July 12, 2001

Ongoing Research Summary

(Pediatric Sling Accident)

The following sources have been consulted and contacted for information related to the subject case:

Standards/Regulations

Safe Medical Devices Act of 1990, October 5, 1990: An amendment to the Federal Food, Drug, and Cosmetic Act “to make improvements in the regulation of medical devices.” Its purpose is “to improve the Medical Device Amendments of 1976, the basic law under which the Secretary of the Department of Health and Human Services…regulates the safety and effectiveness of medical devices.” (74.V.A.1.e)

Food and Drug Administration Modernization Act of 1997, Title II—Improving Regulation of Devices, January 7, 1997: This amendment to the Federal Food, Drug, and Cosmetic Act pertains to regulation of medical devices. Different sections of the Act discuss investigational device exceptions, special review for certain devices, expanding humanitarian use of devices, device standards, premarket notification, device tracking, and postmarket surveillance. (74.V.A.1.d)

Assistive Technology Act of 1998, Public Law 105-394, Nov. 13, 1998: Regulates the design of and access to assistive technology devices for the disabled. Assistive technology devices are “devices that facilitate activities of daily living, that significantly benefit individuals with disabilities of all ages.” (Sec. 2(4)). Lifts and slings would fall into this category. Proposes the use of “universal design principles” that could expand the use of assistive technology devices “by individuals with disabilities of all ages” (Sec. 2(10)). This act repeatedly stresses the right to assistive technology devices by disabled persons “of all ages.” Sec. 214(b), “Assistive Technology for Children and Older Individuals,” allows states to provide financial assistance “for projects designed to increase the availability of assistive technology for populations of children and older individuals.” (74.V.A.1.c)

Code of Federal Regulations Title 21 – Food and Drugs, Part 801 – Labeling, April 1, 1999 Edition: Details label requirements for medical devices. (74.III.D.2)

Code of Federal Regulations Title 21 –Food and Drugs, Part 803 – Medical Device Reporting, April 1, 1999 Edition: Details medical device reporting. “Under this part, medical device user facilities and manufacturers must report deaths and serious injuries to which a device has or may have caused or contributed.” (74.V.A.1.f)

Code of Federal Regulations, Title 21 - Food and Drugs, Part 880 - General Hospital and Personal Use Devices, April 1, 1999 Edition: Includes the identification and classification of a non-AC-powered patient lift (880.5510) (74.III.D.1)

Code of Federal Regulations, Title 21 - Food and Drugs, Part 860—Medical Device Classification Procedures, April 1, 1999 Edition: Defines the three classes of medical devices. Class I (which includes lifts with slings) means the class of devices that are subject to only general controls. Class I devices are not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and which do not present a potential unreasonable risk of illness or injury. Section 860.7 discusses the determination of safety and effectiveness of devices. (74.V.A.1.a)

Code of Federal Regulations, Title 21 - Food and Drugs, Part 812—Investigational Device Exemptions, April 1, 1999 Edition: Provides procedures for the conduct of clinical investigations of devices. (74.V.A.1.b)

Statistics

Lift Injuries 1991 to Present, Consumer Product Safety Commission, National Injury Information Clearinghouse, report dated June 1, 2001: According to CPSC accident investigations, reported incidents and/or death certificates, along with data from the National Electronic Injury Surveillance System (NEISS), 116 people were injured and 11 were killed from 1991 to the present in incidents involving lifts. (74.V.B.3.c)

University of Michigan, “Anthropometry of Infants, Children and Youths to Age 18 for Product Safety Design,“ U.S. Department of Commerce, National Technical Information Service, May 1977, p. 428-435: Provides seated center of gravity statistics for both males and females in different age categories beginning with age two and ending with age nineteen. The mean seated center of gravity for a seven-year-old (the age of the child in this case) is 20.4 cm. The mean seated center of gravity for a nineteen-year-old is 25.1 cm. (74.V.B.3.a)

U.S. Food & Drug Administration, Center for Devices and Radiological Health, MAUDE Database: Provides injury/adverse event statistics for medical devices. Included here are injuries due to the use of an incorrect sling in a lift device. In the database section covering 1996-present, more than 500 records pertain to slings. Six of the records document injuries due to use of an incorrect sling or sling size. In the section covering 1992-1996, 135 sling incidents are recorded. Four incidents involve the use of an incorrect sling or sling size. All ten incidents occurred in a hospital or other health care facility. Seven of the incidents involved a lift/sling device manufactured by Arjo. The three other devices involved were manufactured by Invacare, Guardian and Hoyer. (74.V.B.3.b)

Online Articles/Resources

Duncan, Janell Mayo, “Legal and Policy Issues Relating to the Use of Medical Devices in the Home, and the Home as a Health Care Setting,” HCT Workshop Discussion Paper: Discusses major legal and policy issues relating to the home as a health care setting, including 1) Federal regulation of medical devices used in the home; 2) Federal reimbursement policies for the provision of home care and telemedicine services; 3) tort liability concerns; and 4) access to home care and telemedicine services. (74.V.b.6.d)

