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High-Risk Medical Devices -

Evaluation of Defined Medical Procedure-based Frequencies Christoph Urach1,3, Barbara Glock1, Bettina Maringer2, Gottfried Endel2

1dwh simulation services

2Main Association of Austrian Social Security Institutions - HVB

3Vienna University of Technology

ABSTRACT

Introduction

Information and data on the use of medical products in Austria as well as in other countries needs improvement. The aim of this project is to get a general overview of the amount of interventional procedures which require high-risk medical devices and to analyse subsequently selected groups.

Methods

Medical procedures (MELs) are part of routine care data in Austria. For the analysis MELs, for which a high-risk medical device (class III) is used, were selected. The medical device must be the main part of the procedure and remain more than 30 days in the body. In the first step, an overview of the number of performed MELs of the years 2006/2007 is provided. Afterwards we build 4 MEL groups of frequently used high-risk medical devices for further analysis. The routine care data additionally includes patient information. Therefore in the second step we evaluate the development of the frequency of the selected medical devices over time as well as age and gender-specific differences.

Results

The most frequently used medical devices in the years 2006/2007 were lenses (extracapsular cataract surgery), hip joint prostheses and knee joint prostheses, followed by medical devices for the central circulatory system. The 4 selected MEL-group for detailed analyses were bypasses, heart valves and (coronary and other) stents. Within the time-span from 2001 to 2011 the number of implanted heart valves increased slightly, the amount of stents doubled whereas bypasses slightly decreased. , the frequency of bypasses and coronary stents is for men with the age of 30-

50 years 5 times as much as for women, up to 70 years four times higher than for women. Also

the age-specific peak for these procedures is about 10 years earlier for women than that for men.

Conclusion

Within this project the use of high risk medical devices is indirectly investigated by defined

medical (interventional) procedures in LKF-hospitals. But with routine care data it is not possible to identify the exact type of the implanted product. The amount of implanted bypasses, heart valves and stents demonstrates that a patient registry for high-risk medical devices would not be unimportant. The benefit of a registry depends on its content and its quality. This analysis can help estimating the time to fill such a database until conclusions about quality and safety or other

statistical significant statements can be drawn. A well-structured registry could also be helpful for

the regulatory process of high risk medical devices and a major tool for decision makers. 2/49

KURZFASSUNG

Einleitung

Die Informations- und Datenlage zum Einsatz von Medizinprodukten ist in Österreich wie auch in erbrachter medizinischer Leistungen ein Überblick geschaffen, wie viele Operationen mit

Gruppen einer genaueren Analyse zu unterziehen.

Methoden

und in die Analyse eingeschlossen, bei denen ein Hochrisiko-Medizinprodukt, ab Klasse III verwendet wurde, die Verwendung dieses Hochrisiko-Medizinproduktes den wichtigsten Teil des

wird für alle definierten MEL-Codes ein quantitativer Überblick für die Jahre 2006-2007 gegeben.

Auf Basis dieser Ergebnisse werden vier MEL-Gruppen einer besonderen Betrachtung unterzogen. Mit den Zusatzinformationen zu Patientenalter, Geschlecht und Herkunft werden im zweiten Schritt Unterschiede bezüglich dieser Merkmale untersucht.

Ergebnisse

Die meisten implantierten Hochrisiko-Medizinprodukte der Jahre 2006/2007 waren Linsen, Hüft- und Knieendoprothesen sowie Medizinprodukte für das Herz-Kreislauf-System, wovon vier Lebensjahr immer noch 4-mal so hoch wie bei Frauen. Das altersspezifische Maximum dieser

Conclusio

Da die Quantifizierung der Hochrisiko-Medizinprodukte anhand operativer Einzelleistungen auf

werden, wie detailliert und über welchen Zeitraum eine potentielle Medizinproduktedatenbank

3/49

Contents

1 Introduction ...............................................................................................................................6

1.1 Background ......................................................................................................................6

1.2 Objectives .........................................................................................................................6

1.3 Definition of High Risk Medical Devices ..........................................................................6

2 Methodology .............................................................................................................................7

2.1 MEL-catalogue .................................................................................................................7

2.2 GAPDRG Database ......................................................................................................8

2.2.1 Identifying High Risk Medical Devices in the GAPDRG Database ..............................8

2.2.2 Structure of the GAPDRG Database used for frequency analysis ..............................8

2.3 Data Handling...................................................................................................................9

