Mr. Ramin Fallah, vice chairman of Merchants Union of Medical Devices and vice chairman of Medical Corporates Association, was invited to Nim-Negah radio program to talk about the methods of monitoring and importing medical equipment.
Here, you can read the second part of this interview.
- Alavi: Would you please tell us what the commodities were? Were they really stents or something else imported under the tile of Stent?
+ Ms. Torbati: In any field, there may be some companies that desire to abuse their certificates.
- Alavi: Please tell us about this issue, directly. Was the importer a famous company or a person abusing the brand name of a company? Please provide us with more detail about the incident.
+ Ms. Torbati: The brand whose name was declared was a famous and high-quality entity. And there was not any problem regarding the supply of the distributed commodity. The offender was a company that had received an urgent certificate from us and it was supposed to import a certain number and type of commodity with specific price. The company violated the regulations about the number and type of the commodities imported.
- Alavi: Who did import the devices? What was the exact offence of the importer? Did the importer import original stents or were they fake all? Or did the importer import another commodity under the title of Stent?
+ Ms. Torbati: Actually, the importer committed different types of offences.
- Alavi: You mean the importer did import non-standard stents and also, some other commodities in addition to them?
+ Ms. Torbati: Yes.
- Alavi: Did not the company know that it is under supervision and control? We concern that a ring is missing somewhere and more similar offences will be committed in the future. The customs authorities, also, might not detect the other offences.
+ Ms. Torbati: No, it will not happen, again. As I noted before, we have a distribution system and at the end, the company is supposed to define the end user in the system. The end users are the hospitals, physicians and medical centers whose names are registered in our systems.
- Alavi: Unfortunately, currency rate differences cause many violations in different fields, from meat and chicken market to medical devices. We want to know more about the mechanisms used to prevent these violations. Some problems are of lower importance, but stents are going to be implanted inside the patients’ bodies. Hence, they need more strict and severe monitoring mechanisms.
Would you please tell us how the cargo was detected? And what was the whole story?
+ Ms. Torbati: Medical devices monitoring is an extended program in the whole country. Medical Science universities in all around the country are exact and careful about detection and monitoring. We have powerful and efficient technical detection teams in all cities of the country. Thanks God! The number of offences detected in the field of medical devices is handful and limited and we did not observe that much infringements in this field. That’s because we have active and powerful monitoring teams. About the recent incident, it should be stated that the detection and monitoring teams in the customs place, detected the offence during evaluations and they sent their report to Medical Devices Directorate.
- Alavi: You mean they called you from the customs place and you sent a detector.
+ Ms. Torbati: We received several reports from different sources. The detectors in different sectors and also, the experts in Medical Devices Directorate, detected the the incompatibilities based on the number of imported commodities registered in the system at the time of certificate issuance. Then, the problem was investigated more accurately and finally, it became clear that the company committed an offence.
- Alavi: Mr. Ramin Fallah ! Please share your comments with us.
Generally, a credible and authorized manufacturer considers to recall its products if they show any defection. It required the vendors to collect back the products before they are implanted inside the patients’ bodies.
At the early days of my job in Radio, I heard about the prostheses that were implanted in women’s bodies and later, they were recalled. Is it necessary to extend the monitoring and supervision that much?
+ Mr. Ramin Fallah : Yes. As I noted before, medical devices should be traceable even inside the patients’ bodies.
- Alavi: Are they traceable that much you claim?
+ Mr. Fallah: Unfortunately, they are not.
In my opinion, Ministry of Health and Medical Education, effectively, monitors the procedures with the help of Medical Devices Directorate and Distribution System. The infrastructure for effective monitoring is available. Maybe, the Ministry has got some defects in terms of human resources and they should be resolved. However, after the product is delivered to the hospital or drugstore, it will be sold to the customer and used in surgery rooms.
About the products that are going to be implanted inside the patients’ bodies, a relationship must be created between the deputy of treatment and the Directorate and the features of the products have to be registered in the patients’ cases. The product must be defined by a specific barcode or Shabnam labels. These programs are predicted in the hospital HIH but they are not necessary to be implemented. In the case of any lawsuit, these programs give us the information about the products importer, the importation documents, the time of importation and the currency spent for importation.
The chain must stay connected in a way or another. Medical Devices Directorate does no monitor and supervise the procedures as effective as it has to. Unfortunately, everyone are concerned about selling the 4200-Toman currency though the main concern should be the product quality.
- Alavi: Mr. Ramin Fallah ! It has happened that an importer had received the currency and imported a product other than stents.
+ Mr. Ramin Fallah : It shows that there exists a mechanism to detect the offence.
- Alavi: Was the importer amateurish?
+ Mr. Ramin Fallah : The importer was a little bit naïve. Assuming that s/he released the commodities from customs, s/he had to give a report about to whom s/he sold the product.
