(68 days)
The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves or clinical personnel. The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease. Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances.
Limb Holders (protective restraints) Foam Limb Holder w/Quick Release Buckle Proprietary Names: Polvester Pile Wrist/Ankle Restraint Soft Flannel Wrist/Ankle Restraint Wrist Restraint, Universal
The provided text is a 510(k) summary for Zimmer Limb Holders (protective restraints) from 1996. It details the device's intended use, classification, and comparison to existing legally marketed devices. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria.
The document discusses:
- Safety and Effectiveness: It states that the Zimmer line of restraints has been manufactured and in commercial distribution for over 20 years and are exempt from 510(k) premarket notification procedures and Good Manufacturing Practice Regulations.
- Intended Use: To prevent restless, confused, elderly, or unsteady patients from injuring themselves or clinical personnel.
- Regulatory Context: It mentions Health Care Financing Administration Regulations and Joint Commission on Accreditation of Healthcare Organizations standards related to restraint use, emphasizing appropriate supervision and least restrictive restraint.
- Problems: States that the most significant problems with restraints are attributed to misuse or misapplication, not design or materials.
Therefore, I cannot provide the requested information as it is not present in the given text. The document focuses on regulatory classification and existing market presence rather than a detailed performance study with specific acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter 'Z' inside of a circle. Below the circle, the word 'zimmer' is written in lowercase letters.
V - 6 1996
Patient Care Division 200 West Ohio Avenue P.O. Box 10 Dover, OH 44622-0010 Phone: 330 343-8801
510(k) Summary of Safety and Effectiveness
Contact Information: Paula S. Osorio Director, Quality Assurance & Regulatory Compliance Zimmer Patient Care Division 200 West Ohio Avenue Dover. Ohio U.S.A. 44622 Telephone (330) 364-9483 Fax (330) 343-0995
- Preparation Date: August 30, 1996
- Device Name(s): Limb Holders (protective restraints)
Foam Limb Holder w/Quick Release Buckle Proprietary Names: Polvester Pile Wrist/Ankle Restraint Soft Flannel Wrist/Ankle Restraint Wrist Restraint, Universal
- Classification Name: Protective Restraint
- Comparison Device: Same as above.
"The Zimmer line of restraints is intended for restless, confused, elderly, or Intended Use: unsteady patients. They help prevent such patients from injuring themselves or clinical personnel.
The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease.
Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances."
- Comparative Data: The devices used for comparative purposes are the limb holders as described in this submission. (See Tab G - June 14, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH - for rationale.)
These limb holders are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations, and they are legally marketed by Zimmer Patient Care Division as of the date of this submission. August 30, 1996. These limb holders have been manufactured and in commercial distribution for over 20 years.
The use of all patient restraints in nursing homes is subject to Health Care Financing Administration Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience.
Image /page/0/Picture/19 description: The image shows a geometric design. The design appears to be a complex arrangement of triangles and other shapes, possibly forming a larger, more intricate pattern. The image is in black and white, which emphasizes the lines and shapes of the design.
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Further, the "Revised Standards for Restraint and Seclusion", TX.7.1.3.2.4, 1996 Accreditation Manual for Hospitals, Volume 1, Joint Commission on Accreditation of Healthcare Organizations, applies to all organizations accredited under the 1996 AMH, Volume 1, the Comprehensive Accreditation Manual for Ambulatory Care and the Accreditation Manual for Mental Health, Chemical Dependency, and Mental Retardation Developmental Disabilities. The application of these standards, along with public awareness, and health care provider training, have contributed significantly to ensuring that the least restrictive restraint is used and that restraints are used only when needed for proper medical treatment and that their use is under appropriate supervision.
In our experience, the most significant problems involving restraints are not due to design or materials used, but rather are attributed to misuse or misapplication.
§ 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). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.