Limitations ............................................................................................................................... 11

3 Results of Frequency Analysis ............................................................................................... 12

3.1 Frequency Analysis of the 142 MEL codes ................................................................... 13

4 Detailed Analysis of selected defined medical procedures based on Frequency Analysis ... 15

4.1 Development over time ................................................................................................. 15

4.2 Gender-specific differences .......................................................................................... 17

4.3 Age-specific differences ................................................................................................ 20

4.4 Regional distribution of the selected MEL-groups ........................................................ 21

4.5 Regional distribution of selected MELs 2011 ................................................................ 27

4.5.1 Evaluation of bypasses, heart valves and stents by counting the frequency of single

interventions ........................................................................................................................... 31

4.5.2 Distribution of the number of hospital stays because of bypass, heart valves and

stents standardized to the EU standard population as defined in 2013 ................................ 32

5 Summary ................................................................................................................................ 33

6 Appendix A Description of the 142 observed MEL Codes .................................................. 34

7 Appendix B Description of the Assignment ......................................................................... 37

8 Appendix C Results of the frequency analysis of the 142 MELs ........................................ 40

9 Appendix D Assignment to the four groups for detailed analysis ....................................... 44

References .................................................................................................................................... 49

4/49

List of Figures

Figure 1: Example of a second level assignment of alphanumeric MEL code via another

alphanumeric MEL code to a numeric MEL code, which is used in the database ........................ 10

Figure 2: Example of aggregation of numeric MEL codes to alphanumeric codes ....................... 11

Figure 3: Example of ambiguous assignments of numeric codes to alphanumeric codes. ........... 11 Figure 4: Included hospital stays to the frequency analysis (blue line). Not included hospital stays

are depicted in red. ....................................................................................................................... 12

Figure 5: Stays with selected MEL-groups over time ................................................................... 16

Figure 6: Development of the number of selected medium/ high-risk medical devices over time 19 Figure 7: Comparison of men and women for bypasses, heart valves and stents (sum from 2001-

2011) ............................................................................................................................................. 20

Figure 8: Age-distribution among the patients with bypass, heart valve or stent from 2001 to 2011

...................................................................................................................................................... 21

Figure 9: Sum of hospital stays with MELs for bypasses, heart valves and stents ...................... 26

List of Tables

Table 1: Retrieved and used attributes of the "mbds_aufenthalte" table of the GAPDRG Database Table 2: Retrieved and used attributes of the "mbds_leistungen" table of the GAPDRG-Database Table 3: Description of the used hrmp_ueberleitung 9

Table 4: Group selection for the detailed analysis ........................................................................ 13

Table 5: Development of the number of hospital stays for corresponding groups for 2001 - 201116 Table 6: Time dependent development of performed MELs for bypasses, heart valves and stents

from 2001 to 2011 for men and women ........................................................................................ 17

Table 7: Sum of hospital stays for bypasses, heart valves and stents for age groups in the time-

span from 2001 to 2011 ................................................................................................................ 20

Table 8: Sum of selected medical devices from 2001-2011 on district-level ................................ 22

Table 9: Sum of selected MELs from 2001-2011 on the level of groups of districts (planning units)

...................................................................................................................................................... 26

Table 10: Distribution of selected MEL-groups 2011 for districts .................................................. 27

Table 11: Distrubution of selected MEL-groups 2011 for care regions ......................................... 30

Table 12: Sum of obtained single MELs within the corresponding group ..................................... 31

Table 13: Number of interventions with bypasses, heart valves or stents for the EU

standardpopulation ........................................................................................................................ 32

Table 14: Description of the 142 MEL codes, which are observed in this project ......................... 34

Table 15: The 66 MEL codes ("MEL of 66") that have no matching numeric MEL code, but

another matching alphanumeric MEL code ("Assigned MEL") ..................................................... 37

Table 16: Finally used assignments of alphanumeric MEL codes to numeric MEL codes together

with the level of assignment .......................................................................................................... 38

Table 17: Results of the frequency analysis depicting the frequencies overall over the years 2006

and 2007 (no differentiation of age and gender) in descending order for the MEL codes ............ 40

Table 18: Frequency Analysis of the defined 142 MEL-Codes ..................................................... 44

