In a clinical service, the audit is a way to maintain the quality of services and fight against infections associated with care. These infections have become, over the past few years, a real public health issue. The digestive endoscopy remains an act likely to be at the origin of these infections¹. Fibroscopes are heat-sensitive medical devices and cannot be sterilized with wet steam². They require specific cleaning and disinfection procedures. In addition to the external surface, the interior of the biopsy, air/water and auxiliary channels are exposed in particular to organic fluids and contaminating agents.

These opaque, long, very small diameter canals are difficult to maintain and can constitute potential reservoirs of microorganisms. In most cases, their cleaning is carried out either by swabbing and irrigation for the biopsy and suction channel, or simply by irrigation for the air/water channel and insufflation.

Faulty cleaning of these channels can create a potential risk of iatrogenic, bacterial, viral or prion cross infection³. Microbiological controls are intended to identify a potential risk of contamination of patients⁴. It is a result indicator making it possible to detect a deviation from the expected microbiological quality, to search for the cause and to propose corrective measures⁵.

The "EnSURE^®" luminometer is a device that allows health facilities to quickly determine the cleanliness and effectiveness of cleaning and disinfecting surfaces, rinse water and surgical instruments, including endoscope cavities. This system helps to fight care-associated infections⁶. EnSURE^®, using the SuperSnap^® and EndoSwab swabs^® measures Adenosine Tri Phosphate (ATP). After cleaning, all sources of ATP must be significantly reduced. When ATP comes into contact with the luciferine/luciferase-based reagent in a stable liquid contained in the SuperSnap^® swabs, light is emitted in proportion to the amount of ATP present in the sample to be measured. EnSURE^® measures the amount of light generated and provides information on the level of contamination in a matter of seconds in the Relative Light Unit (RLU). The greater the value, the greater the contamination⁶. The reading of the RLU unit is directly proportional to the amount of ATP collected from the sample with 1 RLU - 1 femtomole ATP (10-15 mole)⁶. A high RLU value indicates a large amount of ATP at the test site. This in turn indicates improper cleaning and the presence of potential contaminants. A proper cleaning gives less ATP to the site. Lower ATP levels produce smaller amounts of light during the bioluminescence reaction and, therefore, a lower RLU value⁶. Results below 45 RLU indicate that endoscope cleaning is compliant. When these results exceed 46 RLU, endoscope cleaning is considered non-compliant⁶. The method is recognized by the NHS (National Health Service) and the RPN (Rapid Review Panel) and is part of the care-associated infection control program⁶.

The objective of our study is to evaluate the effectiveness of the endoscope treatment procedure at gastroenterology II at the Mohamed V Military Instruction Hospital, Rabat and to propose recommendations.

MATERIAL AND METHODS:

We carried out a prospective, analytical investigation, spread over a period of 3 months (September to December), at the level of the Gastroenterology II service of the Military Instruction Hospital Mohamed V, Rabat. A target of 50 samples was achieved. We checked the flexible endoscopes after the manual cleaning stage, which consists of cleaning with a disinfectant detergent. Untreated endoscopes, as well as endoscopes treated but stored for more than one hour, will be excluded from our survey. The validation of cleaning is done by the EnSURE^® System. Two separate samples will be taken. The first concerns the internal channel (working channel) of the endoscope by an EndoSwab^®. The second sample concerns the external surface of the endoscope insertion tube using a SuperSnap^® swab. This swab contains a reagent resistant to the effects of detergents and alkaline solutions. Analysis and exploitation of the results are carried out by Excel software.

RESULTS:

According to the results of our survey, the average age of our population is 55, of which 58% are males. Only 4% of patients had candidiasis as an associated pathology. During exploration, the majority (74%) were under general anesthesia and 26% under local anesthesia. The endoscopes used for the upper digestive tract represent 80% of cases against 20% for the lower digestive tract. The gastroenterology department II has 10 flexible endoscopes of which the endoscope "E1" is the most used (34%), followed by the endoscope "E2" (28%) (Figure 1).