Agency for Healthcare Research and Quality, “Medical Errors: The Scope of the Problem,” Publication No. AHRQ 00-P037, Agency for Healthcare Research and Quality: Discusses where errors occur, noting “care delivered in the home” in addition to traditional health care settings. Looks at the costs and seriousness of the problem. Lists the types of errors, including “misinterpretation of other medical orders.” (74.V.B.6.e)

Schuch, Jonathan Z. and Betty H. Breeden, “Managing the Legal Liabilities and Risks Inherent in the Delivery of Assistive and Rehabilitation Technology Services and Devices,” RESNA Proceedings, 1996: Describes “strategies for effectively managing the legal liabilities and risks associated with the delivery of assistive and rehabilitation technology (AT/RT) services and devices.” The article states: “Because services and products are delivered to consumers, assistive technology practitioners and rehabilitation technology suppliers assume significant legal responsibility for their actions, to the extent that the consumer has a legally enforceable right to AT/RT services that meet or exceed professional standards and to AT/RT products that will not cause injury under normal use” (p. 1). Discusses professional liability and products liability. Notes that “a seller or supplier is subject to liability for negligence relating to his or her function in the distribution of a product” (p. 2). Presents eleven strategies to effectively managing liability. (74.V.B.6.b)

“Improving Patient Care by Reporting Problems with Medical Devices,” A MedWatch Continuing Education Article, Dept. of Health & Human Services, September 1997: Defines the term “medical device,” discusses the premarket review and postmarket surveillance of devices, explains how to identify and avoid problems with medical devices, and describes the process of reporting device-related problems. Notes that healthcare professionals need to “understand how a device should be used, and for which patients it is probably not safe” (p. 3). (74.V.B.6.c)

U.S. Food and Drug Administration, Requirements of Laws and Regulations Enforced by the Food and Drug Adminstration, "VI. Medical Devices,": Summarizes regulations put forth in the Federal Food, Drug and Cosmetic Act and its amendments pertaining to medical devices. Discusses classification of devices, premarket notification for new devices, requirements for all devices, adulteration, misbranding, device registration and listing, good manufacturing practice regulations, banned devices, investigational devices, humanitarian devices, custom devices, and imported and exported devices. (74.V.B.6.a)

Rehabilitation Engineering Research Center on Technology Transfer, Center for Assistive Technology web site: Includes links to related sites, mission statement, strategic goals and contact information. (74.V.B.6.q)

Journal Articles

Dobbs, Jean, “Transfer Devices and Lifts,” New Mobility, Vol. 6(20), March-April 1995, p. 55-56: Discusses transfer devices, lifts and slings. Notes that “Improvements in sling design in the last several years have reduced pressure sore problems associated with poor fit” (p. 56). (74.V.B.4.a)

Scalise, Mardi, “Lift Your Spirits,” New Mobility, Vol. 7(30), March 1996, p. 72: Provides information about specific brands of lifts, lift devices, and transfer devices, including the price. (74.V.B.4.b)

“Special Feature: Lifting & Handling Equipment,” Disability View Magazine, May-June ’99, M & S Publicity Ltd., c1999: Discusses how to find out what you need, hiring a home care company, bathing, slings, equipment providers, and choosing equipment. Notes that “Choosing the correct equipment, of course, is vitally important.” Under the “Slings” section, it states, “Hoists are often only as good as the slings used with them; the choice of sling is one of the most important factors affecting the use of the hoist and the comfort of the person being lifted” (p. 3). (74.V.B.4.d)

Moody, Janis et al., “A Study of Nurses’ Attitudes Towards Mechanical Aids [Lifting and Handling],” Nursing Standard, Vol. 11(4), October 16, 1996, p. 37-42: Researchers interviewed one hundred and eighty-five nurses from a selection of specialties about their attitudes toward mechanical aids for lifting. Common problems identified were lack of proper training in mechanical aid use, mechanical aids and slings being unavailable or inaccessible, arbitrary use of mechanical aids, and spatial constraints to mechanical aid use. The article mentions a 1993 study by McGuire and Dewar in which “56 percent of nursing personnel felt that the amount and type of mechanical aids available did not match their clients’ needs.” Regarding slings, the article states: “The provision of an adequate supply of slings in a range of sizes is essential for the correct use of mechanical aids” (p. 7). Among the conclusions the authors reach are compatibility with other equipment should be taken into account when purchasing mechanical aids; training in, and adherence to, ergonomic principles in moving and handling is advocated in addition to the use of risk assessment and care plans; training programs should be specifically tailored to mechanical aid use, and “It is particularly important to train nurses to fit slings correctly.” (74.V.B.4.e)

Deane, Robin, “Caring for Kids,” Home Health Care Dealer Provider, May 2000: Discusses pediatric home care. States that “Although geriatric and pediatric patients may have the same condition…equipment needs will likely not be the same because of size and personality development issues.” Also notes that “Many home health care organizations are experts at providing care for the elderly but are not as equipped or knowledgeable to provide specialized care for pediatrics.” Includes discussion of PedsLink, a company that offers home care providers the information and tools needed to start or improve a high-quality pediatric program. (74.V.B.4.c)

