1.59 Equipment Quality Assurance
Category: UWHC Administrative
Effective Date: June 1, 2017
Section: Respiratory Care Services
To promote the safety of patients, visitors and employees of UW Health through evaluation of all
equipment owned or rented by Respiratory Care (RC). To minimize the possibility of injury during the
provision of care by ensuring proper function, identifying risks, preventing equipment failure,
monitoring equipment incident history , and educating staff.
A. Equipment Quality Assurance for Respiratory Care in University Hospital, The American Family
Children’s Hospital, and the American Center shall be the responsibility of the RC Equipment
Supervisor in conjunction with Clinical Engineering (CE).
B. All equipment will be evaluated by the RC Equipment Supervisor and/ or CE to determine if it
meets hospital and manufactures specifications before purchase.
C. QA monitoring will be undertaken on an ongoing basis by the staff as well as audits performed
by the RC Equipment Supervisor and/ or CE when deemed necessary.
D. All rented and purchased equipment will be inspected and tested by either the RC Equipment
Supervisor or CE for proper function before it is placed into service.
E. The RC Equipment Supervisor and Education Coordinator will jointly develop an education plan
for new/rented equipment, equipment updates as necessary, and any user problems identified
through monitoring or during the provision of care.
A. Equipment Malfunction
1. If a piece of equipment is not functioning properly or is deemed unsafe, RC staff will
discontinue use of that particular piece of equipment and do the following:
a. Complete an RC Equipment Malfunction Form in its entirety.
b. File a Patient Safety Net report online (include the equipment ID number).
c. Attach the Equipment Malfunction Form to the equipment in question and send
both to the RC Equipment Center, C5/115.
d. If the offending equipment is disposable/ single patient use, include all packaging
and supplies when it is sent to C5/115.
e. The RC Equipment Supervisor will initiate investigations into malfunctioning
equipment, deferring to CE whenever necessary.
2. If the malfunction resulted in serious injury, necessity for immediate medical/surgical
intervention, or death to the patient, the incident must immediately be reported to the
Administrator on Call, supervisor, the charge therapist, and the attending physician
for the patient.
a. The equipment must be impounded in its entirety.
b. The equipment or circuit shall not be disassembled or thrown away.
c. Refer to Administrative Policy 12.40, “Reporting of Device-Related Adverse
Events & Other Product Problems.
3. Product recall notifications are received by CE. The RC Equipment Supervisor shall
assist CE with the resolution of any recalls relating to RC equipment per CE direction.
B. Ongoing Quality Monitoring
1. Specific high risk RC equipment will have QA reports performed by CE as deemed
necessary per the Medical Equipment Management Plan,
a. Highly utilized RC equipment that is not high risk may be selected by the RC
Equipment Supervisor to be monitored in the event of suspected ongoing
b. Equipment monitored will be any equipment purchased or used by RC that
displays recidivistic performance deficiencies.
2. Monitors will contain all or some of the following (this is not all inclusive):
a. Accuracy of equipment
b. Maintenance and malfunction history of equipment
c. Reported adverse events and near misses
d. Analysis of potential monetary waste relating to mal performing equipment
3. QA monitoring will identify equipment problems, thereby helping to reduce the
possibility of equipment failure or patient injury. These will result in
recommendations and actions to improve:
a. Patient safety
b. Patient care
c. Better understanding of equipment
d. Appropriate allocation of RC department resources
4. Results of audits will be reviewed by RC Administrative Leadership, who will then make
recommendations based on the outcome of the audits to improve equipment purchasing,
decrease equipment failure and have an improved equipment selection and utilization
C. New Equipment
Equipment being considered for purchase will be tested and inspected by the RC Equipment
Supervisor and CE as needed to determine the following:
1. Equipment meets or exceeds the manufacture’s specifications.
2. Identification of clinical or safety advantages and risks to patients or staff associated with
3. Meets or exceeds department’s expectations and the mission of the hospital.
4. The Technology Assessment Committee reviews new capital purchases over$100,000.
A. Administrative Policy 9.19 “Internal Education & Training”
B. Administrative Policy 11.35 “UW Health Evaluation of Capital Clinical Equipment
C. Administrative Policy 12.40 “Reporting of Device-Related Adverse Events & Other Product
D. Administrative Policy 12.46 “Product Recalls and Safety Alerts”
E. Administrative Policy 12.64 “UW Health Environment of Care Safety Program Policy”
F. UW Health Medical Equipment Management Plan
G. UW Health Technology Assessment Committee for Medical Devices
Approved by Director and Medical Director of Respiratory Care: