Ms. Alavi, the expert in Nim Negah program- Samalat Radio): In the name of God. Hello to you dear audiences of Salamat Radio. I am Alavi, the expert presenter of Nim Negah program.
As you know, health problems are investigated and discussed in this radio channel.
According to an event occurred within the last weeks, we have decided to talk about how to control medical products Import. Recently, some non-standard and illicit coronary stents have been detected and seized in customs place of Imam Khomeini Airport.
A while back, we heard a news about importation of several thousands of fake implants and prostheses for neck and spinal cord.
And recently, we read a new under the title of “detection and seizure of many non-standard coronary stents in customs place of Imam Khomeini Airport”. However, I, as a public audience, do not know about fake stent and how they are seized in Imam Khomeini Airport. Moreover, another text was attached to the news declaring that the cargo was traded by 4200-Toman currency.
In the current episode of Nim Negah program, we will talk of more details of this incident to get more information about the current conditions of medical equipment quality monitoring. We heard about the offenders cases that it took 7 years from the initial public lawsuit in 2011 to the firm conviction and court judgment. However, these companies were working and importing different equipment until 2015.
Fortunately, Medical Device Directorate of Ministry of Health and Medical Education and other monitoring organizations who are responsible for controlling the quality standards do precisely monitor the medical equipment. Under the current situation, however, and regarding the fact that 4200-Toman currency is spent for the abovementioned devices and that some violations might occur in this regard, we wonder what the executive officials of Health System would do to prevent these kinds of violation.
Hence, we have invited Mr. Ramin Fallah, vice chairman of Merchants Union of Medical Devices and vice chairman of Medical Corporates Association, to hear, from him, more about the methods of monitoring and importing medical equipment.
- Alavi: Hello, Mr. Ramin Fallah. Welcome.
+ Ramin Fallah : In the name of God. Hello to you. I am really glad that you have considered about such important issues, quality and originality of medical equipment. I am at your service.
- Avali: Before we start our conversation, I should note that a phone number is provided to the audiences to call to talk about different issues regarding medical devices quality. If you have got something to say, call +982122021954. Moreover, you can send SMS to +9830000102.
Now, let’s get to the main topic.
Mr. Ramin Fallah ! Explain about the monitoring mechanism adopted by Ministry of Health and Medical Education. Fortunately, a systematic method of monitoring has been already adopted in that Ministry because medical devices are sensitive and important goods. Would you please explain about that?
+ As you noted, medical devices must be monitored and verified in terms of originality, quality and correctness, by the monitoring systems, such as Medical Devices Directorate. The directorate has a specific monitoring structure which is initiated at the time of the good arrival. First, all of the companies that are working in this field have certificates. If a company asks for a certificate, information about the company and those who are legally responsible, their addresses and their business cards must be investigated and authenticated. Moreover, they should provide their work experience. The company should hire a technical supervisor who has been trained in the directorate so that if he/ she observes a violation in importation and other processes, he/ she can submit a report about the incident to the directorate. Moreover, clearance certificate of Medical Devices Directorate is required to release the goods from the customs place. The goods would not be released unless their originality and and quality are confirmed. The goods are going to be distributed based on a series of specific rules.
Since the 4200-Toman currency is allocated to some of medical devices categorized in Group 1, monitoring processes have become more stringent and severe.
Ministry of Health and Medical Education monitors the process of distribution. A virtual warehouse is defined for these goods which is similar to the warehouse of the importer company. The goods characterized by IRC codes are stored in the virtual warehouse. Then it is reported to the Ministry of Health and Medical Education that to what hospital or medical center a device is sold. Moreover, the documents and reports about the sale process are registered in the virtual system. The documents include invoices and also, the physicians’ prescriptions to indicate the purchase process. It means that Ministry of Health and Medical Education knows about the number of devices in the companies’ warehouses and the buyers.
These goals are not realized unless the abovementioned infrastructures operate under effective supervisors’ monitoring. In my opinion, Ministry of Health and Medical Education does not have enough supervisor to reach the desired goals. Unfortunately, a great number of labor forces in Medical Devices Directorate have focused on pricing and they spend a significant fraction of their time on price the goods. So, they are negligent towards the principle responsibility. This type of defection can be resolved through hiring more human resources and focusing on the main duties.
