Time to eliminate the
08/01/2002
by Hank Rahe
For those of you who are not familiar with the universal "10-second rule" regarding food consumption, it goes something like this: If you drop something on the ground, you can eat it if you pick it up within 10 seconds.
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There is a similar version of this rule that is too often practiced in healthcare. This "understood" rule states that you don't have to take proper precautions with parenteral products if they are being delivered to the patient directly following preparation.
Proponents of the rule contend that if the med ication is contaminated, the body will act quickly to fight the infection; yet, there is little support that pa tients actually get secondary infection while still in the hospital.
The fact remains that patients are re leased quickly and do not develop the side effects from the contamination until after release. The more than 100,000 deaths per year from secondary infections in addition to the number of patients who are readmitted to the hospital certainly prove my point: Simply put, contamination control in medication delivery is critical to saving lives.
New medicinal products are more focused in terms of delivery sites and specific interaction. This, combined with the more resistant strains of bacteria and virus, means that we can not allow the deliberate infection of patients with the hope that the body's immune system will compensate for our lack of attention to good contamination control practices.
Proper contamination control is not difficult. It involves three simple factors: proper facilities, a good sanitization program and proper training of personnel. Implementing these elements would reduce patients' deaths as well as healthcare costs.
The quality of the environment created in facilities for the preparation of "sterile" products is generally controlled on a state-by-state basis by the state board of pharmacy. These hard-working volunteers are asked to define the ISO Class 4 and surrounding environments without having the expertise to understand the critical components required for a properly designed cleanroom or barrier isolator.
Without the correct definitions, the quality of the environments is put at risk. For cleanrooms, the correct materials of construction, airflow and pressure differential of the controlled environment need to be defined in a clear and complete way.
The "open cleanroom" is an example of a technology that sounds like it meets requirements for proper preparation. Unfortunately, it lacks critical elements such as pressure differential between the area covered by directional HEPA-filtered air and uncontrolled surrounding areas. It falls far short of the definition used in the FDA guidelines for aseptic manipulation of parenteral products, but offers an economical means of "meeting the regulations."
Sanitizing agents in the pharmacy primarily consist of non-sterile filtered alcohol. Two areas of needed improvement are the sterile filtration of agents and rotation of agents to prevent organisms from developing resistances.
Training has focused on aseptic technique without concern for the contamination created by personnel. People are the major source of contamination, and separations are necessary to prevent the contamination from spreading to parenteral products. Barrier isolators provide a solid wall, or barrier, between the critical clean area and the person, while cleanrooms require the person to gown to create a barrier between them and the product.
Individuals don't typically follow proper gowning techniques in the pharmacy. The level of gowning is limited to scrubs or lab coats, and routine changing of garments when leaving and re-entering the area is not common.
To reduce secondary infections from hospital stays, proper contamination controls need to be implemented, including facilities, sanitization and training for hospital staff.
Hank Rahe is director of technology for Containment Technologies Group and is a member of the CleanRooms Editorial Advisory Board.