June 18, 2007
Infection Control: More Confusion Means More Deaths
By Michael D. Shaw
Many readers of this column are familiar with the statistic that 90,000 deaths occur every year as a result of hospital-acquired infections (HAI) in the US. It is my belief—and this feeling is shared by numerous authorities—that the majority of these infections could be prevented.
You may wonder why there is so much more publicity regarding drugs that have been approved by the FDA, and then are pulled from the market as a result of devastating side effects, compared to the relative silence on HAIs.
Note that even before Big Pharma started marketing directly to the public—”Ask your doctor if [fill-in-the-blank-drug] is right for you,” people always had a direct relationship with drugs. Although they are prescribed by the doctor, the patient himself takes them, and generally knows what meds he is on. If he experiences strange symptoms, he is at least inclined to question whether they could be side effects.
With HAIs, however, the causes are hidden, and especially in cases where contaminated medical devices may be at fault, the patient usually does not have a clue. Indeed, based on the foolishness of how hospitals handle legal settlements in death cases related to devices, one would have to conclude that even medical personnel can be poorly informed in these matters. At any rate, confusion reigns.
As an example, we will relate actual correspondence (with my comments [COMMENT] interspersed and redactions to protect confidentiality) between a chief of critical care/trauma anesthesia [DOCTOR] considering the purchase of laryngoscopes (the devices implicated in the deaths of two preemies at White Memorial Hospital in Los Angeles last year) and a world authority on infection control [IC EXPERT].
The particular brand of instrument in question has a unique type of handle, and the question relates to infection control best practices.
DOCTOR: Does the handle need high-level disinfection?
IC EXPERT: The answer to your question…is somewhat controversial, in part because these devices are not regulated by the FDA, which has classified them as “Class 1” devices, even though rigid laryngoscopes are semi-critical devices that, if contaminated at the time of use, pose a moderate risk of disease transmission.
COMMENT: It is highly unusual for a semi-critical device to be unregulated. Strictly speaking, IC EXPERT means that they are exempt from so-called Premarket notification [510(k) approval]. They are “regulated” in that they still are subject to certain guidelines and administrative procedures, but these are far less rigorous than what is required for similar devices. I can think of no good reason why this situation exists.
IC EXPERT: Semi-critical devices directly or indirectly contact mucous membranes and do not penetrate sterile tissue. Guidelines recommend high-level disinfection (or sterilization) of semi-critical devices.
Failure by the FDA to…have classified them as Class 2 devices has, in my opinion, caused…confusion and variations in clinical reprocessing practices, [and enables] manufacturers of these devices to design and label rigid laryngoscopes without adhering to any minimum infection-control standards whatsoever.
It is my opinion that the blade and handle would both require high-level disinfection, which is in agreement with the position of the American Association of Nurse Anesthetists (www.aana.com). Soiled hands/gloves could also result in contamination of the handle and the transfer of potentially infectious patient bioburden during handling of the rigid laryngoscope. It seems to me that a handle that connects to a high-level disinfected or sterilized blade, but that is designed (and labeled) in a manner that precludes high-level disinfection (or sterilization) is problematic from an infection-control standpoint.
COMMENT: This point of view is also verified by the most elementary practices in standard aseptic technique. Any object that is sterile is compromised once it touches another object that is at a lower level of pathogen removal. The added complication here is that the device in question has a sheath to supposedly protect its handle from contamination. Still, the sheath itself can still become contaminated, one would think, and pathogen transfer to the patient could occur.
IC EXPERT: But this is my opinion. The FDA, at least at this time, is not entirely in agreement with me and has recommended intermediate-level disinfection of those portions of a semi-critical device, such as a rigid laryngoscope, “protected” by a sheath that has been shown to prevent contamination with patient bioburden and potentially pathogenic microorganisms.
If you think the handle can directly or indirectly contact the patient’s mucous membrane (e.g., oral cavity, throat, etc.) and become contaminated with patient debris and disease-causing agents, such as tuberculosis, and, possibly, Clostridium difficile, that could be transmitted to subsequent patients, then high-level disinfection of both the blade and handle would be required, in accordance with the California Department of Health Services’ recent safety alert, which…would apply…whether or not a protective sheath is used.
COMMENT: California’s safety alert came as a result of the deaths of the two preemies at White Memorial Hospital, mentioned above.
IC EXPERT: The Association of periOperative Registered Nurses (www.aorn.org), in disagreement with me, AANA, and the CA Department of Health Services, recommends only soap and water, or low-level disinfection, for the rigid laryngoscope’s handle, to prevent disease transmission. I hesitate to mention AORN’s position, because I think it is irresponsible and poses an infection risk. But, AORN’s is a published recommendation, so I am providing it to you for the sake of completeness. AORN would argue that only soap and water are necessary for the handle, even though it is directly attached to a high-level disinfected or sterile blade. This makes little sense to me.
This has real-life consequences. I believe all of this confusion contributed in part to the recent P. aeruginosa outbreak and deaths at White Memorial linked to inadequate reprocessing of rigid laryngoscopes.
COMMENT: The best way to make a dent in that 90,000 number is to publicize these matters, in a forum such as Health News Digest.