










































9 J Global Clinical Engineering Issue 1:9-23; 2018 

Received April 22, 2018, accepted September 9, 2018, date of publication October 13, 2018

Spin-off use of adverse events data: why and how. 
The case of FDA’s MAUDE

By P Malataras1 and N Pallikarakis2

1University of Patras
2Institute of Biomedical Technology, INBIT

ABSTRACT

Objectives: This paper attempts to measure the impact of the second stage exploitation of FDA’s MAUDE database 
on patient safety, technology assessment and other scientific fields.

Methods: Five bibliographic databases have been queried with the terms “Manufacturer and User Facility Device 
Experience Database” and “FDA AND MAUDE”. A number of eligibility criteria where applied on the results, which led 
to a final group of 117 papers. An extensive study of these publications resulted to a number of interesting findings.

Results: The results concern the evolution of the database exploitation over time, and are examined according to the 
device groups that the identified papers are referring to, the research goals of these papers, the reasons that led the 
authors of these papers to use MAUDE data and finally how these data were used within their research methodology.

Conclusions: Patient safety and technology assessment are two of the scientific fields on which MAUDE database 
has the greatest impact. On average, more than 10 peer-reviewed papers each year involve MAUDE data as a mean 
to reach their research goals. This proves that MAUDE is an exploitable and valuable data source for research in 
these scientific fields.

Keywords – Medical Devices, MAUDE, Adverse Events Reports, Patient Safety, Health Technology Assessment.

INTRODUCTION
Patient safety, health technology assessment and medi-

cal device vigilance are fields that heavily rely on data 
availability. They need valid data from various sources in 
order to extract useful information. A significant source of 
data for medical devices (MDs) appears to come from the 
medical devices vigilance and post-market surveillance 
mechanisms that are imposed by the relevant regulatory 
systems, in most part of the world. The Food and Drug 
Administration (FDA) Manufacturer and User Facility 
Device Experience (MAUDE) database is such a source. 

Millions of medical devices are used today in various 
places (hospitals, clinics, houses, etc.) and thousands of 
new models enter the market every year. Undoubtedly 
these MDs have a significant contribution to the im-
provement of the healthcare services provided. However, 
medical technology, like any other technology, is not risk 
free. There are numerous cases where devices have been 
recalled because of their involvement in adverse incidents 
compromising patients’ health or cases where a “prom-
ising” innovative approach has to be withdrawn after a 

http://www.globalce.org


Malataras and Pallikarakis: Spin-off use of adverse events data: why and how. The case of FDA’s MAUDE

J Global Clinical Engineering Issue 1:9-23; 2018  10

relatively short period of use, because it is not proven as 
safe as expected.1, 2, 3, 4

The largest MDs markets today (USA, EU, Japan, etc.) 
are ruled by regulatory frameworks (Regulations, laws, 
directives, guidelines) according to which a medical device 
has to comply with specific safety provisions in order to 
enter these markets5, 6. One safety requirement, common 
to all these frameworks, is the adverse event reporting 
system or vigilance system that follows the medium and 
high risk devices, after they have entered the market, in 
parallel with the post-market surveillance.5, 6, 7 

A MDs vigilance reporting system aims to increase 
patient safety by preventing the recurrence of reported 
adverse events. This is achieved by mandating users and 
manufacturers of medical devices to report to the health 
authorities, incidents where a medical device contributes 
to an adverse event. According to this mechanism, when-
ever a medical device is  potentially contibuted in a death 
or injury of a patient or user, the manufacturer has to 
report this event and assess if  corrective actions should 
be taken. In parallel, a user reporting system encourages 
users to report to the manufacture and/or to authorities 
any such incident that comes to their attention. The prin-
cipal purpose of the medical devices vigilance and user 
reporting systems is to improve the safety of patients, 
users and others, by reducing the likelihood of reoccur-
rence of a similar event elsewhere in the future. This is to 
be achieved by the evaluation of reported incidents and, 
where appropriate, dissemination of information, which 
could be used to prevent such repetitions, or to alleviate 
the consequences of such incidents.

