Running Head: INADEQUATE CLEANING OF COMPLEX REUSABLE INSTRUMENTS

Inadequate Cleaning of Complex Reusable Instruments

Latoya Rone

University of San Diego

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Patient safety is the prevention of harm to patients by laying great emphasis on care

delivery, error prevention and ensuring a culture of safety by both health care providers and

patients. Health care delivery evolves at a fast pace owing to changes in other related factors

such as care measures and technological functions. Inadequate cleaning of the complex reusable

instruments is among the leading health care issues. This is because the use of contaminated

medical instruments can easily lead to deadly infections or instrument malfunctions (Boyce,

2016). The use of complex reusable clinical instruments such as cannulated drills, endoscopes

and arthroscopic shavers have raised a major medical concern due to their complicated nature

that makes them difficult to clean and disinfect or even sterilize. If these instruments are not

cleaned between uses, there is a likelihood of the presence of contamination, which might prove

difficult to detect by clinicians and might be passed from one patient to another (McGrath et al.,

2017, 38).

It is also estimated that many incidents associated with patient infections are as a result of

inadequate cleaning, which is also attributed to user error, lack of training on handling

techniques and device cleaning methods. The issue has many implications, which range from

deadly patient infections leading to persistent superbug outbreaks, excessive components

breakages and premature equipment failures, hence hindering patient care delivery and quality

health services. The issue is of major concern, therefore of need to explore because apart from

being ranked among the top ten health technology hazards, it is also among the leading cause of

patient risk issues. It is also evident that the health issue holds a potential danger to patient health

and safety because it is the leading cause of patient-infection outbreaks, hence warrants the

greatest attention (Rutala & Weber, 2016).

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The paper will analyze several factors and adverse events associated with inadequate

cleaning of complex reusable instruments such as infections, outbreaks and other effects of

contaminated reusable clinical instruments. The paper will also explore severity of the issue,

frequency, profile and its preventability including factors such as training clinicians on cleaning

steps, procedures, and other actions to be taken to prevent or minimize the health hazard.

Literature Review

Researchers concur that inadequate cleaning of complex reusable instrument is a major

concern in health care. In a study conducted by Southworth (2014), surgical instruments were

identified as potential routes for the transmission of pathogens between patients in health care

facilities. Southworth (2014) believes that the decontamination process when a patient uses these

complex instruments is important as far as prevention of healthcare-related medical problems is

concerned. This idea is supported by Wade et al., (2015), who believes that over 45 million

inpatients and 30 million outpatients in the U.S. undergo surgical procedures annually. During

these procedures, some of which involve complex reusable surgical instruments, patients and

families entrust their welfare to health professionals. Some of these professionals, unfortunately,

do not take necessary measures related to cleaning of surgical instruments. Medical professionals

are required to clean millions of reusable medical instruments that come into contact with

patients’ blood, skin, tissues, and body fluids, but excessive workload means that some of these

precautionary measures may be overlooked.

Concerns about inadequate cleaning of complex reusable devices have also been raised in

hospitals that loan complex design surgical devices and implants (Costa et al., 2018). In

orthopedic surgeries, reusable surgical instruments (RSI) are often acquired through loans. In this

case, loaners tend to set conditions when high-complex designs of RSIs are involved. Lopez et
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al. (2018) and Costa et al. (2018) concur on the issue of cleaning highly complex reusable

complex instruments that are acquired on loan. RSI often prove very complex to clean because

they are sometimes made of single-use implants, such as screws. The problem with these screws

is that they remain in the surgical jar for some time, and as such, are subject to multiple cycles of

reprocessing before they are implanted. Altogether, studies have shown that inadequate cleaning

of reusable surgical devices, as well as exposures of single-use implants to chemical agents can

compromise their quality and safety standards (Wade et al., 2015). The issue of cleanliness of

complex reusable surgical instruments is further complicated in middle and low-income

countries because unlike in developed countries, automated infrastructures of sterilizing these

instruments are almost unavailable (Wade et al., 2015).

