0
0 “Wake up the Ministry of Health and Welfare and the Ministry of Food and Drug Safety, which are ignoring the public’s right to health.”
‘Citizens’ Solidarity with Diabetes Patients’ holds demonstration and press conference
- Reporter Name Nam Nan-woo Mobile Reporter Reporter
- Entered 2024.05.22 16:53
Urges the Ministry of Health and Welfare and the Ministry of Food and Drug Safety to wake up and files a police complaint against G2E, the company that produces insulin injectors.
[Mobile Reporter Nam Nan-woo] ‘Citizens’ Solidarity with Diabetes Patients’ (Chairman Yeon Gwang-in, hereinafter referred to as Citizens’ Solidarity) held a protest in front of the main gate of the Ministry of Health and Welfare on the morning of May 21st, calling for awareness of the Ministry of Health and Welfare and the Ministry of Food and Drug Safety, which are ignoring the public’s right to health. A press conference was held.
Citizens’ Solidarity said it filed seven complaints from February 27, 2023 to September 12, 2023 to the Ministry of Food and Drug Safety’s Office of Advanced Product Licensing and related departments regarding licensing that is deemed to be significantly related to the health and life of diabetic patients. A related meeting was held with three officials from the Ministry of Food and Drug Safety on April 11 of this year, but the Ministry of Food and Drug Safety announced at a press conference that it continues to delay its response and evade its responsibility.
Citizens’ Solidarity is a group of type 2 diabetes patients being treated with insulin pumps and is working to protect patients’ rights. Currently, about 100 members are participating.
Lee Jun-hyeong, Secretary General of Citizens’ Solidarity, is a diabetic and is currently receiving insulin pump treatment. He is seeking treatment after learning that blood sugar control is more precise with the continuous glucose monitor (CGM) technology that has recently been approved and used at home and abroad. While looking at it, it was determined that the six types of CGM-related applications used by domestic companies were not approved at home or abroad, which could cause serious problems for patients’ health. Since February 22 of last year, several formal inquiries have been submitted to the Ministry of Food and Drug Safety to file complaints. It was announced that it had been received.
Secretary General Lee Jun-hyung recently raised the issue of domestic companies using applications related to continuous blood glucose monitor (CGM) technology that are not approved at home or abroad. These apps (Xdrip+, Shuggah, Spike, Glimp, Tomato, and LinkBluCon) have not been officially registered with the Ministry of Food and Drug Safety, and they warned that this could pose a serious risk to patients’ lives and health.
Secretary-General Lee also raised issues with the Ministry of Food and Drug Safety about the legality and safety of the LGS (hypoglycemic infusion stop) function of the above-mentioned ‘DIACONN G8’, but the Ministry of Food and Drug Safety has already approved the LGS (hypoglycemic infusion stop) function of the above-mentioned ‘DIACONN G8’ insulin pump. It was announced that permission had been granted.
What’s more serious is that the hypoglycemic infusion stop function was created using real-time data from a continuous blood glucose monitor made by Dexcom, USA, but it was revealed that it was being used without permission or contract from Dexcom, USA.
Director Lee said that there is a risk of abusing real-time data, so although the API provided officially after consulting with the FDA provides data delayed by 3 hours, ‘DIACONN G8’ did not follow official procedures such as contracting with Dexcom of the United States or obtaining permission to use it. It was stated that the data was actually being used without permission without going through the process.
In addition, in the case of Dexcom’s Dexcom Cloud used in ‘DIACONN G8’, it is not normal as described above, and other methods except Dexcom Cloud are known to retrieve real-time data by virtually hacking data communication without permission from the continuous blood glucose meter company. In particular, he raised issues about G2E’s ‘DIACONN G8’ insulin pump connecting to Dexcom’s continuous blood glucose meter and using real-time data.
He argued that unauthorized use of data without a contract or permission from Dexcom is dangerous and that cybersecurity issues are also serious. In fact, the US FDA claimed that it had recalled the Medtronic MiniMed insulin pump in 2019 due to cybersecurity issues.
