Bedpan washer disinfectors: An in-use evaluation of ... - CCIH

Bedpan washer disinfectors: An in-use
evaluation of cleaning and disinfection
Elizabeth Bryce, MD, FRCPC, a Allison Lamsdale, MASc, b Leslie Forrester, MA, MSc, b Linda Dempster, RN, BSN, MA, b
Sydney Scharf, BA, RN, a Michael McAuley, RRT, BSc, a Ian Clearie, c Sharon Stapleton, RN, BSN, MA, d
and Sheila Browning b
British Columbia, Canada
Background: As part of a comprehensive approach to decreasing Clostridium difficile in our health authority, an evaluation of the
in-use performance of 2 brands of bedpan decontaminators (BPDs) in 2 acute care facilities was performed.
Methods: A continuous quality improvement approach consisting of 5 BPD audits and 4 intervention phases was used over a
16-month evaluation period. Visible fecal soil on processed items was used as the progress indicator, and infection preventionists
performed audits.
Results: A total of 1,982 observations was recorded. Percent failures rates ranged from 7.6% to 33% dependent on the intervention
phase. Polypropylene materials had fewer failures compared with stainless steel. The addition of rinse agent significantly improved
results particularly in polypropylene items (1% failure rate). A number of human factors issues and equipment design features
compromised the BPD’s ability to function adequately.
Conclusion: Users should thoroughly evaluate the in-use efficacy of BPDs and use a step-wise approach to identify and correct
both human and equipment deficiencies. Forced function and compliance features for correct loading of machines, detergent
and rinse agent dispensing, and ability to operate the machine only when detergent is present should be integral to the BPD design.
Key Words: Disinfection; bedpan decontaminators; Clostridium difficile; environmental cleaning.
Copyright ª 2011 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights
reserved. (Am J Infect Control 2011;39:566-70.)
Bedpan decontaminators (BPDs) employ thermal
disinfection methods to safely reuse urinals and bedpans
and protect health care workers from body fluids.
BPDs are expected to conform to International Organization
for Standardization (ISO) 15883 standards prior
to marketing; however, there is a paucity of information
regarding their functionality over time both from
a mechanical and from a user perspective. 1-3 As part
of a comprehensive approach to decrease Clostridium
difficile in our health authority, an evaluation of the
in-use performance of 2 brands of BPDs in 2 acute
care facilities was performed.
From the Infection Prevention and Control, a Quality and Patient Safety, b
Facility Maintenance and Operations, c and Medical Operations Services,
d Vancouver Coastal Health, Vancouver, British Columbia, Canada.
Address correspondence to Elizabeth Bryce, MD, FRCPC, Division of
Medical Microbiology and Infection Control, JPN 1111-899 West 12th
Ave, Vancouver General Hospital, Vancouver, British Columbia V5Z
1M9, Canada. E-mail: Elizabeth.Bryce@vch.ca.
Conflicts of interest: None to report.
0196-6553/$36.00
Copyright ª 2011 by the Association for Professionals in Infection
Control and Epidemiology, Inc. Published by Elsevier Inc. All rights
reserved.
doi:10.1016/j.ajic.2010.10.028
566
MATERIALS AND METHODS
Vancouver General Hospital (a 700-bed adult tertiary
care facility) has 55 BPDs (brand A 5 52, brand B 5 3),
whereas Richmond Hospital (a 243 bed community
care facility) has 32 BPDs (brand A 5 10 and brand
B 5 22). BPDs are located on each clinical unit, in the
soiled utility room. A continuous quality improvement
(CQI) approach was used by a multidisciplinary team
(infection prevention and control, patient safety, facility
maintenance, administration, and human factors
personnel) to cyclically audit, analyze, and implement
improvement measures over a 16-month evaluation
period. Human factors, BPD, and equipment design
features were addressed during the CQI process. Five
BPD audits and 4 implementation events were completed
in 5 phases; the first 3 CQI phases were performed
only at Vancouver General Hospital.
Before the first audit, both BPD brands were generally
used on the ‘‘intense cycle’’; however, users were
able to select the type of cycle they deemed necessary.
After the first audit, an ‘‘intense cycle’’ was programmed
into the BPDs that consisted of stage 1 (cold
water flush), stage 2 (cleaning with detergent and
warm water), stage 3 (cleaning with warm water; no
detergent), stage 4 (cleaning with hot water; no detergent),
stage 5 (cleaning with hot water; no detergent),
stage 6 (steam disinfection at .858C), and stage

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Table 1. Continuous improvement results and improvement measures implemented
Phase
7 (cooling cycle with cold water and rinse agent).
