CERETOM® PORTABLE CT SCANNER

HEALTH TECHNOLOGY ASSESSMENT SECTION

MEDICAL DEVELOPMENT DIVISION
HEALTH TECHNOLOGY ASSESSMENT SECTION
MEDICAL DEVELOPMENT DIVISION
MINISTRY OF HEALTH MALAYSIA
MINISTRY OF HEALTH MALAYSIA
016/2009

016/2009
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DISCLAIMER

Technology review is a brief report, prepared on an urgent basis, which draws on restricted
reviews from analysis of pertinent literature, on expert opinion and / or regulatory status where
appropriate. It is subjected to an external review process. While effort has been made to do so,
this document may not fully reflect all scientific research available. Additionally, other relevant
scientific findings may have been reported since completion of this review.

Please contact: htamalaysia@moh.gov.my, if you would like further information.

Health Technology Assessment Section (MaHTAS),

Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Government Office Complex
62590 Putrajaya

Tel: 603 88831246

Fax: 603 8883 1230

Available at the following website: http://www.moh.gov.my

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Prepared by:
Mr Beh Joo Sin
Research Officer
Health Technology Assessment Section (MaHTAS)
Ministry of Health Malaysia

Reviewed by:
Datin Dr Rugayah Bakri
Deputy Director
Health Technology Assessment Section (MaHTAS)
Ministry of Health Malaysia

Externally Reviewed by:

Prof. Dato’ Dr Abu Hassan Asaari bin Abdullah
Senior Consultant Traumatology and
Head of Emergency Department
Kuala Lumpur Hospital

Datin Dr Zaharah Musa

Head of Radiology Department
Selayang Hospital

DISCLOSURE

The author of this report has no competing interest in this subject and the preparation of this
report is totally funded by the Ministry of Health, Malaysia.

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 EXECUTIVE SUMMARY

Introduction

This technology review was conducted following a request from the Senior Principal Assistant
Director of Engineering Services Division, Ministry of Health (MOH). It was requested to look
into the possibility of installing CereTom® Portable Computed Tomography (CT) scanner in
MOH hospitals especially in the Accident and Emergency (A&E) department.

Objective

The objective of this review was to determine the safety, effectiveness and cost-effectiveness of
CereTom® Portable CT Scanner to diagnose head and neck conditions.

Results and conclusion

The product is Conformité Européenne (CE)-marked and carries European Conformity (EC)
Certificate No. 41315235. In addition, the product was cleared by the United States (US) Food
and Drug Administration (FDA) 510 (k) and carries 510 (k) No. K051765.

Only two studies (one cost analysis study and one prospective (cohort) study of CereTom ®’s
predicate device namely Tomoscan M) were included in this review. There was no retrievable
evidence on CereTom®’s clinical safety except on clinical safety of Tomoscan M. There was no
evidence on effectiveness of CereTom® portable CT scanner retrieved. Similarly, there was no
evidence on cost-effectiveness of CereTom® portable CT scanner retrieved. However, the
product’s core system is priced at US $300 000 (or equivalent to RM 1 061 000) in the US
market.

Recommendation

The device is not recommended for routine use in A&E due to absence of retrievable evidence
on the CereTom® per se. However, since it has US FDA approval and CE mark, it can be
considered as a research tool only if cost is not a concern.

Methods

US FDA 510 (k) Premarket Notification Medical Devices database was accessed for
confirmation of 510 (k) clearance. An electronic literature search was performed in Horizon
Scanning database for any prioritizing summary and Horizon Scanning report. Next, the search
was also performed in Centre for Reviews and Dissemination (CRD) database for any Health
Technology Assessment report. Subsequently, the search was performed in Embase and Medline
for published literature. After that, articles were identified from the bibliographies of retrieved
literature. The literature was then appraised critically with Critical Appraisal Skills Programme
(CASP) checklist.

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 CERETOM® PORTABLE CT SCANNER

1. INTRODUCTION

Computed Tomography (CT) remains the use for the diagnosis and also management of
many central nervous system diseases. Notably, CT is superior to Magnetic Resonance
Imaging in the assessment of head injury.1 Indications for head CT imaging
(angiography and venography) include acute stroke, transient ischaemic attack, acute
subarachnoid haemorrhage and acute head injury.1

According to the Scottish National Health Service (NHS), an Accident and Emergency
(A&E) department is a hospital department which provides a service primarily for the
reception, assessment, examination and treatment of patients who have been involved in
an accident, or have sustained an injury or who have an acute surgical or medical
emergency which may require hospital facilities.2 Among the main conditions presented
in the A&E department are head and neck injuries and stroke.

