Biomedical Engineering, Vol. 42, No. 2, 2008, pp. 82
86. Translated from Meditsinskaya Tekhnika, Vol. 42, No.
2, 2008, pp. 32
35.
Original article submitted May 2, 2007.
Criteria and Methods for Assessing Reliability of Medical
Equipment. Part II: Special Requirements for Reliability
of Medical Equipment and Methods for Improving Reliability
A. A. Toporkov
Some specific features of use of medical equipment
determine parameters of medical equipment reliability
and introduction of these parameters into technical doc

umentation of such equipment:
– the degree of danger of medical equipment failure
to patient or medical personnel;
– function of medical equipment in diagnosis and
treatment processes;
– specificity of working modes of medical equip

ment in diagnosis and treatment processes;
– economic effect of medical equipment failure.
Reliability parameters specified in medical equip

ment documentation are mandatory for effective use of
medical equipment in medical organizations. Medical
equipment failure or disorder of medical equipment func

tion during diagnosis and treatment processes may have
extremely negative effects. The type of the negative effects
varies in different groups of medical equipment.
Depending on the negative effects, medical equipment
falls into five classes (Table 1). This classification allows a
parameter to be selected and quantitatively assessed. The
exploitation parameters (high or limited reliability
resource) and construction parameters (modular, design,
repair, or replacement) are determined by this classifica

tion [9].
Requirements for reliability of medical equipment
and reliability parameters depend on the medical equip

ment tasks and service system [10].
Methods for Increasing Reliability of Medical
Equipment. There are the following methods for increas

ing reliability of medical equipment:
a) backup;
b) decrease in the failure intensity of system ele

ments;
c) decrease in the time of continuous work;
d) decrease in the time of repair;
Federal Control Service in the Sphere of Public Health and Social
Development, Moscow, Russia.
82
e) reasonable periodicity and volume of system mon

itoring.
Object reliability is projected during construction.
Object reliability is implemented in manufacture. Object
reliability is decreased during exploitation. Object reliabil

ity consists of faultlessness, service life longevity,
repairability, and conservability. Methods of increasing
reliability should involve the four components of object
reliability [5, 19]. Projection and construction reliability of
medical equipment is beyond the scope of this work. We
will consider exploitation reliability of medical equipment.
Methods of increase of exploitation reliability of
medical equipment fall into two groups [2, 8, 21].
Group 1 includes methods of object reliability
implemented in projection, construction, and manufac

ture of medical equipment, including exploitation rec

ommendations (feedback experience).
The solution of this problem would increase the
medical equipment quality (reliability). However, lack of
a mandatory collection of exploitation information
makes it difficult to improve medical equipment use,
service, repair, storage, and transportation.
Group 2 includes methods increasing medical equip

ment quality during exploitation. Methods increasing
medical equipment quality include:
– increase in the qualification of medical personnel;
– instrumental methods of control of the system
technical state;
– regular prophylaxis based on reliability theory
methods;
– substantiation of service life of spare parts;
– methods of failure prognosis.
Some methods of system reliability increase can be
regarded as organized:
– broad experimental study of medical equipment
reliability at all stages of development, manufacture, and
exploitation;
– unified information system concerning medical
equipment working ability;
0006
3398/08/4202
0082  2008 Springer Science+Business Media, Inc.
Assessing and Improving Reliability of Medical Equipment 83

TABLE 1. Classification of Medical Equipment by Effect of Failure

Characteristic of class Characteristic of medical equipment group included in the class

A. Medical equipment, the failure of
which is impermissible and may have life

threatening aftereffects on at least one
functional system of a patient’s body or
the patient’s death
A1 – medical equipment providing biocontrol of vitally important functions of the patient’s body
A2 – medical equipment providing support of vitally important functions of the patient’s body or sub

stituting these functions
A3 – medical equipment providing the patient’s placement and manipulation with the patient’s body in
critical and urgent care
A4 – active, passive, and accessory instruments are designed for operations on vitally important organs

B. Medical equipment, the failure of
which may cause deterioration or corrup

tion of the clinical pattern of the disease
or incorrect activity of medical personnel
B1 – medical equipment for monitoring seriously ill, surgical, and post
surgical patients, as well as
patients in resuscitation departments
B2 – apparatuses used for treatment in critical situations, including apparatuses used in terminal and
shock states
B3 – medical equipment for monitoring seriously ill patients and for use in resuscitation departments
B4 – instruments and apparatuses for urgent care, resuscitation

