Reusable medical devices are decontaminated and sterilized often many times by healthcare facilities across the earth. Reprocessing of medical devices comprises several processes and h2o plays an important part in some of these, including cleaning and steam sterilization. The water used is required to accept certain qualities to ensure the effectiveness of the processes. In this short communication, we study findings of our study which measured quality parameters (pH, total hardness) for water used for medical device reprocessing in xiii primary and secondary care public hospitals in Nepal. The mean pH of water used for reprocessing of medical devices varied from 6.48 to 8.05 across the hospitals whereas the mean full hardness of water varied from 5.93 to 402.50 mg/Fifty CaCO3. Although the range of the mean h2o pH beyond hospitals fell inside the recommended range, many of the hospitals had mean full hardness college than recommended for cleaning medical devices. None of the hospitals had mean total hardness suitable for using as feed-water for steam generation. Public hospitals in Nepal should accept appropriate water treatment systems so that the recommended water quality can be achieved to ensure effective decontamination and reprocessing of medical devices.

  • We have highlighted the crucial role of water in reprocessing of reusable medical devices.

  • This is the first ever study reporting quality parameters of water used for medical device reprocessing in public hospitals in Nepal.

  • Hospitals included in the study covered all geographical terrains in Nepal.

  • Recommendations have been made for treatment of water to ensure adequate reprocessing of medical devices.

Healthcare facilities across the globe reuse many medical devices several times past decontaminating and reprocessing them before each use. Some medical devices are used for invasive clinical procedures, such as surgery, and are classified equally disquisitional medical devices. Before each use, these medical devices are subjected to a reprocessing cycle, which includes processes including cleaning and sterilization. Sterilization is the process used to render the product free from viable microorganisms, including the most resistant spores. The denaturing of prions is considered in other processes. Amongst sterilization techniques, moist estrus sterilization (also known equally steam sterilization or autoclaving) is the almost used in healthcare facilities across the globe.

Water has an important role in the reprocessing of medical devices. Water is primarily used during the cleaning and sterilization (steam) processes of the reprocessing cycle. The utilise of h2o during the cleaning process can be for maintaining moistness of used medical devices, rinsing organic solids from medical devices, preparing cleaning solutions (due east.g. detergents) and final rinsing of the decontaminated device, while the utilize of water during moist-heat sterilization processes is mainly for generating steam. Levels of water quality required are different depending upon these processes.

pH and hardness are two of import aspects of water quality. pH is a measure of acidity (pH < 7), alkalinity (pH > 7) or neutrality (pH 7), whereas hardness is determined by the concentrations of calcium (Caii+) and magnesium (Mgtwo+) ions. In addition, other chemic contaminants also determine the quality of h2o. Poor water quality can cause corrosion of devices, hard-h2o deposits on devices, pitting of instruments, inactivation of detergents (and thus inadequate cleaning of devices), pyrogenic reactions in patients due to endotoxins and other pyrogenic agents, and infections in patients due to microbial contamination (Klacik 2015). Production of good quality steam is critical when sterilizing medical devices. Saturated steam (steam in a state of equilibrium between condensation and evaporation) releases the greatest corporeality of latent heat when it comes into contact with cooler surfaces, and thus is the almost effective means of sterilizing medical devices. Superheated steam, wet steam (likewise known as supersaturated steam) and steam containing non-condensable gases are not skillful for this purpose (McDonnell & Sheard 2012). High quality saturated steam can only exist obtained if high quality water is used for generating the steam.

The recommended pH of water for cleaning of medical devices is between 6 and nine (Lyon 2008; McDonnell & Sheard 2012), and a full hardness level of less than 150 mg CaCO3/L is considered the required hardness for cleaning medical devices (Standards Australia & Standards New Zealand 2014; Lyon 2008; McDonnell & Sheard 2012). Full hardness ≤2 mg CaCo3/L is recommended for generating steam for sterilization (Instrument Reprocessing Working Group 2017). Nonetheless, the quality of water used for medical device reprocessing has not been well studied and documented, peculiarly in developing countries. In this short communication, we report findings of a written report which assessed h2o quality (in terms of pH and hardness) used for medical device reprocessing in primary and secondary care public hospitals across Nepal. We as well discuss the potential adverse effects of poor-quality water on medical device reprocessing.

