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First publication in BMJ Qual Saf as 10.1136/bmjqs-2020-012149 on 27 October 2020, Publication on GlobalCE Journal: 10 November 2020

Editorial: Unravelling the magic of latent safety threats 

By Y. David   

Forensic Engineering Section, Biomedical Engineering Consultants LLC, Houston, TX, USA.

Sterile processing errors in medical and dental offices are 
ranked the third highest hazard according to the annual ECRI 
‘Top 10 Health Technology Hazards’ 2020 report.1 Other 
experts have raised similar concerns with sterilisation pro-
cesses. For example, the WHO and the Clinical Engineering 
Division of International Federation of Medical and Biological 
Engineering (IFMBE) have partnered to provide a series of 
webinars with international experts exchanging knowledge on 
COVID-19 related  critical  topics. A recent webinar addressed 
the critical challenge of decontamination and disinfection of 
COVID-19 medical equipment in low-income and middle-
income countries.2 During the webinar, participants asked 
about methodologies to assess whether the transmission 
of infection is borne by technological tools used to fight the 
disease. How can critical lifesaving breathing equipment be 
safely and quickly sterilised and moved from one patient to 
the next? The WHO/IFMBE webinar2 stated that ‘engineers 
and infection control professionals seem to be working in dif-
ferent silos’. Such silos must    be dismantled because medical 
technology is indispensable in the provisioning of healthcare 
services. Disinfection and sterilisation of medical equipment 
are key concerns for healthcare organisations, and they require 
serious consideration of sociotechnical system interactions. 
The annual ‘top 10 Health Technology Hazards report’ is based 
on retrospective studies, yet management of COVID-19 safety 
requires capacity to process real- time data and the input of 
experts     to predict where risks may occur and how to deploy 
plans to maintain a safe healthcare environment.
Alfred et al3 in this issue of BMJ Quality & Safety describe 
the Sterile Processing Department (SPD) as ‘an example of a 
socio-technical  system,  where  people, procedure, technology, 
environment, and organization interact to produce a range of 
proximal and distal outcomes’.3 The goal of their study was to 

‘develop a comprehensive understanding of the SPD assembly 
work system by uncovering key relationships between system 
components, and the sources of variance that might influence 
reliable assembly in instrument reprocessing’. They explain 
their findings as a function of a variety of contributing factors 
including: technological, labelling and human capacity issues. 
The authors’ analysis cogently points to interventions ‘beyond 
the hospital’s traditional focus on individual staff ’. Their re-
sults show the necessity of identifying system components 
and the impact of their interactions, to reveal appropriate 
interventions to improve the quality and safety of care and to 
reduce delays. The emphasis on expanding beyond ‘tradition’ 
is particularly pertinent now.

 SAFETY IS A DYNAMIC NON-EVENT
The rapidly evolving  COVID-19  epidemic has stretched the 
capacity of healthcare systems worldwide; consequently 
shining a light on existing quality and safety processes that 
often go unnoticed because, as Karl Weick advanced, safety is 
a dynamic non-event.4,5 Safety is dynamic because processes 
remain within acceptable limits due to moment-to- moment 
adjustments and compensations by the healthcare workers. 
It is a non- event because safe outcomes are taken for granted 
and often go unrecognised. Paradoxically, the public appreciates 
quality and safety more when the system is unsafe, because 
lack of safety is salient, whereas normalcy is not.
You do not have to look far these days to see how much more  
appreciation the public has for the quality and safety of health-
care. However, this level of interest—concern, really—has 
the risk of isolating the responsibility for healthcare safety 
and quality to the (relatively) small group of professionals 
who actually deliver healthcare. It is further presumed to be 

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David: Unravelling the magic of latent safety threats

