Where did we go wrong?
An excellent example of this trend might be the delayed introduction of isolation technology into the US healthcare industry. Early implementation of the technology was hampered by efforts to eliminate leaks in the system, evaluate the microbial resistance on every substrate, sterilize the interior to a 1 in a million probability of a nonsterile unit, and other matters of little import. These endeavors wasted resources and greatly delayed the implementation of what is widely acknowledged to be a superior aseptic processing technology. These tasks were considered important for ensuring the sterility of the materials produced using isolators.
Although a degree of caution is always necessary, these concerns were clearly off target. Cleanrooms, which have never been sterile, have always leaked, and there are a myriad of substrates treated in a much less effective manner. In pursuit of the perfect isolator, firms lost sight of the real point: the substantial improvement in patient safety that isolation technology afforded. Isolators are inherently safer than cleanrooms and preferable in every way as an aseptic production technology. The hours spent on resolving these allegedly important issues delayed isolator implementation by nearly a decade. The perceived "problems" with isolators persist to this day, and FDA's 2004 aseptic processing guidance contains several misconceptions regarding isolators (5). Lack of awareness about how isolators benefited patients served no one's purposes.
Globally, regulators understand their mission to be one of safeguarding patient health by ensuring that drugs are safe to administer. In the US, a steady evolution of drug regulation shaped the current environment in which the industry operates. The landmark events that resulted in the current good manufacturing practices (CGMPs) industry follows include:
- Nostrums in the late 19th century that led to FDA's creation in 1906
- Diethylene glycol erroneously used in drug products in the 1930s
- Thalidomide administration to pregnant women outside the US in the 1950s
- Large-volume parenteral sterility failures in the 1970s
- Tylenol poisoning in the 1980s.