USA is the biggest medical device market8, 9 and FDA, 
as the relevant organization for market surveillance, is 
also responsible for medical devices vigilance. FDA has 
implemented since the 1990s a database called Manufac-
turer and User Facility Device Experience Database10 for 
reporting of medical devices related with adverse events. 
Nowadays, this database receives more than 800.000 
reports annually.11

Today, MAUDE contains more than 4 million medical 
device reports (MDRs)11 of suspected device-associated 
deaths, serious injuries and malfunctions as well as other 
non-conformities such as packaging and labelling problems, 

unsterilized delivery etc. MAUDE contains MDRs filed by 
manufacturers and importers from August 1996 to present, 
all mandatory user facility reports from 1991 to present 
and voluntary reports filed after June 199312. A portion 
of the database is open to the public, providing valuable 
information on MDs safety. It is accessible through the 
FDA’s website (www.fda.gov) and can be queried through 
a search form. In addition, all main datasets are provided 
to the public as text files importable to common databases.

After an evaluation process, the high volume MDRS or 
the ones involved with a death are investigated by FDA 
and in many cases this investigation leads to corrective 
actions, with obvious benefits for the safety of both pa-
tients and users. At a second stage, this huge amount of 
data appears to be a valuable source for further research. 
Retrospective analysis studies, data extraction techniques 
and other scientific use of these data, offer spin-off benefits 
to patient safety, medical device technology assessment 
and other scientific fields13, 14. 

This study attempts to measure quantitatively and 
qualitatively the second stage exploitation of MAUDE 
and the impact of this exploitation on scientific research.

MATERIALS AND METHODS
Five international bibliographic databases (Science-

Direct, Journals@Ovid Full Text, Pubmed, Web of Science 
and Scopus) have been queried with the terms “Manu-
facturer and User Facility Device Experience Database” 
and “FDA AND MAUDE” in order to find all publications 
that contain these terms. The databases were queried in 
January 2015. The results of these queries were consoli-
dated through the removal of duplicates, which led to an 
initial number of 1.016 unique publications. (The results 
from each database appear in Table 1).

This set of results was filtered according to the publica-
tion type, language and publication time so as to keep only 
peer-reviewed papers, written in English, from 2005 to 
2014. Books, editorials, commentaries, letters, comments 
on a paper, publications in conference proceedings, etc., 
were excluded from the final selection. After filtration, 
381 scientific papers remained.

The next step was to extract out of these 381 papers 
the ones that have used directly data from MAUDE. This 

TABLE 1. Bibliographic Search Results

Bibliographic 
Database

MAUDE AND 
FDA

“Manufacturer and 
User Facility Device 

Experience Database”

ScienceDirect 322a 269

Journals@Ovid 
Full Text 196a 175

Pubmed 54 42

Web of Science 49 41

Scopus 209a 322

Total (without 
duplicates) 631 604

a The search has been performed with proximity indicators 
(MAUDE w/10 FDA) or (MAUDE ADJ10 FDA)

www.fda.gov


Malataras and Pallikarakis: Spin-off use of adverse events data: why and how. The case of FDA’s MAUDE

11 J Global Clinical Engineering Issue 1:9-23; 2018

unsterilized delivery etc. MAUDE contains MDRs filed by 
manufacturers and importers from August 1996 to present, 
all mandatory user facility reports from 1991 to present 
and voluntary reports filed after June 199312. A portion 
of the database is open to the public, providing valuable 
information on MDs safety. It is accessible through the 
FDA’s website (www.fda.gov) and can be queried through 
a search form. In addition, all main datasets are provided 
to the public as text files importable to common databases.

After an evaluation process, the high volume MDRS or 
the ones involved with a death are investigated by FDA 
and in many cases this investigation leads to corrective 
actions, with obvious benefits for the safety of both pa-
tients and users. At a second stage, this huge amount of 
data appears to be a valuable source for further research. 
Retrospective analysis studies, data extraction techniques 
and other scientific use of these data, offer spin-off benefits 
to patient safety, medical device technology assessment 
and other scientific fields13, 14. 

