LITERATURE REVIEW

From the articles given, we found some literature review that can be concluded as:

There were many process of maintenance management used successfully

until 1960s. Start with Run to Failure Maintenance Policy then Preventive
Maintenance (PM) appeared. The first aspect of Preventive Maintenance consists of
scheduled activities of maintaining and part replacement to avoid unpredicted failure.

In 1980s, Condition Based Maintenance (CBM) were developed to reduce

unnecessary scheduled action. Prognostics concept introduced deals with fault
prediction before its happen. So that, Predictive Maintenance (PdM) is a CBM Policy
which it is includes prognostics in its decision process. PdM combine more
information on assets degradation to remain useful life (RUL).

From previous literature review, many researchers concluded that it’s

necessary to handle the gap between academic models and real environment
applications. Besides that, the application of maintenance optimization models to
medical devices is rather scarce and new. Majority of researches just put forward
how to evaluate and improve devices reliability in their design or manufacturing
phase without considering reliability assessment and maintenance strategies of
equipment in operating context. Last but not least, the current maintenance
strategies are effective but it is not evident whether it efficient.

So that, there are importance to managed medical tools and equipment

efficiently and sensibly from the initial step includes acquiring procedure, operative
procedure and the maintenance policies used.
 Refer to another articles that we had study – Downtime Reduction on Medical
Equipment Maintenance at The Directorate of Biomedical Engineering in the
Jordanian MOH (Feb 2017) by A. Al Bashir, A. Al Tawarah and A. Abdul Jawwad
had discussed about the application of Six Sigma (SS) concepts and tools in
planning and execution of corrective maintenance activities and procedure that can
reduce the downtime and increase availability with high quality correction process
that satisfies customer needs. Factor affecting, and controlling, CM times and hence
downtime were identified by applying Six Sigma Methodology – DMAIC (Define-
Measure-Analyze-Improve-Control) in corrective maintenance. This method is
among the best options for Maintenance Management System to achieve
improvements in corrective maintenance, minimizing downtime, reducing cost,
customer satisfaction and reach world class maintenance practice levels for the
medical equipment and tools.

Other than that, the articles from Krishna B. Misra, Vaishali Hedge –
Reliability in Medical Device Industry published on Jan 2008 discussed about the
reliability tools and standard applicable to the equipment industry. There are four
phases of a reliability program to launch safe and reliable medical product were
found by the researches. Reliability takes on even greater significance since medical
device designed for specific application are becoming more expensive. This articles
also explained about several different types of reliability tests that can be performed
over the life of the product cycle. Reliable testing is a part of an integrated test
program involving statistical testing, to optimize the design of the product and the
production processes; functional testing to confirm the design; environmental testing
to ensure that product can operate under the projected environments; reliability
testing to ensure that the product will operate for its expected life and safety testing
to ensure safety of the product.
References :
1) Krishna B. Misra, Vaishali Hegde - Reliability in Medical Device Industry -
Respironics Inc. Sleep and Home Respiratory Central Facility, Pennsylvania, USA
(Jan 2008)
https://www.researchgate.net/publication/284000814_Reliability_in_the_Medical_Device_Industry

2) A. Al-Bashir, A. Al-Tawarah, A. Abdul Jawwad - Downtime Reduction on Medical

Equipment at The Directorate of Biomedical Engineering in the Jordanian MOH -
International of Online Engineering (iJOE) Feb 2017
https://www.researchgate.net/publication/314108209_Downtime_Reduction_on_Medical_Equipm
ent_Maintenance_at_The_Directorate_of_Biomedical_Engineering_in_the_Jordanian_MOH