Fire Safety: Is Your Facility Legal?


Fire safety: Is your facility legal?

The legal stru cture governing nursing home fire safety: A guide to self-examination

Federal regulations expect facilities to “be designed, constructed, equ ipped, and maintained to protect the health and safety of residents, personnel, and the public,” 1 p lus satisfy applicable provisions of the Life Safety Code of the National Fire Protection Association (N FPA, The regulatory framework also de mands that nursing homes have “detailed written plans and procedures to meet all potential emergencies and disa sters, such as fire[.]” 1 The facility must, according to federal regulations, train employees in di saster and emergency procedures when they begin working in the facility, periodically review these procedures w ith existing staff, and conduct unannounced drills (with care not to disturb or excite residents) to test the e fficiency, knowledge, and response of institutional personnel in the event of an emergency.1 Local l aws may surpass federal requirements for staff training in emergencies, as is the circumstance in New York.2

Two deadly nursing home fires in Hartford, Connecticut, and Nashville, Tennessee, last year focused considerable attention on the safety of our nation’s nursing home residents, a highly vulnerable popul ation of elderly and disabled individuals. The general statements in the previous paragraph notwithstanding, ex amination of the lessons learned from these two fires found systemic problems with the adequacy and enforcement of federal fire safety standards that go well beyond these two tragic events.3

Frequency of Nursing Home Fires
The most recent data show that an average of 2,300 of the coun try’s approximately 16,300 nursing homes reported a structural fire each year from 1994 through 1999, and that there was an average of five fire-related nursing home deaths nationwide annually.3 While cooking an d laundry dryers represented the leading causes of fires, resident deaths were chiefly associated with smoking, and resident rooms were the principal areas of fire origin.3 During this same period, one multiple- death nursing home fire resulted in three fatalities.3

In contrast, the fire-related death to ll in 2003 was considerably higher-31 residents died in the nursing home fires in Hartford (16) and Nashville ( 15)3 (table 1). Neither home was required to have an automatic sprinkler system, even though such sy stems are effective in reducing the number of multiple deaths from fires.3 Federal fire safety stand ards do not require sprinklers in older nursing homes, such as the Hartford and Nashville facilities (built in 1970 and 1967, respectively), constructed with certain noncombustible materials (e.g., concrete, steel, or bric k) that have a certain minimum ability to resist fire.3 It is estimated that 20 to 30% percent of nu rsing homes nationwide lack full automatic sprinkler systems.3

Nursing Home Fir e Safety Standards
Nursing home fire safety standards are built on principles that combine certai n construction and operational features along with an acceptable staff response. These standards reflect the mo bility and cognitive limitations of many elderly and disabled residents who cannot be evacuated easily during a fire. The principles include:

  • appropriate facility design and construction, particularly compartmentali zation to contain fire and smoke;
  • provision for fire detection, alarm, and extinguishment (e.g., smoke d etectors and sprinkler systems); and
  • fire prevention policies and the testing of staff response (e.g., t aking steps to isolate the fire and transferring residents to areas of refuge).

Examples of s pecific requirements. The fire safety standards for nursing homes cover 18 categories, ranging from buildin g construction to furnishings. Examples of specific requirements include:

  • use of fire- or smoke-resistan t construction materials for interior walls and doors;
  • installation and testing of fire alarms and smoke detectors;
  • protection of hazardous areas (e.g., laundry rooms);
  • regulation of smoking by residen ts; and
  • development and routine testing of a fire emergency plan.3

New versus existin g nursing homes. In the past, whenever a new edition of the nfpa code was adopted by the Centers for Medica re & Medicaid Services (cms), nursing homes had the option of complying with the new standards or an earlier ed ition.1 Therefore, a nursing home that began serving Medicare and Medicaid residents under the 1967 edition of the standards could continue to be surveyed under those standards up until 2003.3 With th e implementation of the 2000 edition of the nfpa standards, however, cms eliminated the option for facilities t o be grandfathered under earlier Life Safety Code editions.4 All nursing homes participating in Medicare and Medicaid as of March 2003 must comply with the 2000 standards for existing facilities with CMS changes (e.g., strengthened emergency lighting requirements).3

Federal nursing home fire s afety standards in unsprinklered facilities. The nursing home fires in Hartford and Nashville revealed weak nesses in federal nursing home fire safety standards for unsprinklered facilities. For example, federal standar ds did not require either facility to have smoke detectors in resident rooms where the fires originated, and fi re department investigations suggest that their absence might have delayed the notification of staff and activa tion of the buildings’ fire alarms. In light of inadequate staff response to the Hartford fire, the degree to w hich the standards rely on staff to protect and evacuate residents may be unrealistic.