5/49

List of Abbreviations

AIMD active implantable medical devices

DRG Diagnosis-Related Group

EEA European Economic Aerea

ERCP endoscopic retrograde cholangiopancreaticography GAPDRG General Approach for Patient-oriented Ambulant Diagnosis-Related Group HVB Main Association of Austrian Social Security Institutions (dt.: Hauptverband der ICD International Statistical Classification of Diseases and Related Health Problems LKF service-oriented reimbursement of hospitals (dt.: Leistungsorientierte

Krankenanstaltenfinanzierung)

MBDS Minimum Basic Data Set

MD medical device

MEL defined medical procedures (dt.: Medizinische Einzel-Leistung) n-m relation a numeric value can be assigned to more than one alphanumeric value and vice versa)

NA Not Available

PRIKRAF private hospital funding (dt. Privatkrankenanstalten-Finanzierungsfond) 2013

External Review

The Austrian Medical Device Registry, Vienna ([1]) 6/49

1 Introduction

1.1 Background

According to the Austrian Medical Devices Law in translation of European directives concerning

medical devices and in-vitro diagnostics, Austria is obliged to maintain a registry of medical

devices. Registration is obligatory for all persons and companies based in Austria that are

responsible for circulating medical devices for the first time in the European Economic Area,

including authorized representatives, assemblers and sterilizers. This information, including

information on certificates issued by Notified Bodies such as TÜV, needs to be notified by Austria

to the European Database of Medical Devices (Eudamed). ([1]). Medical devices already registered in other EEA member states may be notified on a voluntary basis only; therefore currently a comprehensive registry on national level does not exist. Furthermore there are no standardized methods for approval and reimbursement of medical

devices within the Austrian Social Security Institutions and neither frequencies nor costs for

medical devices have been evaluated so far in Austria. Therefore there is much to explore in this field.

1.2 Objectives

The aim of this project commissioned by the Main Association of Austrian Social Security

Institutions (HVB) is

- to draw a landscape of the use of high-risk medical devices on the Austrian market and - to evaluate the frequency of use of high risk medical devices and - their development by volume in Austrian hospital settings .

1.3 Definition of High Risk Medical Devices

As defined by the Directive 93/42/EEC ([2] medical device (MD) means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; accessory tended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use Furthermore medical devices are distinguished between: - active medical devices - non-active medical devices According to Guidelines relating to the application of the council directive 93/42/EEC on medical 7/49 devices ([3]): an active medical device is

source of electrical energy or any source of power other than that directly generated by the

human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand-alone The classification of medical devices is in accordance with these guidelines ([3]): Medical devices

are classified by 4 risk groups (I, II a, II b, III), depending on the length of their use, degree of the

invasiveness, if it is an active medical device, or on the location of its application. In addition,

class I is differentiated in metric and sterile devices (Is, Im, Ism). High risk medical devices that

are analysed in this report include Class III and Class III_AIMD, i.e. those with an active energy supply such as an implantable cardioverter-defibrillator- and those without it such as a stent).

2 Methodology

To quantify the use of most common high-risk medical devices information of the so-called MEL- catalogue, a list containing all procedures which can be performed in a hospital ([4]), and GAPDRG database will be extracted, combined and analysed for prioritised devices. The frequencies of use of MD will be assessed based on defined medical procedure codes (MEL codes) extracted from the GAPDRG database of the Main Association of Austrian Social Security

Institutions (HVB).

In point 2.2.1. it is explained how High Risk MD can be identified in the GAPDRG database, which is described in section 2.2. Limitations are outlined in section 2.3. Chapter 3 shows the results of the frequency analysis based on MBDS-data for the years 2006 and 2007 and chapter

4 gives a more detailed overview on further selected MEL codes analysed by more specific

aspects like age, sex and district. Chapter 5 gives the more detailed description of the selected MEL codes and the chapters 6-9 (appendices) provide various tables .

2.1 MEL-catalogue

On the basis of the Austrian defined medical procedure catalogue (MEL-catalogue) those medical procedures from the group of the operational procedures are identified, which include: the use of a high risk medical device (class III or class III AIMD) and the use of the high risk medical device is the main part of the procedure (meaning that without this high risk medicine product the procedure would not be performed) and the medical device remained for at least more than 30 days (very often permanently) in the body.