1.1. Head Injury, Traumatic Brain Injury (TBI) and Neck Injury

According to World Health Organization (WHO) International Classification of

Diseases (ICD-10) Chapter XIX Blocks S00 – S09, injuries to the head encompass the
injury of cranial nerves and intracranial injury.3

Although various mechanisms may cause TBI, the most common causes include motor
vehicle accidents, falls, assaults, sports-related injuries and penetrating trauma.4

A head injury may be accompanied by a cervical injury. Although this is an infrequent

event, the need to take measures to 'clear the possibility of cervical spine injury' is well-
established component in the assessment of a patient with head injury.5

Each year, an estimated 1 million people in the UK go to hospital as a result of a head

injury.6 Thus, the estimated incidence rate of head injury was 1639 per 100 000 person-
years. (derived from 6 and 7)

In Malaysia, there was a registry conducted by National Trauma Database from May
2006 to April 2007 prospectively. The participating sites were five Hospitals (Kuala
Lumpur Hospital, Pulau Pinang Hospital, Selayang Hospital, Sultanah Aminah Hospital
and Sultanah Bahiyah Hospital) in the major cities of Malaysia. Among 123 916 trauma
patients (who satisfy the definition of Major Trauma and TBI) admitted to the

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 emergency departments in the five hospitals, it can be concluded that all victims were
suffering from either mild (Glasgow Coma Score1 (GCS) 13 – 15) or moderate (GCS 9
– 12) or severe (GCS 3 – 8) head injuries except those 63 cases of missing data in the
Major Trauma category.8 Thus, the percentage of patients suffering from head injury
among the trauma patients was as high as 99.95% assuming the missing 63 cases were
non-head-injury cases.

1.2. Stroke

According to World Health Organization (WHO) International Classification of

Diseases (ICD-10), stroke is included in Chapter IX cerebrovascular diseases
Blocks I60-I69.3 Stroke is an apt description of the dramatic event frequently produced
by a vascular lesion in the brain.11

The age-adjusted incidence of stroke in the west is between 100 and 300 per 100 000
person-years.12 Besides, a survey of seven cities done between 1986 – 1990 in China
yielded yearly rate of age-adjusted stroke of 216 per 100 000 population.12

This technology review was conducted following a request from the Senior Principal
Assistant Director of Engineering Services Division, MOH. The review was requested to
look into the possibility of installing CereTom® Portable CT scanner in MOH hospitals
especially in the A&E department.

2. OBJECTIVE

The objective of this review was to determine the safety, effectiveness and cost-
effectiveness of CereTom® portable CT scanner to diagnose head and neck
conditions.

1
Glasgow Coma Scale provides a framework for describing the state of a patient in terms of three aspects of
responsiveness: best eye opening (four states), best verbal response (five states), and best motor response (six
states), each stratified according to increasing degree of impairment (assigned with score in descending order
respectively).9 Glasgow Coma Score is, in turn, the sum of scores for all the three aspects. It is scored between 3 and
15, 3 being the worst and 15 the best.10

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 3. TECHNICAL FEATURE

Claiming to be point of care CT scanner, CereTom® also maintains generation of

diagnostic-quality CT image.13 It is designed specifically for scans of the head and
neck.14 Thus, it is claimed to be suitable for patients who are at risk of complications
during transportation to the radiology department.

3.1 The Core System

The core system of CereTom® Portable CT Scanner consists of an eight-slice CT

scanner, imaging workstation and radiolucent scan board and bed adapter .15 (Please see
Figure 1a and Figure 1b)

Figure 1a: The Front View and Side View of Eight-slice CT Scanner

Figure 1b: The Imaging Workstation and Radiolucent Scan Board and Bed
Adapter

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 3.1.1. The Eight-Slice CT Scanner

It is optimised for scanning any anatomy that can be imaged in the 25 cm field
of view.16 Therefore, specifically designed for head and neck anatomy. It
generates up to 8 slices per revolution and is capable of performing non-
contrast, angiography, contrast perfusion and xenon perfusion scans.15, 16

3.1.2. The Imaging Workstation

It is installed with advanced visualisation software package allowing for two-

dimensional (2D), 3D and multiplanar reformation (MPR) viewing.15

3.1.3. The Radiolucent Scan Board and Bed Adapter

This combination of radiolucent scan board and bed adapter is claimed to

virtually adapt to every hospital bed to transform into a safe scanning
platform.15