In its organizational article, Kimberly-Clark (2016) argues that complex reusable medical

devices can be contaminated in two ways: visibly and through hidden bio-burden. Bio-burden,

also known as soil, contains millions of potentially infectious agents. Inadequate cleaning means

that bio-burden would be left on the surfaces of complex reusable devices and this would pose a

risk to patient outcomes. Lopez et al. (2018) concur with this view in his study that links

complex-design reusable devices to contamination during reprocessing. Though in-depth gauges

can be reassembled, biological residues, or soil, that accumulate on the lumen of some of these

reusable instruments cannot easily be removed. Lopez et al. (2018) content that the current

design of reusable surgical instruments obstructs removal of bio-burden and this may have

adverse health effects on patient outcomes.

Kimberly-Clark (2016) highlights different steps that must be taken in place to ensure

that complex reusable instruments are kept adequately clean. One of these steps includes

ensuring that complex reusable devices are sprayed frequently or soaked to keep them sterile
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while they are being transported and stored. Nevertheless, because cleaning of complex reusable

medical instruments takes place in hospital settings, future research should investigate systemic

failures that heighten the risk of cross-infection when cleaning and sterilizing reusable surgical

instruments.

Solution

Kimberley-Clerk (2016) proposed different measures that are necessary to ensure

effective cleaning of the reusable medical equipment, which includes training of personnel,

quality of water, appropriate use of the personal protective equipment (PPE), and adherence to

manufacturer’s guidelines and directions of use. Among the mentioned solutions, training of the

personnel is selected in the current paper, as the most appropriate solution.

Ling et al. (2018) recommend that all supervisors and managers who are involved in the

reprocessing of the reusable medical should have at minimum, a recognized certification or

qualification in a reprocessing, or related course. Other than the initial training, there needs to be

in place, a plan to ensure that those without necessary training obtain it as soon as possible.

Moreover, arrangements for continuous training and re-certification of the already qualified

personnel should also be pursued. The assertions by Ling et al. (2018) are also confirmed by Fast

et al. (2017) who recommend both ongoing and formal training of all the staffs who are both,

directly and indirectly, involved with the decontamination of reusable medical instruments.

Further, Fast et al. (2017) argue that the staffs working within the units involved with the

decontamination processes should be trained on how to use and handle the relevant equipment.

The need for sterilization of the reusable medical instrument is almost an obvious

knowledge among several medical staffs, and indeed, most medical institutions have in place

dedicated units for the same. However, humans are often vulnerable to complacency. As such,
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training is the most appropriate method to set the appropriate foundation for ensuring adequate

decontamination. Further, it ensures that the relevant staffs are abreast of the most appropriate

cleaning methods available. Training of staffs on cleaning reusable medical instruments is

critical to the staffs since it breaks the monotony and provides knowledge about emerging

cleaning trends in an industry that is always fast changing. Knowledgeable staff with regards to

cleaning reusable medical staffs is an enhancement to the patients’ safety.

White Paper Failure Mode and Effect Analysis (Part I)

This part involves the analysis of the failure mode and effects. This is systematic

technique meant for the analysis of failure, prior to implementation. Being the first step in the

study of the system reliability, for this study the item of failure to be analyzed is the training of

the personnel for effective cleaning of the medical equipment that are reusable. The most

appropriate solution that has been considered for the analysis is the training of the personnel. The

figure below unveils a flow diagram depicting the components of the steps involved in the

sterilization of surgical equipment.

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Steps Potential Errors

1 Failure to attend all the trainings, inability to comprehend
training procedures, inability to apply the practical bit of the
training
2 Leaving some instruments in the area, dropping some
instruments along the way, mixing the instruments on
removal.
3 Put on the wrong gears, failure to put on the gears, putting on
the gears inappropriately.
4 Failure to clean up oneself, cleaning up oneself
inappropriately,
5 Breaking the instruments while cleaning, scrubbing
inappropriately,
6 Failure to rinse appropriately, failure to dry,

White Paper Failure Mode and Effect Analysis (Part 2)

1 Process The decontamination process in the cleaning of complex reusable

Step instrument.
2 Potential Falling short of Failing to adhere to Conducting the
Failure current standards. set contamination contamination process
Mode routine. outside of the regulated
Process Step #1

processing area.

3 Potential Failing to have Failure to remove Failing to rinse the

Cause(s) cleaning precede all debris and instruments with water to
disinfection and contamination eliminate chemical or
sterilization through the washer- detergent residue.
processes. disinfector.
4 Severity IV (critical). III (minor). II (very minor).
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5 Probability A (extremely B (remote). B (remote).

unlikely).