C. Medical equipment, the failure of
which does not cause serious complica

tions (like class B), but may cause signifi

cant time losses, disturb diagnosis and
treatment processes resulting in
decreased efficacy of therapy and surgery
C1 – medical equipment providing comprehensive medical examination (functional diagnosis) in hos

pitals and clinical with X
ray departments
C2 – medical equipment providing comprehensive medical treatment in special departments of hospi

tals and clinics
C3 – medical equipment of special hospital departments
C4 – surgical instruments used for surgery in hospital departments of general surgery

D. Medical equipment, the failure of
which may cause short
term work faults,
service delay, and excessive work of acces

sory personnel
D1 – diagnostic devices used for outpatient settings
D2 – apparatuses for treating patients in outpatient settings
D3 – medical equipment for treating patients in outpatient settings, accessory medical equipment of
hospitals
D4 – instruments for diagnosis and treatment of patients in hospital and polyclinics

E. Medical equipment, the failure of E1
E4 – medical equipment, apparatuses, and instruments, which are not directly involved in diagno

which causes only material losses associ
sis and treatment processes, but used in accessory processes, equipment for mechanizing labor of
ated with its repair accessory personnel

– substantiation of reliability regulations and their
inclusion into technological documentation;
– organization of adjustment and reclamation prac

tice.
Reliability of sophisticated medical equipment is
provided during projection and manufacture. This level of
reliability of sophisticated medical equipment gradually
declines during exploitation [1, 7, 20].
Intrinsic reliability of an exploited object is charac

terized by parameter Tmean. Parameter Tmean characterizes
mean service life of the object to failure. This value
depends on failure intensity, elements λi at normal condi

tions or conditions specified by customer. Conditions of
the user manual should be observed [11, 17].
Intrinsic reliability parameter can be calculated
from:
Tmean = t/n = 1/(ngrad + nsp),
where n is total number of failure events during service life
t; ngrad is expected number of gradual failure events; nsp is
mean number of spontaneous failure events.
The actual value of parameter Tmean can be actively
modified during exploitation of systems. The value of
parameter Tmean depends on efficiency of object service
[9, 17].
The probability of detection of a failed element dur

ing exploitation and failure prevention within time inter

val t is:
P(t) = ngrad[1 – e–t/tn]/(ngrad + nsp),
where tn is mean time of detection of failed element.
Time tn depends on the number of elements, method
and productivity of the prognosis apparatus, and skill of
personnel.
Parameter P(t) is determined by the procedure of the
system exploitation. The number of gradual failures can
be reduced to:
negrad = ngrad(1 – P) < ngrad.
If actual exploitation conditions are close to theoret

ical conditions (consumer conditions), personnel is able
84
to compensate environmental factors, and failure intensi

ty λe is less than the theoretical value λ.
The number of spontaneous failures is:
nesp = λet < nsp.
Exploitation reduces the number of spontaneous
failure events:
e
Tmean.e = t/(ngrad + nesp) > Tmean.
Active effect of exploitation in reliability is argued in
the literature. The opposite point of view is that exploita

tion reliability of sophisticated system does not exceed
intrinsic reliability.
System reliability can be increased by redundancy.
However, this increases the system complexity, weight,
and cost [4, 19].
The system is regarded as absolutely reliable if fail

ure of any element does not cause the failure of the sys

tem. Practical implementation of this criterion includes
element
by
element or block
by
block redundancy [6,
8].
Efficiency of redundancy can be estimated using
failure intensity and the following suggestions:
– reliability of all system elements is the same;
– element reliability flow is simple;
– reliability redundancy of all system elements is the
same.
If probability and mean service life to failure of non

redundant system is:
P0(t) = e–Nλt;
Q0(t) = 1 – P0(t);
Tmean = 1/Nλ,
reliability gain of the redundant system over non
redun

dant system is:
GQ = Q/Q0, GT = Tmean/Tmean0, Gl = l/l0,
where l0 is failure intensity of the non
redundant system;
λ is element failure intensity; N is number of system ele

ments.
Probability of failure
free system work with intensity
decrease by the factor of k is:
P(t) = e–l0t/k.
Reliability gain is:
Toporkov
GQ = (1 – e–l0t/k)/(1 – e–l0t);
GT = k;
Gl = 1/k.
At small l0t reliability gain with respect to mean serv

ice life is proportional to k. Therefore, decrease in the
failure intensity substantially increases reliability of sys

tems with long service life and significantly increases reli

ability of systems with short service life [15, 22].
Effective methods of decrease in the failure intensity
are:
– use of reliable elements;
– removal of elements with low reliability;
– alleviation of working modes.
Decrease in the system working time is equivalent to
decrease in the failure intensity. Therefore, projected sys