This study attempts to measure quantitatively and 
qualitatively the second stage exploitation of MAUDE 
and the impact of this exploitation on scientific research.

MATERIALS AND METHODS
Five international bibliographic databases (Science-

Direct, Journals@Ovid Full Text, Pubmed, Web of Science 
and Scopus) have been queried with the terms “Manu-
facturer and User Facility Device Experience Database” 
and “FDA AND MAUDE” in order to find all publications 
that contain these terms. The databases were queried in 
January 2015. The results of these queries were consoli-
dated through the removal of duplicates, which led to an 
initial number of 1.016 unique publications. (The results 
from each database appear in Table 1).

This set of results was filtered according to the publica-
tion type, language and publication time so as to keep only 
peer-reviewed papers, written in English, from 2005 to 
2014. Books, editorials, commentaries, letters, comments 
on a paper, publications in conference proceedings, etc., 
were excluded from the final selection. After filtration, 
381 scientific papers remained.

The next step was to extract out of these 381 papers 
the ones that have used directly data from MAUDE. This 

TABLE 1. Bibliographic Search Results

Bibliographic 
Database

MAUDE AND 
FDA

“Manufacturer and 
User Facility Device 

Experience Database”

ScienceDirect 322a 269

Journals@Ovid 
Full Text 196a 175

Pubmed 54 42

Web of Science 49 41

Scopus 209a 322

Total (without 
duplicates) 631 604

a The search has been performed with proximity indicators 
(MAUDE w/10 FDA) or (MAUDE ADJ10 FDA)

selection led to a final group of 117 papers. Among these 
papers, there were 4 where the authors searched the 
MAUDE database but the results were found to be irrel-
evant to this work. However, these 4 papers were decided 
to be included in the final group because, although they 
finally did not use any data from MAUDE, they took into 
consideration the content of the database. The list of 117 
papers appears in the Reference section (Ref: 14-25, 28, 
31, 33-135).

It should be mentioned that among the 264 excluded 
papers, more than 50 referred to MAUDE data, but this 
reference was either limited to a single comment about 
one or two cases or indirect, using the results of other 
papers that had used the original data. 

The last step was to study again in more detail the final 
group of these 117 papers, focusing on the device groups 
that these papers referred to, the evolution of the database 
exploitation with time, the research goals of these papers, 
the reasons that led the authors of these papers to use 
MAUDE data, how they finally used these data within their 
research methodology, etc. The flowchart for the query 
methodology is shown in Figure 1.

The bibliographic search results were processed ini-
tially with the Mendeley desktop references management 
software and later with Microsoft Excel.

ScienceDirect
(322+269)

Journals@Ov
id Full Text
(196+175)

Web of 
Science
(49+41)

Pubmed
(54+42)

Scopus
(631+604)

Unique Publications
(1.016)

Eligibility Criteria 
(Publication Time, Language 

and Type)
(635)

Paper examined
(381)

Out of Scope
(264)

Final Set
(117)

RESULTS
The analysis of the final set of 117 papers revealed 

the following:
A) Since MAUDE is a database containing MDRs, each 

record is related with a medical device. Hence retrieval of 
data for the second stage usage is also related with medi-
cal devices. The analysis carried out identified the device 
groups that were used as a reference in the papers. These 
device groups were grouped, where applicable, into more 
generic device categories. It should be mentioned that 
although 24 papers were focused exclusively on a device 
type rather than on a group as a whole, only the device 
group was considered for the purposes of this analysis. 

FIGURE 1. PRISMA flow chart for FDA MAUDE system search

TABLE 2. Number of Papers per Device Group

Cardiology Devices 29

Stents 9

Implantable Cardioverter-Defibrillators 7

Vena Cava Filters 6

Automated External Defibrillators 2

Angioplasty Catheters 1

Arterial Closure Devices 1

Catheter Introducing Sheaths 1

Catheters 1

Vascular Closure Systems 1

www.fda.gov


Malataras and Pallikarakis: Spin-off use of adverse events data: why and how. The case of FDA’s MAUDE

