MEDLINE OPEN END FINGER CONTROL MITT

K963504 · Medline · FMQ · Oct 29, 1996 · General Hospital

Device Facts

• Record ID: K963504
• Device Name: MEDLINE OPEN END FINGER CONTROL MITT
• Applicant: Medline
• Product Code: FMQ · General Hospital
• Decision Date: Oct 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

Medline Hand Protectors and Finger Control Mitts may be used with either a wheelchair or a bed. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. May be used with stroke patients to help prevent contracture or to help fingers in rehabilitation. Effectively helps minimize the possibility of the patient removing catheters and IV tubes and helps prevent scratching and itching. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status. Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, to help protect patients from harming themselves or others, to help prevent patients from removing or disabling other medical devices or equipment (catheters, IV lines, etc.), or to help prevent patients from removing, scratching or picking wound sites, incisions, stitches or bandages. Medline Hand Protectors and Finger Control Mitts are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub, and should always be secured to the movable portion of the bed frame, never to the side rails. Medline Patient Safety Products are not intended for use in a motorized vehicle, as they are not designed to withstand the force of a crash. Medline Patient Safety Products are not intended for home use. These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense.

Device Story

Medline Hand Protectors and Finger Control Mitts are physical restraints designed for use in hospitals and nursing homes. The devices consist of mitts (open or closed end) or palm restraints (rigid or flexible) made of cotton, canton flannel, or Koolnit™ fabric, secured by polyester web straps. They are attached to the movable portion of a bed frame or a wheelchair. The device functions by physically restricting hand and finger movement to prevent patients from removing medical equipment, scratching wound sites, or harming themselves/others. Operation is performed by medical or paramedical personnel as part of a structured treatment program. The device provides a physical barrier to mitigate risks associated with patient agitation or cognitive impairment. It is not intended for home use, motorized vehicles, or use with stretchers/toilets.

Clinical Evidence

No clinical trials were conducted. Evidence is based on a literature review of thirteen articles and FDA safety alerts regarding the use of protective restraints. The literature identifies potential complications including emotional desolation, agitation, fractures, nerve damage, and circulatory impairment, emphasizing the necessity of proper patient selection, correct application, and adequate monitoring by healthcare personnel.

Technological Characteristics

Materials: Cotton, canton flannel, or Koolnit™ fabric. Fastening: Polyester web straps. Form factor: Mitts (open/closed end) or palm restraints (rigid/flexible). Design: Mechanical restraint for attachment to bed frames or wheelchairs. No energy source or software components.

Indications for Use

Indicated for patients in hospitals or nursing homes with temporary cognitive deficits, agitation, or restlessness who require protection from self-harm, harm to others, or interference with medical devices (catheters, IV lines) and wound sites. Also indicated for stroke patients to prevent contracture or assist in rehabilitation.

Regulatory Classification

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.

Reference Devices

• Physical Restraints: An FDA Update, American Journal of Nursing (1992)
• Potential Hazards With Protective Restraint Devices; FDA Medical Alert (1991)
• The Misuse of Physical Restraints in the Confused Patient (1986)
• Federal Register/Vol. 57, No. 119 (1992)
• Potential Hazards with Physical Restraint Devices; FDA Safety Alert (1992)
• Restraint and Seclusion; Journal of Psychosocial Nursing (1985)

Submission Summary (Full Text)

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MEDLINE

Medline Industries, Inc.

One Medline Place

Mundelein, Illinois 60060.4486

1.847.949.3109

1.800.950.0128

Fax [phone]

Corporate Quality Assurance/Regulatory Affairs

K965504

# SAFETY AND EFFECTIVENESS SUMMARY

Medline Industries, Inc.

One Medline Place

Mundelein, IL 60060

Phone #: [phone]

Fax #: [phone]

Lara N. Simmons

Corporate Regulatory Affairs Manager

OCT 29 1996

August 27, 1996

Device Name: Protective Restraint, Hand Protector or Finger Control Mitt

Proprietary: Medline Open End Finger Control Mitt, Medline Closed End Finger Control Mitt, Medline Rigid Palm Hand Restraint, Medline Flexible Palm Hand Restraint

Common: Hand Restraint

Classification: Protective Restraint

These devices have been legally marketed prior to the date of this submission, and, in fact, prior to May 28, 1976. The intended use and claims, technological features, materials and physical and mechanical specifications have not been changed.

