MIDAS: Monitoring and decontamination of hospital medical instruments; new ultra-sensitive methods and new government guidelines
Submitting InstitutionsUniversity of St Andrews,
University of Edinburgh
Unit of AssessmentChemistry
Summary Impact TypePolitical
Research Subject Area(s)
Medical and Health Sciences: Medical Microbiology, Neurosciences
Summary of the impact
Impact type: Public Policy; Health (and related economic);
Significance: the research of the MIDAS (Medical Instrument
Decontamination and Screening) group has been used to formulate Department
of Health (DH) policy with respect to both the standard of contamination
monitoring and the quality of instrument decontamination procedures. The
Code of Practice CFPP 01-01, 2012 advocates the adoption of MIDAS's
technology throughout the NHS. With effect from July 2012, this is
contributing to reducing cancelled operations, 126,000 p.a., due to dirty
instruments, minimising the risk of new cases of terminal, Transmissible
Spongiform Encephalopathy (TSE) diseases, and reversal of the fear-driven,
growing trend towards disposable instruments (at an estimated cost of ca
£7bn worldwide). As a minimum estimate, this policy helps the work of
20,000 NHS sterile services hospital staff and contributes to the health
and safety of all patients who now undergo surgery. Edinburgh Biosciences
Ltd is employing four staff (2 PhD level) to manufacture and market
MIDAS's new decontamination monitoring instrumentation.
Research; date; attribution: Between 2002 and 2008 the Baxter and
Jones groups developed and reported new methods to quantify and remove
residual protein contamination on `cleaned' hospital instruments. They set
up MIDAS, the Medical Instrument Decontamination and Screening group, to
develop and apply these methods for in situ, quantitative,
ultra-sensitive detection of surface-bound, biological contamination on
medical devices and for the removal of this contamination to levels below
the limit of detection.
Reach: The code of practice is currently in force at the UK level.
Edinburgh Biosciences is commercialising decontamination monitoring
systems for an international market.
Effective instrument decontamination significantly reduces the
unnecessary burden of cancelled surgical procedures and the waste
generated by use of disposable items.
Three per cent (ca. 126,000 operations) of all operations carried
out annually in the UK have to be cancelled due to instrument
cleaning/failure problems. In the US 34 million surgical operations are
carried out each year, with a similar cancellation rate. There is
currently great concern about healthcare-associated infection, and its
negative impact on the public perception of the NHS. Lack of confidence in
decontamination is leading to increased use of disposable surgical
instruments. The global market for disposable hospital supplies is
currently ca £7bn with expected 6 % annual growth. [GlobalData
report, Mar 2013].
The inability of conventional instrument decontamination methods to
inactivate prion proteins, the infective agents of Transmissible
Spongiform Encephalopathy (TSE) diseases such as Creutzfeld- Jacob Disease
(CJD) has been a recent focus of public and professional concern. By 2009,
there were 61 worldwide confirmed cases of iatrogenic CJD, i.e. that
contracted by transmission during surgery, particularly in neuro- and
National Creutzfeldt-Jakob Disease Surveillance Unit (NCJDSU)].
Recognising that improvements in quality assurance and efficacy of
cleaning of medical instruments would reduce hospital-acquired infections
and cancelled operations the MIDAS (Medical Instrument Decontamination and
Screening) project was set up by Baxter, Baxter, and Jones (all EaStCHEM)
in 2002. With core funding from the Department of Health (DoH) its remit
is the invention, evaluation and application of new methods for
decontamination of medical devices and for the detection of biological
material on surfaces.
The group carried out the first quantitative survey of protein
contamination levels on `cleaned' hospital instruments (DoH report
December 2003; published 2006). They then developed a series of
`latent' fluorescent probes and protocols for in situ labelling of
protein residues on surfaces. They developed a new epifluorescence
scanning technique, EFSCAN, to measure these fluorescent, labelled
residues, pushing the level of detection of proteins on surfaces down to ca.
