There is a growing tendency in the field of medical device to shift responsibilities from the manufacturer to the rest of the distribution chain. Specifically, by setting storage temperatures in a nonsensical way, or by setting a very narrow storage temperature band. What is the problem and how can it be solved? Let's look at it in more detail with two examples.
In the first case, you have suppositories with a specified storage temperature of 3°C to 10°C. In the second case, you have a non-sterile gauze square with a storage temperature range of 5°C to 25°C. The first example is certainly taken seriously by all distributors as a case of a thermolabile device and care is taken in its storage and distribution. In the latter case, distributors are usually less attentive and are unlikely to comply with the transport conditions, pointing out that such products cannot be transported in a temperature controlled chain at the price charged. Moreover, from their point of view, it is unnecessary, because a few hours of non-compliance with the specified temperature does not affect the gauze.
This is usually the case until the first inspection by SÚKL (State Institute for Drug Control), which imposes a painful fine for violation of the conditions set by the manufacturer. And you have to give them the benefit of the doubt, because there is - technically speaking - no difference between the two cases. So what to do about it?
First of all, it must be made clear that nothing can be done at the distributor level. The distributor has to control and measure the conditions prescribed by the manufacturer and provide a technical solution to comply with them. The problem is with the manufacturer who, in the case of the gauze squares mentioned above, probably copied 5°C to 25°C from a competitor's product and then conducted a stability study at these 'normal' conditions. It would have taken very little to verify, using meteorological data, that the gauze (as well as the packaging) is stable over a much wider range of temperatures than can realistically be achieved in Europe during storage and transport. A few extra searches would therefore be sufficient. In the case of some products, due to the materials or to maintain product purity, then to carry out stability tests at marginal temperatures, possibly simulating short-term exceedances. And the whole distribution chain could breathe a sigh of relief that it has less to worry about. Fortunately, some manufacturers have already figured this out. Helping distributors in this case is also environmentally friendly and leads to a strengthening of Europe's energy independence.
Author: Aleš Martinovský