3.2 Scan Dose to the Patient

The dose is controlled by the combination of two settings namely resolution mode (in
turn, controlling scan time of 2, 4 or 6 seconds) and tube current (1 to 7 mA).17 The
scan time of 2 seconds (at the tube current of 7 mA) is recommendable to maintain the
American College of Radiology (ACR) reference limit and to pass the criterion for
ACR accreditation of 80 milli-gray (mGy) [volume CT dose index (CTDIvol)]2.17

2
CTDIvol is CTDI for helical scans and is in units of mGy or Rads (note that 10 mGy is equivalent to 1 Rad).16

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 4. METHODOLOGY

4.1. Literature Search Strategy

4.1.1. On the Technical Safety (or Performance) Only

No search was performed as the regulatory affair certificates were provided by the
requestor. However, the United States Food and Drug Administration 510 (k)
Premarket Notification Medical Devices database was accessed to confirm the
510 (k) Summary provided.

4.1.2. On the Clinical Safety, Effectiveness and Cost-effectiveness

An electronic literature search was performed in Horizon Scanning database for

any prioritizing summary and Horizon Scanning report. Next, the search was also
performed in Centre for Reviews and Dissemination (CRD) database for any
Health Technology Assessment report and National Health Service (NHS)
Economic Evaluation Database report. Subsequently, the search was performed in
Embase and Medline for published literature. Last but not least, articles were
identified from the bibliographies of retrieved literature.

CereTom® is a new device in the market. Therefore, its predicate devices’ terms
including Philip’s Tomoscan, General Electric (GE)’s LightSpeed and Siemens’
SOMATOM (which were mentioned in Food and Drug Administration (FDA)
510 (k) Summary) were also used for the literature search purpose. In the Horizon
Scanning and CRD databases, search terms used were CereTom, Tomoscan,
Tomoscan CT, Tomoscan M/EG, Philips Tomoscan, LightSpeed, GE LightSpeed,
LightSpeed Ultra, SOMATOM, Siemens SOMATOM and SOMATOM Plus.
Whereas in the Horizon Scanning database alone, the terms used were Head
injury and Head injury Tomography. While in the Embase and Medline,
search terms used were CereTom, (Portable CT Scanner AND CereTom) and
NL3000. The publication time window for Embase and Medline databases was
1996 – 2009. Whereas in the Medline alone, the terms used were Tomoscan, (GE
AND LightSpeed), Siemens SOMATOM, SOMATOM Plus, (Mobile CT AND
Tomoscan), (Mobile CT AND Cost) and (Portable CT AND Cost). The
publication time window for Medline database only was 1950 – 2009. Beside
these databases, search terms (Transportable CT AND stroke), (Portable CT
AND stroke), (Mobile CT AND stroke) and Transportable CT Scanner were
used in PubMed database. Only articles related to human were searched for in the
PubMed.

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4.2. Literature Selection

4.2.1 . Inclusion Criteria

a) All published clinical trials were included.

b) Only publication which involved CereTom® or its predicates was included.
c) Only publication with at least one aspect of the following:
i) clinical safety
ii) diagnostic accuracy efficacy
iii) economic evaluation
was included.

4.2.2 . Exclusion Criterion

a) Publication abstract was excluded.

Critical appraisal of the relevant publications was performed using Critical Appraisal
Skills Programme (CASP) checklists. The evidence was not graded based on NHS
CRD, University of York’s Report No. 4 (2nd Edition) due to lack of diagnostic
accuracy efficacy or data contributing to it. The evidence was also extracted into the
evidence tables (see Appendix 1).

5. RESULTS AND DISCUSSION

The search strategy yielded no relevant articles in Horizon Scanning and CRD databases.
Whereas, the searches performed in Embase and Medline yielded two articles18, 19
related to CereTom® and its predicate device i.e. Tomoscan M respectively. Besides, the
searches done in PubMed also yielded two articles20, 21 related to Tomoscan M. In
addition, one publication abstract22 and one article23 were identified from the
bibliographies of the narrative review done by Hayner GJ and Ferenschak J18 on
CereTom®.

Eventually, only two published articles21, 23 were critically appraised after considering
both the inclusion and exclusion criteria. They consisted of one cost analysis study and
one prospective (cohort) study using Tomoscan M compared with conventional CT
scanner done by Mayo-Smith WW et al.21 and Gunnarsson T et al.23 respectively.

