Vaidlustaja täiendav seisukoht ja menetluskulude nimekiri

Greiner Bio One GmbH Bad Haller Str. 32 A-4550 Kremsmünster Austria Expert Opinion 17.12.2019 on the suitability of the products • VACUETTE® QUICKSHIELD Complete • VACUETTE® QUICKSHIELD Safety Tube Holder • VACUETTE® Multiple Use Drawing Needle by Greiner Bio-One GmbH Bad Haller Str. 32, A-4550 Kremsmünster for the prevention of needlestick injuries (NSI) during blood collection, as well as the compliance of the product with the safety requirements of the Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU and the Implementation Guidance for the EU Framework Agreement, Council Directive and Associated National Legislation by the European Biosafety Network. Commissioned Body VPA Prüf- und Zertifizierungs GmbH Dr.-Ing. Dipl.-Chem. Thomas Schochow Papenberger Str. 49 42859 Remscheid VPA Prüf- und Zertifizierungs GmbH 1 Scope of the expert opinion Needle-stick injuries expose the affected person to risks of infection due to transfer of pathogens in contaminated blood. The prevention of needle-stick injuries therefore has high priorities for safe working conditions. The purpose of this expertise is the examination of the presented products VACUETTE® QUICKSHIELD Safety Tube Holder in combination with the separate VACUETTE® Multiple Use Drawing Needle as well as the preinstalled combination VACUETTE® QUICKSHIELD Complete in regard of their capability to prevent accidental needle-stick injuries for healthcare workers during capillary blood collection. It also has to be established whether the combined products meet the requirements of the • Framework agreement on prevention from sharp injuries in the hospital and healthcare sector • European Council Directive 2010/32/EU (adaptation of aforementioned framework agreement) • European Biosafety Network Implementation Guidance • German Technical Rule for Biological Agents TRBA 250 section 4.2.5. (4) 3 For this purpose, the device will be used and reviewed as per the manufacturer's instructions for use (Intended Use). In addition, the safety of the product regarding “foreseeable misuse” is also assessed within reasonable terms, by examining the devices during intuitive usage or intentional manual deactivation of safety mechanisms, i.e. use of the product in a manner not intended by the manufacturer or seller of the product. Although invasive devices are medical devices under European Council Directive 93/42/EEC (Medical Devices Directive) or Regulation (EU) 2017/745 (Medical Devices Regulation), the verification of compliance of VACUETTE® Quickshield products, sets, or needles is at no time part of this report. 2 Regulations 2.1 Framework Agreement on prevention from sharp injuries 1 0F In 2009 the framework agreement was signed by the European Hospital and Healthcare Employers’ Association (HOSPEEM) and the European Public Services Union (EPSU) to prevent sharp injuries in the hospital and healthcare sector. These organizations are the recognized European Social Partners in the hospital and healthcare sector, and therefore the agreement aims to reduce all risks to healthcare workers caused by injuries from any sharps. The purpose of this agreement is • to achieve the safest possible working environment for employees in the hospital and healthcare sector; • to prevent injuries to workers caused by all types of sharp medical objects and instruments which are able to cut and/or prick; 1 HOSPEEM & ESPU, Framework agreement on prevention from sharp injuries in the hospital and healthcare sector, 2009 VPA Prüf- und Zertifizierungs GmbH • to protect workers at risk; • to set up an integrated approach to assessing and preventing risks as well as to training and informing workers; • to put in place response and follow-up procedures. The agreement defines principles to reduce the risk of sharps injuries, ranging from education and training of healthcare workers to the provision of helpful mind sets and working environments. Several topics are covered in-depth, providing strategies to improve all processes regarding possible risks of sharps injuries: • Risk assessment • Elimination, prevention and protection • Information and awareness-raising • Training • Reporting • Response and follow-up This framework agreement mentions safety devices in clause 6, and therefore is relevant for the assessment of said devices: Where the results of the risk assessment reveal a risk of injuries with a sharp and/or infection, workers´ exposure must be eliminated by taking the following measures, without prejudice to their order: • Specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste. These procedures shall be regularly reassessed and shall form an integral part of the measures for the information and training of workers referred in clause 8; • Eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment, providing medical devices incorporating safety-engineered protection mechanisms; […] 2.2 European Council Directive 2010/32/EU 2 1F Directive 2010/32/EU adapts the framework agreement (2.1) and annexed the whole agreement. Thus, the intentions of the agreement are implemented on EU level. However, the goals of the Directive itself have to be implemented in each EU country individually in their own laws. 2 Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU VPA Prüf- und Zertifizierungs GmbH 2.3 European Biosafety Network Implementation Guidance 3 2F The European Biosafety Network