Least restrictive or least understood? Waist restraints, provider practices, and risk of harm

Journal of Aging and Social Policy

Volumn 20, Issue 3, 2008, Pages 305-322

  Capezuti, Elizabeth ^a   Brush, Barbara L ^b   Won, Regina M ^c   Wagner, Laura M ^d   Lawson, William T ^e  

^a NEW YORK UNIVERSITY   (United States)

^b UNIVERSITY OF MICHIGAN SCHOOL OF NURSING   (United States)

^c MOUNT SINAI HOSPITAL   (United States)

^d Kunin Lunenfeld Applied Research Unit and Department of Food and Nutrition Services and Baycrest Centre for Geriatric Care   (Canada)

^e The Law Offices of William T Lawson III Esq   (United States)

Author keywords

Centers for medicare and medicaid services; Licensing and certification; Long term care; Nursing homes; Physical restraint; U.s. food and drug administration

Indexed keywords

AGED; ARTICLE; EXERCISE; GOVERNMENT; HEALTH CARE PERSONNEL; HEALTH CARE QUALITY; HOME FOR THE AGED; HUMAN; NURSING HOME; ORGANIZATION AND MANAGEMENT; POSTMARKETING SURVEILLANCE; UNITED STATES; UTILIZATION REVIEW;

AGED; CENTERS FOR MEDICARE AND MEDICAID SERVICES (U.S.); HEALTH PERSONNEL; HOMES FOR THE AGED; HUMANS; NURSING HOMES; PRODUCT SURVEILLANCE, POSTMARKETING; QUALITY OF HEALTH CARE; RESTRAINT, PHYSICAL; UNITED STATES;

EID: 58149177986     PISSN: 08959420     EISSN: 15450821     Source Type: Journal    
DOI: 10.1080/08959420802050967     Document Type: Article

References (68)

