The Life Cycle of the Medical EquipmentPURCHASING

Heikki Teriö, Ph.D.Department of Clinical Engineering

Medical Technology Management

Need

Procurement

Management

Disposal

Market analysisNeed analysis

Technical specificationClinical testControl measurementExperience feedbackEvaluationDelivery controlEducationMaintenance planningRegistration

Preventive maintenanceCorrective maintenanceSafety assessmentEconomyDocumentationContinuing education

ReserveStorageSpare partsSale

Purchasing a function or a solution

From Vision

to Function

Vision

how will our work look like in 3, 5, 8 years

how will the medical methods be developed

how will the medical technology be developed

how will the economy of the health care system be developed

Purchasing a function or a solution

What we mean by purchasing a function or a solution

function of a piece of device

function of a system

function of an entire treatment room

Purchasing a function or a solution

We need a dialog between the different categories of staff from the very beginning.This is extremely IMPORTANT!

Purchasing a function or a solution

The dialog between the different categories of staff must include:

• how the equipment will be used• what special functions will be needed• what information is needed for the treatment – where can we

find this information• what availability is needed• what environmental demands we can state• how are we going to maintain the function/equipment• how are we going to finance the function/equipment

Purchasing a function or a solution

The new role of the Clinical Engineering

Internal consult• technical knowledge• economic knowledge• medical knowledge• good ability to co-operate

Purchasing a function or a solution

The Purchasing Process

Purchasing team Tender documents Announcement

Opening the tenders

Selection of supplier

Contract

Delivery control

Appeal time 10 daysAppeal

Qualification/evaluation

Delivery

Commission

Restart the process

Payment

Follow-up

The Annual Purchasing at Karolinska

• Total 237 M€21 % of turnover

• Material 128 M€

• Medical equipment 34 M€

• Services 76 M€

Decision to Purchase

A formal decision to allocate money must be made by authorised person.

Specify the type of goods/services required.

Specify the estimated cost.

Also a formal commission to start the purchasing process.

Commission to the Purchase Department

The commission is registered and given an unique ID-no.

The purchasers are assigned commissions by the Purchasing Manager

Larger and/or unusual commissions are discussed within the group and sometimes assigned to a pair of purchasers.

Investment number

On all investments over 1500 € are assigned with the number

Follow-up of the investment from budget to the inventory register

Who is responsible for what?

• Invitation to tender – Purchasing department

• Specifications – User/Clinical Engineering

• Contract terms – Purchasing department

Grupp

Underlag AnnonseringÖppning

Avtal

Besiktning

Remisstid (10) dagarÖverprövning

Utvärdering

Leverans

Uppdrag

Gör om upphandling

Uppföljning

Preparing the tender documentsThe Purchaser contacts the end users and clinical and technical experts.

Together the group prepare the tender documents:

- Invitation to tender

- Requirements specification (LCC)

- Contractual terms

The Purchaser has the overall responsibility for the quality of the documents

The demands on the product shall not be changed

Demands on the goods/servicein the invitation to tender • Explain all the demands that has to be full filled

(goods, services, time schedule etc.)• Explain the demands as a goal, function or result when ever it

is possible• Describe the demands so that they are measurable• Ask for the prise for all goods and services that will be

included (service, maintenance, new versions, updaters etc.)

Grupp

Underlag AnnonseringÖppning

Avtal

Besiktning

Remisstid (10) dagarÖverprövning

Utvärdering

Leverans

Uppdrag

Gör om upphandling

Uppföljning

Environmental demands of the purchasing

Environmental demands are part of the hospitals environmental control system

Relevant environmental demands in central purchasing

There is also national recommendations for different types of medical equipment

Making the purchase public

The invitation to tender is advertised in the bi-weekly ”Anbudsjournalen” and their homepage.

If open procedure advertisement is made in EGT S/TED i Luxemburg.

Open procedure >EUR 200.000.

Distribution of the documents

Companies who see the advertisement and are interested contact the purchaser and request the documents.

Sometimes we contact companies and ask if they are interested to ensure competition.

The purchaser distribute the documents via e-mail or regular mail.

In the future the documents will be made available on our external web.

Clarifications are distributed to the companies usually via e-mail

Opening the tenders

The tenders must be clearly marked

At least two (2) persons must be present at the opening and sign each page

Copies are distributed to end-users, experts etc.

Qualification and evaluation

The purchaser check the tending company and contractual terms.The purchaser make a price/cost evaluation.The end-users and experts check how the tender meets the requirements specification.The tenderer might be given a chance to clarify their tender.Evaluation is made – different methods

EvaluationLowest price

OREconomically most preferable

Ergonomics

Quality

Price

Functionality

Environment

Give the weight / share in the process

Grupp

Underlag AnnonseringÖppning

Avtal

Besiktning

Överprövning

Utvärdering

Leverans

Uppdrag

Gör om upphandling

Uppföljning

Selection of supplier(s)After evaluation we decide on one or more suppliers.

The reason for the selection must be documented and based on the requirements and criteria stated in the tender documents.

All tending companies are informed about which company was selected and why. They can appeal against the decision within 10 days.

Contract

Any open issues in the contract is discussed and final terms agreed.

The contract is sent to the supplier for signature.

We return a signed copy after the 10 days waiting period.

Copies of the contract are distributed to the clinic, Clinical Engineering Department and the Financial Department

Delivery of the goods

All deliveries are made to the goods receipt area.

The goods passed on to the Clinical Engineering department for delivery inspection.

After approved delivery inspection the equipment can be put to use and the warranty time starts.

Termination and follow-up

The contract is entered into a database for future follow-up.

All original documents are archived and kept for minimum 2 years. Decisions and contract for ever.

Follow-ups

Signing service contract after the warranty.

Price adjustments.

Prolonging the contract.

Checking the financial status of the supplier and how they perform.

Clockwork logistics

The users order through the database or by writing free text

Electronic authorizing

Buyer handles the free text order

Central creation of the orders to the distributor through EDI or automatic fax

The barcode is read at the delivery centre

Invoice control at the dept. of Economics.

Received - Payment Received at the clinic

Faktura

Current problems

• Lack of discipline – respect for the law.• Short planning horizon – no understanding for time consuming

process.• Purchases are getting more complex; technically, financially and

legally. Competence must be constantly improved.• The law, ”LOU” develops in the wrong direction – detailed

regulations instead of framework guidelines.• New, ”political” criteria, e.g. environment, equality, social justice • Acceptance for the e-purchase system - conservatism.

Smart Buy in the County Council, SMILIncrease the co-operation within the county council

Large volumes give better prizes and functionality

Better knowledge give better terms

Less suppliers give better terms

Guaranteed volumes give better terms

SMIL

Steering group with county and hospital directors

Project group with purchasing managers meets every 14th day

User engaged via reference groups

New way of purchasing

2 new analyzer positions to the county council

Thank youfor

your attention