was established after the final adoption of the Council Directive 2010/32/EU. Its principal objective is the improvement of the safety of patients and healthcare workers by elimination of sharps injuries. This open network promotes of best practices when using sharps and provides guidance reducing sharps injuries at EU level based on the Council Directive on sharps injuries. Other measures include the training and education od healthcare workers as well as the providing safety engineering technologies. The document Prevention of Sharps Injuries in the Hospital and Healthcare Sector - Implementation Guidance for the EU Framework Agreement, Council Directive and Associated National Legislation provides guidance on the practical implementation of the Directive 2010/32/EU. The principles described in 2.1 are therefore relevant in this document as well. One of the principles explicitly mentioned in the Guidance document involves the hierarchy of measures concerning the protection of healthcare workers as referenced in the Directive itself. For example, the use of safety-engineered protection mechanisms has higher priority over the use of personal protective equipment. According to the Guidance document, the function of the safety mechanism should be evaluated under the following criteria: • The device must not compromise patient care; • The device must perform reliably; • The safety mechanism must be an integral part of the safety device, not a separate accessory; • The device must be easy to use and require little change of technique on the part of the health professional; • The activation of the safety mechanism must be convenient and allow the care-giver to maintain appropriate control over the procedure; • The device must not create other safety hazards or sources of blood exposure; • A single-handed or automatic activation is preferable; • The activation of the safety mechanism must manifest itself by means of an audible, tactile or visual sign to the health professional; • The safety mechanisms should not be easily reversible once activated. The provided products are therefore tested against these criteria to determine whether the product and its safety mechanism comply with the requirements set by the Guidance document of the European Biosafety Network. Products meeting these criteria are considered to be safety-engineered medical devices. 3 European Biosafety Network, Prevention of Sharps Injuries in the Hospital and Healthcare Sector - Implementation Guidance for the EU Framework Agreement, Council Directive and Associated National Legislation, 2010 VPA Prüf- und Zertifizierungs GmbH 2.4 TRBA 250 - Biological agents in health care and welfare facilities German Technical Rule for Biological Agents (TRBA) 250 4 is a compilation of rules, which reflects the 3F state of the art, the state of occupational health and occupational hygiene as well as other scientific knowledge regarding the involvement of biological agents. This document lists concrete terms how to fulfil the requirements set by the Biological Agents Ordinance 5, which applies to all activities involving 4F biological agents, is in itself the national implementation of the Council Directive 2010/32/EU and is part of the Safety and Health at Work Act (Arbeitsschutzgesetz) 6. 5F In this context, the safe blood collection or injection is covered by the TRBA 250 as a non-targeted activity with regular contact with body fluids, resulting in the assigned “Protection level 2”. Therefore, several requirements for safe use of medical devices are listed. Consistent with the risk assessment and hierarchy of protective measures of either Council Directive 2010/32/EU as well as the German Safety and Health at Work Act, healthcare workers are to be protected, first and foremost, by using the best available technology (e.g. safety engineered devices) before education/training of staff or personal protective equipment. TRBA 250, as mentioned before, contains state of the art knowledge regarding the handling of biological agents, and therefore also lists safety measures to prevent needle-stick injuries. 4.2.5 (3) Priority is to be given to selecting suitable and safe work processes and equipment that render the use of pointed and sharp medical instruments superfluous. […] (4) Should it be necessary to use pointed and sharp medical instruments, it is essential to use working equipment that has a safety mechanism (hereinafter “safety equipment”), complies with numbers 1 to 7 below, and presents no or only a minor risk of punctures and cuts, provided this is technically possible and necessary for preventing a risk of infection. 1. Safety equipment is to be used for the following activities with an increased risk of infection or accident: […] − taking blood samples, […] 2. For all other activities that do not fall under point 1, the employer must assess the risk of accident and infection in the risk assessment and take appropriate measures. 