Figure 1: Distribution of endoscopes"E"

Results below 45 RLU indicate that the cleaning of the endoscope is compliant. When these results are greater than 46 RLU, the cleaning of the endoscope is considered non-compliant⁴. The endoscopes used for the upper digestive tract most often reach the level of dissatisfaction. The internal biological control of these endoscopes has shown that 75% of the cleaning situations were not in conformity, whereas the external biological control was not in conformity in 63% of the cases. For lower gastrointestinal endoscopy, the results are better overall, the internal biological control was non-compliant in 10% of the cases, and the external biological control was non-compliant in 20% of the cases.

The results of the samples vary from one endoscope to another. The average rate of non-compliance compared to the target level is 54% for external biological control and 59% for internal biological control. The samples taken on the E3 endoscope represented the maximum rate of non-compliance reached for internal or external biological controls. However 100% of the samples taken on the E6 endoscope were in compliance with the target level (Table 1). Our investigation revealed the non-reproducibility and non-consistency of the quality of manual cleaning of flexible endoscopes depending on the operator. The average of non-conformities compared to the target level of external biological control was 47%, with a maximum of 67% for endoscopes cleaned by operator C and E, and a minimum of 43% for endoscopes cleaned by l operator A. For internal biological control, the average of non-conformities is 58%, with a maximum value of 86% obtained on the cleaned endoscopes by operator A, and a minimum value of 33% obtained on the endoscopes cleaned by operator C (Table 2).

Table 1: Biological control of the different endoscopes

	External biological control		Internal biological control
Endoscope	Conform	No conform	Conform	No conform
1	47%	53%	24%	76%
2	29%	71%	21%	79%
3	0%	100%	0%	100%
4	50%	50%	0%	100%
5	50%	50%	100%	0%
6	100%	0%	100%	0%
7	100%	0%	100%	0%
8	100%	0%	100%	0%
9	100%	0%	100%	0%
10	100%	0%	100%	0%

Table 2: Biological control according to the operator

	External biological control		Internal biological control
Operator cleaning	Conform	No conform	Conform	No conform
A	57%	43%	14%	86%
B	100%	0%	50%	50%
C	33%	67%	67%	33%
D	42%	58%	33%	67%
E	33%	67%	50%	50%
D and E	50%	50%	36%	64%

DISCUSSIONS:

Relatively few publications exist concerning the results of microbiological controls on endoscopes. Furthermore, these results are very variable, mainly due to the significant differences in the sampling methodology, in the laboratory techniques used and in the interpretation criteria used. Thus, the study published by Moses⁷ highlights an average contamination rate of 14.5% (18 out of 124) with an overall higher contamination rate for duodenoscopes. However, the sample collection and analysis methods used in this study had several biases. In a similar study by Machado et al.⁸ between 2000 and 2003, 149 samples were taken randomly from 2 Brazilian university hospitals. The endoscopes were removed after the cleaning/disinfection procedure by injecting 10 to 20mL of NaCl solution into the working channel. Seventy-two samples (48.32%) showed contamination above the action level and 55 samples (61%) showed contamination with Gram-negative bacilli. These alarming results must nevertheless be interpreted with great caution because the method of analysis used in this study (inoculation of 0.1ml) can lead to an over-evaluation of the actual contamination levels. The Australian study published by Linda Bisset in 2006⁹, which involved more than 2,300 samples, showed lower levels of contamination (1.8% for gastroscopes and 1.9% for coloscopes). However, here again, the sampling method and the analysis methods used do not make it possible to precisely define the actual level of contamination of the endoscopes tested. Similarly, the study published by Elizabeth E. Gillespie¹⁰ highlighted very low contamination rates (6 positive samples out of 1,456 samples). However, as in the case of the previous study, the methodology used leads to an underestimation of the actual contamination levels. Other studies have also made it possible to highlight variable levels of contamination, but for the same reasons as those mentioned above (invalid sampling method and analysis), it is impossible to know whether the published values reflect the real level of contamination of endoscopes^11,12. Only the study published in 2011 by Saliou et al.¹³ used a methodology in accordance with the recommendations published by the Directorate General of Health. In this study, out of the 524 microbiological controls carried out between January 1, 2007 and December 31, 2009, 26.7% presented a level of contamination higher than the level of action.

