Medical Device Rules - 2017, India: An Insight

According to “Medical Device Rules-2017” (MDR-2017), “Medical Devices (MDs) are the substances which are used for in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant and substances including mechanical contraceptives, disinfectants and insecticides and devices notified from time to time under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940”. According to this definition, MDs are classified into four classes: - class A, class B, class C and class D. The purpose of this review article is to present an overview of the regulatory registration requirement of MD in India according to the new MDR-2017.

DEVELOPING HOLISTIC ENGINEERING COMPETENCIES IN A BIO-INSPIRED DESIGN COURSE

Bio-inspired design can be found in an increasing number of products and applications from surgical staples inspired by porcupines to bacteria inhibiting foil inspired by sharks. As a methodology, bio-inspired design studies nature, its models, systems, and processes and then imitates or takes creative inspiration from them to solve human problems often sustainably. Bio-inspired design as a methodology is applicable to multiple disciplines and has driven innovations in fields ranging from business to engineering. The increase in interest in this method of design comes directly from our search for sustainable solutions to solving problems. A recent technical elective explores this design methodology to increase a holistic view of design using project-based learning in a community context.

Anatomic Outside-In Reconstruction of the Anterior Cruciate Ligament Using Femoral Fixation with Metallic Interference Screw and Surgical Staples (Agrafe) in the Tibia: An Effective Low-Cost Technique

Background:An anterior cruciate ligament (ACL) rupture is a frequent injury, with short and long-term consequences if left untreated. With a view to benefitting as many patients as possible and preventing future complications, we created a low-cost ligament reconstruction technique.Method:The present article describes an anatomic ACL reconstruction technique.Results:The technique involves single-band reconstruction, using flexors tendon graft, outside-in tunnel perforation, femoral fixation with metal interference screw and surgical staples (Agrafe) in the longitudinal position.Conclusion:We present a simple, easy-to-reproduce technique that, when executed on patients with good bone quality, primarily in the tibia, is effective and inexpensive, favoring its large scale application.