Even though there are many risks and problems for diabetic patients, the Ministry of Food and Drug Safety said in its response on April 11, “It is difficult to answer at this time because we do not understand what the problem is because there is no specific product information,” and also in its response on May 16, “If you “Please understand that it is difficult to determine whether the Xdrip+, Shuggah, Spike, Glimp, Tomato, and LinkBluCon applications you inquired about are applicable to medical devices and can be used in accordance with medical device laws because we cannot confirm the above information.” He said he was questioning whether the Ministry of Food and Drug Safety is truly a government department that protects the health and lives of the people.
Secretary-General Lee said, “I wonder whether the Ministry of Food and Drug Safety is aware of the problem but remains ignorant, or whether it is truly unaware of the seriousness of the problem.” “Are people with diabetes having to fend for themselves?” He questioned.
In addition, in response to a question regarding the LGS (hypoglycemic infusion stop) function raised by Citizens’ Solidarity, the response on July 24 was, “Submit real-time hypoglycemic infusion stop function (LGS) test data using an already approved personal intracorporeal continuous blood glucose measurement system.” “We would like to inform you that it has been reviewed.”
Regarding medical device cybersecurity, “We would like to inform you that the review was conducted by applying the medical device cybersecurity requirements in accordance with the ‘Medical Device Cybersecurity Approval Review Guidelines’ and submitting evidence proving suitability in accordance with the requirements,” an evasive attitude that ignores the essence. He said he was only giving answers.
At the same time, he pointed out that “G2E’s product uses Dexcom’s 3-hour delayed data (blood sugar values 3 hours ago) (Dexcom API), which poses a problem with patient safety,” and added, “G2E has a problem with the manufacturer of the product that claims to be compatible. “It is illegal because there is no partnership or formal contract, so the license should be revoked,” he said.
However, the Ministry of Food and Drug Safety confirmed that “data is being transmitted in real time without using 3-hour delayed data by setting up and testing compatibility tests with Dexcom and Ebot’s continuous glucose monitors (CGM) during the approval review of G2E’s insulin injector.” “We inform you that G2E’s insulin injector uses Dexcom Share data, not the Dexcom API data you mentioned as 3-hour delayed data. Please be advised that the Medical Device Act does not stipulate matters regarding mutual partnerships between two companies when multiple medical devices from different manufacturers are used interchangeably (or interconnected). In addition, we would like to inform you that there is no language restricting the compatible use of other companies’ medical devices in the Dexcom and Abbott continuous blood glucose monitor (CGM) licenses, which G2E claims to be compatible with.”
In response, Secretary-General Lee said, “Isn’t this the same as saying that it is legal to copy and use the original computer software of someone who uses it? “It is hard to believe that this is an answer from the Ministry of Food and Drug Safety, which is in charge of licensing medical devices on which people’s lives depend.”
In addition, “As a result of Citizens’ Solidarity’s email inquiry to Dexcom, it was revealed that in Korea, there has been no contract or partnership with any company, including G2E, and it cannot be used without a contract or partnership.”
Secretary General Lee of Citizens’ Solidarity said, “According to the Ministry of Food and Drug Safety’s response, diabetic patients can freely use any program or product in any country in the world that is connected to a CGM in an insulin injection device, and programs used by others can also be shared. “It means that it can be used,” he said. “So who protects and guarantees the safety and threats to the patient’s life that arise?”
Secretary-General Lee Jun-hyung said, “The Ministry of Food and Drug Safety’s response raises questions about the role of government ministries in protecting the health and lives of the people,” and criticized the Ministry of Food and Drug Safety, saying, “Despite being aware of the problem, the Ministry of Food and Drug Safety is avoiding responsibility.” He urged the government to wake up to protect it.
Meanwhile, Citizens’ Solidarity filed a formal complaint with the police against G2E, which is suspected of deceiving the Ministry of Food and Drug Safety and the public.
Nam Nan-woo, Mobile Reporter Reporter namwoo97@hanmail.net
