ASSESSMENT OF DIFFERENT METHODS OF STERILIZATION OF HSG EQUIPMENT IN RADIOLOGY DEPARTMENTS IN ENUGU URBAN

LIST OF TABLE

CHAPTER TABLES

Table I:  The number of registered radiological centers in Enugu Urban.

Table II: the distribution and location of radiological centers in Enugu Urban,

Table III: Distribution of radiological centers that conduct HSG exams and other related special exams

CHAPTER FOUR TABLES

Table 1: Response by respondents on how long they have worked in the department.

Table II: Distribution of frequency of HSG examination in Radiological departments in Enugu Urban.

Table III:  Distribution of respondent’s response on whether they are aware that HSG equipment are to be sterilized.

Table IV: Distribution of the frequency of sterilization of HSG equipment.

Table V: Distribution of number of HSG Procedures carried out per day in various Radiology Centers.

Table VI: This table shows the distribution of respondent’s response on different methods of sterilization used in their departments.

Table VII: The distribution of the types of chemical used in sterilization of HSG equipment in Radiology department

Table VIII: The distribution of Respondents response on their reason(s) behind their choice of methods of sterilization.

Table IX: Distribution of the frequency of monitoring sterilization process in Radiology departments in Enugu Urban.

Table X: Distribution of the frequency of the respondent’s participation in workshop/seminar in Radiology department in Enugu Urban.

ABSTRACT

This study, Assessment of different methods of sterilization of HSG equipment in Radiology Department in Enugu Urban, was done using questionnaire and interviews methods of data collection. The main purpose of the study was to determine different methods of sterilizing equipment used during HSG procedures in our locality, to assess if attention is given to monitoring of methods used for sterilization of HSG equipment in our locality and to compare the different methods of sterilizing HSG equipment in Radiology departments with a view to recommending the best option available. Eight standard Radiology centers in Enugu Urban were used for this research and a total number of 70 questionnaires were used for the study. The results showed that three major methods of sterilizing HSG equipment are available in the locality of study, which includes high pressure steam (autoclave), Dry heat (oven), and chemicals. 47.84% of the centers make use of chemical,32.47% and 24.21% centers make use of high pressure stem (Autoclave) and dry heat (oven) respectively. The attention given to monitoring of HSG equipment is commendable as 97.57% of the centers monitor the procedure routinely. The result showed that most Radiology centers in Enugu Urban use chemical method of sterilization in preference to high pressure steam (Autoclave) which is a better method of sterilizing HSG equipment. The result simply showed that most Radiology centers in our locality are not in tone with current trend of sterilization as chemicals method of sterilization is hazardous to both patients and staff.

TABLE OF CONTENTS

Title page –       –       –       –       –       –       –       –               i

Approval page  –       –       –       –       –       –       –               ii

Certification-    –       –       –       –       –       –       –               iii

Dedication –     –       –       –       –       –       –       –               iv

Acknowledgement-  –       –       –       –       –       –               v

List of Tables-  –       –       –       –       –       –       –               vii

Abstract   –       –       –       –       –       –       –       –               ix

Table of Contents-   –       –       –       –       –       –               x

CHAPTER ONE: BACKGROUND OF THE STUDY

1.0.  Introduction                                                             1

1.1.  Statement of Problem                                              4

1.2.  Objectives of Study                                                  5

1.3.  Significance of Study                                                       5

1.4.  Scope of Study                                                         5

1.5.  Review of Related Literature                                     6

CHAPTER TWO: BACKGROUND OF THE STUDY

2.0.  Introduction                                                             14

2.1.  Basic Trolley Setting, During HSG Procedures                 15

2.1.1. Radiation Sterilization                                           15

2.1.2. Methods of Heat Sterilization                                 17

2.1.3. Sterilization by Steam                                            19

2.1.4. Sterilization by Dry Heat                                                21

2.1.5. Chemical Sterilization                                            24

2.2.  Monitoring Sterilization Procedures                         29

2.3.  Storage of Sterile HSG Equipment                           31

2.4.  Shelf Life of Sterilized HSG Equipment                    32

2.5.  Other Sterilization Methods                                     34

2.5.1. Gas Sterilization                                                    34

2.5.2. Other Chemical Sterilant                                               35

CHAPTER THREE: RESEARCH METHODOLOGY

3.1.  Research Design                                                      37

3.2.  Target Population                                                    37

3.3.  Selection Criteria                                                     38

3.4.  Source of Data                                                                 38

3.4.1 Primary Source Data                                               39

3.4.2 Secondary Source Data                                           39

3.5   Method of Data Collection                                               39

CHAPTER FOUR

Data Presentation And Analysis                                       47

CHAPTER FIVE: DISCUSSION, SUMMARY, RECOMMENDATION AND CONCLUSION

5.1   Discussion                                                       60

• Summary 65
• Recommendation 66
• Conclusions 68
• Area of Further Studies 69
• Limitations of The Study 69

APPENDIX

REFERENCES

CHAPTER ONE

BACKGROUND OF THE STUDY

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

1. Different methods of sterilizing HSG equipment have not been documented in our locality.
2. It has been observed that enough attention has not been paid to the methods employed in HSG equipment sterilization in our locality.

3Most Radiographers do not know the methods of sterilization of HSG equipment.

1.2.  Objectives of Study

1. To determine different methods of sterilizing equipment used during HSG procedures in our locality.
2. To assess if attention is given to monitoring of methods used for sterilization of HSG equipment in our locality.
3. To compare the different methods of sterilizing HSG equipment in Radiology department with a view to recommending the best options.

1.3.  Significance of Study

This research work,

1. Will document different methods of sterilizing HSG equipment in radiology department in our locality
2. Will define the level of attention exhibited during sterilization methods employed on HSG sterilization.
3. Will suggest the best option of sterilization methods in our locality based on the available local capacity.

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 adopted

According 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 method^8,9,10.   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 facilities¹¹reported 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-organisms¹².  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 sterilization^12,13. 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 period⁸.  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 penetration¹⁴thus, 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 friendly^15,16.  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 25kGy^17,18.  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.

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