In the medical device handling system, storage and transportation are not auxiliary, but mandatory steps that directly affect the safety and security of the claimed product characteristics. Russian regulation assumes that a medical device must meet the requirements throughout its entire life cycle, from release from production to intended use. That is why storage and transportation conditions are considered as part of the quality assurance system.
The requirements for these conditions are established by the manufacturer and fixed in the technical and operational documentation. They are mandatory for all participants in the product handling. Failure to comply with the stated parameters may lead to loss of functional characteristics or sterility and, as a result, to violation of legal requirements, even if there is a valid registration certificate.
In practice, the safety of medical devices is affected by a combination of factors that must be taken into account at all stages of treatment.
1. Physical and mechanical integrity.
Medical devices are sensitive to:
- vibration and shock loads;
- deformations of packaging;
- leakproofness.
This is especially true for sterile products, disposable consumables, as well as products with electronic and optical components. Damage may be invisible visually, but at the same time completely deprive the product of its claimed properties.
2. Microclimate and environmental conditions.
Temperature, humidity, and light have a direct effect on the materials of the product.:
- high humidity can cause corrosion and damage to electronics;
- low humidity reduces the elasticity of rubber and polymer elements;
- exposure to ultraviolet radiation destroys polymers and protective coatings.
Therefore, temperature and climate conditions must be monitored both during storage and transportation.
3. Continuity of transportation conditions.
From a regulatory point of view, transportation is a continuation of the storage process. This means that:
- the conditions set by the manufacturer must be observed on the entire delivery route.;
- sudden temperature changes and lack of cargo fixation are equated to violation of storage conditions;
- the lack of control of logistical parameters creates regulatory risks.
Responsibility for compliance with these requirements is distributed among all participants in the circulation of medical devices. The manufacturer is responsible for correctly defining and documenting the conditions. Distributors and logistics operators are required to ensure their compliance. Sellers and medical organizations, in turn, are responsible for the proper storage of products until use.
4. Violation of storage and transportation conditions can lead to serious consequences.:
- risks to the patient due to the loss of the declared properties of the product;
- claims from the regulator and suspension of product circulation;
- financial losses, including damage to shipments and product recalls.