6 Hazard 10 (catastrophic). 7 (major). 1 (minor).

Score
7 Action Eliminate. Control. Control.
(Eliminate,
Control, or
Accept)
8 Description Ensure always to Control the removal Control for the
of Action have cleaning of debris and elimination of chemical
precede all contamination by or detergent residue
disinfection and utilizing the through rinsing the
sterilization washer-disinfector. instruments with water.
processes.

1 Process Acquiring reusable surgical instruments (RSI) on loan

Step
2 Potential Finding difficulty Inadequate cleaning Exposures of single-use
Failure in the cleansing of of RSIs. implants to chemical
Mode the RSIs. agents.
Process Step #2

3 Potential Not being informed Improper ridding of The accumulation of a

Cause(s) on how to go about residual ATP from biofilm, soil among
the manual the flexible other elements observed
cleansing of RSIs. medullary reamers on the RSIs or screws.
(FMRs), depth
gauges and screws.
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4 Severity V (catastrophic). IV (critical). IV (critical).

5 Probability A (extremely B (remote). D (reasonably).

unlikely).

6 Hazard 10 (catastrophic). 7 (major). 4 (moderate).

Score
7 Action Accept. Eliminate. Eliminate.
(Eliminate,
Control, or
Accept)
8 Description Check to ensure Eliminate residual Eliminate the use of
of Action that the accepted ATP from FMRs, loaned RSIs to prevent
means of manually depth gauges, and against previous film
cleansing RSIs are screws. coats and contamination.
observed.

1 Process Training of personnel on reprocessing and the cleaning of surgical

Step tools.
Process Step #3

2 Potential Failure to have Failure to Failure to hold regular

Failure practitioners with systematically training of staff relative
Mode the proper educate untrained to the decontamination
qualification in staff on how to of reusable medical
reprocessing. initiate reprocessing. instruments.
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3 Potential Employment of Having an Having leadership

Cause(s) unqualified staff organizational unconcerned about the
lacking knowledge culture that fails to familiarization of
of conducting train staff on the personnel with the
reprocessing. manner to conduct organizational culture
reprocessing and education on
systematically. decontaminating
reusable medical
instruments.
4 Severity V (catastrophic). IV (critical). IV (critical).

5 Probability A (extremely C (occasional). B (remote).

unlikely).

6 Hazard 10 (catastrophic). 4 (moderate). 7 (major).

Score
7 Action Control. Accept. Accept.
(Eliminate,
Control, or
Accept)
8 Description Regulate the The health care The institution’s
of Action number of institution should management should
unqualified or agree to train seek to regularly assess
untrained personnel personnel in the personnel on their
employed by the proper manner to understanding of
company. conduct decontaminating
reprocessing. reusable medical
instruments.
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1 Process Appropriate use and decontamination of personal protective

Step equipment (PPE) before, during and after administering are or
evaluation.
2 Potential Failure to inspect Failing to ensure that Utilizing stored PPE
Failure PPE periodically to the PPE is properly without guaranteeing the
Mode ensure the decontaminated after cleanliness of the
equipment remains every use. equipment before its
in working utility.
condition.
3 Potential Lack of proper Storage of PPE Failure to conduct
Cause(s) management without ensuring the periodic inspection of
relative to the decontamination of PPE and ensure regular
Process Step #4

maintenance of the equipment and cleaning of equipment

PPE and the checking for while in storage.
assurance of proper degradation.
disposal of
hazardous waste.
4 Severity III (minor). III (minor). IV (critical).

5 Probability B (remote). B (remote). C (occasional).

6 Hazard 4 (moderate). 7 (major). 10 (catastrophic).

Score
7 Action Control. Control. Eliminate.
(Eliminate,
Control, or
Accept)
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8 Description Control for the Ensuring the Eliminating mistakes

of Action periodic inspection mandatory regarding the cleaning
of PPE to ensure decontamination of of stored PPE prior to its
the equipment PPE upon each use use.
remains in working to ensure storage of
condition. sterile equipment.