Water samples

Waters used for medical device reprocessing in xiii main and secondary care public hospitals across Nepal were tested for pH and hardness. The 13 hospitals included two zonal (secondary care) hospitals, nine district (primary intendance) hospitals and two commune-level (principal care) hospitals (Department of Health Services – Ministry of Health and Population – Government of Nepal 2015). The ix commune hospitals covered all seven provinces of Nepal. Waters used for 12 consecutive medical device reprocessing cycles in each of the zonal hospitals, 15 consecutive cycles in each of the district hospitals and 15 sequent cycles in each of the district-level hospitals were sampled and tested for full hardness and pH. Therefore, altogether 189 water samples were tested for pH and hardness. The calculation of sample size has been described in detail elsewhere (Panta et al. 2019) and was primarily carried out for measuring effectiveness of steam sterilization cycles in these hospitals.

Measurement of water pH and hardness

An HI 96735C Hardness meter (Hanna Instruments Inc., Woonsocket, United states of america) was used for measuring the hardness of the h2o used for reprocessing medical devices in the report hospitals. The meter measures the hardness content as Mgtwo+ and Ca2+ in water samples in the 0–750 mg/L (ppm) CaCO3 range (Hanna Instruments Inc. 2016).

An FG2/EL2 Portable pH Meter (Mettler Toledo, Schwerzenbach, Switzerland) was used to measure the pH of water used for reprocessing of medical devices in the report hospitals. The meter had a chapters to measure out water pH ranging from 0.00 to 14.00, a precision of 0.01 pH units and an accurateness of ±0.01 pH units.

The detailed manufacturer's instructions for testing water for hardness and pH were followed. The instruments used for testing water were calibrated once a solar day during the testing period, according to the manufacturer's instructions. Twelve water samples were tested at each zonal infirmary and 15 water samples were tested at each of the district level and district hospitals. The mean pH and the mean total hardness results for each infirmary were reported.

All xiii hospitals included in this written report used tap water without any prior handling for all steps (including cleaning and steam generation) of medical device reprocessing. Therefore, all the water samples tested for pH and total hardness were untreated water. The mean h2o pH beyond hospitals ranged from six.48 (slightly acrid) to 8.05 (basic). The mean total hardness of water ranged from 5.93 to 402.50 mg/L CaCOthree (Table 1).

Table 1

pH and hardness of water used for reprocessing medical devices in the study hospitals

Hospital type Hospital code Number of water samples tested Hateful pH Mean full hardness (mg/50 CaCO3)
Zonal hospitals 02 12 7.73 402.fifty
08 12 6.88 143.33
District hospitals 01 xv 6.75 179.33
03 15 viii.05 167.00
04 fifteen 6.72 v.93
06 fifteen 6.48 51.93
07 15 6.88 115.67
09 15 6.52 99.67
11 15 vii.25 121.eighty
12 xv 7.27 152.33
13 15 7.40 160.33
District-level hospitals 05 15 7.47 147.00
x 15 6.lx 104.xiii
Hospital type Hospital code Number of water samples tested Mean pH Mean total hardness (mg/L CaCO3)
Zonal hospitals 02 12 seven.73 402.l
08 12 6.88 143.33
Commune hospitals 01 fifteen 6.75 179.33
03 15 eight.05 167.00
04 15 half-dozen.72 5.93
06 15 6.48 51.93
07 15 6.88 115.67
09 xv half dozen.52 99.67
11 15 seven.25 121.80
12 xv 7.27 152.33
13 xv 7.xl 160.33
District-level hospitals 05 15 7.47 147.00
x xv half dozen.60 104.13

The mean pH of h2o used for reprocessing medical devices in the report hospitals ranged from 6.52 to 8.05. This pH range falls within the typical pH range of drink h2o and is considered acceptable for cleaning medical devices (Lyon 2008). Lyon (2008) recommends a pH range (half dozen.v–eight.five) for cleaning medical devices whereas McDonnell & Sheard (2012) recommend pH between 6.0 and nine.0 for cleaning, disinfection and rinsing of medical devices.