100 attomoles mm-2  The new technique was fast and
quantitative, and exceeded the sensitivity of the commonly used ninhydrin
swab test by more than 5 orders of magnitude, and was patented.
In parallel, the group developed RF gas-plasma methods for direct
oxidation and elimination of proteins, including transmissible spongiform
encephalopathy (TSE) infective tissue, from metal surfaces of medical
instruments. Recognising that this method is capable of eliminating the
risk of iatrogenic CJD transmission between patients by surgery, this RF
method was patented.
The proven combination of gas plasma removal, and epifluorescence
scanning to confirm decontamination, led to the work with Edinburgh
BioSciences to develop EFSCAN technology into a device.
Two further research projects were initiated in 2008 arising from funding
from CONTEST, the UK Government's counter-terrorism strategy program on
the detection and decontamination of toxins and biological agents:
`High-Level Decontamination using RF Gas-Plasma' and `Ultra-sensitive
Detection of Specific Biomolecules on Surfaces'. These provided robust
evidence that toxins and biological agents can be detected and effectively
cleaned from the surface of personal possessions and sensitive equipment
in the context of CBRN (chemical, biological, radiological, and nuclear)
clean-up, for example, the demonstration of Bacillus spp spore
inactivation by gas-plasma treatment (2008).
Prof R.L. Baxter, from 05/80 - 08/12 retirement; Dr H.C. Baxter, from
05/98 - 06/12 retirement; Prof A.C. Jones, from 01/89 to date: MIDAS PIs
with complementary expertise in biological chemistry, transmissible
spongiform encephalopathy (TSE), and spectroscopy research.
A.G. Whittaker, E.M. Graham, P.R. Richardson, G. Meek, G.A. Campbell, K.
Grant, H. Halouani: PhD students, PDRAs, and research fellows in the
research groups of the PIs. A. Aitken and M. Casey are collaborating
medical experts at the University of Edinburgh, G. Meek is a collaborating
Dental Surgeon, J.S. Barton, R. Maier and V.I Kovalev are collaborators at
Heriot Watt University, and G. DeLarge is an industrial collaborator in a
RF gas plasma cleaning company (Plasma-Etch).
References to the research
The MIDAS group has been funded by a series of grants from the Department
of Health, as well as funding from the Home Office. The journal articles,
together with official reports, have informed Department of Health policy
with regard to decontamination of surgical instruments.
Publications (Underpinning research has been published in
international, high-quality, peer reviewed, academic journals and
receives citations from across the research area; A number of other
(non-peer reviewed) articles have been published in the popular medical
literature, accessible to a wide range of health professionals.)
 * Quantitative Analysis of Residual Protein Contamination on
Reprocessed Surgical Instruments; R. L. Baxter, H.C. Baxter, G. A.
Campbell, K. Grant, A.C. Jones, P.R. Richardson, A.G. Whittaker, J.
Hosp. Infection, 2006, 63, 439-44. doi:10.1016/j.jhin.2006.03.011.
25 cits, JIF 2.9.
 In Situ Detection of Residual Protein Contamination on
Surgical Instruments for On-the-Spot Monitoring of Decontamination. H.C.
Baxter, A.C. Jones, R.L. Baxter, Am. J. Infection Control, 2012,
40, e166-8. doi:10.1016/j.ajic.2012.04.296.
0 cits, JIF 2.7.
 * Plasma cleaning of Dental Instruments; A.G. Whittaker, E.M. Graham,
R.L. Baxter, A.C. Jones, P.R. Richardson, G. Meek, G.A. Campbell, A.
Aitken, H.C. Baxter; J. Hosp. Infection, 2004, 56,
10.1016/j.jhin.2003.09.019. 28 cits, JIF 2.9.
 * Application of epifluorescence scanning for monitoring the efficacy
of protein removal by RF gas-plasma decontamination. H.C. Baxter, P.R.
Richardson, G.A. Campbell, V.I. Kovalev, R. Maier, J.S. Barton, A.C.
