ClosedSuppliesMarktconsultatie
PCA (Patient Controlled Analgesia) pumps
Leids Universitair Medisch Centrum (LUMC) · Marktconsultatie · 344165
5
5 of 6 core insights found
Measures presence, not accuracy · documents remain authoritative
ScopeAdvicePoints of attentionSuitability requirementsAward criteriaTimeline
Type
Supplies
33194110
Estimated value
Not published
To deadline
Ongoing
Knock-outs
0
exclusion grounds
Award basis
Best price-quality ratio
Assess manuallyconfidence high
Market consultation for the replacement of 49 PCA pumps and the supply of associated disposables and maintenance for LUMC. The focus is on high quality, safety, and ICT integration.
Supplies · Marktconsultatie · National procedure
Complete timeline
CharacteristicsCPV 33Supplies
01What is being requested
Supply of PCA pumps and associated disposables including maintenance for the Anesthesia and Obstetrics departments. The contract includes the replacement of existing equipment and offers the possibility of reordering during a five-year period.
PCA (Patient Controlled Analgesia) pumps and accessories
02Strategic insight
Strategic insight · AI analysis
Ensure that the technical documentation is complete for the in-house management of maintenance. Check whether the ICT requirements regarding network and security are fully supported. Provide a train-the-trainer program to ensure continuity.
03Points of attention
Important · 6
The equipment must have a service life of at least 10 years.Important
If a new model is introduced during the term, it must be offered at the same price.Important
The supplier must be able to supply the required consumables for a minimum of 10 years.Important
The system must be fully integratable with the PDMS.Important
The equipment must be resistant to specific cleaning agents such as 70% alcohol and chlorine solution.Important
The pump must be compatible with an infusion bag of at least 100 ml.Important
04Can I take part?
Technical · 6
Offered equipment must comply with the Medical Device Regulation (2017/745).Technical
Offered equipment must be provided with a valid CE declaration of conformity.Technical
The equipment must comply with the IEC-60601 standards.Technical
If standards are similar, this must be demonstrably proven by means of an attachment.Technical
Technicians active on the work floor of LUMC must act in accordance with Dutch and EU laws and regulations.Technical
Technicians must be able to provide a valid Certificate of Conduct (VOG).Technical
05Process & timeline
Publication of the market consultation on TenderNed
<strong>22 juli 2024</strong>
Deadline for submitting a response within the framework of this market consultation
<strong>4 augustus 2024</strong>
Delivery, installation, and implementation
<strong>31 december 2024</strong>
06Value in context
Estimate not published
The contracting authority did not publish an estimated value — common for a large share of contracts. The EU threshold for leveringen is € 221.000, for reference.
07Likely competitors
#Likely bidderFitWins
1Medtronic Trading NL B.V.SME9430×
2Meyra Retail & Services B.V.SME9022×
3Boston Scientific Nederland B.V.SME8720×
4Medipoint WMO B.V.SME8315×
5Abbott Medical Nederland B.V.SME8116×
6Philips Nederland B.V.SME8115×
08Tender documents
Bijlage 2. Invuldocument vragenlijst PCA pompendocxJul 22, 2024 · 44 KB
TN478683 - EF04 Vooraankondiging die alleen ter informatie wordt gebruikt - algemene richtlijn 20240722135629pdfJul 22, 2024 · 5 KB
Marktconsultatiedocument PCA pompen en toebehorenpdfJul 22, 2024 · 371 KB
Bijlage 1. Programma van Eisen bij marktconsultatie PCA pompenpdfJul 22, 2024 · 132 KB
09Legal themes that may be relevant here
Advies 798> Dit advies gaat over een nadere opdracht voor campagnedienstverlening. Volgens ondernemer is sprake van (de schijn van) partijdiAdvies 765> Dit advies gaat over een opdracht voor beheer en beveiliging van een opvanglocatie voor Oekraïense ontheemden. Ondernemer klaagtAdvies 703> De Commissie oordeelt dat niet aannemelijk is geworden dat de geraamde waarde van de opdracht gelijk aan of hoger is dan het toeComplaint dismissed
10Frequently asked questions
Which medical regulations must the PCA pumps comply with?
All offered products must comply with the 93/42/EEC Medical Devices Directive, including the amending directives 2007/47/EC and the Medical Device Regulation (2017/745) as of 26 May 2021.
What technical requirements are set for the dosage of the pumps?
The pump must be capable of delivering highly accurate medication doses down to 2 decimal places according to the prescribed settings.
What requirements apply to the user-friendliness and the size of the equipment?
The control panel and the interface must be intuitive with a logical menu and navigation system. Regarding size (length, width, height), the pump must be equivalent to or smaller than the currently used pain pump.
What is the requirement for the certification of the offered equipment?
The offered equipment must be provided with a valid CE declaration of conformity. Additionally, the contractor must be able to provide a declaration of conformity upon request demonstrating that the equipment complies with all European and International standards for medical devices.
Which standards must the equipment comply with?
The equipment must comply with the applicable ISO-EN-NEN standards, or a similar standard accepted within Europe. The equipment must also comply with the applicable IEC-60601 standards.
Automatically compiled from the official tender data and documents.
11Estimated value versus the market
p25
€ 317K
€ 317K
median
€ 892K
€ 892K
p75
€ 3,3 mln
€ 3,3 mln
deze opdracht
Gegunde waarden in CPV 33 · leveringen n=528