Ethylene oxide company sterilization data fraud affects hundreds of medical companies, but they are not innocent

Are you lazy or negligent?

Having experienced the new crown epidemic, many people have seen the ethylene oxide sterilization label on the outside of surgical masks
.

Ethylene oxide can be used to sterilize items that are not resistant to high temperature and humidity.

Because of the high technology and high cost of ethylene oxide sterilization facilities, many medical device companies choose to cooperate with professional ethylene oxide sterilization institutions
.

If there is data falsification in the sterilization organization, the spread will be very large

The Italian company Steril Milano has falsified data since 2016 and is suspected of falsifying sterilization data
.

97 different medical device manufacturers with whom it cooperated were affected because of this incident

Steril Milano owns two ethylene oxide sterilization companies.
Although they closed three months ago, there are still many companies affected by their previous business dealings.
Among them, 10 medical companies have begun to voluntarily recall medical devices sterilized by the plant
.

At the end of May, the United States also banned medical devices processed by the sterilization company from entering the United States

But any sterilization can actually be measured by testing.
For example, we know that sterile injections will have sterility testing
.

In addition, many appliances that have passed moist heat sterilization have the sterilization effect verification in the early stage, and there will be marked indicators in the post-sterilization process

For the same reason, ethylene oxide has similar operations
.

We know that after damp heat sterilization, the article has heat in a short time, and we can simply judge it by temperature

       Another method is to mix spore strips in utensils that require ethylene oxide sterilization
.

According to the concentration of ethylene oxide, a known number of spores is selected.

       Therefore, the sterilization effect of these instruments is measurable, not inoperable
.

Moreover, the inserted indicator card or spore strips can be completely hidden, making the sterilization company unable to choose targeted sterilization

       If the company has a corresponding strategy to determine whether the sterilization meets the requirements, it can basically prevent the sterilization company from mass fraud
.
In other words, the lack of internal risk control capabilities of medical companies has caused this situation in which hundreds of companies have suffered
.
Cooperation between enterprises is risky, and the acceptance capability is the guarantee against this risk
.
In our industry, we cannot trust upstream companies 100%
.
Just like you buy raw materials from any company to make medicines, you must test the medicines according to the pharmacopoeia or other regulations before using them, instead of looking at the other party’s factory report and then putting them into use
.

       This incident exposed many problems, one of which is that the medical device company did not establish its own acceptance mechanism, or that the acceptance mechanism had loopholes, which allowed Steril Milano to take advantage of the loopholes
.
We say that we don't want to be 100% perfect victims, but if hundreds of medical device companies face recalls due to this incident, then it can also be said that these companies are not innocent, either lazy or negligent
.
One word of advice to these companies: Don't have the heart to hurt others, and you need to have the heart to guard against others!