Medical Engineering: Quality and Safety at Aesculap

The Aesculap division of B. Braun Meisungen AG is the largest manufacturer of surgical instruments in the world. For safety and materials testing, Aesculap relies on Zwick know-how, using Zwick machines for materials and function testing in widely differing areas. In addition, Zwick provides advice on complex testing situations and can draw on an extensive pool of knowledge of medical engineering.

The Aesculap division of B.Braun Melsungen AG is today the largest manufacturer of surgical instruments in the world, supplying products and services for all core surgical and interventional processes. From sterile preparation, opening, through procedure to closure, Aesculap offers one-stop system solutions for the following areas:

  • surgical instruments / sterile container systems
  • surgical suture material
  • orthopaedics
  • spinal surgery
  • neurosurgery
  • motor systems
  • vascular systems

A broad spectrum, but with the motto ‘safety first’ running throughout. The theme of safety is ever-present at Aesculap – safety for both patients and surgeons, achieved through optimum product quality. This maxim is observed in every area – materials procurement, the research laboratory, production, and final quality control. Small wonder, then, that continual research, development and testing in these areas occupy the highest level of company philosophy.

Quality assurance takes place in various ways and at various stages of production. Products are subjected to thorough chemical, biological, clinical – and physical – tests before they are used on or in patients.

For safety and materials testing Aesculap relies on Zwick’s expertise. Materials are tested for suitability and the end product for functionality. Nothing is left to chance: materials and finished products are tested both statically and dynamically. At Aesculap practically every business segment has its own testing laboratory occupying itself with questions of load limits, elasticity, strength and durability. Zwick testing machines see use in a wide range of areas at Aesculap; in chemical, mechanical and materials laboratories and on various production lines

Laboratory testing situations are even more complex, the emphasis here being on findings from results and various testing approaches, rather than quality control through tolerance values. In addition to testing surgical suture thread, this laboratory also tests hernia mesh used for treatment of inguinal and incisional hernias. In the chemical laboratory the elasticity characteristics and tear strength of new mesh material and improved mesh structures are measured. For individual tests such as these Zwick develops special tools in collaboration with the customer.

A further building houses the mechanical development laboratory, where finished goods and components are tested for function. Surgical instruments, including sagittal saw blades, tweezers, clamps and parts of surgical motor systems, are mounted in a Zwick testing machine in accordance with their geometry and the force distribution for operation of the specimen is recorded.

The field of orthobiologics is concerned with the development of absorbable biological and synthetic implant materials for regenerative cartilage and bone replacement. Tensile and compression tests are the main form of testing for these materials, the work being carried out in the mechanical testing laboratory with the aid of a Zwick Type Z020 machine. Once again, great importance is attached to the reliability of the measured values and the ability to evaluate the results statically and graphically with the testing system. Zwick’s integrated LIMS (Laboratory Information Management System in testXpert® II) allows all measured values to be managed simply in a database and statistical evaluations concerning series testing to be compiled and logged.

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