that limits the patient's movements to the
extent necessary for treatment, examination, or protection of the
patient or others, excluding restraints which are used for a short
duration under the continual supervision of qualified personnel.
FDA does not believe that it would be appropriate to modify the
restraint identification to exclude restraints which are used for a
short duration under continual supervision from 510(k) and CGMP
requirements. These requirements are necessary for restraints that are
intended to be used for short periods of time under supervision because
such restraints may pose risks to patients if they are not used in the
manner the manufacturer intended. FDA advises that ``restraints'' for
use with radiation therapy systems are included under the
classification regulations for radiation therapy systems in
Secs. 892.5050 and 892.5300 (21 CFR 892.5050 and 892.5300). Under those
classification regulations, such restraints are already subject to
510(k) and CGMP requirements. Manufacturers of restraints that are
accessories to other devices should submit their 510(k) submissions to
the appropriate reviewing division for the primary device.
C. Wheelchair Accessories
17. Two comments supported the proposal to revise the
classification regulation for wheelchair accessories labeled or
otherwise represented as restraints. One comment, however, stated that
restraints should not be classified as wheelchair accessories because
this minimizes the importance of decisions regarding whether a
restraint should be used at all and the selection of the appropriate
type of restraint.
FDA disagrees that the chosen classification of wheelchair
accessories intended for use as restraints diminishes the importance of
decisions regarding use of those devices. FDA specifically emphasized
in the proposed rule and in the July 1992 FDA Safety Alert that the
same safety considerations, including proper selection and labeling,
are equally important for wheelchair accessories that are used as
protective restraints.
18. Two comments recommended that FDA adopt an identification of
wheelchair accessories intended for use as restraints that includes all
accessories and all wheelchair components that are manufactured and
marketed with the intent of restricting the patients' movement,
regardless of whether the devices are labeled or represented as
restraints.
FDA agrees with these comments. As discussed in paragraph 13 of
this document, the definition of protective restraint includes any
device that ``is intended for medical purposes and that limits the
patient's movements to the extent necessary for treatment, examination,
or protection of the patient or others.'' In stating in FDA's June 19,
1992, proposed regulation that FDA was exempting wheelchair accessories
from CGMP and premarket notification requirements that were not
``labeled or otherwise represented'' as a protective restraint, FDA did
not mean to imply that it was exempting those wheelchair accessories
that are not labeled or represented as restraints if they are intended
for use as restraints. To clarify that all wheelchair accessories which
are intended to be used as protective restraints must comply with
premarket notification and CGMP requirements, FDA is replacing the
words ``labeled or otherwise represented'' with ``intended for use'' in
the final regulation.
D. Labeling/Human Factors
19. Six comments requested that the agency consider the wide
variety of protective restraints available and evaluate each device
according to its intended use/size/design, without imposing a
``blanket'' labeling requirement for all restraints. For example,
devices such as vests should be labeled to clearly distinguish the
front and back of the restraint, whereas other restraints which have no
front and back should not be required to have such labeling.
FDA agrees that a ``blanket'' labeling requirement in this sense
should not be imposed and that the risks and benefits of each restraint
device should be reviewed individually in determining appropriate
specific labeling for restraint devices. FDA believes, however, that
similar protective restraints should have similar labeling. FDA also
believes that protective restraints should include step-by-step
instructions on how to apply the device and where to secure the ties,
have securely attached warning labels that clearly identify the front
and back of the restraints, and warn users of the dangers of reversal,
preferably using pictorials. Additional labeling instructions are
listed in the draft guidance document discussed in comment 12 of this
document.
20. Several comments expressed concern that the FDA regulation
implies that the only danger of restraints is in their potential
misapplication and that they are safe when used in accordance with the
manufacturer's instructions, and that HCFA's regulations will be
undermined.
FDA disagrees with these comments. FDA's regulation does not imply
that it alone will ensure safe and effective use of restraints. As
explained more fully in both the preamble to FDA's June 1992 proposed
rule and comment 5 of this final rule, FDA's regulations and HCFA's
regulations complement each other, they do not undermine each other.