The hateful total hardness of water varied considerably across the study hospitals, ranging from v.93 to 402.50 mg/L CaCO3. Nearly of the hospitals were supplied with 'hard' water, i.e. water having total hardness ≥120 mg/50 CaCOthree. Recommendations made by different guidelines and authors for water hardness for cleaning medical devices also differ to some extent. The Australian/New Zealand Standard (AS/NZS 4187:2014) recommends using water with total hardness ≤lx mg/L CaCOiii (Standards Australia & Standards New Zealand 2006), whereas some authors accept recommended a threshold of 150 mg/L CaCO3 (Lyon 2008; McDonnell & Sheard 2012). More than than 38% of the hospitals studied had a mean total hardness of water >150 mg/L CaCOthree. This indicates that water in those hospitals is not ideal for cleaning medical devices. Hard h2o causes white deposits or calibration (e.yard. calcium carbonate, CaCO3) on medical devices. Such deposits are difficult to remove with h2o (because of their low solubility; CaCO3 water solubility = 15 mg/50 at 25 °C) and can cause clogging of devices, spotting on devices, and ultimately device harm; the deposits also provide a matrix for bacterial adhesion/growth. A written report conducted in a tertiary care hospital in Nepal reported that stains/spots were the most commonly observed 'damages' on medical devices used for general- and neurosurgery (Munakomi et al. 2018). In add-on, hard water can also inactivate soaps/detergents (by forming inactive calcium salts which are water insoluble) used for cleaning, leading to poor cleaning of medical devices.

Water is non only required for the cleaning process of medical device reprocessing cycles; it is also needed for generating steam for steam sterilization (autoclaving) processes. As with the recommended water hardness for cleaning medical devices, the recommended hardness level for feed-h2o for generating steam also differs betwixt guidelines/authors. McDonnell & Sheard (2012) consider a water hardness of <twenty mg/L CaCO3 every bit acceptable for steam generation, whereas the Instrument Reprocessing Working Group (2017) recommends ≤2 mg CaCO3/L for steam generation. Some other documents recommend using only treated (i.eastward. to change hardness) h2o for generation of steam (Lyon 2008; Department of Health-U.k. 2016). None of the hospitals included in this written report used treated h2o for their steam sterilizers (autoclaves), and but one hospital had a water supply with a mean full hardness <20 mg/L CaCOthree. Hard water, due to the presence of bicarbonate (HCOthree −), when heated may produce non-condensable gases (e.g. CO2) which reduce latent heat release when steam comes in contact with the surfaces of medical devices (Instrument Reprocessing Working Grouping 2017). This tin can ultimately lead to inadequate inactivation or killing of microorganisms. We previously reported a high proportion of steam sterilization failures in these hospitals when the sterilization cycles were tested with biological indicators containing ten6 spores of Geobacillus stearothermophilus (Panta et al. 2019). Although at that place could exist other factors associated with ineffective steam sterilization of medical devices, the effects of hard water cannot be overlooked. Hospitals with hard h2o should treat the water (e.thousand. by use of water softening devices) prior to its apply in autoclaves. Larger hospitals, for example zonal hospitals, should have an appropriate water treatment plant to produce loftier quality water for steam generation. Typically, water treatment includes softening, purification (contrary osmosis, deionization or distillation), and degassing (McDonnell 2017).

In addition to having dissentious furnishings on medical devices, hard h2o can as well cause impairment to the electric heating systems of autoclaves. The hard h2o deposits accumulate on the surface of the electric heating coil and form a thick layer around information technology (Figure 1). Such deposits tin significantly subtract the heating efficiency of the coil and thus significantly increase the length of an autoclave bike (Lyon 2008).

Effigy 1

An autoclave water-heating coil covered with a layer of deposits (most likely to be CaCO3 from hard water) and a newly purchased heating coil (picture taken in one of the hospitals included in this study).

An autoclave h2o-heating gyre covered with a layer of deposits (about probable to be CaCOiii from hard water) and a newly purchased heating coil (picture taken in one of the hospitals included in this study).

