Process of Reprocessing Medical Devices and Equipment for Sterilization

This case study discusses the process of reprocessing medical devices and equipment for sterilization. It covers the importance of PPE, cleaning, disinfecting, and sorting of items. It also explains the loading and unloading of steam sterilizers and the maintenance required for proper functionality. The case study provides a step-by-step guide for the sterilization process and highlights the importance of quality assurance testing and servicing for lifelong reliability and safety of sterilization instruments.

Case study
PROCESS REUSABLE MEDICAL DEVICES AND EQUIPMENT
1

Case study
Case study -1
The reprocessing of medical materials for sterilisation seems to be an easy process but
if understood properly it is a complicated process that requires serious practices to
ensure complete sterilisation.
As per infection prevention principles, biomedical services and occupational health
instructions cleaning and disinfecting are reprocessing practices along with some PPE
rules for workers that are strictly required before sterilisation1.
The personal protective equipment (PPE) rules are very first requirement that workers
should follow to carry on a proper reprocessing for sterilisation. The PPE requirement
includes: -
 Workers should perform hand hygiene both before and after removing gloves
using soap, water, sanitizers and alcohol as per requirement.
 Workers should wear all the PPE equipment’s to avoid the risk of infections
for contaminated stuff (blood and body fluid).
 Workers should follow manufacturer’s recommendations for cleaning specific
equipment’s2.
Further, the cleaning process is performed before disinfection or sterilisation that
involves proper sorting of as critical, semi-critical and noncritical items. The
sterilisation performed for different categories are always different, for example-
critical items undergo steam, chemical or liquid sterilisation, semi-critical involves
thermal or chemical sterilisation and noncritical items are cleaned using detergent.
The cleaning process involves: -
 Workers need to open instruments, remove clips and latches followed by
rinsing instruments with warm water to remove dirt.
 The dirt collected contains four categories of wastes that are clinical,
cytotoxic, anatomical and sharps waste. All these waste have separate
categories of bins where they should be separately and safely disposed off.
Further, the harmful waste is disposed of in biohazard waste destruction bin
for safe destruction.
1 Dorsch, J. A. (2012). Understanding anesthesia equipment. Lippincott Williams & Wilkins.
2 Kucklick, T. R. (Ed.). (2012). The medical device R&D handbook. CRC Press.
2

Case study
 Scrubbing with the brush is performed for proper cleaning further rinsing with
water. Further, instruments are dried using the lint-free cloth and individual
instruments are inspected before sterilisation.
After cleaning disinfecting is performed where immerse instruments are disinfected as
per the manufacturer manual. The instruments are fully covered and kept for
disinfection followed by removal of disinfectant with water. Further, they are dried
with cloth and disinfectant is completely thrown as waste34.
3 Moraru, D., & Moleavin, I. (2014). Assessment of the environmental conditions of a public
hospital. Acta medica transilvanica, 19(4).
4 Agar, J. W. (2012). Personal viewpoint: hemodialysis—water, power, and waste disposal:
rethinking our environmental responsibilities. Hemodialysis International, 16(1), 6-10.
3

Case study
Case study - 2
Sterilisation
For a newly engaged dental assistant, it is important to know that sterilisation is an
essential and imperative part of dental practice. It is required for each and every
dental worker to perform sterilisation as per Australian Standard AS4187 in his or her
medical practice.
The following steps help to understand the complete sterilisation process in the
appropriate manner.
 Firstly, collect the equipment’s required for sterilisation that are steriliser,
packages (paper/laminate materials), sterilization trays (metal or plastic tray
with holes), permanent marker, clean tongs, indicator tape, recording and
monitoring books.
 Pre-clean and dry all the used items
 Put the instruments in the sterilising tray followed by packing the content so
that they are clearly visible through the laminate side. Ensure that sharp
instrument tips are protected to stop damage to packaging.
 The waiting time between packaging and sterilisation should be kept minimum
to avoid contamination.
 Label the packages with the permanent market before sterilisation with
identification name or code and date. Try to record these label in monitoring
books as well for tracking faults in sterilisation process.
 Seal the packages with indicator tape across its width overlapping on each
side5.
Loading steam steriliser
 Ensure that air is completely removed from chamber without blocking the air
vents
 Further, keep instruments in a proper manner that steam is surely able to reach
and saturate all surfaces for sterilisation.
5 Lakhan, P., Faoagali, J., Steinhardt, R., & Olesen, D. (2013). Shelf life of
sterilized packaged items stored in acute care hospital settings: factors for
consideration. Healthcare infection, 18(3), 121-129.
4

Case study
 Assure that all the condensation is completely drained away
 The instruments must not stick out of the tray and even not touch the chamber
walls.
 Arrange unpackaged instruments in a single row in the tray.
 Further, assure that all packaged instruments are lying flat on the tray with
paper side facing down.
 Put Hollowware on the sides of sterilisation tray to let the air and condensation
drain away. Further, let the linen hanging vertically upwards with no further
adding to packages material above it.
 Use distilled water in steam steriliser and allow sterilisation following correct
time + correct temperature + correct preparation process.
Unloading steam steriliser
 Follow the drying cycle after sterilisation is complete where assure that
packages are not open until drying cycle is complete.
 Unload the steriliser using tongs one by one removing single tray or
instrument at one time.
 Remember to wear PPE required for unloading sterilizer.
 Check the change in indicator colour to ensure sterilisation without harming
seal.
 Record the pressure, temperature, time and then sign off.
 Keep instruments on the non-solid surface to let them dry without using fans.
 However, if instruments are to be used directly without drying then use sterile
gloves to remove packaging paper. Single dry instrument using a lint-free
cloth.
For proper maintenance of sterilisation, it is essential to record and monitor the
complete process. This helps to detect faults, improve loopholes and missing
essentials in the process. For record keeping and monitoring an operating manual,
commissioning data copy and a log of the ongoing process, maintenance and
calibration should be kept while performing sterilisation6.
6 Liu, L. M., Curtis, J., & Crookes, P. A. (2014). Identifying essential infection control competencies
for newly graduated nurses: a three-phase study in Australia and Taiwan. Journal of Hospital
Infection, 86(2), 100-109.
5