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5.1. Performance and Clinical Safety

The product was approved under both European Commission’s Medical Devices
Directive (93/42/EEC) and FDA Premarket Notification 510 (k) clearance in 2005 and
2006 respectively.

There was no evidence on clinical safety of CereTom® portable CT scanner retrieved.

However, there was a prospective study conducted by Gunnnarsson et al.23 using

Tomoscan M mobile (whole body) CT for head scanning in the neurosurgery intensive
care unit (NICU) setting compared with conventional CT in the radiology department
(RD) setting. There was a significant difference (p < 0.05) in the occurrence of
(medical) complications during mobile CT scanning compared with conventional CT
scanning.24 Out of 50 mobile CT head scanning of patients with high and medium risks,
only one patient had medical complications (complication rate of 2.0 %).24 Whereas in
another group of 89 patients (with high and medium risks) undergoing conventional CT
scanning, twenty patients had complications (complication rate of 22.5 %).24 The
transport of patients from the intensive care unit is known to increase the risk of
physiological instability or technical mishaps.25 The complications were physiological
changes in blood pressure, rise in intracranial pressure, decrease in O2 saturation,
technical mishaps e.g. respirator-related mishaps.25

5.2. Effectiveness

There was no evidence retrieved on effectiveness of CereTom® portable CT scanner per

se.

5.3. Cost-effectiveness

There was no evidence retrieved on cost-effectiveness of CereTom® portable CT

scanner per se. However, the product’s core system is priced at US $300 000 (or
equivalent to RM 1 061 000) in the US market.26, 27

Nevertheless, there was a cost analysis (notably not cost-minimisation analysis) done by
Mayo-Smith WW et al.21 on CereTom®’s predicate i.e. Tomoscan M as compared with
fixed CT scanner. The total costs (including direct and indirect costs) per Tomoscan M
CT examination were 32.8 % and 31.0 % higher in terms of low-volume model (1 820
examinations for Tomoscan M and 3 153 for fixed CT) and high-volume model (5 460
examinations for Tomoscan M and 14 130 for fixed CT) respectively.28 For Tomoscan
M, the total costs were US $167.20 and US $108.98 for low-volume and high-volume

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 models respectively.29 Whereas for fixed CT scanner, the total costs were US $112.39
and US $75.24 for low-volume and high-volume models respectively.29

6. CONCLUSION

6.1. Performance and Clinical Safety

CereTom® portable CT scanner was approved by both the US FDA and European
Commission.

There was no retrievable evidence on clinical safety of CereTom® portable CT scanner.

However, in the study by Gunnnarsson et al.23 using Tomoscan M, complication rate of
2.0 % (Out of 50 mobile CT head scanning) vs. 22.5 % (out of another group of 89
conventional CT scanning) were recorded. Thus, the use of Tomoscan M mobile CT
was clinically safer than conventional CT scanning.

6.2. Effectiveness

There was no retrievable evidence on effectiveness of CereTom® portable CT scanner.

6.3. Cost-effectiveness

There was no retrievable evidence on cost-effectiveness of CereTom® portable CT

scanner.

7. RECOMMENDATION

Based on the above review, although CereTom® has the approval from the US FDA and
European Commission, its effectiveness cannot be established due to no evidence
retrieved. Hence, high quality diagnostic studies are needed to determine its
effectiveness and cost-effectiveness. CereTom® can be considered as a research tool,
only if cost is not a concern, to produce evidence on its effectiveness and cost-
effectiveness.

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8. REFERRENCE

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Patient UK; 2007 Oct 3 [cited 2009 Sept 28]. Available from:
http://www.patient.co.uk/doctor/CT-Head-Scanning-Indications.htm.

2. Scottish National Health Service. Accident and emergency (A&E) department

[document on the Internet]. Edinburgh: The Governmental Agency; [cited 2009
Sept 28]. Available from:
http://www.datadictionaryadmin.scot.nhs.uk/isddd/2138.html

3. World Health Organization. Injuries to the head (S00-S09) [document on the

Internet]. Geneva: The Organization; 1994 [updated 2006; cited 2009 Jul 16].
Available from: http://apps.who.int/classifications/apps/icd/icd10online/.

4. Crippen DW. Head trauma. Head and neck trauma [document on the Internet].
eMedicine Medscape; 2009 Jul 15 [cited 2009 Jul 16]. Available from:
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5. Scottish Intercollegiate Guidelines Network. Early management of patients with a

head injury [document on the Internet]. Edinburgh: The Network; 2000 [cited 2009
July 24]. Available from:
http://www.sign.ac.uk/guidelines/fulltext/46/section5.html.

