Medical devices review: How to maintain warranty on your products?
How does the ambulance service provider (organization, private or public body) guarantee to the patient that they are using medical devices in compliance “with the law”?
It is actually quite simple: when you purchase a medical device, – ventilator, defibrillator, stretcher, suction unit, etc. -, this is always sold in conjunction with a user’s manual and the additional maintenance information.
The second document has all the information and timings to carry out proper maintenance – general maintenance or extraordinary maintenance – and also contains the maximum device lifespan (this information is now required by the new European Regulation on the subject).
WARNING: The user’s manual – despite its name – usually never contains any health-related information to guide the user in administering first aid. Practitioners must manage this kind of information following international criteria.
The feature that remains the same is the obligation to keep the device in a perfect condition. Whether not, the device may lose CE marking, i.e. it may lose its characteristic of safety as laid out in EU Rules and Regulations.
What does the CE marking guarantee?
The CE marking is applied for the users of a medical device. It symbolizes that the manufacturer has followed all safety rules in realizing a device, which turns out to be certified.
The legislator is aware that the normal wear and tear, any inappropriate use of the device and its progressive ageing will deteriorate the conditions of the product.
Hence, the warranty of functionality it’s also a burden for the user. If a user does not respect the terms of maintenance that are laid out in the user’s manual, the CE marking will decay and the device will therefore not have the required safety compliance to be used in case of necessity.
Maintenance and warranty: what are the current rules in Europe regarding medical devices?
The main European relevant set of rules that regulates the production and the maintenance of these devices is the European Directive 93/42/CEE on medical devices.
Every Nation in the EU has implementend local legislaton following this Directive. Usually, The manufacturer is responsible to supply to the user information on how to install and maintain the device and also any precautions that need to be taken during its use.
The users are bound to follow the information that is being supplied to them. This means that during the entire lifespan of the device and in order to safeguard the safety and security of the patients and the users, the regulations provided must always be followed.
In case no specific information is found, or in case any doubt should arise, the answer can be found in the general regulation for security that gives broader rules on the subject.