J Global Clinical Engineering Issue 1:9-23; 2018  12

According to the analysis performed, the general category 
of Cardiology Devices was the most frequently referred 
(29 papers), while Implantable Devices (22 papers) and 
Endoscopy Devices (14 papers) were the next ones. As 
regards the device groups, Stents (9 papers), Implant-
able Cardioverter-Defibrillators (7 papers), Meshes (6 
papers), Vena Cava Filters (6 papers), Septal Occluders 
(4 papers), and Cochlear Implants (4 papers) were the 
leaders. Finally, there were 8 papers that have not been 
included in this part of the analysis, since they used a 

Implantable Devices 22

Meshes 6

Septal Occluders 4

Cochlear Implants 4

BMP2 protein 3

Breast Implants 1

Cerebrospinal Fluid Valves 1

Heart Valves 1

Silicone-Polyurethane Copolymers 1

Spinal Cord Stimulator 1

Endoscopy Devices 14

Endoscopy-General 4

Endometrial Ablation Devices 3

Endoscopic Stapling 1

ERCP 1

Gastrointestinal Endoscopy 1

Microwave Endometrial Ablation 1

Mucosal Ablation Devices 1

Radiofrequency Ablation 1

Various 1

Laparoscopy Devices 6

Hem-o-lok 3

Laparoscopic Morcellator 1

Laparoscopic Trocar 1

Various 1

Infusion Devices -Pumps 5

Infusion Devices 2

Insulin Pumps 2

Infusion Pumps 1

Prosthesis 4

Artificial Discs 1

Hip Prosthesis 1

Lumbar Total Discs 1

Shoulder Prosthesis 1

Robot Assisted Surgery 4

Transcervical Sterilization 4

Patient-Controlled Analgesia 3

Stone Extraction Balloons And Baskets 2

Stone Baskets 1

Stone Extraction Balloons and Baskets 1

Extracorporeal Oxygenation 2

Extracorporeal Membrane Oxygenation 1

Oxygenator 1

Lasers – General 2

Cosmetic Laser 1

Lasers 1

Ambulance Stretcher 1

Bed Rails 1

Breast Pumps 1

Contact Lenses 1

Ethylene vinyl alcohol copolymer 1

Feeding Tubes 1

Glucose Monitors 1

MRI 1

Operating Microscopes 1

Peritoneal Dialysis 1

Piggybacks 1

Tanning Units 1

Papers referring to Various Device 
Groups 8



Malataras and Pallikarakis: Spin-off use of adverse events data: why and how. The case of FDA’s MAUDE

13 J Global Clinical Engineering Issue 1:9-23; 2018

combination of data related with various device groups. 
The number of papers classified under each group is 
presented in Table 2.

B) As regards the publication time of these papers, 2014, 
2012 and 2007 were the years with the most published 
papers (19, 17 and 14 papers respectively). The linear 

trend line shows that the number of papers that used the 
MAUDE data increases with time (slope =0.6). (Figure 2)

C) Although it was difficult and maybe risky to sum-
marize and classify the research objectives of papers 
covering various scientific areas and subjects, into a few 
generic objectives’ categories, such an attempt was made 
in order to outline the research orientation of the papers 
that use data from the MAUDE database. 

The most common objectives among these papers were 
“to review/identify the reported adverse events/compli-
cations related with a device group or type” (31 papers), 
“to evaluate adverse events” (22), “to evaluate design 
characteristics of a device group or type” (15 papers), 
“to explain why these events occur” (14 papers), and “to 
overview a medical technology and/or its performance” 
(10 papers). Table 3 presents the results of this analysis.

FIGURE 2. Number of papers published each year.