HCFA laws and regulations ensure that restraints are only used on
persons who need restraints, and FDA's regulations will help ensure
that if clinically appropriate, such restraints will be applied safely.
21. Several comments requested that FDA require that restraint
labeling contain specific information including information about all
potentially harmful effects from the use of restraints, including
hazards, side effects, warnings/precautions, and contraindications for
their use. The comments also requested requiring clear delineation in
the device labeling as follows: (1) The front and back of the
restraint; (2) top and bottom of the restraint; (3) length of time the
restraint can be applied safely; (4) frequency with which the restraint
should be released; (5) frequency with which the patient should be
monitored; and (6) minimum standards or qualifications of personnel to
administer restraints. Several comments stated that labeling should be
required to be on the inside or underside of the device in as discrete
a manner as possible to convey necessary information and/or
instructions to users, in order to preserve the dignity and self-esteem
of the individual being restrained.
FDA advises that this regulation will allow FDA to review the
labeling for protective restraints, and that all labeling must provide
material information related to its safe use in accordance with section
502(a) of the act (21 U.S.C. 352(a)). In the preamble to the proposed
rule, FDA stated certain labeling practices that FDA believes are
necessary to help ensure the safe use of devices. Also, specific
suggested labeling is stated in the draft guidance document discussed
in comment 11 of this document. After receipt of individual premarket
notifications, FDA will review the labeling on a case-by-case basis.
With regard to placement of labeling, FDA encourages placement of
labeling in a manner that respects the patient's dignity, as long as
the placement does
[[Page 8437]]
not compromise the visibility of the labeling to the person applying
the restraint.
22. Several comments noted support for the utilization in all
product labeling of pictorials, languages other than English, and
textual information written for low language comprehension levels, in
sufficiently large type to clearly express the message. Several
comments suggested that the use of languages other than English is not
feasible and that the manufacturer's obligation should be limited to
adequate step-by-step instructions in English, with translations made
available by individual employers.
FDA agrees that pictorials and text materials written for low
language comprehension levels are important for effective conveyance of
application and hazard information. FDA also encourages manufacturers
that distribute devices for use by populations who do not use English
as a first language to provide instructions in foreign languages to the
extent possible and in accordance with the foreign language
requirements of Sec. 801.15(c). FDA has discussed human factors
considerations related to labeling with manufacturers, including the
selection of legible font types and sizes. Under 21 U.S.C. 352(c)
labeling statements required by or under the authority of the act must
be placed with conspicuousness and in such terms as to render them
likely to be read and understood by the ordinary individual under
customary conditions of purchase and use. See 21 CFR 801.15.
23. Several comments suggested that in addition to improved
labeling, posters should be made available for use and kept in
accessible view, such as in the restrained patient's room, nurses
stations, and physical therapy facilities.
FDA agrees that posters could be very helpful in promoting proper
use of restraints and has encouraged manufacturers to develop such
posters. Several manufacturers have already implemented instructions on
posters. Placement of such posters should be done in such a way that
they will be readily accessible to personnel but still comply with
nursing facility requirements for a homelike environment, in accordance
with provisions of 42 CFR 483.15(h)(1).
24. One comment noted that warnings and instructions for restraints
should be conveyed in a form suitable for home use as well as
institutional use.
FDA agrees with the comment and encourages use of FDA's guidance on
developing user instruction manuals for medical devices used in home
health care (Ref. 5). The document, entitled ``Write It Right,'' has
been distributed to all domestic and foreign medical device
manufacturers. Copies may be obtained from the Division of Small
Manufacturers Assistance, Center for Devices and Radiological Health,
800-638-2041.
25. One comment stated that experience demonstrates that product
labels and directions cannot in and of themselves protect patients from
injury or death. The comment stated that while the labeling guidelines
proposed by FDA represent a positive step in recognizing the potential
dangers of inappropriately applied or inappropriately supervised use of
restraints, such guidelines may do more to help shield manufacturers
involved in product liability suits than to protect patients from
avoidable accidents.
