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PubMed · 10176361

User reporting systems.

M E Donawa
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Abstract

Under the European vigilance system, manufacturers are responsible for reporting serious incidents or near incidents concerning medical devices to the relevant Competent Authority. However, the European Directives do not require users to report incidents. As a result, user reporting requirements vary among Member States. This article examines the manner in which user reporting is addressed in the European Directives and European vigilance guidance document, some examples of national user reporting systems, and some important issues concerning user reporting.

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Equipment FailureEquipment and SuppliesEuropean UnionGuidelines as TopicHumansProduct Surveillance, PostmarketingRisk ManagementJournal Article

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BibTeXRIS

M E Donawa. 1997. User reporting systems.. https://pubmed.ncbi.nlm.nih.gov/10176361/

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In vitro assessment of back pressure on ventriculoperitoneal shunt valves. Is laparoscopy safe?

BACKGROUND: Whereas there are case reports of laparoscopy in patients with ventriculoperitoneal shunts, there are no studies assessing the potential failure of shunt valves with the increased intra-abdominal pressure of laparoscopy. This study aims to assess this factor. METHODS: An in vitro model was used to assess the potential for retrograde failure of ventriculoperitoneal shunt valves in a commonly used shunt. Nine shunts were subjected to graded increases in back pressure and observed for retrograde valve leak. RESULTS: None of the shunts tested showed any signs of leak associated with the increased back pressure. However, disruption of shunt seals was noted in seven of the nine shunts, occurring at the minimal pressure of 80 mmHg. CONCLUSIONS: There appears to be minimal risk of retrograde failure of the valve system in the ventriculoperitoneal shunt tested. However, tests on different types of ventriculoperitoneal shunts would be needed to confirm these results if laparoscopy is to be considered safe in patients with ventriculoperitoneal shunts in situ.

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