Retrofit cost: A barrier to requiring automatic sprinkler systems in all nursing homes. The Hartford and Nashville fires reopened the debate about the need to retrofit older nursing homes with sprinklers. In their aftermath, Connect icut and Tennessee passed laws requiring all nursing homes to install sprinkler systems. Notably, of Connecticu t’s 254 nursing homes, 206 are fully sprinklered, 31 are partially sprinklered, and 17 have no sprinklers, and of Tennessee’s 343 nursing homes, 229 are fully sprinklered, 90 are partially sprinklered, and 24 have no sprin klers.

The decision to allow older, existing facilities to operate without sprinklers is being reevaluat ed now in light of the 2003 nursing home fires. Historically, CMS and the nursing home industry have considered cost a barrier to requiring installation of automatic sprinklers for all older nursing homes, even though spri nklers are considered to be the single most effective fire protection feature.3 There has never been a multiple-death fire in a fully sprinklered nursing home, and sprinklers now are required in all new faciliti es.3

Although the amount is uncertain, sprinkler retrofit costs remain a concern,4-6 and the nursing home industry endorses a transition period for homes to come into compliance with any new re quirement. If retrofitting is eventually required, it is likely to be several years before implementation begin s. (See News Notes, for recent federal legislation seeking to mandate sprinkler systems in all nursing homes, a ccompanied by reactions from the American Health Care Association and the American Association of Homes and Ser vices for the Aging [AAHSA].)

Although infrequent, multiple-death nursing home fires have prompted some states (e.g., Ohio, Utah, Virginia, Vermont, and West Virginia) to require nursing homes to be retrofitted with sprinklers.3 States can enforce such requirements because state licensure is a prerequisite to oper ation. States with relatively high proportions of unsprinklered nursing homes include Arkansas, Iowa, Pennsylva nia, and Wisconsin.3

As a result of the Hartford and Nashville fires, NFPA is actively consid ering incorporating a sprinkler retrofit requirement into its 2006 update of the Life Safety Code standa rds, as urged by AAHSA (see News Notes).

Oversight of Fire Safety: The Survey Process
On September 11, 2003, CMS began surveying facilities for compliance with the 2000 edition of the < I>Life Safety Code. Every nursing home receiving Medicare or Medicaid payment must undergo a standard surve y not less than once every 15 months, and the statewide average interval for these surveys must not exceed 12 m onths.1,7,8 State survey agency personnel conduct the survey to assess compliance with federal quali ty of care and fire safety requirements.1 Revised survey forms now capture the status of sprinkler s ystems-Fire Safety Survey Report 2000 Code, Form CMS-2786R (Rev. Mar. 2004) and Fire Safety Survey: 2 000 Life Safety Code Worksheet for Rating Residents, Form CMS-2786M (Rev. Mar. 2004). Most states use fire safety specialists within the same department as the state survey agency to conduct fire safety inspections, bu t 16 states contract with their state fire marshal’s offices.3 The fire safety portion of a standard survey is not always conducted concurrently with the quality-of-care review, particularly in states that contr act with their state fire marshals. All personnel conducting the inspections must complete a self-paced, comput er-based course before fulfilling five days of classroom training on fire safety standards.3

These inspections focus on a nursing home’s compliance with federal requirements for healthcare facilities. Whe n a deficiency is found, it is assigned to one of 12 categories according to its scope (i.e., number of residen ts potentially or actually affected) and its severity (e.g., noncompliance with Life Safety Code requirements r esults in actual harm to residents or employees).8 States are required to enter information about su rveys and complaint investigations, including the scope and severity of deficiencies identified, in CMS’s Onlin e Survey Certification and Reporting (OSCAR) system database.

Of the 40 comparative surveys that assesse d fire safety standards in fiscal year 2003, federal surveyors identified on average more than two fire safety deficiencies per home that were either missed or not cited by state surveyors.3 See table 2 for the percentage of surveyed nursing homes cited with fire safety deficiencies on their most recent surveys, by state , as of December 1, 2003. Some of the deficiencies found by federal surveyors were potentially serious, includi ng the absence of required sprinkler systems, improper maintenance of sprinkler systems, inadequate building co nstruction to contain fire and smoke during a fire, and failure to conduct routine fire drills.

