1.0. Introduction
Hysterosalpingographgy (HSG) is a radiological contrast examination used to outline the uterus and the fallopian tubes. It is employed to diagnose a suspected intrauterine tumour, congenital malformation, or suspected fallopian tubes blockage1
. HSG entails the injection of a radio-opaque contrast agent into the cervical canals under fluoroscopy with image intensification. A normal result shows the filling of the uterine cavity and bilateral filling of the fallopian tube with the contrast agent. HSG could be done with either oil contrast agent or water soluble contrast agent. Oil-based media remained popular until the 1960s. Their popularity was based on their ability to demonstrate a good delayed film when image-intensified fluoroscopy was not universally available. Because most HSG is now performed by image intensified fluoroscopy, many experts concluded that oil based media should no longer be used, due to the availability of what are perceived to be safer water soluble peparations2
.This examination is usually done on outpatient basis. It should be performed in the proliferative phase of the cycle to reduce the possibility of radiation exposure of an early embryo3
. In addition, it obviates the unlikely possibility of inducing an ectopic pregnancy by performing the procedure after fertilization and altering embryo transport through the fallopian tube. The procedure should not be carried out during the active stage of any pelvic infection4
.During HSG procedures, HSG equipment such as vulsellumforceps, vagina speculum, uterine sound, uterine cannula, tissue forceps, the couch and some of the devices that are essential to producing successful qualityresultare usually sterilized to enhance aseptic conditions.
However, because they are typically designed for a reuse, they also transmit pathogen if any of the processes involved in their decontamination is compromised. This gives rise to the introduction of pathogenic micro-organisms into the patient’s body and initiate an infection process, owing to the fact that patients in hospitals often have low immunity to infection6
.This leads to iatrogenic or nosocomial infections in the patients. Iatrogenic infection is synonymous to nosocomial infections and they are infections which are as a result of treatment or health care service unit, but secondary to the patient original condition6
.Sterilization of equipment used in HSG procedure can be achieved if any of the steps involved in reprocessing, cleaning, disinfection or sterilization are adquate10
. Sterilization techniques include all the means used to completely eliminate or destroy all micro-organisms on objects, including tools used to diagnose or treat patients. To be effective, sterilization requires time, contact, temperature and with steam, sterilization high pressure.In radiology departments today, there are different method of sterilizing HSG equipment which ranges from radiation form of sterilization, which includes electron beams, x-rays, gamma rays and subatomic particles. Other methods include, high pressure saturated steam using an autoclave, or dry heat using an oven. These methods are the most common and readily available methods of heat sterilization10
. An alternative to high pressure steam or dry heat sterilization is chemical sterilization (often called, “cold sterilization”).Monitoring sterilization procedures is another important aspect of sterilization to ensure effective sterilization and sterilization can be monitored routinely using a combination of biological, chemical and mechanical indicators as parameters.This study is aimed at evaluating the different sterilization methods employed on HSG equipment and disposable HSG kits.
1.1. Statement of Problem
3Most Radiographers do not know the methods of sterilization of HSG equipment.
1.2. Objectives of Study
1.3. Significance of Study
This research work,
1.4. Scope of Study
This study will be restricted to X-ray or radiology departments in Enugu Urban.
1.5 Review of Related Literature
McGill13
in his work reported that the first application of sterilization was through cooking to effect the partial heat sterilization of food and water. He also noted that culture that practice sterilization of food and water has longer life expectancy and lower rates of disability. This is because heat sterilization destroys the disease causing pathogens on food and water. According to medical records, it was shown that heat sterilization of medical instrument has been used in Ancient Rome but it disappeared throughout the Middle Age resulting in significant increase in disability and death, following surgical or medical intervention8
. This increase in disability and death was attributed to lack of aseptic procedure and proper sterilization of medical equipment before and after use. This brought about the preponderance of nosocomial infection in the era. Nosocomial infection as stated by centre for Disease Control can be prevented if proper sterilization and aseptic methods are adoptedAccording to a work by Robins,20
he noted that the use of x-ray in sterilization of medical equipment and paraphernalia is very promising and the sterilization industry is moving towards this direction. X-ray sterilization utilizes x-rays, a form of ionizing energy that provide attractive alternative to nuclear gamma ray for irradiating medical devices. This is because x-ray sterilization method has been shown to be effective in sterilizing medical devices. Though, still in its experimental phase, compared to electron-beam or gamma ray sterilization method. X-ray sterilization has been proved to have some advantages over other types of radiation sterilization method8,9,10
. The result of sterilization test made using x-rays and gamma rays respectively, at the same dose value, revealed that x-ray sterilization takes 2.5 times lesser time and increase total efficiency of the system23
