The world of health or rather the world of e-health? Equipment, technologies, connected products, robotics, etc., in recent years, the Internet of Things has fostered the emergence of new connected, state-of-the-art medical devices (MD). This state-of-the-art equipment is creating new challenges that healthcare institutions must now meet. What are these challenges? What are the appropriate responses?
A medical device, as defined by the National Agency for the Safety of Medicines and Health Products, is any instrument, apparatus, equipment, material, product - with the exception of products of human origin - including accessories and software, used for medical purposes in humans, and whose principal intended action is not obtained by pharmacological, immunological or metabolic means.
The age of the internet of connected objects has encouraged the modernization of medical devices in health care institutions, which are now equipped with intelligent internet-based information systems. The aim of this technological breakthrough is to treat patients more quickly, in particular by digitizing and centralizing medical data to facilitate diagnosis.
In the context of a health crisis such as the one we are currently experiencing - COVID-19 - it seemed essential to us to recall the importance of the technical maintenance of medical facilities that meet a primary need every day: people's health.
Old and new generation medical devices
Health care personnel use medical equipment for diagnosis, prevention, control, mitigation of disease, injury, disability, etc. The treatments assigned to patients are then assisted by the MDs.
1. Older Generation Devices - Robotics
Robotics has been used in the field of medical devices for several decades now. Installations using this technology could almost be called today "generic" or "old generation" equipment. Among them we will find :
• The scanners
• MRI (Magnetic Resonance Imaging)
• Medical beds: robotized / automated / Anti-decubitus mattresses
• Operating room equipment
• Robotic Surgical Procedures
In spite of their seniority, they are still relevant and support the daily work of thousands of professionals. They are now reinforced by new connected devices that have taken an increasingly important place in the healthcare sector in recent years.
2. New generation devices - connected
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This new generation equipment allows data to be retrieved and shared between doctors, thus providing better monitoring of patient information. A revolution for the patient who can manage himself and for the medical staff who save precious time. These connected devices support, among many other functions, the control of diabetes (self-measurement of blood glucose levels), obesity (weight monitoring), cardiovascular diseases (self-measurement of blood pressure, pacemakers, defibrillators monitoring the activity of the heart and automatically transmitting the data to the doctor), etc.
The equipment that enables these new diagnostic and control modes is of the type :
• Oximeter connected
• Stethoscope connected
• Dermatoscope connected
• Connected Otoscope
• Glucometer connected
• Electrocardiogram (ECG) connected
• Doppler probe connected
• Ultrasound scanner connected
• Connected sphygmomanometer
• Visual testing tools, audiogram connected
• Connected respiratory function testing equipment
• Tympanometer connected
... and the list is not exhaustive.
Therefore, as these latest generation devices become essential to health care personnel, health care institutions are faced with the need to keep them in operational conditions. Indeed, it is inconceivable that a technical problem or an unexpected breakdown could occur on medical equipment, which could have serious consequences on the work of healthcare staff and potentially endanger the lives of patients.
The need for maintenance of medical devices
The systems as a whole (old and new generation) are subject to monitoring and maintenance obligations and strict standards framed by rules defined in European regulations. The aim is to ensure the reliability and durability of medical equipment.
The different classes of DMs and their placing on the market
The DMs are classified into categories that determine the level of potential dangerousness that the user may encounter. Depending on the class, the equipment undergoes more or less important controls before being placed on the market.
• Class I :
‣ Elements remaining outside the human body
(compresses, infusers, glasses, crutches etc.), very weak
• Class IIa :
‣ Devices remaining outside the human body but in
contact with blood, bodily fluids, body fluids, blood
products and elements for short-term treatment of lesions
Elements for short-term treatment of lesions that do not
require surgery (e.g. contacts, ultrasound equipment,
sterile materials etc.), moderate production control
• Class IIb :
‣ Devices intended for surgical use, for lesions
of the skin but also internal problems (Dialysis machine,
blood bags, contraception), monitoring high manufacturing
but also monitoring quality assurance
• Class III :
‣ Surgical devices (implants, stents, prostheses, etc.),
very high control of design, manufacture, the logistic follow-up,
quality assurance and must be validated by clinical trials.
These different degrees of control of the equipment upstream imply the continuity of monitoring once these facilities are made available in the establishments.
Regulatory obligations associated with their maintenance
The maintenance of both old and new generation MDs is an essential function for health care institutions and is subject to strict legal obligations.
The Public Health Code defines in particular, in article R5212-5, the maintenance of a medical device as "all activities intended to maintain or restore a medical device in a given state or under given conditions of operational safety in order to perform a required function. The conditions for carrying out the maintenance are fixed contractually, where appropriate, between the manufacturer or the supplier of third-party maintenance and the operator".
This legal framework requires the operator to put in place a strategy for the maintenance of the medical equipment in its establishment, which guarantees the quality and safety of the care provided through the safe operation of these facilities:
"The operator shall ensure the implementation of maintenance and quality controls planned for the medical devices it operates, maintenance is carried out either by the manufacturer or under its responsibility, or by a third party maintenance supplier or by the operator itself" - Public Health Code article R5212-25.
Similarly, medical staff are also ethically aware of the importance and risks involved in managing these facilities, which have considerable implications for patient health. Poor management of these facilities can thus lead to catastrophic situations.
For this reason, health institutions must rely on the latest generation software solutions such as Computer Assisted Maintenance Management, to organize and structure the maintenance operations necessary to comply with the standards in force.
The contribution of CMMS in the medical sector
Today, having a real management program such as the Yuman CMMS has become essential to ensure the maintenance
of medical devices that are becoming increasingly sophisticated. From a technical, organizational and budgetary point of view, this tool will enable the tracking, archiving and analysis of data that will help to implement strategies, respond efficiently and economically to the optimization of equipment productivity and guarantee its availability.
Thus, a CMMS solution integrated into a health care facility will meet the need to improve communication between technicians and health care departments, reduce costs related to breakdowns, control spare parts supply times, optimize interventions, in particular reduce intervention and restart times, and increase equipment availability.
The main objective of CMMS in the health sector will be to centralize all information concerning:
• The equipment:
‣ categorization, location, function, maintenance history
carried out, any incidents that may have occurred
• Spare parts inventory and demand management
• Intervention planning:
‣ execution and follow-up via an intervention request portal
• Analysis and performance indicators - KPI:
‣ synthesis tool and statistics for decision support
A global vision of all the equipment used by the care teams will bring many benefits to the operator in charge of facility management:
• Decision-making support for the renewal of the equipment
and the preparation of a provisional budget:
‣ reinforce the maintenance plan or buy a new one
• A control of the costs of the installations due to a knowledge of
the financial impact of their decisions
• A needs assessment using KPIs
• A control of the interventions of their planning and their cost
• Risk analysis, management, and reduction, thanks to a
Feedback, particularly with regard to breakdowns,
their causes, their frequency
• Precise monitoring of the equipment:
‣ downtime, repair costs, repair time and number of repairs
of interventions, availability of associated spare parts
• A follow-up of maintenance contracts, their cost, their expiry
date and their billing
• Improved internal communication and reduced administrative
Increased equipment lifetime, reduced probability of in-service failures, elimination of the causes of serious accidents, reduced costs and compliance with legal regulations: this is the contribution of CMMS in the health sector!
Opting for a modern and mobile intelligent solution such as Yuman CMMS has become a must.