6. Traumatic brain injury statistics [document on the Internet]. Serious Law; 2009
[cited 2009 Jul 20]. Available from: http://www.seriousinjurylaw.co.uk/brain-
injury-statistics.php.

7. Eurostat of European Commission. Average population by sex and five-year age

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8. National Trauma Database of Association of Clinical Registries in Malaysia.

National Trauma Database May 2006 To April 2007 – First Report [document on
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head injury [document on the Internet]. Edinburgh: The Network; 2000 [cited 2009
July 23]. Available from:
http://www.sign.ac.uk/guidelines/fulltext/46/section2.html.

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10. Glasgow coma scale. Trauma scoring [document on the Internet].
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http://trauma.org/archive/scores/gcs.html.

11. Cerebrovascular diseases. In: Iwao Milton Moriyama, Dean E. Krueger, Jeremiah
Stamler, editors: Cardiovascular diseases in the United States [e-book].
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study. Neurological Journal of South East Asia. 2000;5(2);51-53.

13. Hayner GJ, Ferenschak J. Mobile computed tomography: Evaluation of the

NeuroLogica CereTom. Health Devices. 2008;37(11):324.

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NeuroLogica CereTom. Health Devices. 2008;37(11):325.

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temid=69.

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NeuroLogica CereTom. Health Devices. 2008;37(11):332.

18. Hayner GJ, Ferenschak J. Mobile computed tomography: Evaluation of the

NeuroLogica CereTom. Health Devices. 2008;37(11):325 – 42.

19. Matson MB, Jarosz JM, Gallacher D, Malcolm PN, Holemans JA, Leong C, et al.
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20. Mayo-Smith WW, Davis LM, Clements NC, Cobb CM, Smith WJ, Tung GA. CT
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21. Mayo-Smith WW, Rhea JT, Smith WJ, Cobb CM, Gareen IF, Dorfman GS.
Transportable versus fixed platform CT scanners: Comparison of costs. Radiology

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 [serial on the Internet]. 2003 [cited 2009 Jul 27];226(1):63-8. Available from:
http://radiology.rsna.org/.

22. Masaryk T, Kolonick R, Painter T, Weinreb DB. The economic and clinical
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from: Ovid. http://ovid.com.

23. Gunnarsson T, Theodorsson A, Karlsson P, Fridriksson S, Bostrom S, Persliden J,

et al. Mobile computerized tomography scanning in the neurosurgery intensive
care unit: increase in patient safety and reduction of staff workload. J Neurosurg
[serial on the Internet]. 2000 [cited 2009 Jul 28];93(3):432-6. Available from:
http://thejns.org/.

24. Gunnarsson T, Theodorsson A, Karlsson P, Fridriksson S, Bostrom S, Persliden J,

et al. Mobile computerized tomography scanning in the neurosurgery intensive
care unit: increase in patient safety and reduction of staff workload. J Neurosurg
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http://thejns.org/.

25. Gunnarsson T, Theodorsson A, Karlsson P, Fridriksson S, Bostrom S, Persliden J,

et al. Mobile computerized tomography scanning in the neurosurgery intensive
care unit: increase in patient safety and reduction of staff workload. J Neurosurg
[serial on the Internet]. 2000 [cited 2009 Jul 30];93(3):435. Available from:
http://thejns.org/.

26. Hayner GJ, Ferenschak J. Mobile computed tomography: Evaluation of the

NeuroLogica CereTom. Health Devices. 2008;37(11):330.

27. FXConverter results. FXConverter [document on the Internet]. Oanda Corporation;

[cited 2009 Jul 30]. Available from: http://www.oanda.com/convert/classic.

28. Mayo-Smith WW, Rhea JT, Smith WJ, Cobb CM, Gareen IF, Dorfman GS.
Transportable versus fixed platform CT scanners: Comparison of costs. Radiology
[serial on the Internet]. 2003 [cited 2009 Jul 27];226(1):66-7. Available from:
http://radiology.rsna.org/.

29. Mayo-Smith WW, Rhea JT, Smith WJ, Cobb CM, Gareen IF, Dorfman GS.
Transportable versus fixed platform CT scanners: Comparison of costs. Radiology
[serial on the Internet]. 2003 [cited 2009 Jul 27];226(1):65. Available from:
http://radiology.rsna.org/.

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