TABLE 3. Research Objectives

Papers’ Objectives Number 
of papers Example of Objective

To review/identify reported adverse events/
complications 31 To collate world reports of adverse events (AEs) resulting from lasers used in 

urology15

To evaluate adverse events/complications 22 To raise awareness of the potential hazard of auricular burns associated with 
operating microscope use during otologic surgery16

To examine/evaluate design characteristics of 
a medical device 15 We sought to determine if perforation rates are related to cannula design17

To explain why specific adverse events/
complications occur 14 This study was undertaken to analyze bleeding problems with tension-free vaginal 

tape (TVT) operations18

To overview a medical technology and/or its 
performance

10 This study sought to determine whether infusion device event logs could support 
accident investigation19

To assess the frequency and/or severity of 
adverse events/complications 8

The purpose of this study is to use large databases to assess the frequency and 
severity of such complications and compare them with those of surgical atrial septal 
defect closure20

To evaluate/test a method or a hypothesis 7 The aim of this article is to evaluate a new system and procedure, dedicated to 
oxygenator change-out21

To review a new technology/procedure 7 This document will review the biliary and pancreatic stone extraction devices that 
are currently commercially available in the United States22

To discuss regulatory issues 2 The present analysis aimed to compare the 510(k) and PMA approvals and 
recalls on the basis of the number of devices approved in each group23

To estimate cost 1 To estimate the rates and costs of intravenous patient-controlled analgesia 
(IV PCA) errors from the hospital or integrated health system perspective24



Malataras and Pallikarakis: Spin-off use of adverse events data: why and how. The case of FDA’s MAUDE

J Global Clinical Engineering Issue 1:9-23; 2018  14

D) Equally difficult was the attempt to examine and 
classify the purpose for which the MAUDE data were used 
within those papers. The findings of this analysis were 
similar with the findings of the analysis of the papers’ 
objectives. In brief, the main reasons for the use of MAUDE 
data was “to summarize or review adverse events” (53 
papers) as well as “to explain why these events occur” (42 
papers). Additionally, it was found that 36 papers dealt 
with the evaluation of adverse events or complications, 
and 32 papers provided directly suggestions for patient 
safety measures. Finally, it should be noted that in each 
paper these data could have been used for more than one 
purpose. All the findings of this analysis are presented 
in Table 4.

DISCUSSION
The final number of 117 papers that were found to 

have used MAUDE data cannot be considered as covering 
the whole spectrum of the respective research activities. 
The actual range of MAUDE data usage must be consid-
ered even greater if it is taken into account that among 
the publications that were excluded by the present study, 
there were many papers that a) refer to a unique case 
from MAUDE, b) use partially or complementarily data 
from it or c) refer to other papers based on MAUDE data 
analysis. In addition, it was also found that there were 
many other kinds of publications, such as books, editorials, 

and publications in conference proceedings, which were 
used on MAUDE data. 

The device groups that the papers focused on were 
mainly cardiology devices (Stents and Implantable Car-
dioverter-Defibrillator), implantable devices (Meshes and 
Cochlear implants), endoscopy and laparoscopy devices. 
It is surprising that high risk device groups that are used 
widely in hospitals, such as Respirators, Anesthesia Ma-
chines, ECG, etc., were not among the devices of this list. 
One possible reason for this fact is that the researchers 
have directed their attention to devices that had entered 
the market within or near the period under examination 
(drug eluted stents, robot assisted surgery, transcervical 
sterilization, etc.) or to device groups containing products 

which have been involved in serious recalls (Stents, Oc-
cluders, Cardioverter, Defibrillators etc.)1. 

The number of papers that use data from MAUDE ap-
pears to increase with time, having a time trend with a 
rate of 0.6 (Figure 1). It is expected that in the near future 
the second stage exploitation of MAUDE data will further 
increase given that FDA makes a constant effort to improve 
the quality of data and their accessibility (Unique Device 
Identifier, Total Product Life Cycle, Open FDA etc.)2, 3, 11 

25, 26 in combination with the fact that new or improved 
management and analysis techniques of big data emerge.