Jones, G. DeLarge, M. Casey, R.L. Baxter. New J. Phys. 2009,
11, 115028-42. doi:10.1088/1367-2630/11/11/115028.
3 cits, JIF 4.1.
 R.L. Baxter, H.C. Baxter, A.C. Jones, G.A. Whittaker, G.A. Campbell,
H. Halouani, P.R. Richardson, The University of Edinburgh: `Latent
Fluorescent Probes' 2008, WO/2008/047129.
 R.L. Baxter, H.C. Baxter, The University of Edinburgh: `Plasma
Cleaning Methods for Medical, Surgical and Dental Instruments'. 2006,
Grants Awarded (all peer reviewed)
• Cleaning and Monitoring of Protein Contamination of Surgical
Instruments and Medical Devices (RL Baxter, HC Baxter, AC Jones & G
Whittaker, Department of Health, 2002-6, £1,220k).
• Removal of Infective Protein Residues from Medical Instruments (RL
Baxter, HC Baxter, AC Jones, Department of Health, 2006-7, £130k).
• Evaluation of gas-plasma decontamination for TSE inactivation (RL
Baxter, HC Baxter, AC Jones, Department of Health, 2007-8, £72k).
• High-Level Decontamination using RF Gas-Plasma (RL Baxter, HC Baxter,
AC Jones, Home Office, 2008-10, £120k).
• Ultra-sensitive detection of specific biomolecules on surfaces (RL
Baxter, HC Baxter, AC Jones, Home Office, 2008-10, £120k).
• Assessment of EFSCAN technology for detection of residual protein
contamination on surgical instruments (RL Baxter, HC Baxter, AC Jones,
Department of Health 2011, £100k).
Details of the impact
Results of the MIDAS group on the quantification of contamination levels
on 'clean' surgical instruments have been used to formulate, and are
continuing to influence, government policy. As a minimum estimate, this
policy helps the work of 20,000 NHS sterile services hospital staff and
contributes to the health and safety of all patients who now undergo
surgery, and the technology has been considered at an operation level at
the Home Office for use in the aftermath of a CBRN incident. The new
EFSCAN technology is in the final stages of commercialisation.
1. Public NHS policy: surgical equipment contamination monitoring and
The MIDAS group's research findings described in section 2 have been used
in the formulation of 2012 Department of Health policy. The 2012/13 policy
framework, CFPP-01-01 (Choice Framework for Local Policy Procedures for
Decontamination) is the code of practice for the management and
decontamination of surgical instruments that is adopted throughout the
NHS, as required by the Health and Social Care Act 2008 with regard to NHS
Decontamination (Sterile Services; Parts E and work acknowledged in Parts
A and B) facilities.[S1]
CFPP-01-01 explicitly cites the researchers and describes the studies
completed by the MIDAS group: Part A, see text on P8, paragraph 2.40
(section on 'Protein quantification using epifluorescence scanning'), p29,
paragraph A1 (chapter on 'Inactivation of prions using novel technologies'
describing 'instrument exposure to cold plasma' and further references on
p38, paragraph A86. It also cites the report 'ESAC-Pr: New
Technologies Working Group Report on Prion Inactivating Agents' written by
the working group (2008), of which R. Baxter is a member.[S2] This report
includes citations and references to the MIDAS research on pps
MIDAS has extended the technology through research trials currently
underway with Edinburgh Royal Infirmary, Ninewells (Dundee), Glasgow
Dental Hospital. The consultant microbiologist, leading the work says "The
introduction of new detection technology, such as EFSCAN, is essential
to drive improvements in the standards of decontamination of medical
instruments throughout the Health Service".[F1] Data obtained in
these projects will inform supplements to CFPP-01-01[S1] with regard to
defining maximum permissible levels of protein contamination on
reprocessed surgical devices and driving the adoption of new detection
technology (such as EFSCAN) when commercial systems become available. A
letter of support from a DoH Senior Principal Research Officer states "We
will continue to use the outputs from this study as we develop aspects
of the CFPP in future and anticipate that successful commercialisation
of your technology for assessment of instrument decontamination will