Roller latches (i.e., a type of door-latching mechanism to keep a door closed) are consistently one of the most cited deficiencies under the CMS life safety requirements.4 Improperly maintained roller la tches may present a danger to resident and staff health and safety. One of the most tragic examples of roller-l atch failure occurred in 1989 when a fire claimed 12 lives in a nursing home.4 In all the rooms wher e the door was closed and remained closed throughout the fire, the residents lived. In the rooms where the door was open or originally closed but bounced open, the residents died. During the postfire investigation, the doo rs on the floor above the fire origin were examined, and it was determined that the majority of the doors faile d to stay closed as a result of roller-latch failure. Therefore, based on prior incidents, CMS decided to prohi bit the use of roller latches in existing and new buildings and will phase in this requirement during a three-y ear period that began on March 11, 2003.4 Facilities must replace existing roller latches with posit ive latching devices in existing sprinklered and unsprinklered buildings. During this three-year phase-in perio d, CMS will continue to monitor, through the existing survey process, the maintenance and operation of roller l atches that have yet to be replaced.

How Nursing Homes Address Fire Safety Deficiencies< /b>
If a deficiency is cited, a nursing home might have three alternatives.

1. Submit a pla n of correction. The facility may be required to prepare a detailed plan of correction that eliminates an i dentified fire safety deficiency, which may be verified on a subsequent revisit. The state survey agency must m ake the statement of deficiencies, as well as the facility’s plan of correction, available to the general publi c within 14 days after the deficiencies are presented to the facility.7

2. Obtain a waiver . A facility may request a waiver through its state survey agency if compliance with the requirement would cause the facility unreasonable financial or other undue hardship, and there is no adverse effect on resident h ealth and safety.1,9 In general, waivers are limited to deficiencies cited at “less than actual harm .” A CMS regional office reviews and approves waivers, which may be temporary-to allow a home to develop and ob tain approval of a construction plan-or of a longer term.

As of December 2003, 15% of nursing homes in 3 0 states operated with waivers of certain federal fire standards.3 However, the proportion of homes that have applied for and received waivers varies widely, from less than 1% of facilities in California, Florid a, and Maine, to more than 57% in Ohio, as of 2003.3

The most frequently waived requirement t hat may pose a risk to residents is that the HVAC (i.e., heating, ventilation, and air conditioning) system mee ts applicable codes and is constructed to restrict the spread of smoke and fire within the building.3 As of December 2003, 10% of all nursing homes nationwide (1,556 of 16,334) were cited for deficiencies in thi s area on their most recent surveys; half of these subsequently received waivers of this standard and were not required to make corrections.3 CMS guidance permits a waiver of this requirement in an unsprinklered facility if it has compensating features, such as a complete corridor smoke-detection system, and its air-hand ling system is designed to shut down automatically when smoke detectors or fire alarms are activated. However, NFPA advises that these features are insufficient and that there are no compensating features permitting a nurs ing home to operate safely with such a deficiency, irrespective of the facility’s sprinkler status.3

3. Undergo an assessment using the Fire Safety Evaluation System. As an alternative to correctin g or receiving a waiver for deficiencies identified on a standard survey, a facility may undergo an assessment using the Fire Safety Evaluation System (FSES) 2001 edition.10 One in five nursing homes: (1) receiv es a waiver of one or more fire safety standards, (2) obtains a passing score on FSES, or (3) uses a combinatio n of waivers and FSES.3

FSES, developed by the Department of Commerce’s National Institute of Standards and Technology (formerly the National Bureau of Standards), provides a means for providers who parti cipate in the Medicare and Medicaid programs to avoid potentially costly corrective measures and meet the fire safety objectives of the standards without necessarily being in full compliance with every standard.9 As of December 2003, 7% of all nursing homes nationwide (1,138 of 16,334) were certified using FSES.3 These homes are located in 30 states. FSES uses a grading system to compare the overall level of fire safet y in a specific facility to a hypothetical facility that exactly matches each requirement of the fire safety st andards.3 FSES may be conducted by either the state or the facility, but CMS requires both the state survey agency and the regional office to review the results. Point values are assigned to various fire safety features, such as sprinklers, smoke detectors, construction types (refers to whether combustible or noncombusti ble materials were used to build the facility and to the number of floors), and corridor doors. A facility pass es FSES if its point score meets or exceeds that of the hypothetical facility. Once a facility has been certifi ed using FSES, it continues to be certified on that basis in subsequent years if there are no significant chang es that alter the FSES score. However, an annual survey must still be conducted.