1. Allen, C., Glasziou, P., & Del Mar, C. (1999). Bed rest: A potentially harmful treatment needing more careful evaluation. Lancet, 354, 1229-1233.
2. Anonymous. (2000). Are your restraint policies setting you up for immediate jeopardy citations? LTC Regulator Risk and Liability Advisor, 8(23), 1-3.
3. Aspden, P., Corrigan, J. M., Wolcott, J., & Erickson, S. M. (2004). Patient safety: Achieving a new standard for care. Washington, DC: National Academy Press.
4. Barach, P., & Small, S. D. (2000). Reporting and preventing medical mishaps: Lessons from non-medical near miss reporting systems. British Medical Journal, 320, 759-763.
5. Bloomfield, S. A. (1997). Changes in musculoskeletal structure and function with prolonged bed rest. Medicine and Science in Sports and Exercise, 29, 197-206.
6. Braun, J. A., & Capezuti, E. (2000). The legal and medical aspects of physical restraints and bed siderails and their relationship to falls and fall-related injuries in nursing homes. DePaul Journal of Healthcare Law, 3, 1-72.
7. Brush, B. L., & Capezuti, E. (2002). A historical analysis of siderail use in American hospitals. Journal of Nursing Law, 8, 17-24.
8. Capezuti, E. (2004). Minimizing the use of restrictive devices in dementia patients at risk for falling. Nursing Clinics of North America, 39, 625-647.
9. Capezuti, E., Maislin, G., Strumpf, N., & Evans, L. (2002). Siderail use and bed-related fall outcomes among nursing home residents. Journal of the American Geriatrics Society, 50, 90-96.
10. Capezuti, E., Strumpf, N., Evans, L., & Maislin, G. (1999). Outcomes of nighttime physical restraint removal for severely impaired nursing home residents. American Journal of Alzheimer's Disease, 14, 157-164.
11. Castle, N. G. (2000a). Deficiency citations for physical restraint use in nursing homes. Journals of Gerontology Series B, Psychological Sciences and Social Sciences, 55, S33-S40.
12. Castle, N. G. (2000b). Differences in nursing homes with increasing and decreasing use of physical restraints. Medical Care, 38, 1154-1163.
13. Castle, N. G. (2002). Nursing homes with persistent deficiency citations for physical restraint use. Medical Care, 40, 868-878.
14. Castle, N. G., Degenholtz, H., & Engberg, J. (2005). State variability in indicators of quality of care in nursing facilities. Journals of Gerontology Series A, Biological Sciences and Medical Sciences, 60, 1173-1179.
15. Castle, N. G., & Mor, V. (1998). Physical restraints in nursing homes: A review of the literature since the Nursing Home Reform Act of 1987. Medical Care Research & Review, 55, 139-170.
16. Cauchion, D. (2000, September 25). FDA advisers tied to industry. USA Today, p. A1.
17. Centers for Medicare and Medicaid Services. (1987). Omnibus Budget Reconciliation Act of 1987. P.L. 100-203. Subtitle C. The nursing home reform act. 42 U.S.C. 1395i-3 (a)-(h) (Medicare); 1396r (a)-(h) (Medicaid).
18. Centers for Medicare and Medicaid Services (1998). Assuring the quality of nursing home care. Retrieved March 13, 2006, from http://new.cms.hhs.gov/apps/media/press/release.asp?Counter=340
19. Centers for Medicare and Medicaid Services. (1999). Code of federal regulations: 42 C.F.R. § 483.13 (a).
20. Centers for Medicare and Medicaid Services. (2004a). Manual system. Department of Health and Human Services (DHHS). Pub. 100-07 State operations provider certification. Retrieved March 13, 2006, from http://www.cms.hhs.gov/transmittals/downloads/R5SOM.pdf
21. Centers for Medicare and Medicaid Services. (2004b) Memo to state survey agency directors. Subject: Guidance on working with quality improvement organizations. Retrieved October 14, 2004, from http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter05-01.pdf
22. Centers for Medicare and Medicaid Services. (2005). Code of Federal Regulations, Title 21, volume 8. Food and drugs chapter I, Food and Drug Administration, Department of Health and Human Services, Subchapter H: Medical devices.
23. Centers for Medicare and Medicaid Services. (2006a). Civil Remedies ALJ Decisions. Retrieved March 13, 2006, from http://www.hhs.gov/dab/decisions/browsecr.html
24. Centers for Medicare and Medicaid Services. (2006b). Department of Health and Human Services civil remedies division. Montrose Bay Health and Rehabilitation Center v. CMS. Retrieved March 13, 2006, from http://www.hhs.gov/dab/decisions/CR1186.htm
25. Centers for Medicare and Medicaid Services. (2006c). Nursing home compare. Retrieved March 13, 2006, from http://www.medicare.gov/NHCompare/Home.asp
26. Covertino, V. A., Bloomfield, S. A., & Greenleaf, J. E. (1997). An overview of the issues: Physiological effects of bed rest and restricted physical activity. Medicine and Science in Sports and Exercise, 29, 187-190.
27. Evans, D., Wood, J., & Lambert, L. (2003). Patient injury and physical restraint devices: A systematic review. Journal of Advanced Nursing, 41, 274-282.
28. Fontanarosa, P. B., Rennie, D., & DeAngelis, C. D. (2004). Postmarketing surveillance-lack of vigilance, lack of trust. Journal of the American Medical Association, 292, 2647-2650.
29. Gardner, S., & Flack, M. (1999a). Designing a medical device surveillance network. Report to Congress. Rockville, MD: U.S. Food and Drug Administration.
30. Gardner, S., & Flack, M. (1999b). Final report of a study to evaluate the feasibility and effectiveness of a sentinel event reporting system for adverse event reporting of medical device use in user facilities. Rockville, MD: U.S. Food and Drug Administration.
31. Hampton, T. (2005). Experts point to lessons learned from controversy over rofecoxib safety. Journal of the American Medical Association, 293, 413-414.
32. Harrington, C., Mullan, J. T., & Carillo, H. (2004). State nursing home enforcement systems. Journal of Health Politics, Policy, and Law, 39, 43-73.
33. Institute of Medicine. (1986). Improving the quality of care in nursing homes. Washington, DC: National Academy Press.
34. Joint Commission on the Accreditation of Healthcare Organizations (1998, November 18). Issue 8 sentinel event alert: Preventing restraint deaths. Retrieved March 13, 2006, from http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_8.htm
