A comprehensive fuzzy risk-based maintenance framework for prioritization of medical devices

The prioritization of medical devices into risk management pro-grams based on risk scores has
become a capital task for healthcareorganizations. The medical equipment standards presented by
theJoint Commission on Accreditation of Healthcare Organizations(JCAHO) have forced hospitals in
US to use their own risk manage-ment tools in order to decide which equipment must be involvedin
the MEMP [2]. In 1989, Fennigkoh and Smith [10] proposed adevice classification scheme based on
three criteria: maintenancerequirements, physical harm/risk and equipment function. Theyclassified
medical equipment by assigning scores to the three crite-ria and calculating equipment management
(EM) number using thesummation of values assigned to the three criteria. Their approachincludes
any device with EM number greater than or equal 12 inthe MEMP. In 2004, JCAHO approved the
Fennigkoh and Smithmethod and introduced the standard EC6.10 [11]. This method hasbeen widely
used after publication in The Joint Commission. How-ever, this method is not appropriate for risk
management becauseit merely computes an arithmetic average over three factors, andit is rather
insensible to changes on the estimated risk of medicalequipment. In addition, all of three criteria
have the same weightand different experts’ opinions are ignored and so on. As Tawfiket al. [7] has
mentioned in their recent paper, these shortcomingcould causes some critical equipment (such as
blood gases ana-lyzers, hematology analyzers, and steam sterilizers) to be classifiedas low risk
because they have low scores in two criteria (physicalharm and equipment function).In 1996, the
American Society for Healthcare Engineering.

Failure-Cost Mathematical Model for Medical Equipment Maintenance

In many applications, equipment failures may be divided into two categories, random failures
unpredictable) and those due to deterioration (aging). Fixed maintenance intervals is the most
frequently used approach in maintenance of medical equipment. Newer "as needed" type methods,
such as reliability-centred maintenance (RCM) or condition-based maintenance (CBM), are not
considered for application in healthcare industry anywhere around the world, except few proposals
coming from North America and Australia. Methods based on mathematical models are hardly ever
used or even considered. Yet only mathematical approaches, where component and equipment
deterioration and condition improvement by maintenance, are quantitatively linked, and can
determine the effect of maintenance on reliability of medical equipment. Ridgway [1] noted that
because of the current regulatory pressures to perform preventive maintenance (PM) in accordance
with manufacturer’s recommendations there are currently no reliable statistics available on what
increase in failure rates is expected if no PM at all was performed on various types of medical
equipment. This challenge was addressed by using a global mathematical model to analyse the effect
of PM on mean time to failure (MTTF) and failure rates of infusion
Maintenance Policies for a Deteriorating System Subject to Non-Self-Announcing Failures

failing systems, maintenance activities are crucial to improve system availability performance at a
minimum cost, especially when failures are nonself- announcing, that is, failures can only be
detected through inspections. A maintenance policy can be constructed by the system state and
corresponding action definitions. In these policies, the objective is usually to minimize the expected
long-run cost rate, which can consist of various components such as inspection, downtime, and
maintenance costs [19]. Frequent inspection leads to higher control costs, whereas infrequent
inspection increases the downtime duration and risk, so it becomes important to determine a
comprehensive maintenance policy.

The deterioration process of these systems is a combination of a “gradual degradation” that takes
the system to the next bad state at each transition and a shock process that takes the system
directly to the failed state and is described as a “catastrophic failure” [13], [35]. After the system
state is identified through periodic inspections, one of three maintenance actions (do-nothing,
repair, or replace) is taken. It is known that if an action is carried out after failure detection, it is
called corrective maintenance (CM). If it is performed under some satisfactory operating conditions,
then it is called preventive maintenance (PM) [19]. In particular, we call it minor repair (analogous to
PM) when the repair is performed in the poor state and major repair (analogous to CM) when it is
performed in the failed state. Additionally, both repair types are assumed to be imperfect, meaning
that they take the system to the good state with a given probability. Such an imperfect maintenance
assumption has been adapted by many authors [9], [20], [37]

A corrective maintenance scheme for engineering equipment

that corrective maintenance is still widely adopted in engineering practice. Corrective maintenance
focuses on the identification of cause failures from the failure phenomenon. The failure
phenomenon contains one or more symptom failures. In order to fulfill the corrective maintenance,
various models have been built to represent the failure mechanisms. Iyoob et al. [1] discussed the
impact of five corrective maintenance models to equipment