Case Il lustrations: Investigations and Outcomes
Failure to cite deficiencies. Postfire investigat ions in Connecticut and Tennessee revealed deficiencies that existed, but were not cited, during prior surveys3 (table 3). For example, a survey conducted at the Hartford facility one month prior to the fire did not uncove r the lack of fire drills on the night shift, or that on the night the fire occurred, staff failed to implement the facility’s fire plan. The survey was conducted during the daytime when night-shift staff were unavailable for interviews, and surveyors relied on inaccurate documentation stating that all shifts were conducting fire d rills. On the other hand, Tennessee’s postfire investigation failed to explore staff response, a deficiency cit ed in four prior surveys, and never established a clear chronology of staff response, including whether they cl osed resident room doors to contain the fire and smoke.

Click on image to enlarge vie w.

Lack of smoke detectors. Although commonsense features such as smoke detectors in res ident rooms are effective in alerting staff to a fire while it is still relatively manageable, smoke detectors are not required in unsprinklered nursing homes.3 Cms has stated that it will pursue a regulatory ch ange requiring installation of smoke detectors in every resident room.3

Only nursing homes su rveyed under federal standards for new construction since 1981 are required to have either corridor or in-room smoke detectors.3 According to fire inspectors, the lack of smoke detectors in resident rooms in the Hartford and Nashville facilities might have contributed to a delay in staff response and fire department noti fication.3 Compare this with the presence of smoke detectors in resident rooms in a December 2003 nu rsing home fire in Nevada where a resident smoking in bed while on oxygen started a fire at 2:20 a.m.3 Staff were alerted by the in-room smoke detector, and the fire was extinguished before it caused a significa nt amount of damage. While the resident who started the fire subsequently died as a result of the fire, no othe r deaths were reported. Although the facility was equipped with automatic sprinklers, the buildup of heat from the fire had not reached a level sufficient to activate the sprinklers.

Lack of smoke dampers. Th e new standards require smoke dampers where ductwork passes through a smoke barrier, and older homes, such as t he Nashville facility, will no longer be grandfathered under earlier editions of the Life Safety Code th at do not include such a requirement.3 However, a facility that lacks dampers in ductwork as require d by current federal standards could still be certified for Medicare or Medicaid by obtaining a waiver for this requirement from CMS. However, CMS guidance still requires smoke detectors in resident rooms and fire-rated se paration of resident rooms as compensating features when considering waivers for some unsprinklered one-story, wood-frame facilities.

Fire or smoke barriers in unsprinklered facilities. Another potential weak ness in federal standards, particularly in an unsprinklered facility, is that resident rooms are not required t o be separated from each other by fire or smoke barriers.3 History has shown that smoke is the cause of most fire deaths. Consequently, fire-resistant smoke barriers extending uninterrupted from floor slab to ro of slab passing through all concealed spaces become an important fire-protection feature. In the Hartford nursi ng home fire, residents in the room adjacent to the room of fire origin died from smoke inhalation. Smoke and f ire spread through the space above a false ceiling. The federal standard currently dictates installation of com plete fire and smoke barriers between corridor and resident rooms, not between resident rooms.

Inadeq uate resident smoking policies. Nursing homes must recognize the resident’s right to smoke, adhere to feder al regulations governing smoking, and follow Life Safety Code provisions on the subject.1,2 W ritten facility policy and procedure might address, among other topics:

  • identification and hours for des ignated, well-ventilated smoking area(s);
  • rules for resident smoking;
  • procedures for identifying and documenting unsafe smoking behaviors (e.g., smokes in unauthorized areas, hoards matches, or hands shake) and incorporating the information into resident’s care plan;
  • family notification of resident’s unsafe ac tivities;
  • job description for smoking attendants (e.g., distributing cigarettes, providing lighting serv ices, monitoring disposal of burning ashes, applying and removing smoking aprons, and identifying dangerous or noncompliant behavior);
  • rules for obtaining and keeping cigarettes, lighters, or matches; and
  • r equirements for staff in-service education and training (e.g., training in use of fire blankets and extinguishe rs).11

Facilities should compare their smoking policy with actual resident smoking practices. In addition, they should examine policy and procedure concerning residents who smoke, particularly while physical ly restrained. The resident’s nursing home record should document the risk factors for burns associated with sm oking and the interventions undertaken by the facility to reduce or eliminate the identified hazards: for examp le, instructing the resident in safe smoking practices, allowing the resident to smoke only when supervised, re moving smoking materials from the resident who is unable to comply with facility policy, or requesting visitors not to give smoking materials to the resident.