4 Technical Rule for Biological Agents 250, Biological agents in health care and welfare facilities (TRBA 250) (Edition: March 2014, GMB 2014, No. 10/11 of 27.03.2014, p. 206; Last amended: GMBl 2018 No. 15 of 02.05.2018, p. 259) 5 Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (Biological Agents Ordinance - BioStoffV) of 15 July 2013 (Federal Law Gazette [BGBl.] Part I p. 2514) 6 Safety and Health at Work Act of 7 August 1996 (Federal Law Gazette I p. 1246), as last amended by Article 427 of the Competence Adjustment Ordinance of 31 August 2015 (Federal Law Gazette I p. 1474) VPA Prüf- und Zertifizierungs GmbH 3. Safety equipment for the prevention of punctures and cuts must have the following properties: • It must put neither patients nor workers at risk. • It must be easy to use and application-oriented. • The safety mechanism is an integral part of the system and is compatible with other accessories. • The activation of the safety mechanism must: • be self-triggering or allow single-handed operation; • be possible immediately after use; • rule out subsequent use; • be indicated by a clear signal (tactile, visible or audible). The provided products are therefore tested according to the requirements of TRBA 250 4.2.5 (4) 3. Devices meeting these criteria are considered to be state of the art safety equipment. 3 Facts and findings The products VACUETTE® QUICKSHIELD Safety Tube Holder & VACUETTE® Multiple Use Drawing Needle are used in combination (marketed ready for use as VACUETTE® QUICKSHIELD Complete), so the holder for blood collection tubes with a built-in safety mechanism can be used with any needle for blood collection. The needle component is used for venipuncture and possesses no safety mechanism. Therefore, it is assessed in combination Figure 1: VACUETTE® Multiple Use Drawing with the holder which is recommended by the manufacturer. Needle (left) and VACUETTE® QUICKSHIELD The holder has a safety mechanism which is attached to the part Safety Tube Holder (right) before assembly where the needle is going to be attached, so the safety mechanism of the holder (which in itself is no risk for needle- stick injury) functions as protection for the attached needle. VPA Prüf- und Zertifizierungs GmbH 3.1 Range of assessed products Art.-No. Product 450071 VACUETTE® Multiple Use Drawing Needle 22G x 1” 450072 VACUETTE® Multiple Use Drawing Needle 21G x 1” 450073 VACUETTE® Multiple Use Drawing Needle 20G x 1” 450075 VACUETTE® Multiple Use Drawing Needle 22G x 1½” (LOT 17L08A) 450076 VACUETTE® Multiple Use Drawing Needle 21G x 1½” 450077 VACUETTE® Multiple Use Drawing Needle 20G x 1½” 450230 VACUETTE® QUICKSHIELD Safety Tube Holder (LOT G190233U) 450237 VACUETTE® QUICKSHIELD Complete 21G x 1½” 450238 VACUETTE® QUICKSHIELD Complete 21G x 1” 450206 VACUETTE® QUICKSHIELD Complete 22G x 1½” 450234 VACUETTE® QUICKSHIELD Complete 22G x 1” Table 1: Products included in this expertise – VACUETTE® QUICKSHIELD Safety Tube Holder & Multiple Use Drawing Needles Due to the combination of the same safety mechanism of the VACUETTE® QUICKSHIELD Safety Tube Holder (450230) and different needles, the presented product combination (450230 & 450075) or the already combined product VACUETTE® QUICKSHIELD Complete should have the same safety properties as other needle variants of the same length. Shorter needles of this product line are not tested, but samples of the Visio PLUS line were tested separately with the same safety mechanism. Therefore, the expertise for the entire product line is based on this article combination (450230 & 450075), as well as supporting examinations of different needle variants (length, diameter) of other tests. 3.2 General findings The products VACUETTE® QUICKSHIELD Complete, VACUETTE® Multiple Use Drawing Needle and VACUETTE® QUICKSHIELD Safety Tube Holder are manufactured by: Greiner Bio-One GmbH Bad Haller Str. 32 A-4550 Kremsmünster They display the CE marking (Notified Body 0123, TÜV SÜD Product Service GmbH Zertifizierstellen, Ridlerstraße 65, 80339 München). 3.3 Manufacturer’s instructions for use The manufacturer recommends the equipment to be used by a trained user as well as immediate disposal of contaminated, unsealed or deformed items. For manual combination of the components, the first protective cap of the VACUETTE® Multiple Use Drawing Needle is pulled off. It is subsequently threaded into the VACUETTE® QUICKSHIELD Safety Tube Holder with special care to fasten the needle correctly. The following steps are similar the manually assembled products as well as the pre-assembled product line VACUETTE® QUICKSHIELD Complete: The safety shield of the holder can now be repositioned to the users liking, the black point marking the bevel of the needle tip. After removal of the second protective cap, the combined products are ready VPA Prüf- und Zertifizierungs GmbH for venipuncture and blood collection. After the removal of the last collection tube from the holder, the needle is retracted out of the veins of the patient. The safety mechanism is activated by pushing the shield of the holder over the needle – either with a finger of the hand holding the needle/holder combination or by pressing the shield on a firm surface. The safety mechanism should lock with an audible click, upon which the needle/holder combination is to be safely disposed. 3.4 User experiences The attachment of the needle to the holder is quick, intuitive and unproblematic and is skipped by using the VACUETTE® QUICKSHIELD Complete products. The repositionable shield makes it comfortable for venipuncture. The process of blood collection itself is not different from usual processes. If the instructions are followed and the activation of the safety mechanism takes place immediately after the completed blood collection, the procedure is safe and the risk of needle-stick injuries is reduced. The activation of the safety mechanism can be heard but the haptic feedback is weak. After the activation of the shield, the needle is safely contained under the shield. 