The results of the audit carried out in the Gastroenterology II department of the Mohamed V Military Instructional Hospital reflect the difficulties encountered in ensuring complete manual cleaning of endoscopes in a constant and reproducible manner. Out of all the endoscopes that have been checked, 62% present results higher than normal for internal biological control, and 54% for external biological control. High rates of non-compliance concerned the endoscopes E1, E2, E3 and E4. It was strongly recommended that these endoscopes be removed from the fleet.

This audit enabled us to note the non-reproducibility and the non-consistency of the quality of manual cleaning of flexible endoscopes. Operators A, B, D and E reported the highest rates of non-compliance in bioscope cleaning of endoscopes. After investigation, these operators were the youngest in the service. It is therefore advisable to insist on the training of these operators responsible for the cleaning of these devices, the strict respect of the protocols drawn up from the recommendations issued by the health authorities and the respect of good practices, in particular in terms of hygiene essential to the safety of endoscopic procedures^14,15,16. Like the pharmaceutical industry, good personal hygiene is required to protect the endoscope and avoid any type of contamination¹⁷.

It was also recommended an orientation towards automatic treatment methods. The reproducibility of endoscope washer-disinfectors eliminates the variability of reprocessing depending on the agent that performs it and usually gives good results¹⁰. These washer-disinfectors meet an international standard ISO 15883. There is also an intermediate solution with semi-automated benches. The European Society for Gynecological Endoscopy (ESGE) and the European Society of Gastroenterology and Endoscopy Nusrses and Associates (ESGENA) strongly recommend the use of these washer-disinfectors which have several advantages ^18,19,20: the procedures are standardized and validated; traceability is ensured by printing a paper document which indicates all the characteristics of the different stages²¹; risks are limited for personnel (closed system); the risks of contamination by the environment are reduced; the work is made easier for the person and the time saved is not negligible; there is less risk of damaging the endoscopes. However, this method requires qualified, trained personnel and a significant financial investment.

CONCLUSION:

Endoscopy is an extremely widespread medical procedure performed by trained health professionals who must ensure the safety of their patients. Our audit allowed us to verify the effectiveness of the procedure of manual endoscope treatment in the Gastroenterology II department of the Mohamed V Military Training Hospital, using a ready-to-use test measuring the amount of ATP present after cleaning. Our results show that it is difficult to ensure perfect disinfection of endoscopes. The difficulties encountered are probably related to the complexity of the devices and disinfection techniques used.

In the face of care-associated infections, manufacturers are currently offering automated and rapid endoscope disinfection systems, systems that seek the best patient safety and better protection against direct or cross-contamination while reducing the number of mandatory disinfections. The results observed during the study period should lead to awareness among the personnel concerned, compliance with current recommendations on disinfection of endoscopic instruments, and control of professional practices through regular auditing.

IT is necessary, IT has transformed healthcare in a way that it would be difficult for any healthcare organization to maintain if it does not adapt to such developments²².

CONFLICT OF INTEREST:

There is no conflict of interest in publication of this manuscript.

REFERENCES:

1. Marchetti B., Pineau L., Risque infectieux exogène en endoscopie digestive. Revue Francophone des Laboratoires. 2005; 2005(376): 67‑73.

2. Mignard J.-P., Désinfection des endoscopes. Annalesd’urologie. 2006; 40(S3): S91‑S93.

3. Hepsi Bai J. Knowledge and Practice of Health Care Workers on Infection Control Measures. Asian J. Nur. Edu. and Research. 2015; 5(4): 518-522.

4. Dipti G. Phadtare, Pawar Amol R, R.B. Saudagar. A Brief Review on Quality by Design and Process Analytical Technology. Asian J. Pharm. Ana. 2016; 6(2): 122-130.