FDA agrees that product labeling alone cannot protect patients from
injury or death. However, well-presented labeling that is written in a
salient, informative, and concise manner can motivate the user to read
instructions, which can reinforce demonstration instruction and prevent
misuse of devices. Studies, as early as 1960, illustrate that behavior
can be affected by warnings and safety posters in the workplace (Ref.
6). More recent studies demonstrate that user behavior is clearly
influenced by the presence and location of warnings and adequate
instructions for use (Ref. 7).
FDA agrees that clearer labeling may in some instances help shield
manufacturers from product liability. However, regardless of any effect
on product liability, improved labeling, which may help reduce the
incidence of injury and death is important. To supplement the
beneficial effects of improved labeling, FDA advises that adequate
training and education of health care providers is necessary for safe
and effective use of restraints.
26. One comment stated that knots tied in some restraints are often
difficult to untie in the event of an emergency, and if it were at all
possible, restraints that tie should be replaced by those that release
with a clasp of some kind.
FDA supports the development of safe innovations that would improve
the ease of use of restraint devices.
E. Sizing/Color Coding
27. Several comments stated that a universal color coded sizing
system should be adopted throughout the industry to help facilitate
selection of the appropriate restraint size and reduce incidences of
misapplication of an incorrect size that could lead to deaths or
injuries.
FDA agrees with the comments. FDA also notes the availability of a
voluntary new sizing standard for women over the age of 55, which might
be of use in designing restraints for geriatric patients, who typically
have upper torso dimensions that are substantially different from
younger patients. The standard, entitled ``The Development of Body
Measurement Tables for Women 55 and Older and the Relationship to Ready
to Wear Garment Sizes,'' is available from the American Society for
Testing and Materials, 1916 Race St., Philadelphia, PA 19103.
28. One comment from a manufacturer noted that for 54 years their
company has manufactured restraints in accordance with a particular
color code for size, and that this color code has become the most
commonly used and understood color code by users of restraints. The
comment stated that if FDA decides to adopt a different color standard
than what the comment perceives as the ``prevailing standard,'' it will
create serious confusion among users because of the extensive user
familiarity with that color coding standard. Another comment stated
that color coding sizes for restraints would have a substantial
financial impact on industry.
This regulation is not requiring the adoption of a color-coded
sizing standard. However, FDA encourages manufacturers to develop an
industry-wide voluntary standard.
29. Two comments noted that manufacturers produce a selection of
sizes of certain types of restraints (e.g., vests), but that this does
not ensure that facilities have purchased adequate sizes or the entire
line of vest restraints for utilization in their facility.
FDA advises that selection of the appropriate size and type of
restraint is critical for safe and effective use of the device and that
clinicians and purchasing agents should consult medical practice
guidelines and instructions for use in determining the appropriate
size.
F. Flame Retardancy
30. FDA explicitly solicited comments regarding whether some or all
restraints should be made of flame resistant materials. Several
comments supported a universal requirement for flame resistant
restraints, citing the following reasons:
(1) There have been reports to FDA of at least six patients dying
or being injured as a result of deliberately or accidentally igniting
their restraints;
(2) Clinicians report having seen many restraints with ash and
cigarette burns in them, further indicating a
[[Page 8438]]
safety problem with respect to flammable materials;
(3) Many of the persons who are restrained may retain their right
to smoke in designated areas. These patients may have poor posture
control or hand dexterity, or may be confused, increasing the chances
of an accident. Also, visitors and other residents unaware of a
potential fire hazard may give smoking materials to the resident
without staff knowledge;
(4) Many nursing home residents may use oxygen, or be in close
proximity to other residents who use oxygen, increasing the danger of
fire.
