News in English     | 14.08.2020. 17:45 |

Džemić: Ventilators from China should have already been entered in Register

FENA Hana Imamović

SARAJEVO, August 14 (FENA) - After the Institute of Metrology of Bosnia and Herzegovina performed an expert analysis of the documentation of 100 ventilators from China procured by the Federation of BiH for more than 10 million KM, it was determined that they have multiple uses guaranteed by the manufacturer and they should be entered in the Register and distributed to hospitals.

Director of the Institute of Metrology of BiH Zijad Džemić confirmed this in an interview with FENA, explaining that the Institute started the analysis of documentation and assessment of ventilator compliance in June at the request of the Investigative Commission of the FBiH Parliament, and later the Agency for Medicines and Medical Devices of BiH and FBiH Civil Protection Administration (FUCZ).

Based on the submitted documentation, the Institute determined that the manufacturer is a respectable Chinese company and the oldest company that has been producing medical instruments in China for more than 30 years. Certain characteristics were immediately determined, but it was necessary to inspect the documentation that was in the packages, which was done after the ventilators were unpacked.

As the Director added, after the first inspection of the documentation, the Agency for Medicines and Medical Devices of BiH could form a commission and start entering that instrument into its Register, but especially after their letter on July 30, there were no more dilemmas that it was necessary to enter ventilators into the Register and distribute them to hospitals.

“In this case, we have determined that there is no reason for the instrument not to be registered and distributed to hospitals. The only thing missing is a service technician, but we are expecting a response from China soon to authorize someone as a service technician, because without that the warranty period would be lost,” Džemić pointed out.

He said that the documentation showed that the company's representative office for Europe is located in Dublin, which is an address from the box, which was also problematized in the media, so they contacted them, but they explained that they are authorized only for European Union countries.  

Also, EC Declaration of Conformity was requested, which the manufacturer is obliged to submit only to the members of the European Union. It is a document that combines data about the device, but they are already contained in other documentation.

Everything about the instrument is written in the documentation, says Džemić, all the information about what kind of instrument is, whether it is invasive or not, whether it is used for intensive care or not, and no one has the right to refute what the manufacturer claims which were confirmed through a series of certification procedures and instrument and factory.

If someone questions that, it is necessary to prove the opposite in the same or better laboratory, says Džemić, and there is no such laboratory in Southeast Europe, so it is the duty to respect what the manufacturer has declared in its documentation.

“Therefore, the instrument is both invasive and non-invasive, because it has several different modes in which it can work. It is safe for intensive care although there is no strict ICU ventilator because intensive care involves the presence of different ventilators in relation to the needs of the patient. The instrument that arrived in BiH is primarily stationary, and can be used in an ambulance if it has an oxygen bottle,” Džemić explained.

When asked about the procedure of medical instruments delivered to Bosnia and Herzegovina through donations and distributed to hospitals, Džemić explained that all medical equipment or medicines, regardless of how they come to BiH by donation or are paid, must go through the same procedure defined by the Law on Medicines and Medical Devices of BiH.

The Council of Ministers of BiH passed a decision to distribute the donated instruments to medical institutions but did not request that the Law be violated and did not imply that their decision derogates from legal procedures.

As Džemić explains, some donated equipment is already in hospitals, without being included in the Register, nor have the technical parameters been determined, nor is it known whether they are invasive or not, nor whether they are for intensive care or not or who is a service technician of that equipment.

As Director of the Institute for Metrology of BiH Zijad Džemić concluded, no medical instrument in BiH has been thoroughly examined so far as is the case with ventilators that arrived from China.

Apart from China, the device is exported to many countries such as Korea, Indonesia, India, the Philippines, Malaysia, Russia, Ukraine, Italy, France, Spain, South Africa, Argentina, Mexico, Australia and Colombia.

(FENA) A. B.

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