TABLE 4. Purposes of MAUDE data use

The MAUDE data have been used: Number of 
Papers

To summarize the adverse events related with a device group or type 53

To explain why specific adverse events occur 42

To evaluate adverse events or complications 36

To suggest patient safety measures 32

To assess a device group or type 30

To estimate how frequent is the occurrence of an adverse event or to calculate trends 30

To assess the safety of a technology or of a medical procedure 24

To assess the severity of adverse events/complications 15



Malataras and Pallikarakis: Spin-off use of adverse events data: why and how. The case of FDA’s MAUDE

15 J Global Clinical Engineering Issue 1:9-23; 2018

The examination of the papers’ research objectives 
clearly shows that the majority of the papers under con-
sideration contributes directly or indirectly to patient 
safety by reviewing or summarizing the adverse events/
complications related with a specific device group or type 
(31 papers), by evaluating adverse events/complica-
tions (22 papers), by explaining why these events occur 
(15 papers) or by assessing the frequency or severity of 
adverse events (8 papers). Additionally, the contribution 
to technology assessment is also significant through 
the evaluation of the devices’ design characteristics (14 
papers), the overview of a medical technology and its 
performance (10 papers) and the review of new technol-
ogy and/or medical procedures (7 papers). Finally, the 
papers in question have a contribution in other fields 
too. For example, 7 papers used MAUDE data in order 
to test or evaluate a method and 2 papers discussed the 
regulatory issues for medical devices.

The fact that the MAUDE database is a useful source 
for patient safety purposes is further supported by the 
examination of the manner in which these data are used 
in the papers. It was found that MAUDE data have been 
used among others to summarize the adverse events re-
lated to a device or a medical procedure, to explain why 
adverse events occur and to suggest specific measures. 
The ultimate goal of the above-mentioned uses was to 
inform the medical community as well as MD designers 
and manufactures about the problems that could arise, the 
likelihood for them to occur, the underlying mechanisms 
that lead to these complications, the ways to avoid or to 
deal with these events and the measures to eliminate their 
consequences. Besides, MAUDE appears to be a useful tool 
as regards technology assessment too, since its data have 
been used in order to assess the use of medical technolo-
gies and medical devices, as well as to estimate the risk 
of the utilization of a device or procedure. It is also worth 
mentioning that from this analysis, it was found that 14 of 
the papers used the MAUDE database as a source in order 
to test or evaluate a method, a procedure or a hypothesis. 
For example, MAUDE data were used to evaluate the role 
of human factors in acute care equipment decisions27 
and to examine whether the log files could assist in an 
accident investigation19.

During the papers’ analysis, other useful information 
was also gathered, pertaining to research limitations in-
serted by the use of MAUDE data as well as to the quality 
and integrity of these data. In many papers it is mentioned 
that the MAUDE data and the use of adverse event reports 
data in general, inserted certain limitations dealing with 
the reporting rate and the denominator issue28. As regards 
the reporting rate, there is a general belief that not only 
adverse events are under-reported but there is also a lack 
of information about the ratio representing the number of 
adverse events reported versus the number of real events 
that have occurred. Similarly, there is a lack of baseline 
numbers (e.g. total number of surgical procedures relevant 
to a product, total number of specific devices used, etc.) 
that could be used as denominators. Both these limita-
tions make the data unsuitable for determining rates29, 30. 

Moreover, there was criticism as regards the consis-
tence and quality of the MAUDE data. Some researchers 
have doubts about their quality, stating that the data 
provided by FDA are not structured in a common way, 
are not complete and their accuracy is debatable, thus 
obstructing the analysis procedures. Others commented 
that the information and degree of detail contained within 
these reports are highly variable, making interpretation 
of the reports difficult and causality often uncertain29, 31. 

During the period 2005-2014, MAUDE data could be 
searched either by an online search form provided by the 
FDAs’ web site or by downloading them in txt formatted 
files. The majority of the studies have used the online 
search form. There were only a few that have used the 
MAUDE data provided in txt format. This is probably 
because the insertion of these txt files into a relational 
database is not an easy task given the amount of data 
(some tables have more than 3 million rows) and because 
the txt files need some technical preparatory actions in 
order to be ready for insertion. It is expected that the 
openFDA web site (https://open.fda.gov/) which provides 
capabilities for easier and more comprehensive access to 
the data in addition with the further use of the database 
with contemporary big data analysis tools or data min-
ing techniques will lead to a more intense exploitation 
of MAUDE database.

https://open.fda.gov/


Malataras and Pallikarakis: Spin-off use of adverse events data: why and how. The case of FDA’s MAUDE