1 Process Adherence to the manufacturer’s guidelines and directions of use.

Step
2 Potential Not relying on the Switching to other Potential for personnel
Failure disinfectant decontaminating failing to account for the
Mode manufacturer’s data equipment which malfunctioning of
concerning the personnel has no decontamination
decontamination of experience or equipment.
complex reusable familiarity with in
instruments the absence of
training.
Process Step #5

3 Potential Clerical errors in Purchase of new Faulty decontamination

Cause(s) understanding the decontaminating tools leading to
decontamination equipment while inadequate cleaning of
process of complex failing to familiarize complex reusable
reusable personnel with the instruments.
instruments. manufacturer’s
guidelines.
4 Severity IV (critical). V (catastrophic). V (catastrophic).

5 Probability B (remote). A (extremely C (occasional).

unlikely).
6 Hazard 4 (moderate). 7 (major). 10 (catastrophic).
Score
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7 Action Eliminate. Control. Control.

(Eliminate,
Control, or
Accept)
8 Description Ensure minimal Provide training to Regulate the frequency
of Action clerical errors in personnel on the faulty decontamination
understanding the manufacturer’s equipment is utilized
decontamination guidelines regarding through ensuring regular
process relative to the decontamination inspection of the
complex reusable process when equipment to minimize
instruments. purchasing new inadequate cleaning of
decontamination complex reusable
equipment. instruments.

1 Process Appropriate use of water.

Step
2 Potential Failing to sterilize Failing to rinse Wastage of water for
Failure oneself and ensure complex reusable cleaning of complex
Mode decontamination instruments reusable instruments.
through cleaning. appropriately or
Process Step #6

leaving them to dry.

3 Potential Lack of discipline Lack of discipline in Taking significant time
Cause(s) in ensuring to ensuring to adhere to rinsing the complex
adhere to high high levels of reusable instruments.
levels of sanitation sanitation required
required of medical of medical
personnel. personnel.
4 Severity II (very minor). III (minor). II (very minor).
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5 Probability D (reasonably C (occasional). A (extremely unlikely).

possible).

6 Hazard 4 (moderate). 7 (major). 1 (minor).

Score
7 Action Control. Control. Control.
(Eliminate,
Control, or
Accept)
8 Description Ensure medical Ensure medical Regulate the amount of
of Action personnel ensures personnel maintains water utilized in
to sterilize high levels of cleaning to preserve the
themselves after sanitation and resource for
handling complex thoroughness when emergencies.
reusable rinsing complex
instruments. reusable
instruments.

Quality Measurement Plan

The proposed solution to the technology hazard of inadequate cleaning of complex

reusable instruments are to ensure appropriate usage of the protective equipment, training the

staff, ensuring quality water is used and ensuring staff adhere to manufacturer’s directions of use.

The indicators that can be of use in the process to assess the success of our technology are as

follows: The percentage of trained personnel who adhere to the systematic education on cleaning

surgical tools. Additionally, another indicator would be incidences of the appropriate usage of

personal protective equipment (PPE). There is also a good percentage of staff who use water

appropriately to clean the instruments. Finally, there is the actual number of staff that adhere to

manufacturer’s direction of use. The indicators will be monitored by healthcare personnel of the
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hospital who will be in charge of measurements of performances so that they can evaluate and

afterward communicate on how the various indicators meet the goals of the hospital.

The outcomes of the evaluation process will be based on the responsiveness of the

training process on how to clean the medical instruments (Smith, Mossialos & Papanicolas).

There will be a productivity assessment to monitor whether the resources used are effective in

meeting key strategies of the hospital (Smith, Mossialos & Papanicolas). The data will be

collected through observational study that will involve monitoring how the staff members

participate in cleaning medical equipment (Sarkies, Bowles, Skinner, Mitchell, Haas, Ho &

Plumb, 2015). There are other ways of data collection such as electronic administrative data and

manual data collection from the staff members. The data will be collected before and after

administering the training exercises with a duration of six months between the periods.

Conclusion

Since patient safety is the prevention of harm to patients by laying great emphasis on care

delivery and adequate cleaning of complex reusable instruments must be executed to avoid

infections, outbreaks and other effects of contaminated reusable clinical instruments. Solutions to

ensure effective cleaning of the reusable medical equipment include: training of personnel,

quality of water, appropriate use of the personal protective equipment (PPE), and adherence to

manufacturer’s guidelines and directions of use (Kimberley-Clerk, 2016). The most appropriate

solution that has been considered for the analysis is the training of the personnel. Future course

of action will be measured through staff training survey; number of contamination outbreaks

prior to training being implementation verses number of current outbreaks. Results will assist in

staff training revision.

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