Title: Hospital Summit. Processes and KPIs Health Care Value Chain Rafael Provencio
1Hospital Summit. Processes and KPIsHealth Care
Value Chain Rafael Provencio
2Table of contents
- Regulatory Framework EU
- Hospital Value Chain
- Processes
- KPIs
3What is the goal of the regulatory framework?
- The target of the regulatory framework is to keep
safety and performance on Medical Devices
4General Framework
Directive 93/42/EEC concerning Medical Devices
In vitro medical devices
Directive 98/79/EC
Human blood/plasma
Directive 2000/70/EC
Human blood/plasma
Amendments
Directive 2001/104/EC
Regulation 1882/2003
Commitees to assist the Commision
Directive 2007/47/EC
Active implantable Medical Devices
5General Framework
- Some topics about medical device safety
- Complete safety is not achievable
- It is a Risk Management issue
- It is deeply linked with device performance
- It must be considered through the life spam of
the device - It requires shared responsibility over all parts
involved
6General 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
With this goal the essential requisites are being
established so they must be fulfilled by the
devices and accessories, including software
7Definitions 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
8Definitions 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.
9Classification of DevicesEU EFTA
Risk
Class I Non Invasive, Reusable surgical
instruments, invasive lt1min
Annex IX of the Council Directive 93/42/EEC
10Classification of DevicesEU EFTA
Risk
Class IIa Blood Pressure Monitor, ECG, CPAP
System, contact lenses, spirometer
Annex IX of the Council Directive 93/42/EEC
11Classification of DevicesEU EFTA
Risk
Class IIb Invasive long term, supply energy,
medicine administration, ionizing radiation,
therapeutic devices, monitoring of therapeutic
devices
Annex IX of the Council Directive 93/42/EEC
12Classification of DevicesEU EFTA
Class III Connection to nervous system, heart or
central regulatory
Risk
Annex IX of the Council Directive 93/42/EEC
13Classification of DevicesEU EFTA
Class III Connection to nervous system, heart or
central regulatory
Risk
Class IIb 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 lt1min
Annex IX of the Council Directive 93/42/EEC
14Definitions 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 manufacturers 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.
15Directive 93/42/EEC in the Devices Life Cycle
Installation
Development
Manufacture
Packaging Labelling
Sale
Production
Disposal
Purchasing
Maintenance
Promotion
- User trainings
- Adverse events surveillance
- Use the device according to the designed purpose
- Ensuring that the device is performing as it was
designed
- Legal representative of the Manufacturer
- Acquire proper knowledge
- Ensure installation (Art. 2)
- Post-market surveillance (Art. 10)
- Essential requirements Art. 3
- CE Marking Art. 17
- Declaration of conformity Art. 11
- Details of conformity assesment
The lack of, or inappropriate, calibration and
maintenance can seriously jeopardize their safety
and performance. These issues are often
overlooked or underestimated World Health
Organization
GMPs ISO standards ISO 90012008 ISO 140012005,
ISO 134852003
No homogeous situation Up to every hospital
ISO 90012008 ISO 140012005 ISO 134852003
16Directive 93/42/EEC in the Devices Life Cycle
Installation
Sale
Installation
Development
Manufacture
Packaging Labelling
Sale
Production
Disposal
Promotion
Purchasing
Maintenance
Promotion
Maintenance
- User trainings
- Adverse events surveillance
- Ensuring that the device is performing as it was
designed
- Legal representative of the Manufacturer
- Adquire proper knowledge
- Ensure installation
- Post-market surveillance
- Essential requirements Art. 3
- CE Marking Art. 17
- Declaration of conformity Art. 11
- Details of conformity assessment
GMPs ISO standards ISO 90012008 ISO 140012005,
ISO 134852003
No homogeous situation Up to every hospital
ISO 90012008 ISO 140012005 ISO 134852003
ISO 90012008, ISO 140012005, ISO 134852003
17Table of contents
- Regulatory Framework EU
- Hospital Value Chain
- Processes
- KPIs
18What 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)
19What 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!
20Obstacles to the Healt Care Value Chain
- Paper shuffling
- Lengthy product ordering and delivery cycle times
- Multiple product handling activities
- Excessive inventory carrying costs
- Lack of information sharing among trading
partners - Little information on product location and
utilization - Operational focus (instead of customer focus)
- Pressure to cut short-term costs
- Lack of trust between partners
- Lack of easy business mechanics (e-commerce)
- (The Health Care Value Chain producers,
purchasers and providers - Lawton R. Burns)
21Value Chain vs. Five Forces
22Table of contents
- Regulatory Framework EU
- Hospital Value Chain
- Processes
- KPIs
23What 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
24How do we work in processes?3 Cases in real world
1
2
3
Lack of Trust Duplication
Lack of Process Mgmt. Bottlenecks
Process Management Integration
25Why is this so important?
- Every person knows exactly what to do
- We put the focus in the overall outcomes
- Every action is replicable
- We can easily measure the performance
- We can introduce changes and analyze the results
26Process Management at the hospital
27Process Involvement at the Biomedical Department
Society
Purchase Devices
IB Mgmnt.
Installation
Prev. Maintenance
Corrective Maintenance
Disposal
Tools Management
Personal Management
Clinicians
Patients
Purchase Services Parts
Installed Base Management
Training Capacitating
Vendors Management
Budget Control
Administration
28Table of contents
- Regulatory Framework EU
- Hospital Value Chain
- Processes
- KPIs
29What 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)
30Types of KPIs
31Some Examples of KPIs
Subject
Indicator
Activities/Interventions
Activities per device
Activities per department
Activities per type
Activities Externalized vs. Total
Installations
Average time per installation
Preventive Maintenance
CTOM Completition Time on Maintenance
IMOT Inspection Maintenance On Time
Corrective Maintenance
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 ()
32Some Examples of KPIs
Subject
Indicator
Employees
Trainings per department
Technical trainings per employee
Activities per employee
Installed Base
Devices over End Of Service
Age Pattern of devices
Financial
Total Maintenance Cost per Device
Maintenance Cost per department
Cost of Inadequate use
Maintenance Cost per Functional unit
Maintenance Cost per Device and Manufacturer
33Is this the end? Next steps
34Is this the end?Answer the following questions
- Do I have written down processes?
- Do I have a Process Owner defined per process?
- Is the involved personnel trained and committed?
- Do I have defined at least 1 KPI per process,
with a specific target? - Is the process owner monitoring the process?
- Do I have a specific and regular program to
analyze a KPI deviation, and take the proper
actions? - Is the process owner empowered to introduce
changes his/her process? - Do I have support from the top management?
35Obstacles
36Challenges/Obstacles
The top Management is not committed. We have
other priorities
37Challenges/Obstacles
We have externalized some activities. Over this
we do not have proper information
38Challenges/Obstacles
We dont have time. The daily work is too much
39Challenges/Obstacles
Theres a lot of change resistance. Not everybody
is on board
40Challenges/Obstacles
We dont have the proper tools and applications
41There is always a first step
42I everybody still on board?
43Thank you for your attention.