J Global Clinical Engineering Issue 1:9-23; 2018  16

Finally, it is worth mentioning the positive impact of 
the transparency of MAUDE database comparing it with 
the European Databank on Medical Devices (EUDAMED). 
In the EU, legislative changes imposed stricter and more 
detailed monitoring and enforcement requirements for 
both notified bodies and national competent authorities, 
in response to increasing safety concerns. Recently, the 
enforcement of a more rigorous new legislation in the 
form of two Regulations136, 137 has been voted by the 
European Parliament. The use of the European Databank 
on Medical Devices (EUDAMED), containing regulatory 
information on MDs available on the EU market, includ-
ing recalls, is also reinforced. However, regarding the EU 
user reporting system for medical devices adverse events, 
there is not an overall collection of the reports submitted 
to the national competent authorities. This is due to the 
decentralised structure of the EU regulatory system, in 
combination with the fact that there is no provision for 
a centralised collection into the EUDAMED. Additionally, 
the EU policy that does not allow the public access to all 
these data, including the recalls, prohibits their analysis 
by independent researchers. 

A research comparing the impact of the transparency 
of EU vigilance system with the one of FDA for the period 
2004-2015, found that there are no papers or reports, even 
from a central EU body, based on the EUDAMED data138. 
However it is a fact that EUDAMED can provide similar 
information. As an example, Bliznakov et.al139 performed 
a survey on medical device recalls, concerning only de-
vices using software, based on FDA data for the period 
1995-2002. It was found that about 25% of the recalls 
studied, were caused by software failures. As might be 
expected, the proportion of these recalls due to software 
problems increased, from 17% in 1995 to 34% in 2002. 
Follow up studies140, 141 revealed that this proportion 
went up to 40% in year 2012. These authors, performed 
in parallel a survey on recalls caused by software failures 
using EUDAMED data, and found very similar results. 
Unfortunately, those results could not be published due 
to the restrictions on the use of EUDAMED data.

CONCLUSIONS
FDA provides public access to a portion of its post-

market surveillance database, thus allowing researchers 
outside FDA to carry out analyses and studies based on 
the raw data, with a consequent spin-off benefit for public 
health. The fact that, in spite of the limitations, more than 
10 peer-reviewed papers each year use MAUDE data shows 
that MAUDE is an exploitable and valuable data source. 

According to the analysis of the papers, MAUDE data-
base is used mainly for research works related to patient 
safety and technology assessment compared to other 
scientific areas. It is also observed that the MAUDE data 
are mainly used to evaluate devices that are relatively new 
to the market, or to investigate issues related with these 
devices. Additionally, it was found that MAUDE is a useful 
data source when it is required to summarize adverse 
events related with a device as well as when the reasons 
that could lead to an adverse event have to be examined. 
Finally, MAUDE data exploitation increases with time 
and is expected to be even more intensive in the future.

Undoubtedly, there are improvements that could increase 
the exploitation of MAUDE database. However, despite 
limitations, restrictions and criticism, it is a common con-
clusion among the majority of the papers studied, that the 
MAUDE database is a useful and valuable tool for patient 
safety and technology assessment. The benefits resulting 
from the MAUDE use should be taken into consideration 
by the EU, so as to move in the direction of enhancing 
and improving the data collection procedures from the 
vigilance system as well as to increase the transparency 
of EUDAMED as explicitly stated in the regulations136, 137: 
“..vigilance and market surveillance should be significantly 
reinforced, whilst provisions ensuring transparency and 
traceability regarding medical devices should be intro-
duced, to improve health and safety … The objectives of 
the database are to enhance overall transparency, includ-
ing through better access to information for the public 
and healthcare professionals …”. Additionally individual 
researchers should be allowed to have access to relevant 
data, in order to be able to perform similar studies that 
significantly contribute to equipment improvement and 
patient safety.

et.al


Malataras and Pallikarakis: Spin-off use of adverse events data: why and how. The case of FDA’s MAUDE

17 J Global Clinical Engineering Issue 1:9-23; 2018

CONFLICT OF INTEREST
The authors declare that there is no conflict of interest 

regarding the publication of this paper.

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