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.
CONCLUSION: From training courses using virtual cases, we found that there was no consensus on 'patient use' point of view of medical devices. There was a significant difference in applying definitions of adverse events written in guidelines regarding the medical device associated incidents. Our results point out that international harmonization effort is needed not only to harmonize differences in regulations between countries but also to overcome diversity in perspectives existing at the site of medical device use.
PURPOSE: To report the clinical profile of 34 ocular TB cases observed during 6 years period in Hospital Universiti Sains Malaysia (HUSM).
METHOD: A retrospective review of medical records from 34 patients diagnosed with ocular TB in HUSM from January 2011 until December 2016.
RESULTS: The mean age was 43 ± 14.6 years old. Both male and female affected in about 1:1 ratio. The majority of subjects were local Malays (91.2%). Risk factors included previous contact with pulmonary TB patients (38.2%), and patients with underlying diabetes mellitus (26.5%). Most patients showed normal chest radiography (79.4%). However they had positive Mantoux test (94.1%) and raised erythrocyte sedimentation rate (ESR) value (58.8%). Uveitis was the most common ocular manifestation of ocular TB (70.6%) while the rare ocular manifestations included optic perineuritis and optic neuritis, orbital apex syndrome, orbital cellulitis, sclerokeratitis, corneal ulcer and conjunctival abscess. All patients responded well to anti-TB treatment, but visual outcome was variable.
CONCLUSIONS: This review shows the diverse entity of ocular TB spectrum in an endemic area. Good clinical response to anti-tuberculous therapy supported the presumed diagnosis of ocular TB in majority of the cases.
METHODS: Case report.
RESULTS: The patient presented with painless sudden visual loss and progressive shallowing of the anterior chamber caused by hemorrhagic Descemet membrane detachment. She had corneal neovascularization and a positive syphilis serology. Owing to the risk of pupil block glaucoma, the patient had surgical drainage of the blood via an ab externo approach.
CONCLUSIONS: This case illustrates a previously unreported complication of syphilitic interstitial keratitis. The patient recovered good visual acuity and had residual pigment deposits in the pre-Descemet interface.