Biomedical Engineering Reference
In-Depth Information
Figure 5.5-16 SPC-''Real Time'' SPC Application.
Medical equipment risk criteria
Physical risk (PR)
Lists the ''worst-case scenario'' of physical-risk potential
to either the patient or the operator of the equipment
(Table 5.5-2)
.
Figure 5.5-17
illustrates a virtual instrument application
that demonstrates the way that four ''static'' risk cate-
gories (and their corresponding values) are used to de-
termine the inclusion of clinical equipment in the Medical
Equipment Management Program at Hartford Hospital.
Each risk category includes specific subcategories that are
assigned points, which, when added together according to
the formula listed below, yield a total score that will range
from4to25.
Considering these scores, the equipment is catego-
rized into five priority levels (i.e., High, Medium, Low,
Grey List, and Non-Inclusion into the Medical Equip-
ment Management Program). The four static risk cate-
gories are Equipment Function (EF), Physical Risk (PR),
Environmental Use Classification (EC), and Preventive
Maintenance Requirements (MR).
Environmental use classification (EC)
Lists the primary equipment area in which the equip-
ment is used
(Table 5.5-3)
.
Preventive maintenance requirements (MR)
Describes the level and frequency of required mainte-
nance
(Table 5.5-4)
. The Aggregate Static Risk Score is
calculated as follows:
Aggregate Risk Score
¼
EF
þ
PR
þ
EC
þ
MR
Using the criteria's system described above, clinical
equipment is categorized according to the following
priority of testing and degree of risk:
Equipment function (EF)
Stratifies the various functional categories (i.e., therapeu-
tic,diagnostic,analyticalandmiscellaneous, of equipment).
The specific rankings for
High risk
Equipment that scores 18-25 points on the criteria's
evaluation system. This equipment is assigned the
highest risk for testing, calibration, and repair.
this category are listed in
Ta b l e 5 . 5 - 1
.
