Analysis of the French health ministry's national register of incidents involving medical devices in anaesthesia and intensive care.

This study details all incidents involving medical devices used in anaesthesia and intensive care reported to the relevant authorities in France in 1998. There were 1004 reports during that year. Incidents were classified as serious (harmful to patients) in 11% of cases; death resulted in 2% of cases. Equipment for ventilation and infusion, and monitors of all kinds, accounted for most of the reports, representing 37%, 30% and 12%, respectively, of all reports. The leading causes of failure varied according to the category of device. User errors, quality control problems during production of the device and design faults were the three main causes. The problems identified during the study period enabled the faulty medical devices to be improved in 12-44% of cases. We conclude that post-marketing vigilance is a useful way of improving the quality of medical devices.

[Electroencephalographic effects of sevoflurane in pediatric anesthesia: a prospective study of 20 cases]. / Effets électroencéphalographiques du sévoflurane à l'induction chez le jeune enfant: étude prospective sur 20 cas.

OBJECTIVE: To study electroencephalographic (EEG) changes in children during induction of anaesthesia with 8% sevoflurane. PATIENTS: Twenty patients were consecutively included (ASA I-II; aged: 13-101 months). MATERIAL AND METHOD: Prospective study; approved by the Ethics Committee; written informed consent obtained from parents; anaesthesia induced with 8% sevoflurane in oxygen; no premedication was given; to collect the EEG data, non-invasive electodes were installed before induction; EEG was recorded continuously and stored on a computer for later analyses (descriptive analysis). RESULTS: Myoclonics movements were observed during induction of anaesthesia in two boys. Myoclonics movements stopped spontaneously without therapy. Epileptiform EEG activity (spikes and poly-spikes, burst suppression) was observed. In the 18 others cases, during sevoflurane induction, EEG changed rapidly with an increase in the range of beta activity (> 13 Hz) (n = 15) and in slow (< 8 Hz) and delta activity (< 4 Hz). In 14 patients, at time of laryngoscopy, the EEGs showed monophasic slow data activity (sharp high-voltage slow waves). Periods of EEG isoelectrical (burst suppression) were seen without spikes in four cases. CONCLUSION: At 2 MAC, epileptiform EEG activity has been observed during sevoflurane anaesthesia. In a short group of patients, this raises the question of avoiding sevoflurane in patients who have a history of epilepsy.

[Perfusion instruments: analysis of product surveillance in 1998 and its on-the-job training. Subcommittee 4b for Product Surveillance]. / Matériels de perfusion: le bilan de la matériovigilance en 1998 et ses enseignements pour la pratique. Sous-commission 4b de matériovigilance.

OBJECTIVES: To analyze retrospectively the data base of the French national vigilance reporting system concerning infusion devices during the year 1998. METHODS: Each report has been reviewed and classified, except implantable catheter ports. RESULTS: The study included 309 reports. Among them, 28% concerned infusion pumps and 72% single use devices, i.e. catheters, infusion lines, taps, connectors, etc. We observed six deaths and 23 severe incidents. Only 25% of devices could be formally investigated by manufacturers. The origins of incidents were very different between infusion pumps and single use devices. The first showed simple failures, software errors, maintenance omissions or errors, and problems related to obsolescence of the device. The second revealed manufacturer quality insurance failures, design and utilization errors, and problems related to the technique itself rather than device. DISCUSSION: Our findings are similar to the few data available in international literature. They address the need to obtain an adequacy between the performances of devices which vary with generations of devices and the clinical risks: newest and safest devices should be preferred for the infusion of the most critical drugs.

[Equipment surveillance of implantable catheter ports (1996-1998). Members of Sub-Commissions 4a and 4b for Equipment Surveillance]. / Matériovigilance des chambres à cathéter implantables en France (1996-1998). Les Membres des Sous-Commissions 4a et 4b de Matériovigilance.

We analyse all incident reports to the French Health Ministry over the 1996-1998 period, concerning implantable catheter ports. They represent 7% of all reports in the field of anaesthesia and intensive care. Two hundred eleven reports have been analysed. There were 93 catheter ruptures with 77 intravascular migrations. In more than 50% of cases, a pinch-off syndrome mechanism was responsible of these ruptures and a displacement of the O'ring was involved in 25%. Additional minor complications were reported and discussed in regard to literature. We conclude that implantable catheter ports may lead to serious incidents which are preventable in most cases.

Ketamine: new uses for an old drug.

Over the years, ketamine has found many applications in paediatric anaesthesiology. Recent insights into the mechanism of its central action, and the pharmacology of its isomers have led to a re-evaluation of this drug, expanding the range of indications in adults. The best examples of the uses of ketamine as an analgesic are: in brief diagnostic or therapeutic procedures, during the post-operative period in neonates and infants as well as in paediatric anaesthesia and intensive care.

[Sheehan's syndrome: a recurrent obstetrical complication]. / Le syndrome de Sheehan: une complication obstétricale toujours d'actualité.

Case report of a 25-year-old primigravida who sustained a necrosis of the anterior pituitary gland after a haemorrhagic Caesarean section. The diagnosis was delayed, as the early symptoms (apathy, anorexia, nausea, orthostatic hypotension and hypoglycaemia) were imputed to more usual causes.