- Alavi: Maybe no medical devices were in the cargo containers.
+ Mr. Ramin Fallah : The main problem is with the urgent certificate. Unfortunately, we have a great problem. Why did the official vendor not import the product? The vendor had imported the same cargo for several years.
- Alavi: Ms. Torbati! Why did the official vendor not import the product?
+ Ms. Torbati: I should mention a point about the previous discussion about whether or not the product feature are registered in the patient’s case. As Mr. Fallah said, our hospitals are required to register in the system and the patient’s case the features of the medical product.
- Alavi: Is this program implemented, Ms. Torbati? If we ask you about the features of a stent implanted inside a specific patient in a certain hospital, can you give us an answer?
+ Ms. Torbati: We do not have the information but the hospital do.
- Alavi: Is not the hospital obliged to register the information in your website?
+ Ms. Torbati: In our website, the production or importation license for a product and the documents about distribution procedures and delivery confirmation of the hospitals are loaded. However, the information about the receiver patient are not included in our site. We are sure that the hospital keeps those information.
- Alavi: Is it required to include the information about receiver patients in your site?
+ Ms. Torbati: No, it is not. That’s because the hospitals do register information the receiver patients. We can receive any information we want from Ministry of Health and Medical Education.
- Alavi: So, can you have access to those information?
+ Ms. Torbati: Yes, we can.
- Alavi: Let’s talk about the recent incident. You were equipped with the proper mechanism to detect the offence. However, did you look for the root causes of this happening? Why did the representative vendor not import the product? Definitely, there were some gaps in your plans so that an importer asked for an urgent certificate and did not know exactly what to do.
+ Ms. Torbati: We do not have any limitations. The representative company can import a demanded number of a commodity based on the information in the system. We are also responsible for identifying the deficiencies in our country and preventing any subsequent problems. According to the bylaws and regulations of operation in the field of medical devices, we are allowed to resolve any deficiencies by parallel and urgent importation. In other fields and for the other commodities, also, we do the same. So far, fortunately, we have been being successful in preventing the deficiencies.
- Alavi: You are responsible for resolving the deficiencies and shortages. However, such problems, like the recent incident, might occur. Mr. Fallah! What do you suggest to solve the problem?
+ Mr. Ramin Fallah : Urgent certificate is a necessity. However, this is not the way to identify the root cause for failure of the representative vendor to import the commodity. The vendor could not import the medical devices because Ministry of Health and Medical Education did not pay people the money it should.
- Alavi: Insurance companies did not pay the money.
+ Mr. Ramin Fallah : A defective chain has been created in which a person is trying, for two years, to get his money. We cannot persuade the vendor to import the device; so, we have to ask someone else to do so due to need for treatment. If the second person imports the commodity based on the formal procedures, he will join the “Bankrupt” group because he cannot get his money, too. His offence is denounced but the root cause of the offence is that anybody who purchases the commodity of the importer, s/he has, legally, ethically, normally, to pay the price. If not, such happenings would be observed.
- Alavi: The insurance company, also, suffered from lack of supply and other problems.
+ Mr. Fallah: I do not mean that they did not pay the money, intentionally. However, no matter how strict and severe we monitor the procedures, if the root cause of this problem is not resolved, it might happen again. The representative vendor is less likely to violate the rules than those who seek urgent certificates.
- Alavi: Ms. Torbati! We’ll hear your final word.
+ Ms. Torbati: I want to assure the people of my country that Ministry of Health and Medical Education, strictly, supervises every procedures of medical devices supply, from importation to distribution. So far, we have not had any severe problem in our country. We have designed different systems for receiving people’s comments and recommendations. Hence, whenever people find a quality problem in medical devices or they identify any offence, they can send their reports for us through an online system.
- Alavi: Cases of the two offenders who imported fake implants and prostheses in Isfahan have been being open for several years. Is it possible for Ministry of Health and Medical Education to ban the offenders’ activity up to the time of the court final decision? It is written in the news text that they were free to continue their work until the final decision of the court were issued.
+ Ms. Torbati: Yes, definitely. All cases of offence are presented to Medical Devices Technical Committee, and Ministry of Health and Medical Education would make the final decision based on any case severity and its threats for the society.
- Alavi: Hence, the offenders would be banned from working until the final decision of the court is issued. And our fellow countrymen can be sure that they can address the problems in the way we have explained. If they think that someone is violating the rules, they can send a report to the authorities of Medical Devices Directorate. We are glad that the cargo was detected before it arrives the treatment system.
Thank you, Ms. Torbati, for answering us, responsibly. And thanks to Mr. Fallah, the vice chairman of Medical Engineering Corporates Association, for attending our radio show.
The dear guests and I say goodbye to you.