Cause for concern
Hospital`s aseptic practices don`t even cover the basics
By Hank Rahe, CONTAIN-TECH
Centers for Disease Control (CDC) statistics show a significant increase in nosocomial infections, which are infections acquired during a hospitalization1. William Jarvis, M.D., acting director of the Center For Disease Control hospital infections program, reported that hospital-acquired infections cost 90,000 lives and $4.5 billion a year. Why does this happen in the United States, which has a hospital system armed with advanced technology and wonder drugs for fighting infections?
The reason was brought home to me in the middle of writing this article. A close family member was involved in a medical emergency requiring emergency room treatment, followed by surgery. During my visits to the hospital, which included the emergency room and inpatient room, it became apparent that hospitals simply do not provide the basics for successful contamination control.
Aseptic and sterile techniques and practices are not implemented in a number of critical areas of hospital facilities. The practice of sterilization and good aseptic technique is necessary for the control of infectious diseases. Three areas within the hospital facility are critical to reducing the potential for spreading infection. These areas include patient receiving, surgery, and its supporting areas, and the pharmacy. The facility must be designed with contamination control in mind. Control of airborne particulate and cleanable surfaces are the two cornerstones to a successful contamination control program.
Patient care rooms
As I visited with my injured family member in the emergency room suite, I had to question the hospital`s priorities in terms of the facility. The lobby area at the entrance is beautiful to behold. It has a massive, open atrium area and staircase, which add zero value to patient care. In contrast, the emergency room suite was quite a different story. Most likely, an untrained eye would not see the problems that create a high level of concern for contamination control in such a setting. The ceiling was inlaid acoustical tile and in no way was cleanable. Several areas had tiles that were slightly lifted. The air handling system had a single ceiling duct and seemed to use the hallway as a return. There were several surfaces in the room where contamination could collect and spread from patient to patient. The “dust bunnies” hanging from the sprinkler head and the ceiling framework reinforced this fact.
Is it any wonder that nosocomial infections are on the increase, when hospital facilities have such significant lapses in contamination control design? Airborne particulate, a primary source whereby disease is transmitted from person to person, is controlled through the use of HEPA or ULPA filtration. Proper room pressurization and controlled access will go a long way in containing the transfer of infectious disease.
A patient suite should be protected from outside contamination and the area outside the suite should be protected from any potential contamination that the patient may carry. To this end, the suite should have cleanable surfaces, controlled access and a way of controlling contamination by people. The two major sources of contamination by people are the hands and the feet. Individuals entering and leaving the potentially contaminated area should be required to wash their hands, don gloves and wear disposable shoe coverings.
Is cost the concern? We only need to look at the potential savings available, by reducing the $4.5 billion annual cost and loss of life, to quickly determine that the answer surely must be that a better understanding of the principles of contamination control is needed. Do we need to establish facility standards for patient care areas and practice standards for personnel working in these areas? This certainly seems to work in other areas of the life sciences, such as the pharmaceutical and device manufacturing industries. The guidelines provided by the FDA (see box on page 25) result in consistent quality facilities, which are monitored to protect the quality of the products the manufacturers provide.
Surgery and support areas
Surgery suites and the areas that support the surgery, such as central sterilizing, are critical areas within the hospital in which the patient is most likely to be exposed to infection during a surgical procedure.
Cleanroom technology has been adapted in several hospital surgery suites as a means of particulate control, with a number of Class 1,000 and 10,000 rooms in use. There are several key questions that should be explored toward improving infection control in this area of the hospital. What incremental level of particulate control offers the best trade between cost and benefit? Are the engineering tools that are readily available being used to develop the best model for a surgery suite capable of reducing the potential of infection through particulate control?
Surgery suites are very dynamic areas having large stationary objects, such as overhead lights, which could potentially block the positive effects of the directional airflow. A significant amount of research is needed to model the impact of the dynamics and provide for the best location for both air inlets and returns.
In many hospitals, the central sterilizing area is responsible for preparation of the instruments used in the surgery. An interesting comparison, in the quality of environment and methods used, can be drawn between the hospital central sterilizing area and a pharmaceutical company preparation area for parenteral products. The comparison is intended to highlight critical areas for infection control. The basis for comparison is the standard facility and methods used in the pharmaceutical setting.
A. Cleaning of tools, instruments and components.
Is the washing of the materials accomplished with a validated method? A validated method is one that demonstrates a defined result and can be consistently repeated.
What is the quality of the water used in washing and final rinse of the components?
B. Preparation area for components before autoclaving.
Is the area used for wrapping instruments a Class 100 environment?
Are the components placed into containers, or bio shield, in such a configuration as to allow complete penetration of the steam resulting in a seven log reduction when challenged?
C. Autoclave.
What are the materials of construction of the autoclave chamber and tubing?
Has the autoclave been validated, in terms of temperature distribution?