Wahl, Margaret, “Save Your Back! A Guide to Lifting and Transferring at Home,” Quest, Vol. 6(1), February, 1999: Utilizes text and photos in explaining how to use a sling. Discusses floor and ceiling model lifts. (74.V.B.4.g)

Book Excerpts

Healthy People 2010: Objectives for Improving Health, “Chapter 17: Medical Product Safety, U.S. Food & Drug Administration: This chapter’s goal is to “ensure the safe and effective use of medical products.” It mentions MedWatch, the FDA’s medical products reporting program. It describes the four categories of medical product risks: product defects, known side effects, medication or device errors, and remaining uncertainties. On device errors, the chapter notes that “Errors also involve unintended substitution of the wrong product for the prescribed product…Substantial numbers of injuries and deaths occur annually because of medication or device errors” (p. 17-6). The chapter also discusses risk communication and confrontation, and lists objectives for safer health care. (74.V.B.5.a)

Scherer, Marcia J., Living in the State of Stuck: How Technologies Affect the Lives of People with Disabilities, “Chapter Seven: Dilemmas, Challenges and Opportunities,” Brookline Books, c1993: This chapter discusses the need for a model when matching a person and a technology (MPT), characteristics of the milieu, milieu factors influencing device use, characteristics of the person, and characteristics of the assistive technology. It is noted that by consulting a model such as the MPT model, one can help provide the rationale for funding a device or training for that device, demonstrate an individual’s improvement in functioning over time, and help organize information typifying the needs of clientele. (74.V.B.5.b)

Manufacturers/Dealers of Slings/Lifts

There are many web sites for manufacturers of slings/lifts in general. Listed below are the major ones. Fewer companies deal in pediatric slings/lifts. The following are the pediatric dealers:

Barrier Free Lifts Inc.: They manufacture a variety of slings and lifts for both adults and children. The Tonya Lift for pediatric use is a smaller version of their Motorized Patient Positioner, in which the smaller size “enables the sling to better conform to children, ensuring safety and comfort.” Mobility Concepts Inc. is a distributor of Barrier Free Lifts products. Midwest Barrier Free Lifts is another distributor. (74.III.F.1.a&b, u)

Vancare Inc.: Their VANDER-LIFT 450 has a “heavy-duty frame with expandable base [that] offers tip-resistant support for residents/patients from pediatric to 450 lbs.” Their “variety of durable slings meet size requirements to 450 lbs. and are comfortable for all residents/patients regardless of most range-of-motion limitations.” (74.III.F.1.f)

Convaid Inc.: Listed in the Rehabmall.com web site, Convaid is a manufacturer of mobile positioning systems for children and young adults. (74.III.F.1.e)

Innovative Products Inc.: Also listed at Rehabmall.com, they claim, “Our equipment gives children the opportunity to experience freedom and mobility for the first time.” They build to specification, depending on individual needs. (74.III.F.1.e)

Abilitations: Listed at Rehabmall.com, they publish a 192-page catalog of products with a focus on children’s rehabilitation and therapy. “Products are available for sensory integration, movement, positioning, exercise and play.” (74.III.F.1.e)

Guldmann: Their “Lifting Accessories” brochure includes guidelines on choosing the size of a sling. The sizing chart includes specifications for children. (74.III.F.1.r&s, y)

The following are some major sling manufacturers: (74.III.F.1.g)

Ted Hoyer and Company (A Division of Sunrise Medical): They manufacture a transfer lift sling, one-piece sling with headrest, one-piece split sling, and a two-piece sling.

Invacare Corporation: Manufacturer of the subject sling. They manufacture a two-piece sling, one-piece contour sling, and a headrest sling. (also 74.III.F.1.t, x)

Barrier Free Lifts Inc.: They manufacture a universal sling, universal head support sling, two-piece quick sling, three-piece quick sling, Lexa sling, closed seat sling, full stretcher and partial stretcher sling, Patron Tubular sling, and the Dolphin Patient Positioner.

Waverlyglen Systems Ltd.: They manufacture a hammock sling, universal sling, positioning sling, hygiene sling, stretcher sling, and a walking sling.

The following are lift system manufacturers: Apex Dynamics Healthcare Products, Arjo Inc., Platinum Healthcare Equipment, Portable Entry Systems, Rand-Scot Inc., V. Guldmann A/S, Wy’East Medical Corporation, Columbus McKinnon Corporation, DayLight Technologies Inc., Medi-Man Rehabilitation Products, Mobility Transfer Systems, Patient Handling Technologies, Inter Care Scandinavia A/S, Ginco Medical Equipment, SureHands International, and BHM Medical (74.III.F.1.a-q, v, w)

The following are some local dealers of slings/lifts:

Chelsea Community Hospital Pharmacy: Weight chart used for fitting Hoyer slings. (74.V.C.1)

University of Michigan Medical Center, Department of Pediatric Physical Medicine and Rehabilitation—Mott: Discussion of lifts/slings. (74.V.C.2)