1.1. the Purpose of This Document Is to Evaluate the Device S General Characteristics And

1.0 Purpose

1.1. The purpose of this document is to evaluate the device’s general characteristics and utilization properties.

2.0 Scope

2.1. The document involves a better look into the various interactions the lavage has with its users and their patients.

3.0 References

3.1. Function-Means Tree

3.2. Hazard Analysis

3.3. Function – Means Tree

4.0 Human Factors Engineering Analysis

4.1. Device overall characteristics

4.2. Device user interface

4.3. Device use

4.4. Device user population

4.5. Device use environments

4.6. Human use-related hazards

4.7. Proposed verification and validation

5.0 Revision History

5.1. No revisions were made to this document

5.2 On April 22, 2005 revisions were made to this document

Human factors analysis in risk management

Device Overall Characteristics

• A pulse lavage is used to irrigate a wound during operations or other procedures. The temperature of the solution dispensed from the lavage can affect the rate of infection and healing time for the wound. Studies show a solution of 22 degrees Celsius significantly delays healing and predisposes patients to wound infections. To solve that problem the temperature is increased ( 37 degrees Celsius (average body temperature is recommended).
• Pulse lavages are used in numerous procedures and operations. One specific use for a pulse lavage is in hip replacement surgeries. The demographic for hip replacements tend to be older people. But since lavages are so frequently used the patient population is varied.
• A regular pulse lavage is comprised of these main components; a reusable hand piece, saline solution and reservoir, disposable nozzle and tubing, and a pump. Our device needs a heating element so that the temperature of the solution can be controlled.
• The use of our device is the same as other pulse lavages; the only difference is the ability to control the solution’s temperature. The device is utilized to perform the same tasks as other devices currently used. The addition of the heating element does not change the utilization of the lavage, which is the irrigation of wounds etc. It merely contributes to the patient’s “quality of health” …….

Device User Interface

• The interface will be almost identical to that of current models. The only noticeable exterior changes will be the addition of a temperature control and readout.

Device Use

• The device will be used in an identical manor with respect to current models.
• The pump “cartridge” is inserted into the pulse lavage hand piece. The pump “cartridge” has a tube running from the hand piece into the solution reservoir. The nozzle shaft is inserted into the pump and secured. When the supply of solution in the reservoir is depleted it needs to be replaced.
• The only change in use would be the control of the temperature of the saline solution.

Device User Population

• This device should not be used by the patients themselves, instead only those trained to use the lavage should operate it. The intended user is a doctor or surgeon.
• The hand piece is reusable to cut down on hospital’s cost and waste. The tubing and nozzle are disposable to reduce the risk of contamination and infection. The hand piece is small and light to reduce the risk of fatigue and discomfort.
• The user will have to be trained in order to safely operate this device. A proper temperature and pressure needs to be selected so as not to hinder a patient's recovery. Also the user will have to be knowledgeable regarding the assembly and maintenance of this device.
• The device is not to be used by anyone not properly trained.

Device Use Environments

• The device is intended to be used in a hospital setting. It is most commonly utilized in an ER and operating room.

Human Use-Related Hazards

• Possible hazards include fire and burns, but all have a low likelihood of occurrence so the overall concern is small.
• Chemicals found in PVC tubing and IV can leach out from the material into the solution.

Proposed Verification and Validation

• Since this is a redesign on a current device that is overall very successful, fewer tests a required than usual. A prototype can be tested in house. Barring functional and safety problems, the device could be tested in a medical setting shortly after construction.

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