[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



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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Register, FDA is announcing the availability of a draft guidance 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