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The injury triggered numerous complications with his heart and diabetic condition, and landed him in the hospital.
Second- and third-degree burns to a foot scalded from boiling water and pasta in a pot that was dropped on the way to the sink was just the beginning for my grandfather, Anthony F. DeSorbo.
The injury was a blow to his immune system, and hospital-borne viruses wreaked havoc on his stomach and glands, blocking the road to recovery. My grandfather has the will of 10 men, but his immune system is still that of an 86-year-old man. And even though he's pulling through, it's a scare for the entire family because what started out as a serious injury escalated into something even worse because of hospital-borne viruses.
In a column he penned for CleanRooms last February, Hank Rahe cited a Centers for Disease Control and Prevention (CDC) report that hospital acquired infections claim 90,000 lives and cost $4.5 billion a year. [See CleanRooms, “Sterility assurance,” February 2000, p. 10.]
“Centers for Disease Control statistics have shown a significant increase in nosocomial infections,” writes Rahe, a member of the CleanRooms Editorial Advisory Board and director of Contain-Tech (Indianapolis). “These are infections that are acquired during a hospital stay.”
Rahe also points out that aseptic and sterile techniques and practices that are not implemented result in extended hospital stays, which result, in extreme cases, in death. Most hospitals, he says, are regulated by agencies, which lack the resources to implement the necessary regulations. “State to state regulations also present problems in consistent care. Some states have regulations and the resources to enforce them, while others do not,” Rahe says. “This is one of those areas where federal regulations would add value.”
Thankfully, the Food and Drug Administration is taking action to establish and enforce regulations surrounding sterile products.
A review of comments on the concept paper Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness was scheduled by the FDA for mid-August. That paper is based upon Chapter 1206 of the United States Pharmacopoeia, a platform that Rahe says is inadequate to assure compliance. His thoughts are clear in a July letter to the FDA, which calls for collaborative industry effort to establish firm requirements for facilities, personnel gowning, training and quality assurance. [See “FDA sets sights on sterile products standard,” p.1]
Rahe's approach is logical, after all that's how numerous other standards have come to pass in the contamination control industry. The effort, however, should not just be a cause for the FDA, USP and the American Society of Health-System Pharmacists. It needs to be a collaborative measure, and a swift one at that, involving all interested parties. Visit www.fda.gov. Click the search button and enter the docket number “00N-1357” on the left, and make sure to highlight “dockets” on the right. Read the concept paper and submit your comments the next time the FDA solicits public comment.
Just think of how that kind of protocol can increase the chances for someone in the hospital who may not be able to fight hard like Tony DeSorbo.
Mark A. DeSorbo
Associate Editor