Alternatively, multiple comments opposed requiring all protective
restraints to be constructed of flame resistant material, citing the
following reasons:
(1) Adequate and appropriate supervision is the best means of
prevention of burn and smoke inhalation injuries to individuals who are
being restrained;
(2) Many other items found on or near the bed are not flame
resistant, such as bed linens, pajamas, clothing, and even the
patient's hair, so having restraints made of flame resistant materials
would not serve a useful purpose. Residents might be better served
through establishment of a smoke-free environment;
(3) Labeling of restraints as flame resistant might actually
encourage smoking in bed by providing a false sense of security to both
residents and health care providers, who might relax smoking policies;
(4) The availability and effectiveness of flame resistant
restraints is limited by current technology. Some device components are
not readily available in flame resistant material, so requiring
restraints with this property might be prohibitively expensive. Also,
textile materials treated with flame resisting chemicals will burn if a
source of ignition is present, and the flame retardancy of some devices
is destroyed after the first laundering of the device. Warnings against
the exposure of protective restraints to ignition sources should
adequately address concerns related to burn injuries;
(5) Flame resistant vests are now marketed with very little success
due to the higher price (approximately 30 percent). This cost outweighs
the negligible benefit that might be derived with a universal
requirement for flame resistant restraints.
Several comments also stated that FDA should study the actual
contribution to patient safety that would be afforded by flame
resistant restraints versus the economic impact of replacing devices
currently in use. One comment suggested that the comfort and care of
the patient should be the primary concern and that secondary issues
should include whether fire resistant materials make the restraint less
flexible or more likely to cause rubbing or irritation; the effect on
safety features of the device; and the extent of protection flame
resistant materials would actually offer in the event of fire.
FDA has carefully considered the comments submitted and concluded
that although there are potential fire hazard concerns for some
patients, adequate and appropriate supervision is the most effective
and useful means of preventing fire-related injuries associated with
restrained patients. Some additional benefit, however, may occur by
using flame-resistant restraint material on patients who smoke.
Although FDA does not believe it is appropriate to require the use of
flame-resistant materials for all restraints, FDA recommends that
health care institutions develop and implement policies for the use of
flame-resistant restraints for patients who smoke while in restraints.
G. Training, Education, and Guidelines for Use
31. Several comments advocated increased training, education, and
FDA development of guidelines for restraint use to promote the safe
application of restraint devices. Several comments suggested that FDA
should publish a consumer (family) guide or brochure on the appropriate
use of restraints, the risks and benefits of restraint prescription and
application, and the potential side effects and hazards of restraint
use.
FDA agrees that adequate training and education for users of
restraints in all care scenarios is critical to the safe and effective
use of restraints and FDA strongly encouraged increased education about
restraint use in its July 1992 Safety Alert issued to health care
professionals. FDA has actively participated with health care
associations in the development of guidelines for use of medical
devices in the past and is willing to participate in such efforts for
protective restraints. FDA advises that in using restraints,
institutions are required to meet all State and local laws and HCFA
requirements, and are encouraged to meet guidelines developed by
professional health care organizations. With regard to publication of a
consumer guide, the FDA 1992 Safety Alert on restraints contains
information about restraint use specifically directed towards patients
and family members. Copies of FDA's Safety Alert are available upon
request from the Office of Surveillance and Biometrics (HFZ-500),
Center for Devices and Radiological Health, 5600 Fishers Lane,
Rockville, MD 20857.
32. One comment stated that because the liability burden for
patient morbidity and mortality caused by restraints is increasingly
shifted to nursing home staff, FDA should consider requiring
manufacturers to offer training and accessible advice to nursing homes
with device questions or problems, as a component of the new premarket
notification and CGMP rules.
Such requirements are beyond the scope of this rulemaking. However,
FDA encourages health care facilities to request training when
purchasing restraints and if such training is not made available, to
reconsider their purchasing policies. Manufacturers have already been
strongly urged by FDA to develop training videos and other materials to
assist health care facilities in training their staff in the proper
application and use of their products.