17 J Global Clinical Engineering Vol.3 Issue 2: 2020J Global Clinical Engineering Vol.3 Issue 2: 2020  16

David: Unravelling the magic of latent safety threats

products of compromised quality, safety and efficacy, in terms 
of poisoning, inadequate or no treatment, contributions to drug 
resistance, the related economic burden, and erosion of public 
trust in the health system; … urgent action is needed by the 
international community, Member States and relevant actors 
in health systems… to develop appropriate norms, standards 
and guidelines, including taking into account national, regional 
and international needs and initiatives,… to prioritize support 
for establishing and strengthening regional and subregional 
networks of regulatory authorities… to promote the greater 
participation of Member States in existing international and 
regional initiatives for collaboration and cooperation… to 
support the building-up of effective national and regional 
regulatory bodies and networks… to raise awareness of the 
importance of effective regulatory systems within the health 
system context’.10 In other words, system safety is dependent 
on coordination of all levels, not each level in isolation, and is 
a shared responsibility. Interventions to address disinfection 
and sterilisation risks are dependent on the coordination of 
all stakeholders, including the public.
As we begin to transform from fragility to vitality, this is the 
moment to convert the present heightened awareness into a 
strategy of education. Together, we should adopt guidelines 
for incorporating healthcare technology life cycle manage-
ment beyond the focal point of products entry into the market 
and expand it to include consideration of the entire health-
care technology life cycles. From ideation to obsolescence, 
healthcare technology should be benchmarked at every 
stage based on indicators that every member including the 
public can understand, relate to and embrace as measure of 
minimum acceptable performance level for safety and qual-
ity. This will include the public, who for example may begin 
using home-based medical technology more than ever, in 
gaining participation to make care decisions. Every segment 
of care providers will now have tools to assess the whole life 
cycle of medical  products  from   installation, performance 
assurance, upgrades, reallocation and retirement from one 
market to another.
Regardless of the reasons that led to relegating the quality 
and safety role only to those professionals who were formally 
tasked with it, we must embrace the strategy to expand the 
responsibility to the public. Instead of a single product men-
tality, let us challenge our ability to measure and embed pre-
dictive preventive measures of system performance. Critical 
characteristics of safety and quality management can be used
to measure and mitigate latent risks and can be used to rank 
healthcare delivery and provide a ‘report card’ that can en-
hance choices the public can make. I suggest, therefore, a call 
for action to establish national institutions and international 
cooperation that will promote and harmonise safety and quality 

indicators relating to technological tools being deployed in 
our healthcare delivery systems.
No more magic show.

Funding The authors have not declared a specific grant for this 
research from any funding agency in the public, commercial 
or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Commissioned; internally 
peer reviewed.

ACKNOWLEDGEMENT
The GlobalCE Journal acknowledges the permission given 
from BMJ Quality and Safety to post this Editorial.

REFERENCES

1. Emergency Care Research Institute (ECRI). Top 10 
health technology hazards for 2020. Expert insights 
from health devices. Special report, 2019. Available: 
https://www. ecri.org/landing-2020-top-ten-health-
technology-hazards [Accessed Sep 27].

2. International Federation of Medical and Biological En-
gineering (IFMBE). Online course 7. Decontamination-
Disinfection of critical COVID-19 equipment, health 
workers, and patients. Available: https://ced.ifmbe.
org/covid19/guruPrograms/16-covid19/16-covid19-
townhalls-decontamination.html [Accessed Sep 27].

3. Alfred M, Catchpole K, Huffer E, et al. Work systems 
analysis of sterile processing: assembly. BMJ Qual Saf 
2020:bmjqs-2019-010740.

4. Weick KE. Organizational culture as a source of high 
reliability. Calif Manage Rev 1987;29:112–27.

5. Reason J. Safety paradoxes and safety culture. Inj 
Control Saf Promot 2000;7:3–14.

6. Zhang J, Li J, Wu Z. The Chinese experience - fighting 
against COVID-19, Shanxi Medical engineers. Global 
Clinical Engineering Journal 2020;2:35–8.

7. Alfred M, Catchpole K, Huffer E, et al. Work systems 
analysis of sterile processing: decontamination. BMJ 
Qual Saf 2020;29:320–8.

their job to teach and apply medical, engineering and other 
scientific knowledge to improve the quality and safety of ev-
erything related to the healthcare services. However, we now 
realise that these presump tions need to be examined. Recent 
global conditions have demonstrated that national emergency 
response plans and the stocking of medical supplies fell short 
of expectations. Yet with the inclusion of experts specifically 
trained in safety and quality, these plans are already better 
networked with the supply chain that is being designed to 
be patient ready when urgently needed. Similarly, safety and 
clinical engineers were finally permitted to use ultraviolet 
radiation as sterilisation technology in patient care spaces. 
Ultraviolet radiation is not a new tool, but it is now applied 
because of expert recommendations and consequently it 
now plays an important role in protecting medical personnel, 
patients and family members.6

All of this begs the question: why has COVID-19 spurred recog-
nition on the part of the public, and by medical professionals, 
of safety and quality controls in the delivery of healthcare? 
Pandemics highlight the existing people and processes that 
keep our systems safe and the fact that these elements of our 
system are not failsafe. There are threats in the system that 
remain latent because people are dynamically adapting in 
real time, but when the system is stretched too far, the threats 
no longer remain dormant. Deploying a predictive model of 
quality and safety, with professionals specifically trained in 
these areas, will be impactful to show in which scenarios 
such threats are likely to appear and can be timely mitigated.

