Introduction Processes and KPIs Health Care Value Chain. Rafael Provencio

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1 Introduction Processes and KPIs Health Care Value Chain Rafael Provencio

2 Table of contents 1. Regulatory Framework EU 2. Hospital Value Chain 3. Processes 4. KPIs 2

3 What is the goal of the regulatory framework? The target of the regulatory framework is to keep safety and performance on Medical Devices 3

4 General Framework Directive 93/42/EEC concerning Medical Devices Directive 98/79/EC In vitro medical devices Amendments Commitees to assist the Commision Directive 2000/70/EC Human blood/ plasma Directive 2001/104/EC Regulation 1882/2003 Human blood/ plasma Active implantable Medical Devices Directive 2007/47/EC 4

5 General Framework Some topics about medical device safety: i. Complete safety is not achievable ii. It is a Risk Management issue iii. It is deeply linked with device performance iv. It must be considered through the life spam of the device v. It requires shared responsibility over all parts involved 5

6 General Framework Target of the sanitary legal environment: Guarantee the free movement of those within the EU territory, offering, at the time, an adequate protection level so the products that circulate do not represent risks for the health or safety of the patients, users or third persons and reach the defined performance, by the manufacturer when used under the previewed conditions Product Safety Ergonomic design Electromag. compliance User knowledge With this goal the essential requisites are being established so they must be fulfilled by the devices and accessories, including software Protection Radiation 6

7 Definitions: Medical Device Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, 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 physiological process control of conception 7

8 Definitions: Accessory Accessories are products in their own right and, although being treated as devices [they] do not follow, as general rule, the classification of related devices in conjunction with which they are used. The question whether a product is a device or an accessory has not practical consequence. Following the article 1(1) of Directive 93/42/EEC, accessories shall be treated as medical devices in their own right. 8

9 Classification of Devices EU & EFTA Portable ECG, thermal blanket, thermal cushion, newly-born cradle, mannequin Risk Class I Non Invasive, Reusable surgical instruments, invasive <1min Annex IX of the Council Directive 93/42/EEC 9

10 Classification of Devices EU & EFTA Risk Class IIa Blood Pressure Monitor, ECG, CPAP System, contact lenses, spirometer Annex IX of the Council Directive 93/42/EEC 10

11 Classification of Devices EU & EFTA Class IIb Risk Invasive long term, supply energy, medicine administration, ionizing radiation, therapeutic devices, monitoring of therapeutic devices Anesthesia device, central gas station, vaporizator, respirator, bronchial aspirator, infusion pump, incubator, hyperbaric chamber, pacemaker Annex IX of the Council Directive 93/42/EEC 11

12 Classification of Devices EU & EFTA Class III Connection to nervous system, heart or central regulatory Risk Annex IX of the Council Directive 93/42/EEC 12

13 Classification of Devices EU & EFTA Class III Connection to nervous system, heart or central regulatory Class IIb Risk Invasive long term, supply energy, medicine administration, ionizing radiation, therapeutic devices, monitoring of therapeutic devices Class IIa Invasive short term, administer or exchange energy Class I Non Invasive, Reusable surgical instruments, invasive <1min Annex IX of the Council Directive 93/42/EEC 13

14 Definitions: Manufacturer The natural or legal person responsible for defined manufacturing activities related to a device with a view to its being placed on the market under the manufacturer s name. The reason for this link with the placing on the market is that the directives aims to subject to its protection requirements the transaction of a device from the sphere of a manufacturer towards the public. 14

15 Directive 93/42/EEC in the Device s Life Cycle Manufacturer Vendor At the Hospital Development Manufacture Packaging Labelling Sale Installation Production Disposal Purchasing Promotion Maintenance Legal representative of the User trainings Essential requirements: Art. 3 The lack Manufacturer of, or inappropriate, calibration Adverse events surveillance CE Marking: Art. 17 and maintenance can seriously jeopardize Acquire proper knowledge Use the device according to the Declaration of conformity: Art. 11 their safety and performance. These issues Ensure installation (Art. 2) designed purpose are often overlooked or underestimated Details of conformity assesment Post-market surveillance Ensuring that the device is World Health (Art. Organization 10) performing as it was designed GMPs ISO standards: ISO 9001:2008 ISO 14001:2005, ISO 13485:2003 ISO 9001:2008 ISO 14001:2005 ISO 13485:2003 No homogeous situation Up to every hospital 15

16 Directive 93/42/EEC in the Device s Life Cycle Manufacturer Manufacturer Vendor At the Hospital Development Manufacture Packaging Labelling Sale Installation Production Disposal Purchasing Promotion Maintenance Essential requirements: Art. 3 CE Marking: Art. 17 Declaration of conformity: Art. 11 Details of conformity assessment Legal representative of the Manufacturer Adquire proper knowledge Ensure installation Post-market surveillance User trainings Adverse events surveillance Ensuring that the device is performing as it was designed GMPs ISO standards: ISO 9001:2008 ISO 14001:2005, ISO 13485:2003 No homogeous situation ISO 9001:2008 ISO 9001:2008, ISO No Up homogeous to every hospital situation ISO 14001: :2005, ISO 13485:2003 Up ISO to 9001:2008, every hospital ISO ISO 13485: :2005, ISO 13485:

17 Table of contents 1. Regulatory Framework EU 2. Hospital Value Chain 3. Processes 4. KPIs 17

18 What is the Value Chain? The entire production chain from the input of raw materials to the output of final product consumed by the end user. (M. Porter) 18

19 What is the Value Chain? The entire production chain from the input of raw materials to the output of final product consumed by the end user. (M. Porter) Focus in the in the interests of the whole process Optimize all activities from all players Define the best relationships beween the players Collaborative approach Trust is Needed! 19

