During the past 25 years, the medical technology industry has developed an amazing number of life saving and life enhancing products. These products and therapies have helped millions of patients to live longer, better quality lives. With continuing innovation and the rapid advancement of technologies, medical devices are currently one of the fastest growing industries and the global market figure for 2006 is expected to exceed US$260 billion.
Government policies translated into national regulations that are enforced by legislation form a necessary part of a country’s overall national health system in order to ensure access to high quality, affordable medical devices that are used and disposed of safely and appropriately.
Health care-associated infection is a major issue in patient safety even in countries with well developed regulatory and healthcare systems. Regulatory controls for medical devices play an vital role in the fight against health care-associated infections.
Sterility and its maintenance, together with the prevention of cross-infection, are at the top of any list of critical factors in patient care. The packaging around medical devices that allow those devices to be sterilised, provides a microbial barrier and maintains sterility effectively up to the point of use is known as a sterile barrier system. A sterile barrier system is an essential part of a sterile medical device.
(A sterile barrier system is defined as “the minimum packaging configuration that provides a microbial barrier and allows aseptic presentation of the product unit at the point of use”. This is distinct from protective packaging which is defined as the “packaging configuration designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use”.)
Manufacturing medical devices and their sterile barrier systems in a highly regulated environment can be extremely challenging and traceability throughout the whole life cycle is essential. This is amply illustrated by the lists of product recalls for medical devices which can be found on national regulatory agency websites in Europe, for example, on the Medicines and Healthcare Products Regulatory Agency (UK) website (www.mhra.gov.uk) and on the FDA website, at List of Device Recalls in the USA.