UNDERSTANDING WHAT KEEPS OUR SYSTEMS 
SAFE

Without sufficient knowledge of what protects us, the am-
biguous methodology for optimal provisioning of staff and 
patient safety was initially like performing magic. Starting 
with the elderly community and later with all ages, it has been 
like watching a Houdini act—how did that illusion which we 
were watching just happen? Will it happen again? As noted 
above, we need to re-examine the presumptions we hold 
about delivering safe and high-quality healthcare services. 
Once we understand the latent threats in the system, these 
can become controllable features. What appears to be magic is 
anything but. There are many system factors at play—people, 
processes and technologies— that are keeping us safe, but 
they require further attention if they are to remain safe under 
unprecedented conditions.
Neither safety nor quality seems to have kept up in the rush 
to find an effective response to the pandemic. Whose job is 
it to keep up? As pointed out by Alfred et al3 regarding the 
instrument assembly process and a previous paper on the 
decontamination of instruments7 if we fail to identify all the 

system factors and their interactions, we fail to understand 
what keeps our systems safe. Consequently, we make as-
sumptions about the backbones of our system, and when 
the system reaches its breaking point, we jump to solutions 
that are not aligned with the true root cause of the problem 
because we do not understand the mechanisms that underlie 
the safe operating state.
Previous examples regarding problems with instrument re-
processing have already pointed to the lack of understanding 
on the systems factors at play that led to poor solutions. For 
instance, I participated in an investigation in 2005 following 
the exposure of patients during surgeries in Duke University 
Health System, to instruments that were processed between 
procedures in hydraulic fluid instead of cleaning detergent.8 
The hospitals did not detect the problem for weeks, despite 
complaints from staff members that the instruments felt 
unusually slick. The mix-up occurred when an elevator com-
pany drained hydraulic fluid into empty detergent barrels 
and the detergent supplier mistakenly redistributed them. 
The COVID-19 pandemic has emphasised the importance 
of decreasing instrument contamination risks9 as well as a 
general sense of urgency that may impose the risk of jump-
ing to solutions too quickly. It is important to note that these 
latent safety threats have been there all along, but we  are just 
noticing them more now than before because some of them 
are no longer latent. It was never magic; it was always the 
steady and adaptive coping of system factors—mostly people 
in the background—that never got recognised.
People around the world are now more clearly recognising 
their own responsibility and the benefits of adopting a more 
safety-oriented culture in their personal lives as well as in the 
products they use. The respect of paying homage to safety 
reached such a high awareness that one must again wonder, 
why did it take a global devastating pandemic to bring us to 
this level? And can the same be stated about quality?

URGENT NEED TO IMPLEMENT APPROPRIATE 
SOLUTIONS FOR SOCIOTECHNICAL PROBLEMS
Alfred et al3 in their analysis of sterile processing already 
pointed to the need ‘for a wider range of interventions to en-
hance system performance beyond the hospital’s traditional 
focus on individual staff behaviours and motivations’. System 
safety is thus dependent on the coordination of healthcare staff 
and management at the front line of service deliveries with 
the manufacturers who produce medical products, regulatory 
bodies and government who monitor its introduction into the 
market and clinical engineers who manage it over its life cycle 
use. This was acknowledged and highlighted by the 67th World 
Health Assembly when they issued a declaration in 2014 that 
states, in part, ‘[C]oncerned by the impact on patients of medical 

ecri.org/landing
https://ced.ifmbe.org/covid19/guruPrograms/16-covid19/16-covid19-townhalls-decontamination.html
https://ced.ifmbe.org/covid19/guruPrograms/16-covid19/16-covid19-townhalls-decontamination.html
https://ced.ifmbe.org/covid19/guruPrograms/16-covid19/16-covid19-townhalls-decontamination.html


David: Unravelling the magic of latent safety threats

J Global Clinical Engineering Vol.3 Issue 2: 2020  18

8. The New York Times. Surgical Tools 'Washed' in 
Hydraulic Fluid. Available: https://www.nytimes.
com/2005/06/13/us/ surgical-tools-washed-in-
hydraulic-fluid.html

9. Aj B, Brown C, Abdelrahman T, et al. International 
surgical guidance for COVID-19: Validation using an 

international Delphi process - Cross-sectional study. 
Int J Surg 2020;79:309–16.

10. World Health Organisation. Regulatory system strength-
ening for medical products. Sixty-seventy World health 
assembly, 2014. Available: https://apps.who.int/gb/
ebwha/pdf_files/ WHA67/A67_R20-en.pdf?ua=1 
[Accessed Sep 27].

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surgical-tools-washed-in-hydraulic-fluid.html
https://apps.who.int/gb/ebwha/pdf_files
https://apps.who.int/gb/ebwha/pdf_files
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