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The mother of a child with a congenital heart condition pleads for Gore to provide the vascular grafts needed for her child’s sugery. (provided by Cheon Sae-rom)
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Four kinds of vascular grafts for pediatric heart surgeries not mentioned in talks
Patient advocacy groups are claiming that some of the materials necessary for medical operations on congenital heart conditions are omitted from the South Korean government’s negotiations with medical equipment manufacturer Gore about resuming the supply of artificial blood vessels, called vascular grafts. Although 20 vascular grafts in three categories have been supplied to the country, enabling some surgeries to proceed, the negotiations don’t include four kinds of vascular grafts that are needed for some pediatric heart surgeries. That could cause another delay of surgeries, these groups say. Sources from the Korea Congenital Heart Disease Patient Group, the Ministry of Food and Drug Safety (MFDS) and the Ministry of Health and Welfare told the Hankyoreh on Mar. 28 that the government is in negotiations with Gore about resuming a supply of these materials and that the supply is likely to officially resume as early as the middle of April. “In video meetings with Gore, we’re discussing ways to resume the supply to the level it was in before Gore’s withdrawal [from the South Korean market]. The negotiations will be completed soon, which should restore the supply of therapeutic materials such as vascular grafts and suture thread,” said an MFDS official. In an official document sent to the Ministry on Mar. 8, Gore requested an exemption from Good Manufacturing Practice (GMP), and the Ministry’s position is that this protocol would be unnecessary if the materials were supplied by way of the National Institute of Medical Device Safety Information. But there’s a considerable difference between the therapeutic materials requested by patient advocacy groups and heart surgeons and the list that’s actually being negotiated. Since the details of the resupply being negotiated by the government excludes four kinds of vascular grafts (12, 14, 22, 24mm) and three patches, heart surgeries for children could be delayed once more if hospitals exhaust their supplies, according to these groups. “We’ve made several requests directly over the phone, but Gore continues to refuse to supply four kinds of vascular grafts,” said Ahn Sang-ho, head of the Korea Congenital Heart Disease Patient Group. “We’ve also provided a list of the necessary vascular grants to the government, but it’s negotiating the materials that Gore says it’s willing to supply,” Ahn added. Once the resupply is made official, the MFDS is planning to hasten to reopen a supply of the therapeutic materials requested by patient advocacy groups. “We’ve requested an association of heart surgeons to provide us with a list of therapeutic materials necessary for our negotiations with Gore, but those documents haven’t come in yet,” said an MFDS official. By Kim Yang-joong, medical correspondent Please direct comments or questions to [english@hani.co.kr]