make it available to NHS Trusts for their surgical sterilisation
The CONTEST funded research demonstrated the efficacy of the EFSCAN
technology for both detection and decontamination of material from
possessions and equipment clean-up after a CBRN incident. In a
corroborating letter, the DoH CBRN Research Manager states "There is a
clear concept of use of the research findings, namely to detect
contamination and provide clean possessions and other sensitive items in
the aftermath of a CBRN incident... results from the projects have been
considered at an operational level at the Home Office".[F3]
3. Economic: commercialisation of EFSCAN for detection of
Through Edinburgh Research Innovation, MIDAS exploited the IP developed
in the 2002-8 research. Working with Edinburgh Biosciences, a
proof-of-concept EFSCAN instrument for hospital Sterile Services
Departments use was constructed in 2011-12. In early 2013, Edinburgh
BioSciences was awarded a SMART:SCOTLAND grant of £100k by Scottish
Enterprise to develop and bring the EFSCAN system to market by the end of
2013. Edinburgh Biosciences UK has four salaried people now developing the
EFSCAN proof-of-concept design into commercial prototypes for manufacture
and marketing. Two are PhD level engineers, one Masters (mechanical
engineering); and an electronic engineer (honours degree). The Edinburgh
Biosciences CEO said "Following the successful development of a
proof-of-concept instrument, Edinburgh Biosciences Ltd. sees commercial
exploitation of this instrument as a key element of its business launch
plan. As the reliability and performance characteristics of the system
are confirmed, marketing and sales of the instrument will expand
internationally from a UK base. The US is a target market given that
awareness of the problems of contamination of surgical instruments is
already in the public domain".[F4]
A portable `hand-held' fluorescence detector for fast detection of
biomolecules on surfaces, in the context of homeland security, has also
The press (Telegraph, Guardian, Scotsman newspaper articles; BBC News and
radio, and specialist publications) note the value to public and the
profession, and cite MIDAS's work directly. Examples include BBC
reports,[S3],[S4] and an Association for Perioperative Practice report
which cites [S1], stating "The prevention of infection is one of the
fundamental principles of patient care...The effective decontamination
of surgical instruments is critical in the management of healthcare
associated infection and patient safety; therefore it is essential that
practices and processes applied to thorough decontamination of all
surgical instruments is of the highest quality and reflects modern day
Sources to corroborate the impact
[S1] Choice Framework for local Policy and Procedures (CFPP) 01-01. March
2013 — 'Management and decontamination of surgical instruments used in
acute care'. https://www.gov.uk/government/publications/management-and-decontamination-of-surgical-instruments-used-in-acute-care.
(Section E as well as
acknowledgements in Section A and B)
[S2] 'ESAC-Pr: New Technologies Working Group Report on Prion
Inactivating Agents' (August 2008.http://webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh.gov.uk/prod_consu
[F1] A corroborating letter is provided by the microbiology consultant,
based at Glasgow Dental Hospital, responsible for decontamination in NHS
Glasgow and Clyde Hospital, who led the study using EFSCAN on "Reducing
the risk of vCJD by improving the cleaning of neurosurgical instruments",
funded by the Scottish Government.
[F2] A corroborating letter from the Senior Principal Research Officer,
Department of Health Policy Research Programme.
[F3] A corroborating letter from the CBRN Research Manager, Research
& Development Division, Department of Health.
[F4] A corroborating letter from the CEO of Edinburgh Biosciences.
[S3] Surgery patients at risk from CJD, 2011: http://www.bbc.co.uk/news/health-12898082.
[S4] Unsafe surgical instruments delay Glasgow operations, 2013:http://www.bbc.co.uk/news/uk-
[S5] Report from the Association for Perioperative Practice http://www.afpp.org.uk/news/resources/decontamination).