H. Chemical Restraints
33. Two comments noted that they do not support the use of
pharmaceutical options as chemical restraints in substitute for
physical restraints and stated that FDA is well positioned to address
the issue of the misuse of chemical restraints. The comments
recommended that FDA consider labeling recommendations for
manufacturers of drug products frequently used for chemical restraint.
FDA is advised that guidelines for the use of chemical restraints
in nursing homes are being finalized by HCFA, but such controls are
beyond the scope of this medical device rule. If the comments wish to
express concerns regarding labeling of specific drug products believed
to be misused as chemical restraints, those comments should be referred
to FDA's Center For Drug Evaluation and Research, Division of
Neuropharmacological Drug Products (HFD-120), 5600 Fishers Lane,
Rockville, MD 20857.
III. The Final Rule
Persons required to file premarket notification submissions under
section 510(k) of the act (21 U.S.C. 360(k)) and the procedures in
subpart E of 21 CFR part 807 must file a premarket notification
submission for any protective restraint device already marketed or
intended to be introduced or delivered for introduction into interstate
commerce for commercial distribution on or after September 3, 1996.
[[Page 8439]]
All protective restraints that are introduced or delivered for
introduction into interstate commerce on or after September 3, 1996,
are required to be manufactured in compliance with the CGMP regulations
in 21 CFR part 820.
In a notice published elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a draft guidance
document for the preparation of a premarket notification (510(k))
submission.
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) 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.
V. Analysis of Impacts
FDA has examined the impacts of the final 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 final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
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 this final rule only removes an exemption
and subjects manufacturers of patient restraints to the same
requirements as manufacturers of other devices, the agency certifies
that the final 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.
VI. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. ``FDA Safety Alert: Potential Hazards with Restraint
Devices,'' Food and Drug Administration, Rockville, MD, July 15,
1992.
2. Johnson, R., FDA, letter to restraint manufacturers,
February, 1992.
3. ``Labeling: Regulatory Requirements for Medical Devices,''
HHS Publication No. FDA 89-4203, Food and Drug Administration,
Rockville, MD, August, 1989.
4. Office of Device Evaluation, ``Device Labeling Guidance,''
No. G91-1, Food and Drug Administration, Rockville, MD, March 8,
1991.
5. ``Write It Right: Recommendations for Developing User
Instruction Manuals for Medical Devices Used in Home Health Care,''
Food and Drug Administration, Rockville, MD, August, 1993.
6. Laner, S., and R. G. Sell, ``An Experiment on the Effect of
Specially Designed Safety Posters,'' Occupational Psychology,
34:153-169, 1960.
7. Wolgalter, M. S. et al., ``Effectiveness of Warnings,'' Human
Factors, 29(5):599-612, 1987.
List of Subjects
21 CFR Parts 880 and 890
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
880 and 890 are 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 880.6760 is revised to read as follows:
Sec. 880.6760 Protective restraint.
(a) Identification. A protective restraint is a device, including
but not limited to a wristlet, anklet, vest, mitt, straight jacket,
body/limb holder, or other type of strap, that is intended for medical
purposes and that limits the patient's movements to the extent
necessary for treatment, examination, or protection of the patient or
others.
(b) Classification. Class I (general controls).
PART 890--PHYSICAL MEDICINE DEVICES
3. The authority citation for 21 CFR part 890 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).
4. Section 890.3910 is revised to read as follows:
Sec. 890.3910 Wheelchair accessory.
(a) Identification. A wheelchair accessory is a device intended for
medical purposes that is sold separately from a wheelchair and is
intended to meet the specific needs of a patient who uses a wheelchair.
Examples of wheelchair accessories include but are not limited to the
following: armboard, lapboard, pusher cuff, crutch and cane holder,
overhead suspension sling, head and trunk support, and blanket and leg
rest strap.
(b) Classification. Class I (general controls). If the device is
not intended for use as a protective restraint as defined in
Sec. 880.6760 of this chapter, it is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter, and
is also exempt from current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Dated: February 15, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-4719 Filed 3-1-96; 8:45 am]
BILLING CODE 4160-01-F