Unsupervised residents smoking. In Lawson v. S kyline Healthcare Center, for example, an unsupervised California nursing home resident with AIDS who was t aking medication that often made him fall asleep in his wheelchair suffered severe burn-related injuries after accidentally lighting the wrong end of a cigarette, causing a fire that spread to his body.12 He wou ld obtain cigarettes from a nurse’s station, and a staff member was supposed to supervise him while he smoked. Jurors found both parties negligent and apportioned fault at 70% percent to the nursing home and 30% for the re sident. The California Court of Appeal affirmed the jury verdict, disagreeing with the defendant nursing home’s arguments that under the doctrine of assumption of the risk, the resident was solely to blame for his injuries .

Poor posture control, hand dexterity, or confusion increases the chances of burn-related injuries and deaths among nursing home residents who smoke. In Taylor v. Vencor, Incorporated, for instance, a reside nt who required direct supervision while smoking cigarettes because of mental and physical problems died from b urns after her nightgown caught fire.13 The wrongful death action alleged that the facility failed, through inadequate staffing of its designated smoking area and other negligent behavior, to adequately observe and supervise the resident while she smoked. The North Carolina Court of Appeals allowed the wrongful death sui t to advance, concluding that the claim constituted ordinary negligence rather than medical malpractice; thus, the court did not require review by a qualified expert witness willing to testify that the facility’s medical c are fell below the applicable standard of care because “preventing a resident from dropping a match or lighted cigarette upon themselves, while in a designated smoking room, does not involve matters of medical science.”

Similarly, in Donson Nursing Facilities v. Dixon, for instance, the Georgia Court of Appeals held a nursing home liable for failing to supervise a mentally confused resident who, while smoking in bed, started a fire that killed him.14 The facility knew of the resident’s careless smoking habits and propensity to set fires while smoking and failed, despite this knowledge, to exercise any supervision of the decedent.

Visitor providing residents with smoking materials. Family members, visitors, other residents, or fa cility staff may provide smoking materials to residents. Consider LeBlanc v. Midland National Insurance Comp any, where the Louisiana Court of Appeal affirmed a verdict in favor of the nursing home after a resident w as burned while smoking a pipe, reasoning that the facility at one time had removed all smoking materials, but the resident’s family demanded that the resident be allowed to smoke.15 In Black v. Trevilla Nurs ing Home of New Brighton, for example, the Minnesota Court of Appeals learned of an unattended, wheelchair- bound resident who allegedly died as a result of a burn sustained from “combustibles, smoking materials, matche s, or other incendiaries” negligently allowed by the facility.16

Purposeful or accidental igniting of physical restraints. The deliberate, purposeful, or accidental igniting of physical restraints also may result in death or injury.17,18 For example:

    A 76-year-old nursing home resident diagnos ed with dementia died two days after suffering third degree burns over 56% of his body when his clothing caught fire. Allegedly, the resident was found standing and ablaze from the waist up after facility staff responded t o screams. In a subsequent negligence lawsuit, the decedent’s surviving heir claimed that the resident had been placed in a vest restraint without a physician’s order in violation of federal and state regulatory rules and procedures. She also claimed that the facility administrator had instructed employees to restrain the resident when his family members left the premises after visiting. The plaintiff also alleged that the facility had an i neffective smoking policy despite knowledge that some residents had cigarettes and lighters. She theorized that the resident’s roommate, who also suffered from dementia, either lit a cigarette for the decedent or tried to help him use a cigarette lighter to burn off the restraining vest’s straps. The resident’s room was cleaned and painted at night immediately after the fire. A fire investigator allegedly found a trash bag in a Dumpster con taining the decedent’s clothing and the remains of the vest. The administrator denied the allegations. A Texas Department of Human Services investigation prompted the establishment of an involuntary trusteeship to operate the facility and return it to compliance with federal and state regulations. A $1,350,000 settlement ended the negligence suit.19

Residents, staff, and public safety personnel deserve the highest level of protection from the risks presented by fire. CMS must improve its oversi ght of nursing home fire safety by, among other possibilities, reviewing the appropriateness of exemptions to f ederal standards granted to unsprinklered facilities, strengthening fire safety standards to include mandatory sprinkler systems in all nursing homes, and thoroughly investigating any future multiple-death nursing home fir es to evaluate the adequacy of fire safety standards.

