“Biocompatibility Testing Of Medical Devices: Selection Of Appropriate Tests From The Manufacturer's Perspective”

Biocompatibility testing of medical devices is very crucial to determine the safety of medical devices and gives a long-term business advantage. From the regulatory perspective, submissions for approval of medical devices by regulatory agencies require that biocompatibility assessment be conducted to assure safety of the device or material. Safety data can be obtained by testing according to certain prescribed or recommended guidelines, including guidance documents developed by the International Organization for Standardization (ISO) and FDA. These guidelines include ISO10993, "Biological Evaluation of Medical Devices," and the guidance document released by FDA in 1995, blue book memorandum #G95-1, "Use of International Standard ISO10993, 'Biological Evaluation of Medical Devices'-Part 1: Evaluation and Testing.", with further draft versions in 2013.

Selection of tests for biocompatibility testing is defined in the ISO10993 standard. Some tests such as intracutaneous test, acute systemic toxicity test, and hemolysis are very straight forward. However, there is ambiguity with other tests such as sensitization, hemocompatibility, cytotoxicity, implantation and genetic toxicology.

There is a range of tests options available for sensitization - GPMT, Beuhlers, LLNA. Different regulators prefer different tests, depending on the type of devices. Selection of appropriate sensitization test is important. Similarly, cytotoxicity has a range of options for cell lines and endpoints. Hemocompatibility tests are very ill defined and genetic toxicology requires an appropriate battery of tests. For implantation tests there are various options in terms of site of implantation, duration implantation and choice of animal models. Manufacturers have always found selection of appropriate biocompatibility tests challenging.

“Electron Beam Accelerators : Technology For The Sterilization Of Medical Devices”

Developments in Electron Beam technology have led to its increased use in the sterilization of medico-surgical equipments and medical products. This can be accomplished by bombarding the equipment/products with a beam of energetic electrons from an Electron Accelerator. The Apar Industries ltd has set up the Electron Accelerator facility in Khatalwada, Dist Valsad and is being used for sterilization of medical products besides other applications. This is the only facility in the whole of Western India. The advantages of Electron beam are that it is a flexible and fast process compared to other methods and can be accomplished in the finished packed condition.

“Product Reference Codes And Unique Device Identifier: Japan Experience And Potential Benefits For Indian Healthcare”

Background: Lack of a harmonized UID for each medical consumable from the manufacturer to end user, i.e the hospitals across channel partners such as importers, dealers, distributors and thereafter within the same hospital or group of hospitals, various departments viz., main store, sub-store, billing, pharmacy etc., leads to several confusions such as duplication of the master data, mishandling with ordering, delivery or billing. After the products usage, the insurance reimbursement mandates specific norms and then, during the follow-up if there is an incident, it’s reporting and a recall when instructed by the regulatory agency will be smooth with a UID.

Experience in Japan: Medius Solution developed the system named “Meccul” taking seven years in Japan. Meccul has a search portal which brings to every stake holders desk top, the entire list of products and when integrated with the Hospital Management System, it avoids the cumbersome task of creating and updating the master data. The Meccul system in 2007 had only 12 hospitals and now has 3000 hospitals as clients with 600 manufacturers enrolled and 400000 items listed.

Potential Benefits: Similar system if developed and implemented in India, it will not only avoid the need of each hospital to have their own master data and its constant updating but also will help the manufacturers with easy reach of their product information to the end users, avoid communication errors throughout the supply chain enabling an error free, faster and efficient planning of logistics, delivery, in-house inventory management and traceability ultimately adding to patient safety.