A functional maintenance review also occurred at
this time to ensure that the BPDs were meeting manufacturer’s
specifications. In phase 2, the ‘‘intensive
cycle’’ was again reprogrammed to now become the
default setting with a steam disinfection cycle of 90
seconds. Machines were also programmed not to
work if the detergent dispenser was empty. Phase 3
focused on small group intensive education sessions
on 2 pilot wards. Phases 4 and 5 expanded the intensive
education campaign to involve all wards and
included Richmond Hospital in the CQI process.
Machines were adjusted to operate only with both
rinse agent and detergent present in phase 5. Temperature
probes were used during phase 5 on all
BPDs to confirm that machines were achieving thermal
disinfection as per ISO standards.
Audits for the presence of visible fecal soil on processed
items were conducted by infection preventionists
after the improvement measures were implemented at
each phase of the evaluation. Item type, material composition
(polypropylene vs stainless steel), presence or absence
of rinse agent and detergent, and clinical unit were
also recorded.
RESULTS
No. items
audited
Table 1 describes the CQI cycle, audit results, and
improvement measures implemented. A total of
1,982 visual inspections was conducted in the audits.
% Failure
rate Postaudit intervention measures
1 141 23 Staff education
Reposting of instructions for proper use
Machine error codes reviewed and functional issues addressed
Temperature adjusted to 908C
2 359 27% Automatic default of machines to intensive detergent cycle
Machine programmed to halt if detergent dispenser empty
Error code interpretation simplified
System for maintenance to report all malfunctions to ward management established
3* 531 19.4 Vendor provides intensive education on all shifts on 2 pilot units
Infection Control supervises and monitors all BPDs on 2 pilot wards
4 y
511 7.6 Intensive education campaign expanded to involve all wards
Maintenance revises quality program to regularly review functionality of machines
Richmond Hospital included to determine if results and observations are similar in another
facility
5 440 33 All machines adjusted to use only both rinse agent and detergent
Processed items not passing inspection continue to be sent to Sterile Processing for cleaning
and disinfection
Trial of manual cleaning of spray heads on selected machines
Comparison of functionality and machine age conducted
*Phase 3 involved 2 pilot units (intensive care unit and a medical floor) only.
y Phases 4 and 5 involved Richmond Hospital.
Bryce et al. 567
Failure rates declined to 7.6% on 2 pilot wards only
after an intensive education campaign was conducted
and was combined with daily monitoring of processed
items by the Infection Prevention and Control
team. This level of monitoring and education could
not be sustained both on the pilot unit and the
rest of the facility, and failure rates returned to previous
levels within 2 months. When Richmond
Hospital was included in the CQI process, failure
rates were similar, indicating that this was not an isolated
institutional issue. Brands A and B had similar
performance failures. All machines passed temperature
probes tests (phase 5) during their entire wash/
disinfection cycle using the ‘‘intensive’’ disinfection setting.
All machines passed the functional maintenance
check in phase 1 (phase 4 for Richmond Hospital).
Table 2 compares results when rinse agent was present
during the wash/disinfection cycle. Interestingly,
inclusion of the rinse agent, while not decreasing the
failure rate to acceptable levels, resulted in a significant
improvement. Polypropylene materials had a lower
failure rate compared with stainless steel items; the
failure rates for polypropylene and rinse agent in combination
were 1% (P , .0006).
Observations by infection preventionists that the
spray heads were occasionally visibly contaminated
with fecal soil and individual apertures appeared to
be obstructed led to a comparison of machine age and
failure rates (Table 3). Machines that were less than
2 years past installation had significantly fewer processing
failures. Both human factors issues and BPD

568 Bryce et al. American Journal of Infection Control
September 2011
Table 2. Comparison of failure rates when rinse agent present
Item
machine features and equipment design flaws were
identified and are listed in Table 4.
DISCUSSION
Safe reprocessing of equipment is a priority in preventing
the spread of infection to patients and staff.
One of the most commonly used reprocessing machines
is the bedpan washer/disinfector or BPD, which,
importantly, minimizes the risk of staff exposure to
body fluids and fecal material. ISO standards clearly
outline the expected performance parameters; however,
BPDs are seldom subjected to field trials where
human factors, machine design functionality, and
equipment features that influence the cleaning and decontamination
process are evaluated and addressed.
The emergence of hypervirulent strains of Clostridium
difficile and reports of increasing rates of C difficilerelated
infection emphasize the need to rigorously
evaluate the equipment cleaning process and implement
interventions to minimize the potential for cross
transmission. 4-6
The percent of processed items with visible fecal soil
in the audits was disturbing. The initial plan was to
evaluate visible soiling followed by microbiologic and
ultraviolet light testing if fecal soil was not detected.
