Research and Development assistance Patent and grant assistance

Institutional Review Board (IRB) approval assistance Equipment planning for clinical areas and new programs Generating reports to administration including clinical capital equipment purchase tracking Computerized clinical instrumentation inventory Centralized patient-care instrumentation history files Centralized instrumentation technical manuals library Equipment evaluation library Instrumentation pre-purchase evaluation

RFQ generation Purchase requisition review Bid evaluation

Vendor and manufacturer interface Coordination of outside services

Acceptance testing (initial checkout, incoming inspection, incoming test) of new equipment safety, operation, and technical specifications Clinical equipment installation coordination and supervi­sion

Defect resolution and documentation User in-service training

Preventive maintenance test procedure generation and up­date

Testing of rental, loaner, demonstration, patient-owned, and physician-owned equipment for hospital use Scheduled PM Equipment repairs Equipment upgrades

Oversight and evaluation of equipment service contracts Emergency clinical engineering support to all patient-care areas

On-call and recall for critical care areas Specialized clinical engineering support dedicated to cardi — othoracic surgery Quality assurance and risk management Regulatory agency survey support Equipment related patient incident investigation Hazard and recall alert notification

Clinical engineering participation on hospital and health center committees Represent hospital on the University Healthcare Consor­tium (UHC) Clinical Engineering Council Represent hospital in the New York City Metropolitan Area Clinical Engineering Director’s group BMET internship programs

NYC Board of Education Substitute Vocational Assistance (SVA) internship programs Volunteer training

Clinical engineering staff and departmental development.

Equipment Modification. At times clinical engineering is called on to modify instrumentation. Modification must not be done indiscriminately. Care must be taken so as not to violate the integrity of the equipment. It is best to limit modifications to external operations. Nonmanufacturer approved internal modifications must be approached with extreme caution and are best not done as they may void warranties and violate FDA guidelines. This includes securing devices to a cart so they will not fall off in transit or be stolen, assembly of de­vices into working systems, and modification of equipment to allow easier PM. For example, a monitor used in an endo­scopic video system may have to be secured to a cart, or, a medication cart may have to be modified to allow its use as a crash cart. Crash carts typically are medication carts that house a defibrillator, suction device, O2 tank, and supplies. Purchased as separate entities, integration is required. Elec-

Figure 5. Equipment modification, crash cart. Equipment modification takes many forms and runs the gamut from modifying a specific device to assembling separately pur­chased components into functioning systems which may not be available commercially, or which must have specific characteristics to satisfy institution requirements. Shown here, a medication cart was modified by clinical en­gineering to accept an electrical outlet strip and retractable reel (with 25-ft line cord), O2 cylinder, a defibrillator, and an aspirator so that it can be used as a cardiac arrest crash cart, which is brought to the patient bedside for resuscitation during patient cardiac or re­spiratory emergencies.

tric reel extension cords, auxiliary power outlets, as well as on/off switches and tie-down straps to prevent defibrillator removal must be added (Fig. 5). Another example is the con­struction and assembly of an operating room (OR) transport cart connected to the patient bed upon transport from the OR to the Cardiothoracic Intensive Care Unit (CTICU), which houses a ventilator, monitor, defibrillator, and dc to ac supply. An example of a modification that assists in PM is the exter­nal provision for a jumper (with manufacturer approval), which when removed allows the backup thermostat of a hy­perthermia blanket to be tested, without the need for disman­tling the unit. Equipment controls may also be physically con­stricted so as to prevent inadvertent operator-induced error. Examples include covering of stylus heat adjustment controls (after optimization), limiting rotation of a ventilator alarm control to prevent complete alarm shut-off, and plugging an unneeded ECG sync-pulse phone jack output to prevent its use with a defibrillator as it induces too much signal delay.

Research and Education. Most health-oriented universities with teaching hospitals have education, research, and health care as their mission. Clinical engineering is capable of pro­viding support for all of these goals. Clinical engineering as­sistance with health care has already been discussed. With regard to education, in addition to providing in-service educa­tion, clinical engineers are called on to teach courses in the health-related professions. Clinical engineering support for research activities includes assistance in the selection of ex­perimental equipment, setting up a laboratory, measurement technique, grant writing, patent applications, and IRB ap­proval. Also included are the design, prototype development, and final construction of special-purpose devices that are not readily available commercially or that can be more cost effec­tively built in-house.

Involvement in research and educational activities are beneficial to a clinical engineering department. These chal­lenging opportunities help to keep the staff technically compe­tent and involved at the forefront of technology. Such activi­ties also bring prestige to the department, enhancing its professionalism and reputation, helping it to gain additional resources.

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