Has the autoclave been validated in terms of a sterilization, by demonstrating a seven log reduction of organisms?
Are validated load patterns used in the operation of the autoclave?
Does the autoclave have Class 100 environments at the entrance and discharge doors?
Is instrumentation and temperature mapping checked on a routine schedule?
D. Transfer of materials to the operating suite.
Is a controlled environment provided for transfer?
Pharmacy
In most hospitals, the pharmacy is the area in which products that are given to the patient intravenously are prepared. This type of product is called parenteral and typically is delivered in one of the following forms; syringes, 100 ml plastic bags called piggy backs or larger volume bags ranging from 500 to 3,000 ml.
This form of patient delivery is very effective since the product is delivered directly to the body`s distribution system, the blood stream. If not done properly, it can also result in a major infection control problem.
The Centers For Disease Control reported “lapses in hospital aseptic techniques and use of intravenous anesthetic were blamed for unusual outbreaks of bloodstream infections at seven hospitals.”2 The authors concluded that because the medications involved support the rapid bacterial growth at room temperatures, strict aseptic techniques are essential during the handling of the products. Testing indicated there was no contamination of unopened containers of product, while cultures from syringes in use showed positive contamination.
What is the basic problem that would allow this to occur and does it go unnoticed in many cases in most hospitals? The hospital, by definition, is a facility with a higher potential for transmittal of infectious diseases. Without the proper level of filtration, air systems can become a carrier of bacteria and viruses. The pharmacy IV areas are generally equipped with laminar flow hoods or Class II biological safety cabinets, which are placed in uncontrolled environments. This may put unrealistic expectations on the use of aseptic technique for infection control.
The understanding of sanitizing agents and the time it takes for them to effectively kill is seriously lacking in most training programs. Non-sterile isopropyl alcohol is the typical sanitizing agent used, and in a number of cases, rotation of the sanitizing agents is not practiced. This leads to organisms building a resistance to the sanitizing agents, or in some cases, the sanitizing agent becomes the source of contamination.
New technology should increase the ability to control the environment in which parenteral products are prepared. The use of isolators, as a replacement for laminar flow technology of hoods and cleanrooms, greatly reduces the dependence on aseptic technique and removes the pharmacist or pharmacy technician from the critical environment in which the product is prepared. This technology provides a closed system, eliminating the continual movement of the hands and arms into and out of the critical zone of laminar flow hoods.
An additional benefit of the new isolator technology in the pharmacy should be a reduction in allergies developed by exposure to the products on a routine basis. This should be especially helpful in antibiotic exposure.
Like any new technology, successful implementation will depend on selection of well-designed, ergonomically friendly workstations and proper training.
Conclusion
Delivery of healthcare in the hospital setting may be the weak link in the system, unless significant strides are made to control infectious diseases in three critical areas.
Improvement in design and implementation of contamination control principals in the physical facility in which the patient is housed is critical. Value added in terms of quality of care does not happen in the front lobby. The value is added to patient care by the delivery of particulate controlled air and physical surfaces that can be cleaned and sanitized within the areas where the patients are treated.
Develop models for surgery suites that reduce the potential for contamination while in use and support these suites with contamination-free materials. Using pharmaceutical aseptic processing facilities and techniques, develop validated methods for delivery of materials with a high level of sterility assurance to the point of use — the surgery suites.
Encourage the use of new technology such as isolators within the pharmacy to protect the sterility assurance of products.
Look for innovative and cost effective ways to adopt other new technologies. Encourage new regulations which set a quality standard that will reduce the cost and save lives. Currently, we are paying a high price for the lack of proper infection control within our hospitals.
Hank Rahe is director of technology at Contain-Tech. He has over 30 years experience in the health care industry, as well as fours years in academia. His experience includes both management and technical assignments with Eli Lily as well as technical consulting assignments with a number of major manufacturers of parenteral products worldwide. He is a recognized expert in the areas of conventional and advanced aseptic processing. He is the President of the International Society of Pharmaceutical Engineers, and is a member of the CleanRooms Editorial Advisory Board.
References
1. Health Facilities Management, May 1998, Vol. 11 Issue 5, p. 64.
2. Health Letter on the CDC, Sept. 4, 1995, p.6, Kimsey, Ken.
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photo by Photodisc
Guidelines to follow for quality facilities
FDA
Current Good Manufacturing Practices
CFR 21 Parts 210 & 211
Current Good Laboratory Practices
Guidelines on sterile drug products produced by aseptic processing, June 1987 (Currently under revision)
OSHA
Hazard Communication; Final Rule
29 CFR Part 1910, et al.
ISO
Aseptic Processing of health care products
ISO/TC 198
ISPE
Baseline Guide – sterile manufacturing facilities
ASHP (American Society of Health System Pharmacists)
Standard practices of ASHP 1995-96
The Parenteral Society
Environmental Contamination Control Practices Technical Monograph No. 2, 1989