Excluded from the analysis were medical devices like in-vitro diagnostics, resorbing surgical

suture material, dental medicines and intrauterine devices (coil), because either data on these devices are not stored in the database of the social security systems. Most commonly used MD will be further analysed with respect to its volume and frequency of use. Because of recently published papers about the frequency and the regional variability of cataract surgery (2011) ([5]) and knee joint prostheses (2013) ([6]), it was decided to focus on treatments with medical devices included in the MEL catalogue for the cardiovascular system (see chapter 4 for details). The MEL classification system lists every defined medical procedure that gets reimbursed. It was introduced in 1997 and had some changes in the structure since then. Furthermore it is part of the procedure and diagnoses-oriented hospital financing (LKF Leistungsorientierte 8/49 Krankenanstaltenfinanzierung) in Austria, which is another version of the DRG-System (diagnosis-related groups), a system for financing hospitals. The DRG-weights are based on the mean actual costs for the procedures and the length of the hospital stay.

2.2 GAPDRG Database

The data analysed is extracted from the GAPDRG database of the Main Association of Austrian Social Security Institutions. The abbreviation GAPDRG means General Approach for Patient- oriented Ambulant Diagnosis-Related Group. The database stores patient-oriented (but pseudonymized) reimbursement data of the Austrian social security systems for the years 2006 to 2007. This includes data on medications, hospitalizations, services in the extramural area, sick leaves, and also defined medical procedures (dates and frequency) and diagnoses (coded in accordance to the International Statistical Classification of Diseases and Related Health Problem ICD). For other years this statistical information based on anonymous data is not available in this format.

2.2.1 Identifying High Risk Medical Devices in the GAPDRG Database

Medical devices per se are not included in the GAPDRG database. The Main Association of Austrian Social Security Institutions identified 134 medical procedures (MELs) for which high risk medical devices according to the criteria stipulated in section 2.1 are needed and 8 MELs for bypass operations to describe the interventional development for coronary heart diseases over the years (see chapter 5 Appendix A, 142 MEL codes). The identified MELs provided by the

HVB are specified via alphanumeric codes.

2.2.2 Structure of the GAPDRG Database used for frequency analysis

For the frequency analysis of the researched alphanumeric MEL codes the MBDS-data set is used which is stored in the tables mbds_leistungen and mbds_aufenthalte, displaying hospitalizations (in public hospitals) for the years 2006 and 2007 together with data on defined medical procedures for each stay. The retrieved attributes of the tables are listed in Table 1 and

Table 2.

Table 1: Retrieved and used attributes of the "mbds_aufenthalte" table of the GAPDRG

Database

mbds_aufenthalte (hospital stays)

Attribute Description

jahr year of hospitalization ka_nr ID of the hospital aufenthalt_id ID of the duration of stay in the hospital gesl sex of the patient entlassung_alter age of the patient at the time of discharge land province where the hospital is located entlassung_art type of discharge punkte_totale total amount of LKF-points The attributes jahr, ka_nr and aufenthalt_id are the key attributes of the table mbds_aufenthalte and identify the other entries of this table clearly, meaning that no other entry with these key attributes exists. The LKF-points represent the arising costs for each hospital stay. 9/49 Table 2: Retrieved and used attributes of the "mbds_leistungen" table of the GAPDRG-

Database

mbds_leistungen (defined medical procedures for each stay)

Attribute Description

jahr year of hospitalization ka_nr ID of the hospital aufenthalt_id ID of the duration of stay in the hospital id ID of the entry in the database mel numeric code of the defined medical procedure, performed during this hospital stay datum_leistungserbringung date of the defined medical procedure The id in mbds_leistungen is the key attribute and identifies the other attributes of the entry clearly, which is relevant, because one defined medical procedure within one hospital stay could

be performed twice at the same day and therefore will be counted twice in the frequency

analysis. Next to the MBDS-data also PRIKRAF-data (private hospital institutions) is available for 2001-

2007, but because of structural differences and inconsistencies a frequency analysis is not done

for this data set.

2.3 Data Handling

As mentioned before the identified MELs provided by the HVB are specified via alphanumeric codes, but those stored in the GAPDRG database are numeric codes. This is due to the fact that

2008 a new (different) structuring system was introduced for MEL codes. Therefore the

alphanumeric codes need to be matched to the numeric codes fur further analysis.