Effigy ane

An autoclave water-heating coil covered with a layer of deposits (most likely to be CaCO3 from hard water) and a newly purchased heating coil (picture taken in one of the hospitals included in this study).

An autoclave water-heating coil covered with a layer of deposits (most likely to be CaCO3 from hard water) and a newly purchased heating roll (picture taken in i of the hospitals included in this study).

Strengths and limitations of this report

At that place are other aspects of h2o quality such equally conductivity (east.g. due to high chloride concentration) which may also bear on cleaning and sterilization efficiency (Kremer & McDonnel 2020). Withal, total hardness and pH are arguably the two near important parameters for h2o quality measurement in a sterilization context. In this report, we measured and reported full hardness and pH of waters from different public hospitals which comprehend all geographical regions including mountains, hills and plains, and all seven provinces of the country. This may be the first report systematically measuring and reporting some quality parameters of waters from healthcare facilities across Nepal.

The role of water in medical device reprocessing is crucial in the cleaning of used medical devices and in the generation of steam for sterilizing medical devices. Additionally, the quality of h2o may also have an impact on the functioning of sterilizing equipment. All primary and secondary care public hospitals in Nepal used tap h2o for reprocessing of medical devices and the water pH fell within an acceptable range (i.e. pH 6.0–9.0). Withal, tap waters from many of the hospitals were hard (i.e. full hardness >150 mg/L CaCO3) and used for different processes of medical device reprocessing bike, such as cleaning (including final rinsing) and steam generation. Tap (potable) water without any treatment is rarely appropriate for medical device reprocessing procedures and treatment of water before being used for medical device reprocessing should be standard in the hospitals. Hard water requires softening to make it suitable for cleaning used medical devices whereas water needs boosted treatment such every bit demineralization to be suitable for final rinsing of the cleaning procedure. Ideally, only treated (i.e. softened, purified and degassed) h2o is recommended for generation of steam for sterilization. Installing a water handling plant in larger hospitals, such as zonal hospitals, for the purpose of medical device reprocessing is a adept option. For smaller hospitals, water filtration may be an affordable solution.

All relevant data are included in the paper or its Supplementary Information.

Department of Wellness Services – Ministry of Health and Population – Government of Nepal

2015

Almanac Study 2013/2014

.

Section of Health-UK

2016

Health Technical Memorandum (HTM) 01-01: Direction and Decontamination of Surgical Instruments (Medical Devices) Used in Acute Intendance. Part C: Steam Sterilization

.

Hanna Instruments Inc

2016

Total Hardness EPA Portable Photometer – HI96735

.

Musical instrument Reprocessing Working Group

2017

Instrument Reprocessing: Reprocessing of Instruments to Retain Value

.

Klacik

South.

2015

The essential elements of h2o quality

.

Healthcare Purchasing News

39

(

four

),

30

–

33

.

Kremer

T. A.

McDonnel

G.

2020

.

Biomedical Instrumentation & Technology

54

(

4

),

304

–

309

.

Lyon

S.

2008

Water quality and its affect on the decontamination process

.

Managing Infection Control

8

,

82

–

97

.

McDonnell

G. E.

2017

Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance

, second edn.

ASM Press

,

Washington, DC

.

McDonnell

G.

Sheard

D.

2012

A Practical Guide to Decontamination in Healthcare

.

John Wiley & Sons

,

UK

.

Munakomi

S.

Shah

R.

Shrestha

Southward.

2018

.

F1000Research

7

,

102

.

Panta

Grand.

Richardson

A. K.

Shaw

I. C.

Chambers

S.

Coope

P. A.

2019

.

PLoS One

fourteen

(

11

),

e0225595

.

Standards Australia & Standards New Zealand

2014

Reprocessing of Reusable Medical Devices in Health Service Organizations

.

© 2021 The Authors

This is an Open Admission article distributed under the terms of the Creative Eatables Attribution Licence (CC By 4.0), which permits copying, adaptation and redistribution, provided the original work is properly cited (http://creativecommons.org/licenses/past/4.0/).