Ergonomic problems originating in the use of high-frequency and ultrasonic medical devices

Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG geförderten) Allianz- bzw. Nationallizenz frei zugänglich.This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.High-frequency and ultrasonic medical devices are widely used in laparoscopic surgical procedures. Using these devices can result in ergonomic problems. Two studies were performed: in a questionnaire surgeons were asked to evaluate laparoscopic surgical instruments. Based on the resulting 74 data sets it was possible to define various improvements to the design of instruments. In a subsequent field study 70 surgical procedures were observed to comprise user caused problems in the interaction with medical devices

Aspects of prospective user-oriented software design in integrated operating rooms

Die Vielfalt medizinischer Geräte und Software im OP-Saal zur Ausführung minimal invasiver Interventionen nimmt, besonders in Hinblick auf die intraoperative Einbindung bildgebender Verfahren, stetig zu. Dabei verfügt nahezu jedes einzelne Gerät über ein eigenes Bedienkonzept. Selbst integrierte OP-Säle, die ein Touch Panel einer zusammengeführten Steuerung aller medizinischen Geräte bereitstellen, weisen hinsichtlich des Bedienkonzepts erhebliche ergonomische Mängel auf. Am Beispiel laparoskopischer Eingriffe wurde eine Feldstudie zur Evaluierung des Ist-Zustandes existierender Arbeitsbedingungen und Arbeitsabläufe durchgeführt. Europaweit wurden in sechs Referenzkliniken intraoperative Workflows aus Sicht der Gerätesteuerung durch externe Beobachter protokolliert und retrospektiv hinsichtlich auftretender Nutzerprobleme (Human Errors) ausgewertet. Die Ergebnisse der Auswertung für eine Stichprobe von 87 operativen Eingriffen werden vorgestellt. In aktuellen Richtlinien für eine Entwicklung medizinischer Software (DIN EN 62366, DIN 60601-1-6, IEC 80001, DIN ISO 14971, DIN ISO 9241-210, DIN ISO 13485) werden die ergonomischen Aspekte integrierter Systeme bisher nicht adressiert. In dieser Arbeit werden Vorschläge zur Erweiterung einzelner Normen für den Entwicklungsprozess medizinischer integrierter Software vorgestellt. Hierbei stellen Touch Panel Lösungen für integrierte OP-Säle verschiedener Hersteller einen interessanten Anwendungsfall zur Untersuchung der Forschungsfrage dar, da selbige eine zentralisierte Benutzerschnittstelle aller medizinischen Geräte im OP darstellen.The variety of medical appliances and software applied in operating rooms to conduct minimal invasive interventions is steadily increasing, in particular in respect of the use of imaging procedures. Almost each individual medical device has a distinct concept of usability. Even integrated operating rooms, which provide a touch panel for the central control of all medical devices suffer from significant ergonomic deficiencies in respect of the concept of usability. Using laparoscopic surgeries as an example,a field study was undertaken to evaluate the current state of working conditions and procedures. In six reference hospitals throughout Germany, external observers monitored and retrospectively analysed workflows during surgery with a focus on the occurrence of human errors. Partial results for a sample of 87 surgical procedures are being presented. The ergonomic aspects of integrated systems are not described in current guidelines for the development of medical software (DIN EN 62366, DIN 60601-1-6, IEC 80001, DIN ISO 14971, DIN ISO 9241-210, DIN ISO 13485) so far. Touch panel solutions for integrated operating rooms from different manufacturers represent an interesting use case for investigating the research question of interaction problems with integrated software solutions since they represent a centralized user interface of all medical devices in the operating room

Il santuario di Santa Maria di Leuca tra pericoli del mare e guarigioni miracolose