20 Obstacles to the Healt Care Value Chain 1. Paper shuffling 2. Lengthy product ordering and delivery cycle times 3. Multiple product handling activities 4. Excessive inventory carrying costs 5. Lack of information sharing among trading partners 6. Little information on product location and utilization 7. Operational focus (instead of customer focus) 8. Pressure to cut short-term costs 9. Lack of trust between partners 10. Lack of easy business mechanics (e-commerce) (The Health Care Value Chain: producers, purchasers and providers Lawton R. Burns) 20

21 Value Chain vs. Five Forces 21

22 Table of contents 1. Regulatory Framework EU 2. Hospital Value Chain 3. Processes 4. KPIs 22

23 Das verknüpfte Bild kann nicht angezeigt werden. Möglicherweise wurde die Datei verschoben, umbenannt oder gelöscht. Stellen Sie sicher, dass der Link auf die korrekte Datei und den korrekten Speicherort zeigt. What is a process? A collection of related, structured activities or tasks that produce a specific service or product (serve a particular goal) for a particular customer or customers. It often can be visualized with a flowchart as a sequence of activities with interleaving decision points or with a Process Matrix as a sequence of activities with relevance rules based on the data in the process. (Wikipedia) Dept. 1 Dept. 2 Dept. 3 23

24 Das verknüpfte Bild kann nicht angezeigt werden. Möglicherweise wurde die Datei verschoben, umbenannt oder gelöscht. Stellen Sie sicher, dass der Link auf die korrekte Datei und den korrekten Speicherort zeigt. How do we work in processes? 3 Cases in real world Lack of Trust Duplication Lack of Process Mgmt. Bottlenecks Process Management Integration Dept. 1 Dept. 2 Dept. 3 Dept. 1 Dept. 2 Dept. 3 Dept. 1 Dept. 2 Dept. 3 24

25 Das verknüpfte Bild kann nicht angezeigt werden. Möglicherweise wurde die Datei verschoben, umbenannt oder gelöscht. Stellen Sie sicher, dass der Link auf die korrekte Datei und den korrekten Speicherort zeigt. Why is this so important? Dept. 1 Dept. 2 Dept Every person knows exactly what to do 2. We put the focus in the overall outcomes 3. Every action is replicable 4. We can easily measure the performance 5. We can introduce changes and analyze the results 25

26 Process Management at the hospital 26

27 Process Involvement at the Biomedical Department Society Purchase Devices New IB Installat ion Prev. Mainten ance Correctiv e Mainten ance Dispos al Clinicians Tools Management Personal Management Purchase Services & Parts Installed Base Management Training & Capacitating Vendors Management Budget Control Patients Administration 27

28 Results of the questionnaire Do you have formalised processes at your Department? Do you control performance metrics regularly with the team? 10% 40% 60% 90% Yes No Yes No 28

29 Results of the questionnaire II Which are the most critical processes to you? 25% 20% 23% 19% 15% 10% 5% 13% 13% 10% 10% 6% 3% 3% 0% Personnel Management Preventive Maintenance Corrective Maintenance Installed Base Mgmt. Budget Control Training & Capaciting Installation Purchase Services Facility Management 29

30 Results of the questionnaire III Which are the main challenges to implement KPIs 80% 70% 70% 60% 50% 40% 30% 20% 10% 20% 10% 0% Lack of time and resources Lack of training and knowledge Lack of IT tools 30

31 Table of contents 1. Regulatory Framework EU 2. Hospital Value Chain 3. Processes 4. KPIs 31

32 What is a KPI? key performance indicator (KPI) is a type of performance measurement. KPIs are commonly used by an organization to evaluate its success or the success of a particular activity in which it is engaged. (example of a KPI Dashboard) 32

33 Types of KPIs Cuantitative Cualitative Directional Financial 33

34 Some Examples of KPIs Subject Activities/Interventions Installations Preventive Maintenance Corrective Maintenance Indicator Activities per device Activities per department Activities per type Activities Externalized vs. Total Average time per installation CTOM: Completition Time on Maintenance IMOT: Inspection Maintenance On Time FTFR: First Time Fix Rate CTOR: Completition Time On Repair Activities due to Bad Use vs. Total Source of Contact: (Telephone vs. e-ticket) By device type Availability of devices (%) 34

35 Some Examples of KPIs Subject Employees Installed Base Financial Indicator Trainings per department Technical trainings per employee Activities per employee # Devices over End Of Service Age Pattern of devices Total Maintenance Cost per Device Maintenance Cost per department Cost of Inadequate use Maintenance Cost per Functional unit Maintenance Cost per Device and Manufacturer 35

36 Is this the end? Next steps 36

37 Is this the end? Answer the following questions: 1. Do I have written down processes? 2. Do I have a Process Owner defined per process? 3. Is the involved personnel trained and committed? 4. Do I have defined at least 1 KPI per process, with a specific target? 5. Is the process owner monitoring the process? 6. Do I have a specific and regular program to analyze a KPI deviation, and take the proper actions? 7. Is the process owner empowered to introduce changes his/her process? 8. Do I have support from the top management? 37

38 Obstacles 38

39 Challenges/Obstacles The top Management is not committed. We have other priorities 39

40 Challenges/Obstacles We have externalized some activities. Over this we do not have proper information 40

41 Challenges/Obstacles We don t have time. The daily work is too much 41

42 Challenges/Obstacles There s a lot of change resistance. Not everybody is on board 42

43 Challenges/Obstacles We don t have the proper tools and applications 43

44 There is always a first step 44

45 I everybody still on board? 45

46 Thank you for your attention.

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