The Health Ministry suspended a Hanoi NGO's operating license after an effort to treat a group of poor children suffering from cleft lip and palate resulted in three infant deaths.
On Monday, the ministry ordered Khanh Hoa Province's Department of Health to review the protocol for the cleft lip and palate surgeries offered by the Center for Researching and Aiding Smile Operation (OSCA), after three sedated infants died between Saturday and Monday.
The central province was assigned to prevent the center from conducting any further surgeries and impose punishments for any violations it discovered.
Khanh Hoa police will also review the OSCA team's professional licenses and conduct a forensic review to determine the causes of death.
Tuoi Tre newspaper reported that OSCA was chaired by Pham Van Ai, a Hanoi doctor who conducted a breast augmentation surgery that killed a woman in 2011.
Vice Minister of Health Nguyen Thi Xuyen pledged to look into Ai's involvement.
OSCA began offering corrective surgeries to impoverished children suffering from cleft palate syndrome in 2011 with support from Khanh Hoa's Military Hospital 87.
The surgeries have proceeded, every year since.
The 'biggest tragedy' in Vietnam's medical history
This year, 56 babies were scheduled to receive treatment, but the tragic outcome prompted the group to stop at 11.
Nguyen Ngoc Tuyet Van, 11 months old, and Pi Nang Tuan Huu, 19 months old, sank into critical condition after receiving anaesthesia.
Van died four hours after being rushed to Khanh Hoa General Hospital on Saturday morning in a deep coma.
Huu was admitted an hour after Van, suffering seizures caused either by a lack of oxygen to the brain or an overdose of anaesthesia. He survived until Monday morning.
Nguyen Quang Minh, 14 months old, remained normal throughout the sedation process but developed complications after surgery. He was rushed to the provincial hospital on Saturday afternoon but died the following morning.
Doctors described him as being in respiratory and cardiac decline brought on by anaphylactic shock caused by the anesthesia.
The eight other infants treated by the group were reportedly sent home with no reported complications.
Nguyen Ngoc Tuyet Suong, Van’s mother, said her family wouldn't cause problems for the doctors involved, but wanted the investigation to determine the cause of death to prevent further tragedies.
“Nothing can compensate me for the loss of my daughter. But I feel there’s something wrong with the medicine.
“I hope the authorities will identify the real problem, so the incident won’t happen to other children.”
Luong Ngoc Khue, head of the ministry’s Examination and Treatment Department, told Tuoi Tre the incident is “the biggest” anesthesia-related tragedy in the Vietnam's medical history.
Khue is participating in the province's investigation.
“We will examine the whole process carefully... We will engage leading experts.”
Investigators have collected samples of the anesthesia used during the procedure. Forensic tests are currently underway.
All checked, but not sure
Dr Le Tan Phung from Khanh Hoa Health Department, who is in charge of monitoring medical work permits in the area, said OSCA submitted academic profiles of its members to receive approval for the operations.
He added that the medicines used in the procedure hadn't yet expired, but he also said he couldn't be sure that the anesthesia wouldn’t cause shock.
Nguyen Thi Thanh Binh, the woman who sedated Huu and Van, said: “the 11 babies were sedated with sevoflurane and fresofol.”
Binh has been an anesthesiologist for nearly 30 years, worked at numerous hospitals and offered her services at a number of charity operations.
She claimed this was the first time she had lost a patient.
Pham Van Tien, deputy director of the military hospital, said his hospital provided rooms, equipment and anesthetics; OSCA’s staff was in charge of the procedure.
Bui Xuan Minh, director of the Khanh Hoa Health Department, said he expects reports on the incident by the end of Tuesday.
OSCA's website at osca.org.vn has been inaccessible since at least Monday morning, according to a screen notice.
The group’s managers visited the bereaved families on Monday and gave each VND120 million (US$5,660).
Dang Thi Thu Hoai, the managing director, said the center has successfully treated around 2,500 children nationwide since it was founded in 2007.
Hoai said the center sent five experienced doctors to administer the procedures over the weekend.