Case study
Case study -3
Maintenance of steriliser
For getting a good quality performance of a steam steriliser it is essential to provide
regular maintenance programme that ensures proper functionality. Any kind of
malfunction in maintenance process can lead to damage to sterilise. The below
provided are details of daily, weekly, monthly and as scheduled maintenance process
that is required to maintain a steam steriliser.
Daily maintenance
Clean the steriliser regularly especially the rubber chamber seal, sterile trays and inner
surface with mild detergent, warm water and a soft cloth. Further, rinse well before
use.
Use nylon scourer to clean the metal surface of chamber seal very gently using mild
detergent and water.
Weekly maintenance
Weekly clean the sterilisation chamber, tray racks, trays and outer surfaces using
disinfectant, mild detergent and warm water
Water reservoir should be drained and flushed on weekly basis.
Monthly maintenance
Lubricate hinge and closing mechanism of door monthly if required using silicone-
lubricating spray. However, try to use the lubricating spray very rarely.
Remove and clean debris from primary filters on monthly basis
As scheduled
Bacterial filters and chamber seals require periodic replacement depending on the
brand, rate of usage, age and handling of steriliser. Therefore, this maintenance is
required to be scheduled by the operator as per need7.
Importance of quality assurance of sterilisation equipment
Quality assurance testing and servicing will ensure lifelong reliability and safety of
sterilisation instrument. The regular servicing and validity test are two methods that
ensure the quality of steriliser. Regular service via manufacturer or approved service
company shall reduce breakdown frequencies ensuring the safe use of steriliser.
Further, below provided four validity tests ensure the validity of steriliser
Heat distribution test- Detect the coldest spot of the chamber
7 Reed, C. S., Gorrie, G., & Spelman, D. (2013). Hospital infection control in Australia. Journal of
Hospital Infection, 54(4), 267-271
6

Case study
Penetration time test- Measuring the real time taken for challenge pack centre to
reach active temperature of sterilisation
Cycle confirmation test - Validation single sterilisation cycle as per Australian
standards
Biological test- This test confirms consistency of steriliser for medical functionality8.
8 Dillard, D. (2014). Research Guides: DISASTERS: Social Work Guide: Disasters: Health and
Medical Fields Issues and Topics.
7

Case study
Bibliography
Agar, J. W. (2012). Personal viewpoint: hemodialysis—water, power, and waste
disposal: rethinking our environmental responsibilities. Hemodialysis
International, 16(1), 6-10.
Dillard, D. (2014). Research Guides: DISASTERS: Social Work Guide: Disasters:
Health and Medical Fields Issues and Topics.
Dorsch, J. A. (2012). Understanding anesthesia equipment. Lippincott Williams &
Wilkins.
Hadi, R., Vickery, K., Deva, A., & Charlton, T. (2010). Biofilm removal by medical
device cleaners: comparison of two bioreactor detection assays. Journal of
Hospital Infection, 74(2), 160-167.
Havens, W. H., & Hennick, R. J. (2012). U.S. Patent No. 8,203,124. Washington, DC:
U.S. Patent and Trademark Office.
Jabbari, H., Alikhah, H., Alamdari, N. S., Behzad, M. N., Mehrabi, E., Borzui, L., &
Bakhshian, F. (2012). Developing the use of quality indicators in sterilization
practices. Iranian journal of public health, 41(7), 64.
Kucklick, T. R. (Ed.). (2012). The medical device R&D handbook. CRC Press.
Lakhan, P., Faoagali, J., Steinhardt, R., & Olesen, D. (2013). Shelf life of sterilized
packaged items stored in acute care hospital settings: factors for
consideration. Healthcare infection, 18(3), 121-129.
Lever, M., & Ho, G. (2012). Reducing energy for cellulose ethanol production by the
use of sterilising agents in lieu of steam. Renewable energy, 43, 403-406.
Liu, L. M., Curtis, J., & Crookes, P. A. (2014). Identifying essential infection control
competencies for newly graduated nurses: a three-phase study in Australia and
Taiwan. Journal of Hospital Infection, 86(2), 100-109.
McDonnell, G., & Sheard, D. (2012). A practical guide to decontamination in
healthcare. John Wiley & Sons.
McGain, F., Moore, G., & Black, J. (2016). Hospital steam sterilizer usage: could we
switch off to save electricity and water?. Journal of health services research &
policy, 21(3), 166-171.
Moraru, D., & Moleavin, I. (2014). Assessment of the environmental conditions of a
public hospital. Acta medica transilvanica, 19(4).
Patel, P. B., Thula, K. C., & Maheshwari, D. G. (2015). Medical device regulation
and its comparison in Europe, Australia and India. Indo American Journal of
8

Case study
Pharm Research, 5(03), 1211-22.
Reed, C. S., Gorrie, G., & Spelman, D. (2013). Hospital infection control in
Australia. Journal of Hospital Infection, 54(4), 267-271.
Van Eldik, D. A., Zilm, P. S., Rogers, A. H., & Marin, P. D. (2014). A SEM
evaluation of debris removal from endodontic files after cleaning and steam
sterilization procedures. Australian dental journal, 49(3), 128-135.
9