In the context of the health crisis we are currently experiencing due to the Covid-19 pandemic, the maintenance of medical equipment is even more important than in normal times. Choosing the right CMMS allows us to efficiently adapt to both health constraints and the requirement for maximum reliability that weighs on the medical sector.
Maintaining medical equipment at the time of Covid-19
The maintenance of medical equipment is subject to particularly strict regulations due to the considerable health stakes that weigh on the sector. The current worldwide Covid-19 epidemic is further reinforcing these constraints.
Standards applicable to the maintenance of medical equipment
Article R. 5212-25 of the French Public Health Code stipulates that maintenance is the responsibility of the operator as soon as the medical equipment is put into service: “the operator shall ensure the implementation of maintenance and quality controls planned for the medical devices he or she operates. Maintenance is carried out either by the manufacturer or under its responsibility, or by a third party maintenance provider, or by the operator himself or herself”. It is therefore up to the operator to define a maintenance policy for all the medical equipment he or she operates, whatever its class (I, Iia, IIb or III).
A decree of March, 3rd 2003 lists the medical devices concerned by the maintenance obligation:
- Class IIb and III medical devices resulting from the classification rules provided by the Order of April 20th, 2006 (amended by the Order of March 15th, 2010).
- medical devices necessary for the definition, planning and delivery of radiotherapy treatments ;
- medical devices necessary for the production and interpretation of radiodiagnostic images ;
- medical devices for diagnostic or therapeutic purposes exposing persons to ionizing radiation ;
- medical devices necessary for the performance of nuclear medicine procedures;
21 CFR Part 11
The 21 CFR Part 11 standard concerns the maintenance of machines and equipment mainly in the pharmaceutical, medical and food processing sectors. Issued by the American FDA (Food and Drug Administration), it is mandatory for all companies marketing products in the USA. In particular, this standard obliges companies to follow strict processes regarding data collection and archiving. It is built around two main axes:
- the electronic signature, which is intended to certify critical information or documents and, where appropriate, to comment on them;
- the audit trail, the purpose of which is to keep a record of any action or modification that has occurred to the data or structure.
The 21 CFR Part 11 standard therefore imposes strict and advanced management of access and user rights, a log of connections and accesses and a precise definition of the hierarchical schemes applicable to the validation of the most sensitive data.
Maintaining medical equipment during the Covid-19 outbreak
During the Covid-19 pandemic, maintaining medical equipment is both more important and more complex. On the one hand, they have to be cleaned even more frequently than usual. On the other hand, the sustained activity in some medical sectors at the peak of the health crisis, and the resumption of activity at a sustained pace in other sectors with the deconfinement, requires particularly rigorous and efficient maintenance, in order to ensure the reliability of the equipment while disrupting its use as little as possible. Finally, the operation of teams with a limited number of staff complicates their work, and that of the managers responsible for organizing interventions.
Choosing the right CMMS software to maintain medical equipment
Even more than in normal times, choosing a CMMS software adapted to the medical sector and to the health crisis ensures optimal maintenance of medical equipment.
CMMS, an essential tool for the medical sector
The standards that apply to the maintenance of medical equipment, and in particular the 21 CFR Part 11 standard, make it virtually mandatory to have a CMMS-type maintenance management platform. This makes it possible to clearly record information on the tasks carried out. In addition, it is easier to consult the history of interventions. Finally, the loss of information and the risk of errors are greatly reduced.
However, older generation CMMS solutions are often not adapted to the medical sector and the particularly strict standards that weigh on it. As a result, they are complex and not very intuitive to use, which raises a major issue when all operations must be carefully recorded, and slows down the work of the teams.
Next-gen CMMS help you comply with standards
A next-gen CMMS solution such as Mobilty Work represents a major step forward for the maintenance of medical equipment in compliance with standards such as 21 CFR Part 11. Designed on the model of everyday applications, it is very easy to use. It allows users to enter and consult data and information very easily. This helps to ensure that the teams responsible for maintaining medical equipment strictly comply with standards and that every intervention is meticulously recorded.
In addition, thanks to its numerous functionalities, Mobility Work’s app makes it possible to carry out an in-depth analysis of the equipment maintenance strategy. It also makes it possible to satisfy maintenance audits very simply, and to meet the requirements of the 21 CFR Part 11 standard in this area.
Adapting to health restrictions thanks to mobile CMMS
In addition, next-gen CMMS, also called “CMMS 4.0”, are mobile. This means that such an application can be used from any connected mobile device (smartphone, tablet, laptop, etc.). In times of strong health constraints and frequent teleworking, this represents a major asset.
Both maintenance teams and managers can consult all the documents and information they need at any time. For the former, this allows them, for example, to have access during their interventions to the recommendations of equipment manufacturers and the processes imposed by standards. For the latter, it makes it much easier to analyze the maintenance strategy and adapt it to the situation. It also makes it easier to manage a small workforce and comply with exceptional health standards.
The maintenance of medical equipment is subject to many constraints. Some, such as 21 CFR Part 11, are structural. Others, such as the health measures to combat the Covid-19 epidemic, are circumstantial.
To meet these major challenges, it is crucial to choose an adapted and efficient CMMS solution. Thanks to Mobility Work, compliance with all standards is simpler to implement, and maintenance becomes more rigorous, more efficient and easier at the same time.