However, the high percentage of processing failures
readily detected by observation alone made microbiologic
and ultraviolet marker testing somewhat moot,
and the multidisciplinary group elected to pursue process
improvement measures using visual observation
as the progress indicator.
Previous studies by Alfa et al using TOSI testing devices
(Pereg GmBH, Waldkraiburg, Germany) and microbial
and ultraviolet assessments demonstrated that
ward BPDs did not provide an equivalent level of cleaning
compared to sterile processing department washer
Rinse agent No rinse agent
Total Failure, n (%) Total Failure, n (%)
P value
Metal bedpans and pot handles 77 17 (35) 187 93 (50) ,.0004
Polypropylene bedpans and slipper pots 71 4 (1) 73 20 (27) ,.0006
Totals 148 21 (14) 260 113 (44) ,.0001
NOTE. Fischer exact test (2-tailed).
Table 3. Comparison of failures rates and machine age
Year of installation
Number of
observations
Failures,
n (%) Significance
Before 2008 (n 5 32) 321 123 (38.3) P , .001
After 2008 (n 5 6) 80 6 (7.5)
disinfectors. 2 Of particular interest was that the presence
of ultraviolet light marker after the wash cycle
highlighted the inadequacy of washing by ward BPDs.
These observations were made despite controlled conditions
using trained personnel and ensuring that items
were placed properly and processed promptly. Under
normal ward operating conditions and in the presence
of a considerable protein load, it is not surprising that
higher failure rates were detected.
The evaluation of medical equipment using human
factors principles identifies quality and safety issues
of equipment in health care institutions. 7-11 A number
of human factors issues contributed to the processing
failures of the BPDs. Staff did not always process soiled
equipment promptly leaving human waste to dry onto
surfaces, a practice that likely enhanced the protection
of microorganisms against thermal disinfection. 12 Infection
preventionists observed that items were frequently
double stacked in the BPDs, compromising
the ability of the machines to effectively clean items.
Although there was a signed and dated checklist posted
for both cleaning and ward staff to check detergent dispensers
to ensure they were filled, this was not routinely
done, and empty detergent dispensers were
observed. Many staff also indicated that they were
not sure how to properly load the bedpan(s) into
the decontaminator. Staff found the loading racks confusing
and could not clearly identify where a bedpan
should be properly placed in the BPD. Staff would include
perineal care pads as part of the bedpan contents
when processing, resulting in sewer line blockages and
further machine failures. Prior to the CQI process, during
one 6-month period, over 500 maintenance calls
for machine failures (largely because of blockages)
were recorded.
As identified by the Institute of Medicine, ‘‘To err is
human,’’ a major contributor to error in health care is
poor device design. 11 Design flaws of the BPD that contributed
to human error were identified. The user interface
and BPD display was confusing in that errors were
displayed as codes that staff could not interpret. The
display on older machines was also poorly illuminated,
making it easier not to notice an error code signal. The
BPD could be operated with an empty detergent

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Table 4. Factors contributing to processing failures
Human Soiled items not processed immediately after use
Improper loading of BPD
Loading of more than one item into machine
Disposal of paper products other than toilet tissue in machine leading to machine failure
Failure to fill machines with detergent and/or rinse agent
Placement of single use urinals into BPDs for processing
Machine Error codes not explained
No warning light when detergent dispenser empty
Bedpan contents spill over spray head when door closed
Rinse agent and detergent dispenser connections not clearly identified
Design of BPD rack does not provide physical cues or indicators of where soiled items should be loaded
Operation of door not hands free
No forced compliance features for proper loading
Higher temperature facilitates baking of fecal material to stainless steel surfaces
Accessory equipment Inner rims of certain brands of bedpans inaccessible to spray heads
Metal predisposes to baking of fecal material if inadequately washed
Physical design of bedpans does not properly fit into BPD rack
Used pericare items clog the BPD
BPD, bedpan decontaminators.
dispenser because the user was provided no feedback
that the detergent or rinse agent was empty. These
items are all violations of Nielsen’s usability heuristics,
a set of 12 principles for optimal user interface design.
Principles of particular interest in this evaluation included
(1) the match between the design and the real
world (the system should speak the users’ language,
eg, error codes that are easily interpreted); (2) error prevention
(careful design that prevents the problem from
occurring in the first place, eg, spray heads that are not
exposed during disposal of fecal material); (3) recognition
rather than recall (making objects, actions, and options
visible through clear accessible instructions, eg,
clearly labeling rinse and detergent connections); (4)
consistency and standards (eg, ability to understand
what cycle to use); and (5) visibility of system status
(eg, ability to detect the working or nonworking state
of the BPD: empty detergent, clean bedpan in BPD). 13
These human factors and machine design issues
were largely addressed by policy and procedural
changes, and requests to the vendor on forcefunctioning
the design of the BPD to include customized
racks, clearly defined error codes, and device operation.
