Methods: We described three different surgical techniques for correction of penile paraffinoma based on our single-centre experience. Informed consents were obtained from patients whose photographs were taken during the operation step.
Results: In general, three patients had simple excision biopsy with primary suturing, four patients underwent single stage excision of circumferential granuloma with bilateral scrotal skin flap reconstruction and one patient experienced dual stage procedure. Three of them were injected with paraffin, one with silicone and the remaining four were unable to identify the substance used. All patients successfully underwent the surgical procedure and four of them had minor post-operative surgical site infection and wound gapping.
Conclusion: All patients recovered well and the mean International Index of Erectile Function (IIEF-5) score obtained was 24.25. In our experience, excision biopsy was adequate for focal mass and reconstructive surgery using bilateral scrotal flap was suitable for circumferential mass.
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.