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.
METHODS: The Birmingham Eye Trauma Terminology (BETT) system was used to classify injuries as globe ruptures, penetrating eye injuries (PEIs), intraocular foreign bodies (IOFBs) or perforating injuries. Demographic data, past ocular history, mechanism of trauma, ocular injuries, and best-corrected visual acuity (BCVA) before and after treatment were recorded.
RESULTS: The 205 OGIs included 80 globe ruptures, 71 PEIs, 48 IOFBs and six perforating injuries. Falls predominated in older age groups compared to the other mechanisms of injury (p<0.0001). A fall was responsible for 33 globe ruptures and 82% of these had a history of previous intraocular surgery. Globe rupture and perforating injuries had poorer visual outcomes (p<0.05), consistent with previous studies. Alcohol was implicated in 20 cases of OGI, with 11 of these due to assault. PEIs and IOFBs commonly occurred while working with metal. BCVA was significantly worse following removal of an intraocular foreign body. We found presenting BCVA to be a good predictor of BCVA at the time of discharge.
CONCLUSIONS: The causes of OGI varied in association with age, with older people mostly incurring their OGI through falls and younger adults through assault and working with metal. Globe ruptures occurring after a fall often had a history of intraocular surgery. The initial BCVA is useful for non-ophthalmologists who are unfamiliar with the ocular trauma score to help predict the BCVA following treatment.
CASE REPORT: A case of ureterovaginal fistula associated with a neglected vaginal foreign body. The patient was complaining of a foul-smelling vaginal discharge and lower abdominal pain. On vaginal examination, a hard and large foreign body was found. Examination under anesthesia was performed, and an aerosol cap was removed from her vagina. The patient developed urinary incontinence after removal of the foreign body. Subsequent work-up demonstrated the presence of a right ureterovaginal fistula. The patient underwent an abdominal ureteroneocystostomy. At one year follow up, the patient had fully recovered.
CONCLUSION: Ureterovaginal fistula following neglected vaginal foreign body is a serious condition. Early diagnosis, treatment of infection and proper surgical management can improve the outcome and decrease complications.