.American institute of Architects, guide lines for design and construction of hospital and health care facilities11
reported that gamma ray though widely used, has been shown to have adverse effect on the product or device it was irradiated with. These effects range from changing the colour of the material to affecting the chemical property of the material. For instance, MDS Nor Dion, a world leading innovator in molecular medicine, generally recommend that gamma irradiation should not be used on products with Teflon, which can degrade under gamma irradiation. In the same vein, Biosterle Technology stated that from researches conducted, that it has been shown that electron-beam sterilization can be harmful to products or degrade them19
. Example, rubber and polypropylenes materials have been shown to be degraded by electron12
.Also, the effectiveness of any method of sterilization is dependent on the type of micro-organism present, the number of micro-organism present, the amount and type of organic material that protects the micro-organisms and the number of cracks and crevices on equipment that might harbor micro-organisms
12
. Also, studies have shown that improper cleaning affects the efficiency of sterilizations of equipment using either chemical or heat (dry or steam) sterilization method. Cleaning reduces the microbial load on the equipment and increases the efficiency of any sterilization12,13
. This is because cleaning exposes the micro-organisms thereby making it possible for direct interaction with the sterilant.Donald10
in his work reported that the sterilization industry is looking for alternatives to these other methods as well as replacement for ethylene oxides and steam sterilization method. Steam sterilization is one of the most widely used methods but it is not suitable for heat sensitive materials and instruments. This is because most medical equipment and medical paraphernalia cannot withstand prolonged heat and moisture required of the steam sterilization process. This leads to alternative sterilization categories: chemical sterilization and radiation sterilization, which allow heat and moisture sensitive materials to be sterilized.Dulworth.et al8
reported that chemical sterilization though can be used to sterilize items that are labile or moisture sensitive, it have been shown to leave toxic residues on sterilized items. It equally possess several physical and health hazards to personnel and patients. Some of them are known to be carcinogenic. Repeated inhalation exposure may cause asthma, it may have effects on the nervous system, liver and kidneys or causes cataracts. The National Toxicology Program, recently upgraded Ethylene Oxide, to a known human carcinogen and the international Agency for research on cancer (IARC) classified it as a group 1 Carcinogen. The same hold for other chemical sterilants like ozone, and glutaraldehydes. Glytaraldehydes products are being withdrawn from the European market due to concerns that it is toxic and harmful to health care staff in hospitals8
. John Walker, director of quality system and regulatory compliance of Steris, observed that anything that goes through chemical sterilant absorbs it13
. Thus, the additional resources need to process it after sterilization. Like in Ethylene Oxide Sterilization method, the aeration time may be long and is needed to make sterilized items safe for handling and patient use8
.
Though, every category of sterilization method has its disadvantages. They still have shown some advantages. For example, steam sterilization is readily available, highly effective and inexpensive. While dry sterilization are used for materials that are damaged by or are impenetrable to moist heat. Hot air can penetrate water insoluble materials like grease or oil as well as less corrosive materials and sharp instruments than steam. Chemical sterilizations, on its own, is a low temperature method that is highly penetrative and active against bacteria, spores and virus. They come in various forms and can often be used as disinfectants but can also sterilize instruments if used for prolong period
8
. These are the advantages of these categories but their disadvantages outweighed their advantages hence the yearning for a better alternatives.X-ray sterilization has been shown to be a clean process that does not leave a toxic residue on the devices7
. And so does not require any further processing after irradiation of the device. Unlike electron-beam sterilization, where product density possess a limitation, x-ray radiation penetrate much more deeply than particle-based electron-beam14
. Some studies claim though Gamma and X-ray irradiation are nearly interchangeable from a physics perspective (considering their frequency and wavelength), x-ray irradiation can have higher energy and therefore have slightly better penetration14
thus, offer excellent product penetration in sterilization and thoroughly treating the surface and interior of a product. It has equally be shown to have faster treatment time, more flexible and more environmentally friendly15,16
. This is because x-ray sterilization unit unlike gamma cobalt 60 unit can be turned off when not in use. Thus, reducing hazard in the area of the facility17
.However, most of these studies were done at the commercial dose level and utilized dose of 25kGy17,18
. The x-ray photon energy in use in the diagnosis has enough energy to cause ionization, resulting in disposition of energy in the material and pathogens irradiated and thereby killing the pathogens5
. This is a result of biological effects of x-rays on these pathogens. The initial events are ionization and excitation of atoms and molecules of the microbial pathogens and finally the biological effect which precipitate as the cell death of the micro-organism involve. This study is to find out whether the different methods of antiseptic sterilization equipment need in HSG procedures is capable of proper sterilization.