35. Kohler, P. O., & Wunderlich, G. S. (2001). Institute of Medicine: Improving the quality of long-term care. Washington, DC: National Academy Press.
36. Lachs, M. S., Williams, C. S., O'Brien, S., & Pillemer, K. A. (2002). Adult protective service use and nursing home placement. Gerontologist, 42, 734-739.
37. Marty, D. A., & Chapin, R. (2000). The legislative tenets of client's right to treatment in the least restrictive environment and freedom from harm: Implications for community providers. Community Mental Health Journal, 36, 545-556.
38. Medicare Quality Improvement Community. (2006a). Nursing home quality improvement. Retrieved March 13, 2006, from http://www.medqic.org
39. Medicare Quality Improvement Community. (2006b). Physical restraints. Retrieved March 13, 2006, from http://www.medqic.org/dcs/ContentServer?cid=1104361982667&pagename=Medqic%2FContent%2FParentShellTemplate&parentName=Topic&c=MQParents
40. Miles, S. (1996). A case of death by physical restraint: New lessons from a photograph. Journal of the American Geriatrics Society, 44, 291-292.
41. Miles, S. H. (1998). Restraints: Controlling a symptom or a symptom of control. HEC Forum, 10(3-4), 235-243.
42. Miles, S. H. (2002a). Concealing accidental nursing home deaths. HEC Forum, 14, 224-234.
43. Miles, S. H. (2002b). Deaths between bedrails and air pressure mattresses. Journal of the American Geriatrics Society, 50, 1124-1125.
44. Miles, S. H., & Irvine, P. (1992). Deaths caused by physical restraints. Gerontologist, 32, 762-765.
45. Mohr, W. K., & Mohr, B. D. (2000). Mechanisms of injury and death proximal to restraint use. Archives of Psychiatric Nursing, 14, 285-295.
46. Parker, K., & Miles, S. H. (1997). Deaths caused by bedrails. Journal of the American Geriatrics Society, 45, 797-802.
47. Psaty, B. M., Furberg, C. D., Ray, W. A., & Weiss, N. S. (2004). Potential for conflict of interest in the evaluation of suspected adverse drug reactions: Use of cerivastatin and risk of rhabdomyolysis. Journal of the American Medical Association, 292, 2622-2631.
48. Ruben, B. S., Dube, A. H., & Mitchell, A. K. (1993). Asphysxial death due to physical restraint: A case series. Archives of Family Medicine, 2, 405-408.
49. Schoeneman, K., & Graber, D. R. (1996). Trends in restraint prevalence in US nursing homes, 1990 through 1994. American Journal of Public Health. 86, 1480-1481.
50. Strumpf, N. E., & Tomes, N. (1993). Restraining the troublesome patient: A historical perspective on a contemporary debate. Nursing History Review, 1, 3-24.
51. Todd, J. F., Ruhl, C. E., & Gross, T. P. (1997). Injury and death associated with hospital bed siderails: Reports to the U.S. Food and Drug Administration from 1985-1995. American Journal of Public Health, 87, 1675-1677.
52. Topol, E. J. (2005). Arthritis medicines and cardiovascular events-"house of coxibs." Journal of the American Medical Association, 293, 366-368.
53. U.S. Food and Drug Administration. (2000). MDR: Medical device reporting. Retrieved March 13, 2006, from http://www.fda.gov/cdrh/devadvice/351.html
54. U.S. Food and Drug Administration. (2002). MDR: Medical device reporting-general information. Retrieved March 13, 2006, from http://www.fda.gov/cdrh/mdr/mdr-general.html
55. U.S. Food and Drug Administration. (2004). FDA acts to strengthen the safety program for marketed drugs. Retrieved March 13, 2006 from http://www.fda.gov/bbs/topics/news/2004/NEW01131.html
56. U.S. Food and Drug Administration. (2006a). FDA issues guidance on hospital bed design to reduce patient entrapment. Retrieved March 13, 2006, from http://www.fda.gov/bbs/topics/NEWS/2006/NEW01331.html
57. U.S. Food and Drug Administration. (2006b). Draft guidance for industry and FDA staff: Hospital bed system dimensional guidance to reduce entrapment. Retrieved March 13, 2006, from http://www.fda.gov/cdrh/beds/guidance/1537.pdf
58. U.S. Food and Drug Administration. (2006c). Hospital bed safety. Retrieved March 13, 2006, from http://www.fda.gov/cdrh/beds
59. U.S. Food and Drug Administration. (2006d). MAUDE database: Manufacturer user facility and distributor experience database. Retrieved March 13, 2006, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm?searchoptions=1
60. U.S. Food and Drug Administration. (2006e). MDR: Medical device reporting database. Retrieved March 13, 2006, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMDR/Search.cfm
61. U.S. General Accounting Office. (1984). Statement of Franklin A. Curtis before the House Committee on Energy and Commerce, Subcommittee on Health and the Environment, on the federal regulation of medical devices. Washington, DC: U.S. General Accounting Office.
62. U.S. General Accounting Office. (1999a). Nursing homes: Complaint investigation processes often inadequate to protect residents. Report to the Special Committee on Aging, U.S. Senate. GAO/HEHS-99-80. Washington, DC: U.S. General Accounting Office.
63. U.S. General Accounting Office. (1999b). Nursing homes: Proposal to enhance oversight of poorly performing homes has merit. Report to the Special Committee on Aging, U.S. Senate. GAO/HEHS-99-157. Washington, DC: U.S. General Accounting Office.
64. U.S. General Accounting Office. (2000). Nursing homes: Sustained efforts are essential to realize potential of the quality initiatives. Report to the special committee on aging. U.S. Senate. GAO/HEHS-00-197. Washington, DC: U.S. General Accounting Office.
65. Wagner, L. M., Capezuti, E., & Ouslander, J. G. (2006). Reporting near-miss events in nursing homes. Nursing Outlook, 54, 85-93.
66. Walshe, K., & Harrington, C. (2002). Regulation of nursing facilities in the United States: An analysis of resources and performance of state survey agencies. Gerontologist, 42, 475-487.
67. Wood, A. J., Stein, C. M., & Woosley, R. (1998). Making medicines safer: The need for an independent drug safety board. New England Journal of Medicine, 339, 151-1854.
68. Zhang, X., & Grabowski, D. C. (2004). Nursing home staffing and quality under the nursing home reform act. Gerontologist, 44, 13-23.