Initial Hazard Analysis Rev 1.3
Three-Segment TLSO Brace
Team Members:
Dave Hower
Anjani Ravindra
Jessica Schaberl
Kimberly Zawrotny
Revision Log:
Date / Rev / Changes Made / Signed12/15/06 / 1.0 / Initial Document
1/30/07 / 1.1 / Revision Log Added
3/12/07 / 1.2 / Hinge Hazard Added
4/13/07 / 1.3 / Grammatical Revisions
Severity Levels:
· A severity level of 1 is assigned if the brace will be unable to function due to the hazard, or if there is the possibility of significant harm to the patient due to the hazard.
· A severity level of 2 is assigned if the patient suffers from prolonged discomfort due to the hazard, or if the proper function of the brace is impaired by the hazard.
· A severity level of 3 is assigned if the patient suffers from brief discomfort due to the hazard, and the function of the brace is not impaired.
· A severity of level 4 is assigned if there is no patient discomfort and no impairment of function of the brace.
Potential Hazards:
1. Improper Molding to Patient
· Custom-fitted TLSO braces are molded to fit securely around a patient’s midsection, covering the area from hips to shoulder blades. If the brace is molded improperly, it will not be able to fit around the torso correctly, thus impairing function. If the patient gains or loses significant amounts of weight, the brace may no longer fit the patient properly.
· Improper molding can occur from incorrect measurements or an error in the production process.
· If the brace is too tight, the patient’s breathing will be hindered. If the brace is too loose, the patient’s spine will not be immobilized to the degree necessary to inhibit twisting or bending. This same problem occurs if the brace is too short to cover the prescribed length of the body.
· The severity of these risks is assessed as a level 1.
· Care must be taken during the measurement and molding procedures to ensure that the TLSO is built to the proper dimensions. The patient should have the ability to try on the brace before taking it home, and request any desired corrections at this time. If the brace no longer fits due to significant change in body type, the patient should request a new brace.
2. Improper Placement
· The segments of the custom-fitted TLSO brace follow the contours of the patient’s body. If the TLSO brace is placed improperly on the patient’s torso, the contours will not line up properly with the natural lines of the body. This could lead to the brace not fastening correctly, thus preventing spine immobilization and hindering recovery. If the brace was able to fasten while improperly positioned, the patient could experience discomfort from the poorly aligned contours of the brace. The patient may also have difficulty breathing if the positioning caused excessive tightness in the area of the chest.
· Improper placement could occur from human error if patient or hospital staff fails to follow directions.
· The severity of these risks is assessed as a level 2.
· To avoid this risk, the properly molded brace should not be able to fasten unless it is in the approximately correct position. Patients should also be given written instruction and training in the proper placement techniques prior to being sent home with the TLSO brace.
3. Connection Failure
· The TLSO brace is designed to fasten behind the patient with three straps. If these straps are not connected securely, or if they are damaged in such a way as to prevent secure fastening, the brace will be unable to be held around the torso of the patient. This would inhibit the brace from immobilizing the spine.
· Connection failure could be caused by damage to the connection site or straps, overuse of the brace, or human error of incorrect connection procedure.
· The severity of these risks is assessed as a level 2.
· To avoid this risk, patients will be instructed in the proper means of connecting the brace before being sent home. Further, the straps will be made durable enough to withstand repeated use. Frequent inspection of the connection site will help avoid unexpected connection failure. Labels will indicate the service life of the brace, and warn against using the brace after the prescribed period of time is over.
4. Hinge Failure
· The side segments of the TLSO brace attach to the chest segment by hinges. If the hinges were to stick, the side segments would not easily fall into place behind the patient during the suggested log rolling procedure for brace placement. Further, the hinges could be weakened by repeated use. This could lead to the patient struggling to put the brace on, or the side segments moving in an improper manner.
· Hinge failure could be caused by damage to the hinge or overuse of the brace.
· The severity of this risk is assessed as a level 2.
· Frequent inspection of the hinge will help avoid hinge failure. The hinge should be durable enough to withstand repeated use. Labels will indicate the service life of the brace, and warn against using the brace after the prescribed period of time is over.
5. Material Failure
· Breaking from Applied Force
o Breaking of the material, such as fractures or cracks, could occur. This could lead to potentially serious injury of the patient, if the break results in sharp edges. Material breakage would also compromise the ability of the brace to immobilize the spine.
o The brace could break if excessive force from a high impact incident occurs.
o The severity of this risk is assessed as a level 1.
o To limit the possibility of this risk, materials will be selected that allow the brace to withstand 1000 lbs of force without breaking. Frequent inspection of the brace will help avoid unexpected cracks from going unnoticed.
· Warping from Heat/Humidity/Fluid Contact
o There is a possibility that the materials will warp. Warping could distort the molded contours of the brace, leading to discomfort or inappropriate inhibition of movement. Further, if one material is deformed to a greater extent than another, the function of the brace could be compromised.
o The TLSO brace could warp if it is exposed to conditions that exceed those allowed by the Product Design Specifications.
o The severity of this risk is assessed as a level 2.
o To avoid this risk, a warning label will be affixed to the chest segment of the brace, warning the user not to expose the brace to conditions exceeding those allowed by the Product Design Specifications.
6. Skin, Clothing, or Hair Pinching
· The segments of the TLSO brace have the potential to pinch or squeeze the skin, hair, or clothing during placement.
· Pinching could be caused by human error of failing to clear hair, skin, or clothing from the hinge sites.
· The severity of this risk is assessed as a level 3.
· To avoid this hazard, flexible material will extend beneath the hinges to act as a buffer between the skin of the patient and the moving segments.
7. Skin Irritation
· Skin irritations could result from an allergic reaction to the brace materials. Irritations may also occur from excessive sweating due to the non-breathable nature of the brace material.
· If any portion of the TLSO brace comes in contact with a patient’s skin, there is a potential for skin irritation to occur.
· The severity of these risks is assessed as a level 2.
· In order to avoid these hazards, patients should be asked if they have any known allergies prior to being fit for this TLSO brace. The brace should also have a warning label affixed to the chest segment, indicating that this brace is intended to be worn over a layer of clothing to prevent irritation.
8. Scratching
· Scratches to the skin or to soft surfaces could results from incidental contact with rough hinge surfaces on the outside of the brace.
· If skin or other surfaces are scraped across the edge of a hinge, scratching could result.
· The severity of these risks is assessed as a level 3.
· In order to avoid these hazards, hinges will be selected that do not have sharp edges. Hinges should not extend more than 0.25” from the brace surface.
Initial Hazard Analysis Rev 1.3
4/13/07