CASE REPORT: A 34-year-old woman with intractable epigastric pain was referred to have repeated endoscopy with biopsy. She was found to multiple gastric erosions and nodules that were diagnosed as inflammatory lesions both endoscopically and histologically. Meanwhile, she developed an acute onset of severe back pain associated with a pathologic compression fracture in the T3 thoracic vertebral body. Imaging studies disclosed a disseminated systemic disease involving abdominopelvic lymph nodes and cervical and thoracic vertebral bodies. The needle biopsy of the pelvic lymph node disclosed diffuse proliferation of monomorphic small round cells that were diffusely positive for CD30 and ALK. A diagnosis of ALK+ ALCL with a monomorphic SC pattern was rendered.

METHODS: Asian countries were categorised into three groups; 'lower middle-income country', 'upper middle-income country' and 'high-income country'. The Medline/PubMed database was searched for articles published from January 2005 to December 2014 using relevant key words. Articles were excluded if they examined a specific injury mechanism, referred to a specific age group, and/or did not have full text available. We extracted information and variables on pre-hospital and hospital care factors, and regionalised system factors and compared them across countries.

RESULTS: A total of 46 articles were identified from 13 countries, including Pakistan, India, Vietnam and Indonesia from lower middle-income countries; the Islamic Republic of Iran, Thailand, China, Malaysia from upper middle-income countries; and Saudi Arabia, the Republic of Korea, Japan, Hong Kong and Singapore from high-income countries. Trauma patients were transported via various methods. In six of the 13 countries, less than 20% of trauma patients were transported by ambulance. Pre-hospital trauma teams primarily comprised emergency medical technicians and paramedics, except in Thailand and China, where they included mainly physicians. In Iran, Pakistan and Vietnam, the proportion of patients who died before reaching hospital exceeded 50%. In only three of the 13 countries was it reported that trauma surgeons were available. In only five of the 13 countries was there a nationwide trauma registry.

METHODS: An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases.

RESULTS: All 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders.

METHODS: We trained twenty-three participants from twelve Asia-Pacific Economic Cooperation (APEC) member economies about international guidelines for medical device vigilance. We developed and used six virtual cases and six questions. We divided participants into six groups and compared their opinions. We also surveyed the country's opinion to investigate the beginning point of 'patient use'. The phases of 'patient use' are divided into: 1) inspecting, 2) preparing, and 3) applying medical device.

RESULTS: As for the question on the beginning point of 'patient use,' 28.6%, 35.7%, and 35.7% of participants provided answers regarding the first, second, and third phases, respectively. In training for applying international guidelines to virtual cases, only one of the six questions reached a consensus between the two groups in all six virtual cases. For the other five questions, different judgments were given in at least two groups.