Temporary shortages or disruptions for lab supplies are announced in many sectors. What solutions are available?
The current economic situation affects the everyone’s daily life by creating these shortages on laboratory devices
The economic crisis has had many impacts and has disrupted the whole supply chain of raw materials that are essential to many consumables or lab furnitures manufacturing.
In this environment, each manufacturer has to reconsider the sources of its materials to ensure the activity’s continuity under the best conditions, with the patient’s safety and the diagnostic performance at the heart of these decisions.
When a medical device (MD or IVD) manufacturer is faced with this situation, it must use all its expertise to provide technical and qualitative answers within a reliable and realistic timeframe.
Medical device regulations are evolving with changes in regulatory status also impacting product availability.
Some product lines are no longer considered as medical devices (e.g. micropipettes and cones); these are therefore available but under a different regulatory status for general laboratory use.
As for the product lines that must keep the CE mark but do not meet the new regulation in full, they are suspended and unavailable for sale while the regulatory file is updated. These interruptions are also temporary.
LAVIEDULABO has developed many tools to keep you informed of regulatory changes and their impact through articles.
Among the products affected by these shortages, the case of sterile medical devices is critical and strategic. Some of them are sterilized in double wrapping, i.e. bags considered as a primary and secondary packaging whose performance is essential to ensure a sterile barrier.
These packaging modifications require technical and regulatory validations to be able to introduce compliant products on the market as soon as possible.
Raw material shortages for these bags have imposed on manufacturers the need to find an alternative; sourcing work has therefore been committed in an economically complicated context to which are added strong regulatory constraints due to our diagnostic activity.
It is not a definitive discontinuation, but a temporary suspension caused by the current crisis.
Alternative solutions available?
While waiting for these products with certificates attesting to their compliance with the medical device regulation, alternative solutions exist to allow the activity continuity of all laboratories.
These alternative solutions must meet the needs of the laboratories regarding use so that the diagnosis is not inaccurate.
They must not require major changes in analytical methods in order not to introduce contamination risks or diagnostic errors.
To propose the best solution, adapted to each laboratory, it is necessary to adapt the alternative solutions.
Therefore LABELIANS teams are available to laboratories to propose temporary alternative solutions in line with their activity.