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Julie A. Br aun, JD, LLM, is a Chicago-based attorney and writer. To comment on this article, please send e-mail to To order reprints i n quantities of 100 or more, call (866) 377-6454.


  1. Code of Federa l Regulations, Title 42, Subpart B, Sections 483.15(b)(3) [self-determination and participation]; 483.70 [physi cal environment], 483.75(m) [disaster and emergency preparedness], 488.110 [survey process procedural guideline s] 488.307 [unannounced surveys], 488.308 [survey frequency].
  2. National Fire Protection Association. Life Safety Code. Quincy, Mass.:National Fire Protection Association, 2000.
  3. General Accounting Office. Nursi ng Home Fire Safety: Nursing Home Fires Highlight Weaknesses in Federal Standards and Oversight. Washington, D. C.:General Accounting Office, 2004.
  4. Centers for Medicare & Medicaid Services. Medicare and Medicaid prog rams: Fire safety requirements for certain health care facilities. Final rule. Federal Register 2003;68(7):1374 -88
  5. Shannon JM [interview]. Fire protection guidelines for nursing homes. Nursing Homes/Long Term Care M anagement 2004;53(5):40-2.
  6. Edwards DJ. NH News Notes: The heat is on nursing homes to install sprinkler systems. Nursing Homes/Long Term Care Management 2003;53(12):10-11.
  7. 42 United States Code. Sections 1395 i-3(g)(2)(A)(i),(iii)(I) [Medicare], 1395i-3(g)(5)(A)(i) [Medicare], 1396r(g)(2)(A)(i), (iii)(I) [Medicaid], 13 96r(g)(5)(A)(i) [Medicaid].
  8. Centers for Medicare & Medicaid Services. State Operations Manual. Section 7 410A [applying enforcement regulations to Life Safety Code surveys].
  9. Centers for Medicare & Medicaid Ser vices. Memorandum to State Survey Agency Directors from Thomas E. Hamilton, Director, CMS Survey and Certificat ion Group: Life Safety Code (LSC) and State Performance Standards, No. S&C-04-33. May 13, 2004.
  10. Centers for Medicare & Medicaid Services. Memorandum to Survey and Certification Regional Office Management, State Surv ey Agency Directors, and State Fire Authorities from Steven A. Pelovitz, Director, U.S. Department of Health an d Human Services, Centers for Medicare & Medicaid Services: Adoption of new fire safety requirements for long t erm care facilities et al, No. S&C-03-21. May 8, 2003.
  11. Levine JM et al. Cigarette smoking and fire safet y in the nursing home: Case study with recommendations for smoking policy. Journal of the American Medical Dire ctors Association 2000;1(5):232-5.
  12. Lawson v. Skyline Healthcare Ctr., No. B142164, 2001 WL 1190581 (Cal. App. Oct. 3, 2001).
  13. Taylor v. Vencor, Inc., 525 S.E.2d 201, 201 (N.C. Ct. App. 2000), review denied, No . 108POO, 351 N.C. 646, S.E.2d (N.C. May 4, 2000).
  14. Donson Nursing Facilities v. Dixon, 337 S.E.2d 351 (G a. Ct. App. 1986).
  15. LeBlanc v. Midland National Insurance Company, 219 So.2d 251, 253 (La. Ct. App. 1969) .
  16. Black v. Trevilla Nursing Home of New Brighton, No. C5-90-1520,1991 WL 132756 (Minn. Ct. App. July 23, 1991); review denied (Sept. 13, 1991) (unpublished opinion).
  17. Department of Health and Human Services, F ood and Drug Administration. Medical Devices; Protective Restraints; Revocation of Exemptions From the 510(k) P remarket Notification Procedures and Current Good Manufacturing Practice Regulations. Final Rule and 510(k) Gui dance Document. Federal Register 1996;61(43):8431-9.
  18. Miles SH, Irvine P. Deaths caused by physical restr aints. Gerontologist 1992;32(6):762-6.
  19. ECRI. Restraints: Resident death from burns. Issues in Continuin g Care Risk Management June 1999;5:15-16.

Topics: Articles , Regulatory Compliance , Risk Management