Pittsburgh, PA 15261 / Rotational Stability Measurement Device
Doc. No.: BIOCOM1 / Revision: 1
Date: 4/3/05 / Approval: QA Mgr.
Biocompatibility Analysis
Rotational Stability Measurement DeviceUNCONTROLLED UNLESS ISSUED WITH A RED STAMP
This document is the confidential property of KSK Group and may not be reproduced without prior written consent. / STAMP HERE
APPROVED BY: / Signature: / DATE
Author / April 3, 2005
Stephanie Bechtold
Clinical / April 3, 2005
Kara Wagner
Engineering / April 3, 2005
Stephanie Bechtold
Quality/Regulatory / April 3, 2005
Katie Dillon
Management / April 3, 2005
Kara Wagner
Change Record:
REV / DATE / DESCRIPTION OF CHANGE / AUTHORIZATION
1 / April 3, 2005 / Initial Draft / QA Manager
2
Distribution List:
All project research personnel
CONTENTS
Purpose……………………………....…………………..3
SCope……………………………………………………...3
PRocedure……………………………...………………3
Appendix a – Biocompatibility analysis..…4
Purpose
The purpose of a biocompatibility analysis is to determine the risks associated with the interaction between the device and the body. For a surface device such as this one the device should remain biologically inert through the period of time that it is in contact with the patient.
Scope
This document is to be used to guide product related research and conceptual design development. This document is not intended to serve as a formal product specification but to be used as a means of developing meaningful design input requirements for intended characteristics of the final product. This document will not become part of the formal design history file but information derived from activities described herein may result in design history file material.
This document will aid in determining biological hazards of using the device and suggest ways to prevent harmful interaction with the patient.
Procedure
Materials used, method of manufacturing, and duration of contact were identified and analyzed based on their effects on the patient. Materials safety data sheets were consulted to determine any harmful interactions. Methods were proposed for monitoring of the patient and prevention of irritation.
Appendix A - Biocompatibility Analysis
This document will summarize the issues associated with biocompatibility testing of the Rotational Stability Measurement Device. The device consists of an Aircast® Pneumatic Walker boot and a plexiglass brace which stabilizes the hip joint. Both components are lined with padding for the patient’s comfort. The patient is fitted in the boot and the brace for a period of no more than 30 minutes, and the user’s contact with the device is limited. Devices such as the KT1000 and the Rolimeter which measure anterior-posterior stability of the knee are similar but their designs have been streamlined so to minimize contact with the patient. Due to the complex nature of measuring rotational motion of the knee, more stability is needed from the device in order to minimize extraneous motion. This added contact with the patient requires several safety issues to be examined.
This is a surface device, only contacting the skin for a limited exposure of less than 24 hrs. Issues such as cytotoxicity, sensitization, and irritation/intercutaneous activity may occur with this device due to expansive contact with the skin. To prevent direct contact of the device with the skin and contamination between patients, a fresh sock will be worn between the skin and the boot. The patient will be given fresh surgical scrubs to wear during testing, and will form a barrier between the plexiglass brace and the skin. The patient will be continually monitored for signs of irritation.
Aircast assures its customers that all of its products are latex-free, eliminating the risk of an allergic reaction to the boot. The use of aircells to apply compression to the ankle joint could be hazardous to the patient if the aircells are overinflated. Continuous monitoring will be done to ensure that circulation is maintained.
The plexiglass device should not be used under high temperatures. As with any plastic, vapors may be released if the acrylic is melted and may cause harm to the patient and the operator. Plexiglass should be handled under standard industrial hygiene and safety practices. The plexiglass should be wiped down between each patient using a mild ethanol solution.
This device uses several predicate biomaterials as components in its design, which have been thoroughly tested. Thus, limited biocompatibility testing for cytotoxicity and sensitizaton should be conducted to assure this device’s compatibility.