Hospital Summit. Processes and KPIs
Health Care Value Chain
Rafael Provencio
Table of contents
1. Regulatory Framework EU
2. Hospital Value Chain
3. Processes
4. KPIs
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
What is the goal of the regulatory framework?
The target of the regulatory framework is to keep safety and performance on
Medical Devices
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
General Framework
Directive 93/42/EEC concerning Medical Devices
Amendments
Directive 98/79/EC
In vitro medical
devices
Directive 2000/70/EC
Human
blood/plasma
Directive 2001/104/EC
Regulation 1882/2003
Commitees to assist
the Commision
Active implantable
Medical Devices
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Human
blood/plasma
Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Directive 2007/47/EC
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
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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
Electromag.
compliance
User
knowledge
Ergonomic
design
With this goal the essential requisites are being
established so they must be fulfilled by the devices
and accessories, including software
Protection
Radiation
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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”.
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Classification of Devices
EU & EFTA
Risk
Portable ECG, thermal blanket, thermal cushion, newly-born
cradle, mannequin…
Class I
Non Invasive, Reusable surgical instruments, invasive <1min
Annex IX of the Council Directive 93/42/EEC
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Classification of Devices
Risk
EU & EFTA
Class IIa
Blood Pressure Monitor, ECG, CPAP System, contact lenses, spirometer…
Annex IX of the Council Directive 93/42/EEC
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Classification of Devices
EU & EFTA
Class III
Risk
Connection to nervous system, heart or central regulatory
Annex IX of the Council Directive 93/42/EEC
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Directive 93/42/EEC in the Device’s Life Cycle
Manufacturer
Development Manufacture
Vendor
Packaging
Labelling
•CE Marking: Art. 17
Installation
Promotion
Purchasing
•Essential requirements: Art. 3
Sale
At the Hospital
Production
Disposal
Maintenance
•User trainings
•Legal representative of the
“The lack Manufacturer
of, or inappropriate, calibration
•Adverse events surveillance
and maintenance can seriously jeopardize
•Acquire proper knowledge
the device according to the
their
safety
and performance. These •Use
issues
•Declaration of conformity: Art. 11
designed purpose
•Ensure installation
(Art. 2)
are often overlooked
or underestimated”
•Details of conformity assesment
•Post-market surveillance
World Health
Organization
(Art.
10)
GMPs
ISO standards: ISO 9001:2008
ISO 14001:2005, ISO 13485:2003
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
ISO 9001:2008
ISO 14001:2005
ISO 13485:2003
•Ensuring that the device is
performing as it was designed
No homogeous situation
Up to every hospital
Directive 93/42/EEC in the Device’s Life Cycle
Manufacturer
Development Manufacture
Packaging
Labelling
Purchasing
•Essential requirements: Art. 3
•CE Marking: Art. 17
•Declaration of conformity: Art. 11
•Details of conformity assessment
GMPs
ISO standards: ISO 9001:2008
ISO 14001:2005, ISO 13485:2003
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Manufacturer
Vendor
Sale
Installation
Promotion
At the Hospital
Production
Disposal
Maintenance
•Legal representative of the
Manufacturer
•User trainings
•Adquire proper knowledge
•Ensuring that the device is
performing as it was designed
•Ensure installation
•Adverse events surveillance
•Post-market surveillance
ISO 9001:2008
ISO 9001:2008, ISO
ISO 14001:2005
14001:2005, ISO 13485:2003
ISO 13485:2003
Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
No homogeous situation
to every hospital
NoUp
homogeous
situation
Up
every hospital
ISOto9001:2008,
ISO
14001:2005, ISO 13485:2003
Table of contents
1. Regulatory Framework EU
2. Hospital Value Chain
3. Processes
4. KPIs
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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)
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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!
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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)
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Value Chain vs. Five Forces
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Table of contents
1. Regulatory Framework EU
2. Hospital Value Chain
3. Processes
4. KPIs
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Dept. 2
Dept. 3
How do we work in processes?
3 Cases in real world
1
2
Lack of Trust
Duplication
Dept. 1
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Dept. 2
Dept. 3
3
Lack of Process Mgmt.
Process Management
Bottlenecks
Integration
Dept. 1
Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Dept. 2
Dept. 3
Dept. 1
Dept. 2
Dept. 3
Why is this so important?
Dept. 1
Dept. 2
Dept. 3
1. 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
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Process Management at the hospital
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Process Involvement at the Biomedical Department
Society
Purchase
Devices
IB
Mgmnt.
Installat
ion
Prev.
Mainten
ance
Correctiv
e
Mainten
ance
Dispos
al
Personal Management
Purchase Services & Parts
Installed Base Management
Training & Capacitating
Vendors Management
Budget Control
Administration
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Patients
Clinicians
Tools Management
Table of contents
1. Regulatory Framework EU
2. Hospital Value Chain
3. Processes
4. KPIs
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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)
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Types of KPIs
Cuantitative
Directional
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Cualitative
Financial
Some Examples of KPIs
Subject
Activities/Interventions
Indicator
Activities per device
Activities per department
Activities per type
Activities Externalized vs. Total
Installations
Preventive Maintenance
Average time per installation
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 (%)
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Some Examples of KPIs
Subject
Employees
Indicator
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
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Is this the end?
… Next steps
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
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?
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Obstacles
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Challenges/Obstacles
The top Management is not committed. We have other priorities
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Challenges/Obstacles
We have externalized some activities. Over this
we do not have proper information
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Challenges/Obstacles
We don’t have time. The daily work is too much
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Challenges/Obstacles
There’s a lot of change resistance. Not
everybody is on board
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Challenges/Obstacles
We don’t have the proper tools and
applications
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
There is always a first step
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
I everybody still on board?
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Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012
Thank you for your attention.