Medical devices, by their very nature, have a direct impact on their users’ health. They require significant investment and high maintenance costs. It is therefore essential for facilities equipped with such devices to have a reliable and efficient CMMS program that suits the medical sector.
Maintenance in the medical industry
Every health care facility must deploy a maintenance program for its medical devices. The complexity of this software depends on the size and type of the facility, its location and the resources required. But the underlying principles of an effective maintenance solution are always the same, regardless of the characteristics of the facility.
Maintenance is the responsibility of the operator as soon as the medical device is put into service. If the operator uses an external maintenance provider, it is recommended that their respective obligations and responsibilities be laid down in a contract.
Article R. 5212-25 of the French Public Health Code states that "operators shall ensure the implementation of maintenance and quality controls provided for the medical devices they operate. Maintenance operations are to be carried out either by the manufacturer or under its responsibility, by a third party maintenance supplier, or by the operator itself".
It is therefore up to the operators to define a maintenance policy for all the medical devices they operate, whatever their category (I, IIa, IIb or III). Although it seems obvious to set up a maintenance policy for so-called "critical" medical devices, the maintenance of category I and IIa medical devices must not be neglected. A significant proportion of materials vigilance incidents whose identified cause is linked to a maintenance defect concern this type of devices, such as patient lifts or medical beds.
The impacted medical devices
The decree of March, 3rd 2003 sets out the list of medical devices subject to maintenance requirements:
- medical devices necessary for the production and interpretation of radiodiagnostic images;
- medical devices necessary for the definition, planning and delivery of radiotherapy treatments;
- medical devices necessary for the performance of nuclear medicine procedures;
- medical devices for diagnostic or therapeutic purposes exposing persons to ionizing radiation;
- categories IIb and III medical devices resulting from the classification rules set out in the Order of April, 20th 2006 (as amended by the decree of March, 15th 2010).
For all these devices, operators are required to apply the provisions laid down in the above-mentioned Article R. 5212-28 of the French Public Health Code:
- have an up-to-date inventory of the devices they operate, stating for each of them the common and trade names of the device, the names of its manufacturer and supplier, the serial number of the device, its location and the date of its first entry into service;
- define and implement guidelines designed to ensure the delivery of maintenance activities and internal or external quality controls of the devices and specify the modalities in writing;
- have the information needed to assess the provisions adopted for the organization of maintenance and internal or external quality control, as well as the procedures for carrying them out;
- implement the controls as defined by Article R. 5212-27;
- to keep, for each medical device, an up-to-date register in which all maintenance and internal or external quality control operations are recorded;
- to allow access to the medical devices and the information provided for in this article to any person in charge of maintenance and quality control operations.
The maintenance of medical equipment can be divided into two main categories: inspection and preventive maintenance, and corrective maintenance.
Inspection and preventive maintenance
This category includes all the activities planned to ensure the equipment is operating properly and to prevent breakdowns or failures. Performance and safety inspections are simple procedures designed to verify that a device works correctly and can be used safely.
In preventive maintenance, upkeep operations are scheduled to extend the life of a device and prevent failures, such as replacement of spare parts, calibration, lubrication or cleaning. An inspection can be performed alone or in combination with preventive maintenance operations. It can be relatively invasive, as it involves disassembling, cleaning or replacing some of the device’s components.
The identification of a medical device failure occurs when a malfunction is reported by an operator of said medical device, or during a preventive maintenance inspection. In order to restore the piece of equipment as quickly as possible, immediate and effective troubleshooting is necessary to understand the failure and determine its cause.
Corrective maintenance can be performed on a single component, a printed circuit board, or the entire medical device, which is then replaced. It is important to choose the right level of maintenance for each situation, depending on the financial, material and human resources available, and the urgency of the need for repair.
The benefits of a CMMS software for the healthcare sector
In the medical sector as in all other industries, maintenance plays a very important role in the activity of an organization. Hospitals, clinics, medical laboratories or even long-term care facilities have an interest in having a suited CMMS solution to meet the many challenges they face.
Centralize and clarify information
Compared to paper or Excel files, CMMS software in the medical sector makes it possible to clearly record information on the maintenance activities carried out. This makes it easier to consult the history of maintenance operations on a given piece of medical equipment and simplifies its use. Loss of information and the risk of errors are considerably reduced.
Record basic documentation and equipment
While basic documentation can be updated on paper records or spreadsheets, the use of a CMMS software facilitates efficient record keeping and the monitoring and improvement of performance, as indicated by WHO.
Next-gen CMMS applications come along with tools to analyze all your maintenance data and monitor your performance.
In addition, a CMMS software allows to meet the requirement of rigorous maintenance in a medical environment thanks to the registration of all equipment and material. It is thus possible to add pictures, the location of each piece of medical equipment in the facility, detailed technical sheets, etc. Thanks to this easily accessible data, the availability of the devices is significantly increased, which is essential in a medical or hospital environment.
Ensuring procedural compliance
Having a complete history of all maintenance operations is essential, as only actions recorded in writing or digitally are legally recognized. The digitization of information using CMMS makes it possible to trace all interventions carried out on equipment and to ensure that statutory controls have been carried out. In addition, it allows very rapid extraction of the history in the event of an inspection. Finally, having an electronic signature functionality allows technicians to validate interventions directly on site.
The benefits of 4.0 CMMS for the healthcare sector
The structures in the medical sector are more likely to turn to conventional and renowned software, which are, however, very expensive and difficult to use. Next-gen solutions such as Mobility Work are disrupting this outdated software, as they are more user-friendly and easy to get accustomed to.
Mobility Work allows technicians to be autonomous: calendar, checklists, task creation, maintenance plans, notifications for each new activity...
This type of application allows better interconnectivity between services, in particular thanks to profiles adapted to departments other than maintenance. The Purchasing department, for example, can thus benefit from good visibility on maintenance activities and better anticipate future needs. Orders are then placed more quickly, and procurement lead times and maintenance costs are reduced. This interconnectivity facilitates communication and collaboration between departments, and thus the work of biomedical engineering, which is particularly demanding.
In addition, a mobile application such as Mobility Work, which can be accessed at any time and from anywhere, enables a more reliable monitoring of interventions and reduces the risk of human failure. Teams in charge of medical device maintenance can easily and quickly log their interventions in the application, access all the compliance documents they need and consult intervention indicators and reports at any time.
While the adoption of CMMS is invaluable for medical facilities, choosing a next-gen solution allows them to avoid the shortcomings of traditional software while benefiting from the latest technological advances. This makes maintenance in the medical sector easier and more reliable.