In the first part of this project the 142 alphanumeric MEL codes identified according to the

selection criteria outlined in section 2.1 and the previously provided table of assignments are read into the database to hrmp_mel_142hrmp_ueberleitung structure of the second table is shown in Table 3. Table 3: Description of the used attributes of the provided assignment table hrmp_ueberleitung

Attribute Description

id ID of the assignment jahr_von Starting year of the validity of this assignment jahr_bis year until the assignment is valid mel (mostly) numeric MEL code of the assignment; some entries have alphanumeric assignments mel_neu alphanumeric MEL code of the assignment These two tables are matched to generate a smaller table where only the latest assignments are used. Only assignments of alphanumeric MEL codes to a numeric MEL code that are valid within the observed years 2006 and 2007 are presented in this table. 10/49 Complications arose, because not all of the 142 alphanumeric MEL codes matched a numeric MEL code. There are 66 alphanumeric new MEL codes that have no directly assigned numeric old MEL code, but they match another new alphanumeric MEL code . They are listed in Table 15 in Appendix B together with this assigned alphanumeric MEL code. The newly assigned MEL codes shown in the column Assigned MEL list of the researched 142 MELs except for two, which are marked red in Table 15. This means that the researched MEL code XN020 matches the alphanumeric MEL code DE100, which already is in the list of the researched 142 MEL codes, therefore a valid match exists.

For these 66 codes the year of the valid assignment is 2009 and for some 2010 (attribute

jahr_von) meaning that the assignment is valid since 2009 (resp. 2010). The loss of these 66 out of 142 codes -codes in 2006 acceptable. Therefore these alphanumeric MEL codes which are matched to another alphanumeric MEL-code in 2009 are first matched to their corresponding other alphanumeric MEL-code for 2009. Afterwards these corresponding MEL-codes are matched to their assigned numeric MEL codes in 2006 Assigned MEL. This means that the corresponding alphanumeric

MEL-code is listed twice in the assignment table, once for the matching for the original

alphanumeric MEL-code in 2009 and the second time for the matching of the numeric MEL-code in 2006. For all but one (MEL: AP020) a match is found within a valid year. An example of this processsecond level assignmentFigure 1. Figure 1: Example of a second level assignment of alphanumeric MEL code via another alphanumeric MEL code to a numeric MEL code, which is used in the database For example: The original identified alphanumeric MEL code AF030 (Implantation einer oder mehrerer Foramen Ovale-Elektrode(n) ± Implantation of one or more Foramen-Ovale- Electrode(s)) is assigned to the alphanumeric code AFS10 (Elektrodenimplantation zur Neuromodulation, 4-polig Implantation of Electrodes for neuromodulation, 4-pole). This assignment has been valid since the year 2009. AF030 has no other match in the assignment table. In a second step the new match AFS10 got researched and an assignment to the numeric MEL code 1241 was found. This assignment has been valid until 2008. For this second assignment only MELs for the years 2006 and 2007 are valid. In this special case shown in Figure 1 another second level assignment is available for AFS10 to 1246, but this assignment was only valid until (jahr_bis) 2003 and therefore it is not used for further analysis. Furthermore it has to be mentioned, that these second level assignments also exist for some other alphanumeric MEL codes, which have already a valid direct assignment apart from that. But the direct assignments were prioritized for our analysis. The process of second level assignment is only used for those MEL codes that have no other assignment. The final assignments used in the following frequency analysis are listed in Table 16 of Appendix B. The first, fourth and seventh column show the researched alphanumeric MEL code, the second, fifth and eight column show the assigned numeric MEL code and the third, sixth and ninth column show for direct assignment, copied from the provided table hrmp_ueberleitungen via another alphanumeric code. There are 75 codes that match directly a numeric code, 66 codes of second level assignment and one code that has no match. 11/49

Limitations

Researching the assignments seen in Table 16 (see Appendix 7), the following aspects have to be kept in mind: Some of the alphanumeric codes have more than one valid assignment to a numeric code. This means that in the further analysis the frequencies and LKF-points, assigned to these numeric codes, are aggregated. An example is shown in Figure 2. AA140 (Elektrodenimplantation zur Tiefenhirnstimulation, einseitig Implantation of electrodes for deep-brain stimulation, one side) has two assigned numeric MEL codes, so their frequencies, but also the other attributes like LKF-points, are added up in the following frequency analysis, whereas HG020 (Endoskopisches Legen einer Jejunalsondequotesdbs_dbs27.pdfusesText_33

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