- Alavi: So we can state that the information about devices that are transacted with 4200-Toman currency and are categorized in Group 1, the names of importer companies whose certificates are issued by Medical Devices Directorate and the processes of good release are available and it is possible for the supervisors to access all these information at any time.
+ Ramin Fallah : Not all types of medical devices are transacted by 4200-Toman currency. Ministry of Health and Medical Education has divided the devices into two groups: Group 1 and Group 2. The commodities of Group 1 are transacted by the official currency and the commodities of Group 2 are covered by NIMA currency. However, it should be kept in mind that we are supposed to consider about the devices originality.
Within a few months later, commodities purchased by 4200-Toman currency might not there exist anymore. However, monitoring of importation and originality of the devices is still necessary.
- Alavi: Just like what has happened recently. We have heard about detection and seizure of many non-standard coronary stents in customs place of Imam Khomeini Airport. It means that the stents are not applicable at all but they had been purchased with 4200-Toman currency. The ambiguity of this event is that the stents had been purchased with the 4200-Toman currency; therefore, there exists a company or person who was allowed to imports these devices with that type of currency. If these non-standard devices are imported based on official procedures, how they are seized in the customs place? Given the sensitivity of the problem, we wonder about the realities and details of this event. Previously, non-standard prostheses were imported and used, in a similar way.
Let us know more about the details. We will talk to one of the authorities of Ministry of Health and Medical Education to hear her explanations and see how, despite all the infrastructures, the cargo was detected and the other kinds of violations are prevented.
Ms. Torbati, the director of Medical Devices Engineering and Maintenance Department of Medical Devices Directorate in Ministry of Health and Medical Education is here with us.
Hello, Ms. Torbati.
+ Ms. Torbati: In the name of God, the compassionate and merciful. Hello to you and dear audiences.
- Alavi: Thanks for being with us.
Fortunately, as Mr. Ramin Fallah has noted, Ministry of Health monitors and observes the procedures for importation of medical devices.
However, we sometimes hear some contrary news. For example, a while ago, the public lawsuits initiated in 2011 led to definitive conviction of two persons accused of importing fake prostheses.
Recently, a cargo containing non-standard fake coronary stents has been detected and seized in Imam Khomeini Airport customs place. Since the cargo had been transacted with the 4200-Toman currency, it is inferred that there exists an importer who is specifically importing medical devices to whom the currency of 4200-Toman is dedicated. Hence, the importer was completely known. Moreover, the commodities must be investigated before release. How did the importer do such a violation? Tell us more about the details. Did the cargo really contain non-standard stents? Or they imported something other than stents with the currency of 4200-Toman?
+ Ms. Torbati: As you stated, since the medical devices are considered as sensitive commodities, strict and precise regulations have been issued for them in Medical Devices Directorate. All commodities that are needed to be imported are investigated in terms of quality, safety and function and also, of manufacture considerations. We have expert investigation teams in Medical Devices Directorate that investigate all the imported commodities, one by one, and finally, the manufacturer and importer companies are registered and the commodities are imported.
Different types of monitoring are considered for various fields, including customs, etc..
Your questions are about the commodities that are transacted with the official currency. Therefore, I should note that Medical Devices Directorate has a system called “Devices Distribution System”. All of the companies that has receive official currency from the Directorate are required to provide the correct information in the system, regarding the number of commodities to be imported. It means that the companies should declare to which hospital or physician they sell a device.
- Alavi: So you know how many of a certain commodity are imported and to whom they are sold.
+ Ms. Torbati: Yes, exactly. We monitor everything. During the monitoring procedure, if any kind of rule violation is detected, we would warn the offenders and also, refer the case to judicial authorities. So, people can be sure that there exists a process for total monitoring. On the other hand, there are some hospitals and physicians that evaluate the information and features of a device before use. If they detect any quality defection, they can inform us about the problem through MEDICAL DEVICE REPORTING (MDR) and it will be addressed.