Forced compliance features so that machines could
only operate on the ‘‘intense cycle’’ and could not function
without detergent, methods to permit disposal of
perineal pads using an alternate system, clearly outlining
who was responsible for ensuring detergent dispensers
were filled, and the performance of quality
maintenance checks addressed most of the previously
described issues. New signage and education to complement
these administrative and engineering controls
were implemented. Despite these interventions, failures
persisted. A significant decrease in process failures was
noted only when a very intensive one-on-one education
Bryce et al. 569
campaign was combined with daily monitoring and supervision
by Infection Prevention and Control team staff
on 2 pilot wards. Such measures proved unsustainable
over the long-term and impractical for implementation
throughout the facility. The CQI process, when extended
to the Richmond community facility, confirmed
that this was not an isolated facility issue.
Several of the auditors observed that, on occasion,
the spray head apertures appeared to be clogged. The
machine design was such that human waste was
dumped over the spray heads when the door was
shut and the bedpans emptied; this likely compromised
the spray apertures. Processing failures were
most evident in machines more than 2 years old, again
suggesting that, over time, spray heads could become
obstructed. These observations lead to the theory that
the addition of the rinse agent (which has a descaling
chemical) might improve cleaning efficacy, and results
were reanalyzed to compare machines with or without
the presence of rinse agent at the time of the observations.
Machines that used rinse agent did show a statistically
significant decrease in failed items; combined
with the increased failures noted with increasing
machine age, it is likely that obstructed spray heads
contribute to BPD disinfection failures. The multidisciplinary
team recommended that all machines use rinse
agent and the procedural change was communicated to
all the floors. Unfortunately, the dispenser connections
for rinse agent and detergent were not clearly identified
creating a potential for staff to incorrectly connect
the fluids. Facility maintenance subsequently had to
color code the dispensing lines for detergent and rinse
agent as a mitigation measure.
Stainless steel items failed more often than polypropylene,
likely because the surface temperature of the

570 Bryce et al. American Journal of Infection Control
September 2011
latter items was higher and, without adequate washing,
fecal material baked onto the surface. 14 The hospitals
are currently in the process of increasing the inventory
of polypropylene items and removing metal bedpans
wherever possible. Finally, spray heads that did not
reach into all surfaces of processed items were a BPD
machine design flaw that contributed to the impaired
cleaning efficacy. This was particularly evident with
one brand of bedpan that had a deeper bowl and rolled
edges and highlights that one must consider the equipment
used on the clinical units when evaluating cleaning
efficacy.
The multidisciplinary team continues to work on a
program to clean and replace spray heads, reinforce
education, and facilitate immediate and correct loading
and processing of items. In the interim, items that remain
visibly soiled after processing through the BPD
are sent to the Sterile Supply Department for thorough
cleaning and disinfection.
BPDs perform an important function in minimizing
risk of exposure to body fluid and fecal material, however,
our data strongly suggest that users should thoroughly
evaluate the in-use efficacy of BPDs (ideally
prior to procurement) and use a step-wise approach
to correct any identified human and equipment deficiencies.
BPDs should not only be simple to operate
and user friendly, but be designed to minimize human
errors (eg, when loading the machine and when replacing
detergent and rinse agent). Furthermore, they
should be designed so that component parts are
shielded from fecal soil during the disposal stages of
operation. Regular inspection of the machines by
maintenance personnel to ensure that spray heads
are fully operational and the machines are functioning
optimally is suggested. (In retrospect, it may have been
beneficial to evaluate the machines using either TOSI
tests or a dye monitor particularly upon initial procurement.)
Forced compliance features for correct loading
of machines and detergent and rinse agent dispensing
with machine operation only in the presence of the latter
agent should be integral to the BPD design. A setting
that incorporates multiple rinses and cleaning cycles
with a prolonged steam disinfection is recommended.
Consideration should be given to the preferential use
of polypropylene items where practical and where
evaluation suggests that reprocessing failures could
be decreased. Purchasers of BPDs are encouraged to
involve user groups and stakeholders upfront and
advocate for these design changes through further
technical and usability in-use studies.
This report highlights the importance of evaluating
equipment for usability from an infection control perspective
in a working health care environment. The authors
hope that it also serves as an example of the need
to integrate human factors analysis in the health care
procurement process of medical devices and equipment.
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