La chiesa e il complesso sorgono sul mare, su un’area di intensa frequentazione, e furono ricostruiti più volte dopo assalti e incursioni. Non sopravvive quasi nulla delle fasi più antiche: il piazzale del santuario è delimitato su due lati da un porticato con archi a tutto sesto, sul lato ovest da un edificio a due piani utilizzato nel tempo dal clero e dai pellegrini. La facciata attuale è articolata in due registri, scanditi da una doppia galleria di arcate addossate al prospetto originario. Al centro del piazzale è collocata la colonna con la statua della Vergine. La chiesa è a navata unica con transetto, copertura a volta a botte unghiata, fornici laterali con due altari, cantoria in controfacciata. Sull’altare maggiore è collocata l’immagine della Madonna con Bambino. La tradizione – nutrita soprattutto dagli storici seicenteschi Pirreca e Tasselli e ripresa da Montorio – descrive un santuario meta di pellegrinaggi sin dal Medioevo: cavalieri crociati avrebbero pregato ai piedi della Madonna di Leuca prima di imbarcarsi verso la Terrasanta e la località avrebbe costituito un approdo per le navi dirette in Oriente. Il pellegrinaggio promosso da Alfonso d’Aragona da Brindisi a Leuca (o da Foggia a Leuca) nel 1456 dopo il terribile terremoto, conferma che nel XV secolo il santuario era già esistente e noto, tanto da essere meta di un percorso di espiazione e ringraziamento. Tasselli riferisce di miracoli operati dalla Vergine, soprattutto legati ai pericoli del mare e ricorda alcuni pellegrini famosi. Nella tradizione dei Libri miraculorum dei grandi santuari, descrive un grande concorso di folla, proveniente dalla Puglia e dall’Italia e amplia l’area di provenienza dei pellegrini e di diffusione del culto, citando dedicazioni in onore di santa Maria de finibus terrae in Francia e nelle Fiandre. Serafino Montorio nel suo Zodiaco di Maria (1715), cita la monumentale opera di Tasselli e riporta alcuni dei miracoli più significativi, volti soprattutto ad enfatizzare le capacità taumaturgiche della Madonna, anche in concorrenza con altri santuari, registrando la trasformazione da santuario specializzato nella salvezza dai pericoli del mare a luogo caratterizzato da guarigioni.The church and the complex are located on the sea, in an area of intense traffic, and were rebuilt several times after assaults and incursions. Almost nothing of the older phases survives: the sanctuary square is bordered on two sides by a portico with round arches, on the west side by a two-storey building used over time by the clergy and pilgrims. The current façade is divided into two registers, punctuated by a double gallery of arches leaning against the original façade. In the center of the square is the column with the statue of the Virgin. The church has a single nave with transept, barrel vaulted roof, lateral arches with two altars, choir loft on the counter-façade. On the main altar there is the image of the Madonna with Child. The tradition - nourished above all by the seventeenth-century historians Pirreca and Tasselli and taken up by Montorio - describes a sanctuary that has been a destination for pilgrimages since the Middle Ages: Crusader knights would have prayed at the feet of the Madonna di Leuca before embarking towards the Holy Land and the location would have constituted a landing place for ships bound for the East. Furthermore, the pilgrimage promoted by Alfonso of Aragon from Brindisi to Leuca (or from Foggia to Leuca) in 1456 after the terrible earthquake, confirms that in the 15th century the sanctuary was already existing and known, so much so that it was the destination of a journey of expiation and thanks. Tasselli refers to miracles performed by the Virgin, especially linked to the dangers of the sea and recalls some famous pilgrims. In the tradition of the Libri miraculorum of the great sanctuaries, it describes a large crowd coming from Puglia and Italy and expands the area of origin of the pilgrims and diffusion of the cult, citing dedications in honor of Santa Maria de finibus terrae in France and in Flanders. Serafino Montorio (1715), cites the monumental work of Tasselli and reports some of the most significant miracles, aimed above all at emphasizing the thaumaturgical abilities of the Madonna, also in competition with other sanctuaries, recording the transformation from a sanctuary specialized in salvation from the dangers of the sea to a place characterized by healin