Source: Sina Pharmaceutical

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. This feature makes it widely used in the field of medical devices.

Because of the technicality 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. On June 2nd, the US FDA announced a case of falsification of sterilization agency data.

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. The fake sterilization data includes syringes, intravascular drug delivery devices and other types. This incident can be described as a major recent man-made disaster.

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 the entry of medical devices processed by the sterilization company into 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 example, when sterilizing the culture medium in our laboratory, we can choose to place a sterilization indicator strip, and make a basic judgment whether it reaches the sterilization temperature by changing the color.

For the same reason, ethylene oxide has similar operations. We know that after damp heat sterilization, the article has heat in a short period of time, and we can simply judge it by temperature. After ethylene oxide sterilization, there will be residues in a short period of time, which is very similar to the heat residues of moist heat sterilization above. However, the residual amount is difficult to detect, requires a lot of equipment investment, and it is not easy to indicate the sterilization dosage concentration of ethylene oxide. What should I do?

Another method is to mix the spore strips in the utensils that need to be sterilized by ethylene oxide. According to the concentration of ethylene oxide, a known number of spores is selected. In theory, this number of spores can be completely killed at this concentration. Therefore, after ethylene oxide sterilization, take out the spore strips and put them in the culture medium. In addition, select the unsterilized spore strips of the same batch and the same specification as the positive control, and take another medium that was prepared at the same time as the blank control. After constant temperature incubation, if the positive control bottle is turbid, and the sterilized spore strip bottle and the blank control bottle are clear, it means that the sterilization is qualified. If the sterilized spore strips are also turbid, and the blank control is clear, it means that the sterilization has not met the requirements. Of course, in this case, factors such as human contamination should also be excluded. Even without such a tedious operation, there is a kind of discoloration indicator card that can judge whether it has been treated with ethylene oxide.

Therefore, the sterilization effect of these appliances is measurable, not inoperable. Moreover, the inserted indicator cards or spore strips can be completely hidden, making sterilization companies unable to choose targeted sterilization. So when it comes to this, can the hundreds of companies affected by this Italian company also be regarded as "100% victims"? The answer is doubtful.

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 such a situation in which hundreds of companies have suffered. The cooperation between enterprises is risky, and the acceptance ability 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: there is no harm to others, and the need to guard against others!

Kaiyi Technology Co., Ltd. takes ISO9001-2015 and ISO13485-2016 as the quality assurance benchmarks, a professional mask production base, professional production technology and a complete quality system. The main production and operation of second-class medical equipment, disposable medical masks, disposable flat masks, disposable children's masks, KN95 masks are the varieties produced all year round.