5. Advaita B. Patel. Analytical Method Validation: Collation between International Guidelines. Asian J. Research Chem. 2017; 10(6):857-866. doi: 10.5958/0974-4150.2017.00143.2

6. https://www.hygiena.com/healthcare.html. Accessed, December 14, 2019

7. Moses F., Lee J., Surveillance cultures to monitor quality of gastrointestinal endoscope reprocessing. Am J Gastroenterol. 2003; 98(1): 77‑81.

8. Machado A., Pimenta A., Contijo P. et al. Microbiologic profile of flexible endoscope disinfection in two brazilian hospitals. ArqGastroenterol. 2006; 43(4): 255‑8.

9. Bisset L., Cossart Y., Selby W. et al. A prospective study of the efficacy of routine decontamination for gastrointestinal endoscopes and the risk factors for failure. Am J Infect Control. 2006; 34(5): 274‑80.

10. Gillespie E.E., Kotsanas D., Stuart R., Microbiological monitoring of endoscopes: 5-year review. J GastroenterolHepatol. 2008; 23(7 Pt 1): 1069‑74.

11. Chiu K.W., Tsai M.C., Wu K.L. et al. Surveillance cultures of samples obtained from biopsy channels and automated endoscope reprocessors after high-level disinfection of gastrointestinal endoscopes. BMC Gastroenterology. 2012; 12: 120.

12. King-WahC., Long-Sheng L., Keng-Liang W., Surveillance culture monitoring of double-balloon enteroscopy reprocessing with high-level disinfection. Eur J Clin Invest. 2012; 42(4): 427‑31.

13. Saliou P., Garlantézec R., Baron R. et al. Contrôles microbiologiques des endoscopes au centre hospitalier régional de Brest du 1^er Janvier 2007 au 31 Décembre 2009. Pathol Biol. 2011; 59: 88‑93.

14. Padmaja A., Leelavathi A., Rambabu C., Sesha Kumar K., Veena Bai R., Swathi S., Anil Kumar P.. A Study to Assess the Knowledge, Attitude and Knowledge on practices regarding Infection control in Paediatric Intensive Care unit among 3rd Year B. Sc. Nursing students, CON-SVIMS, Tirupati. Int. J. of Advances in Nur. Management. 2020; 8(2):107-112.

15. R. Danasu, Rajesh. A Study to assess the effectiveness of Hands on Clinical Training Program on needle stick injuries and its safety measures among student nurses at SMVNC, Puducherry. Int. J. of Advances in Nur. Management. 2019; 7(3): 225-233.

16. Mitesh D Phale. PAT: A New Weapon for Pharmaceutical Industry. Research J. Pharm. and Tech.2 (4): Oct.-Dec. 2009; Page 611-616.

17. Muddukrishna B S, Vamshi Krishna T., Lalit Kumar, M. Sreenivasa Reddy, Thunga Girish, Girish Pai K. Personnel Hygiene in Pharmaceuticals: Its importance and requirements for personnel involved in the manufacturing of quality medicines. Research J. Pharm. and Tech 2016; 9(10):1647-1649. doi: 10.5958/0974-360X.2016.00331.0

18. Beilenhoff1 U., Neumann C.S., Rey J.F., et al. ESGE-ESGENA guideline: Cleaning and disinfection in gastrointestinal endoscopy. 2008; 40: 939‑57.

19. Pineau L. Laveurs-désinfecteurs d’endoscopes. Hygienes. 2002; 6: 431‑40.

20. Babu. D. Nursing Information Systems. Asian J. Nur. Edu. & Research 2(2): April-June 2012; Page 76-78.

21. Madhuri Gupta, Arvind Kalia. Empirical Study of Software Metrics. Research J. Science and Tech. 2017; 9(1): 17-24.

22. Medha Piplani Verma, Sandhya Gupta. Software Development for Nursing: Role of Nursing Informatics. Int. J. Nur. Edu. and Research. 2017; 5(2): 203-207.

Received on 19.06.2020 Modified on 10.09.2020

Research J. Pharm. and Tech. 2021; 14(6):3191-3194.

DOI: 10.52711/0974-360X.2021.00556