tem working time should be decreased if possible [3].
Coefficient of readiness is an important parameter of
a system element:
Kr = Tmean/(Tmean + Trec).
Reduction of recovery time Trec allows the system
working condition to be increased at any time (Kr). In
other words, this increases system readiness.
System recovery factors are:
– automation of laborious troubleshooting;
– automation of system control and working modes;
– redundancy;
– reasonable design;
– reasonable exploitation documentation.
These factors affect the following parameters:
– mean time of reparation expectation;
– mean time of spare element shipment;
– necessary number of spare parts.
Recovery time after failure of a sophisticated system
significantly depends on the availability of spare parts.
Recovery time of ready
to
use systems is 10
20 times
increased by non
availability of spare parts [8, 14, 18].
The number of spare elements (units) is calculated
individually:
nmeani = λiNiTe,
where nmeani is mean expected number of failures for ele

ments and units of the i
th type; λi is failure intensity of
elements and units of the i
th type; Ni is number of
working elements and units of the i
th type in the sys

tem; Te is total service life during the system exploita

tion.
Assessing and Improving Reliability of Medical Equipment
The main component of complex system safety and
working ability is to maintain reliability of elements and
units at a necessary level. Technical support (TS) is an
important component of complex system safety and
working ability.
TS includes organization and technical measures
directed toward a decrease in the failure intensity. The
main goals of TS are prevention of wear, corrosion, and
aging; maintenance of main technical characteristics at a
required level; prolongation of equipment service life [13,
18]. TS includes prophylaxis and exploitation tests.
In recent years, the problem of technical monitor

ing, technical service, and metrological support of med

ical equipment requires legislative regulation. Contempo

rary industrial basis of monitoring and documentation is
either absent or requires substantial rearrangement. There
are no unified technical documents and unified require

ments for technical documentation of medical activity
and expert evaluation of medical equipment licensing.
Medical organizations require more funding for technical
service of medical equipment.
Regular prophylactic testing of medical equipment
increases its reliability. Periodicity of prophylactic testing
of medical equipment should provide necessary probabil

ity of failure
free work. In addition to failure
free work,
periodicity of prophylactic testing depends on the follow

ing factors: working time and character of medical equip

ment; service life of elements; cost; aftereffects of failure
[2, 11].
The time of prophylactic testing of medical equip

ment depends on the following factors:
а) at normal service life l(t) = const and allowable
reliability decrease Pallow or Qallow, the time of prophylac

tic testing of medical equipment is selected to provide
failure probability:
Q(t) ≤ Qallow = 1 – e–lt; tpr ≤ ln(1 – Qallow)/l;
b) regular service of equipment of long
term contin

uous working mode intended to replace elements, prelim

inary estimates of mean service life before gradual failure
Tmean and mean square deviation of service life σTmean(t)
should be obtained:
Tpr = Tmean – nσTmean(t),
where number n selected to provide failure probability
less than the allowable limit.
There are two methods of TS of sophisticated sys

tems:
– regular TS within selected time interval (including
optimal time interval);
85
– measurement of system parameters vulnerable to
external factors and aging before system TS. In other
words, the organization of TS in accordance with actual
system state. This TS is called “exploitation in accor

dance with state”. Regular testing is based on information
about system failure [12, 14].
Normalization and Optimization of Quantitative Re

liability Parameters. Normalization of reliability parame

ters of most industrial objects is economically substantiat

ed [16, 21]. Medical equipment is not used in industry.
The cost of normalization of reliability of medical equip

ment is difficult to estimate. There are methods for esti

mation of comparative efficiency of medical equipment,
e.g. coefficient of comprehensive economical evaluation:
CCEE = QΣ /BΣ,
where QΣ is target
oriented equipment work during the
exploitation period; BΣ are total expenditures for equip

ment cost (capital investment) and exploitation (current
investment).
It should be noted in conclusion that prognosis of
working ability and reliability of sophisticated systems
includes diagnosis and prophylactic measures. This
reduces failure probability during medical equipment
exploitation to a minimal level. Modern sophisticated sys

tems contain main technical subsystems, various devices,
and complicated control algorithms. The problem of reli

ability of modern sophisticated systems is far from being
solved. Moreover, technological progress increases the
level of complexity, construction, and uniqueness of
sophisticated systems. Existing methods of implementa

tion of safety and reliability of sophisticated systems are
limited and fairly expensive. Therefore, development of
new methods of implementation of safety and reliability of
sophisticated systems is rather important and urgent.
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Toporkov
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