## 1.0 General Description

Medline Hand Protectors and Finger Control Mitts are designed for use with either a bed or wheelchair. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. Medline Hand Protectors and Finger Control Mitts may be used with stroke patients to help prevent contracture or to help fingers in rehabilitation. They can effectively help minimize the possibility of the patient removing catheters and I.V. tubes and help prevent scratching and itching. They are made of cotton, canton flannel or Koolnit™ and are secured by polyester web straps.

## INTENDED USE OF THE DEVICE

Medline Hand Protectors and Finger Control Mitts may be used with either a wheelchair or a bed. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. May be used with stroke patients to help prevent contracture or to help fingers in rehabilitation.

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Effectively helps minimize the possibility of the patient removing catheters and IV tubes and helps prevent scratching and itching.

These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status.

Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, to help protect patients from harming themselves or others, to help prevent patients from removing or disabling other medical devices or equipment (catheters, IV lines, etc.), or to help prevent patients from removing, scratching or picking wound sites, incisions, stitches or bandages.

Medline Hand Protectors and Finger Control Mitts are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub, and should always be secured to the movable portion of the bed frame, never to the side rails.

Medline Patient Safety Products are not intended for use in a motorized vehicle, as they are not designed to withstand the force of a crash.

Medline Patient Safety Products are not intended for home use.

These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense.

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A reasonable search of all information known or otherwise presently available to Medline Industries, Inc. has been conducted. Such a search is defined as examining articles in medical literature, FDA literature, and company documents concerning safety and effectiveness information for safety restraints. Following is a summary of and citation to the safety and effectiveness data found in that search.

Specific safety and effectiveness data outlined in the literature include actual as well as potential complications which may occur and are summarized as follows:

Emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, death, and strangulation attributed to incorrect supervision, handling or application of protective restraint devices by medical or paramedical personnel. These incidences seem to be the result of inappropriate patient selection (physically restraining a patient for whom physical restraint is contraindicated), incorrect restraint selection, errors in correctly applying the device, and/or inadequate monitoring of patients when restrained.

When used correctly and for indicated circumstances, protective restrains provide benefits to many patients, such as precluding patients with temporary medical related cognitive deficits from impairing the resolution of their physical problems by involuntarily discontinuing life-support or other needed medical interventions, temporarily reducing the mobility of agitated patients, helping patients maintain an upright position in a wheelchair, helping to prevent patients from sliding down in a bed or wheelchair, or helping patients feel safer in a bed or wheelchair.

Medline Industries, Inc. offers a variety of additional materials to help insure the safe and proper use of it's patient safety products, including posters and videos. Medline Industries, Inc. stresses the importance of patient monitoring, and that these products should only be used upon advice of a physician or other trained, licensed healthcare professional.

A total of thirteen articles were reviewed for this 510(k) submission. The articles listed in the citation contained pertinent data for establishing the safety and efficacy of protective restraints.

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# CITATION

Physical Restraints: An FDA Update, American Journal of Nursing From FDA Nurses 1992; 74: November 1992, Mary D. Weick, RN, MSN.

Potential Hazards With Protective Restraint Devices; FDA Medical Alert, dated November 14, 1991; MDA91-3

The Misuse of Physical Restraints in the Confused Patient; This paper was presented by Ms. Barbara Fitgerald, Ward Sister, Geriatric Unit, St. James Hospital Dublin at the INO Nursing Association for the Elderly Day Conference in April, 1986.

Federal Register/Vol. 57, No. 119/Friday, June 19, 1992/ Proposed Rules

Potential Hazards with Physical Restraint Devices; FDA Safety Alert, dated July 15, 1992

Restraint and Seclusion; Journal of Psychosocial Nursing, June 1985, Vol. 23, No. 6, Janice M. Roper, RN, MS, Adam Courtts, MS Janet Sather, RN, and Rosella Taylor, RN.