hospital summit. processes and kpis health care value chain rafael provencio

Hospital Summit. Processes and KPIsHealth Care Value Chain

Rafael Provencio

Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.20122 |

Table of contents

1. Regulatory Framework EU

2. Hospital Value Chain

3. Processes

4. KPIs


What is the goal of the regulatory framework?

The target of the regulatory framework is to keep safety and performance on Medical Devices


General Framework

Directive 93/42/EEC concerning Medical Devices

Directive 98/79/EC

Directive 2000/70/EC

Regulation 1882/2003



Am

end

men

ts

In vitro medical devices

Human blood/plasma

Human blood/plasma

Commitees to assist the

Commision

Active implantable Medical Devices


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


General Framework

TargetTarget 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

Electromag.compliance

ProtectionRadiation

Ergonomicdesign

User knowledge

Product Safety


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


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”.


Classification of DevicesEU & EFTA

Class I

Non Invasive, Reusable surgical instruments, invasive <1min

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k

Annex IX of the Council Directive 93/42/EEC

Portable ECG, thermal blanket, thermal cushion, newly-born cradle, mannequin…



Class IIa

Blood Pressure Monitor, ECG, CPAP System, contact lenses, spirometer…

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k




Class IIb

Invasive long term, supply energy, medicine administration, ionizing radiation, therapeutic devices, monitoring of therapeutic devices

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k


Anesthesia device, central gas station, vaporizator, respirator, bronchial aspirator, infusion pump, incubator, hyperbaric chamber, pacemaker



Class III

Connection to nervous system, heart or central regulatory

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k




Class I

Non Invasive, Reusable surgical instruments, invasive <1min

Class IIa

Invasive short term, administer or exchange energy

Class IIb

Invasive long term, supply energy, medicine administration, ionizing radiation, therapeutic devices, monitoring of therapeutic devices

Class III

Connection to nervous system, heart or central regulatory

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Directive 93/42/EEC in the Device’s Life Cycle

Development ManufacturePackagingLabelling

Purchasing

Sale Production

Maintenance

Disposal

Manufacturer At the Hospital

GMPsISO standards: ISO 9001:2008

ISO 14001:2005, ISO 13485:2003No homogeous situation

Up to every hospital

Promotion

Installation

Vendor

•Legal representative of the Manufacturer

•Acquire proper knowledge

•Ensure installation (Art. 2)

•Post-market surveillance (Art. 10)

ISO 9001:2008ISO 14001:2005ISO 13485:2003

•User trainings

•Adverse events surveillance

•Use the device according to the designed purpose

•Ensuring that the device is performing as it was designed

“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

•Essential requirements: Art. 3

•CE Marking: Art. 17

•Declaration of conformity: Art. 11

•Details of conformity assesment


Directive 93/42/EEC in the Device’s Life Cycle

Development ManufacturePackagingLabelling

Purchasing

Sale Production

Maintenance

Disposal

Manufacturer At the Hospital

Promotion

Installation

Vendor

Sale

Promotion

Installation

Manufacturer

Maintenance

GMPsISO standards: ISO 9001:2008

ISO 14001:2005, ISO 13485:2003No homogeous situation

Up to every hospital

ISO 9001:2008ISO 14001:2005ISO 13485:2003

ISO 9001:2008, ISO 14001:2005, ISO 13485:2003 ISO 9001:2008, ISO

14001:2005, ISO 13485:2003

No homogeous situationUp to every hospital

•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

•Essential requirements: Art. 3

•CE Marking: Art. 17

•Declaration of conformity: Art. 11

•Details of conformity assessment


Table of contents



3. Processes

4. KPIs


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)


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!


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)


Value Chain vs. Five Forces


Table of contents



3. Processes

4. KPIs


What is a process?

Dept. 1 Dept. 2 Dept. 3

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)


How do we work in processes?3 Cases in real world


1 2 3

Lack of TrustDuplication

Lack of Process Mgmt.

BottlenecksProcess Management

Integration

Dept. 1 Dept. 2 Dept. 3 Dept. 1 Dept. 2 Dept. 3


Why is this so important?


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


Process Management at the hospital


Process Involvement at the Biomedical Department

Purchase Devices

IBMgmnt.

InstallationPrev.

MaintenanceCorrective

Maintenance Disposal

Tools Management

Personal Management

Purchase Services & Parts

Installed Base Management

Training & Capacitating

Vendors Management

Budget Control

Pat

ient

s

Administration

SocietyC

linic

ians


Table of contents



3. Processes

4. KPIs


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)


Types of KPIs

Cuantitative Cualitative

Directional Financial


Some Examples of KPIs

Subject IndicatorActivities/Interventions Activities per device

Activities per department

Activities per type

Activities Externalized vs. Total

Installations Average time per installation

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

Preventive Maintenance CTOM: Completition Time on Maintenance

IMOT: Inspection Maintenance On Time

Availability of devices (%)


Some Examples of KPIs

Subject IndicatorEmployees 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


Is this the end?… Next steps


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?


Obstacles


Challenges/Obstacles

The top Management is not committed. We have other priorities



We have externalized some activities. Over this we do not have proper information



We don’t have time. The daily work is too much



There’s a lot of change resistance. Not everybody is on board



We don’t have the proper tools and applications


There is always a first step


I everybody still on board?

Thank you for your attention.

hospital summit. processes and kpis health care value chain rafael provencio

Documents

hospital summit

process management

biomed event

medical devices directive

medical device medical

medical device safety

general framework directive

ec directive