3.5 Deactivation of safety mechanisms The safety mechanism of the VACUETTE® QUICKSHIELD Safety Tube Holder could not be opened again without using tools. Upon opening the safety shield of a locked mechanism on a 1,5” needle, the needle is bent without exposing the tip. If the safety shield is opened after securing a 1” needle, the needle is bent and only at the end of the 130° movement of the shield the bent needle slips out of the retaining flap, possibly exposing the tip for needle-stick injury. 4 Evaluation of facts and findings 4.1 General During the process of blood collection – including the disposal – exists a risk of needle-stick injuries due to the use of sharp objects (needles). The prevention of NSI therefore reduces the risk of potentially serious infection of healthcare workers. The consequent use of safety-engineered devices - in combination with training, the ban of recapping, and safe disposal – has been shown to significantly lower the risk of needle-stick injuries. Legal acts and ordinances, both on EU as well as national level, give requirements and suggestions for safety devices. Given the training of healthcare workers in safe usage and disposal as well as providing ways to safely dispose used devices, the use of the examined devices is assessed according to the aforementioned regulations. 4.2 Council directive 2010/32/EU & Framework agreement Due to the annexed framework agreement within the Directive the requirements of both legal documents are evaluated at once. VPA Prüf- und Zertifizierungs GmbH The combination of VACUETTE® QUICKSHIELD Safety Tube Holder & VACUETTE® Multiple Use Drawing Needles as well as the pre-assembled product VACUETTE® QUICKSHIELD Complete does meet all requirements of aforementioned documents. • [The purpose of this agreement is] to prevent injuries to workers caused by all types of sharp medical objects and instruments which are able to cut and/or prick; Though no requirement of the framework agreement regarding the product itself, the intention of the framework agreement is met due to the encapsulation of the sharp tip of the needle. Thus, during the complete process of blood collection, the risk of needle-stick injuries is greatly reduced. • [Clause 6] Specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste The procedure of blood collection itself is safe if handled according to the Instructions of Use, thus meeting the requirements of the framework agreement. Given the disposal into safe sharps containers, the process of disposal by the healthcare worker into the container is safe due to the complete encapsulation after activation of the safety mechanism. • [Clause 6] Eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment, providing medical devices incorporating safety- engineered protection mechanisms Even if the venipuncture itself, as well as a short period in the retraction phase, exposes the needle for possible touch by the user, the user should have his hand located on safe locations on the holder/shield during handling, thus being able to push the shield over the needle immediately after use. If the mechanism is locked, the risk of needle-stick injuries is reduced by the safety-engineered protection mechanism. A shorter needle (1” or less) could possibly be exposed again if the used equipment is not disposed immediately and if there is a force able to open the safety shield in a rotation manner for ca. 130°. The risk of both situations (longer time until disposal and intention to/possibility of completely open the safety shield) is minimized by the Instructions of Use by the manufacturer, which clearly states: - Recommended training of the user according to Instructions of Use (see below) - Disposal as soon as possible after use - Explicit restriction of forced release of the safety mechanism - Restriction to bend needles or use bent needles Therefore, the expert deems the probability of misuse to be very low, if the combination of VACUETTE® QUICKSHIELD Safety Tube Holder & VACUETTE® Multiple Use Drawing Needles or the VACUETTE® QUICKSHIELD Complete product is used according to the Instructions of Use and is disposed immediately after use. Therefore, the safety mechanism lowers the risk of needle-stick injuries until disposal, making it a safety engineered protection mechanism. 4.3 European Biosafety Network Implementation Guidance The requirements of the Implementation Guidance provided by the European Safety Network are met. • The device must not compromise patient care The combined device can be used similar to normal needles, therefore being no threat to either patient or user. • The device must perform reliably During examination of the safety mechanism, the mechanism could be activated reliably in all instances. It was not possible to release the needle once more with exception of intentional disregard of the Instructions of Use. VPA Prüf- und Zertifizierungs GmbH The activation could be hindered if the needle is not screwed to the holder completely, needing far higher pressure to activate the locking mechanism of the shield. However, according to the Instructions of Use, the needle should be screwed on tightly, thus reducing the possibility of misuse. • The safety mechanism must be an integral part of the safety device, not a separate accessory The safety mechanism is already attached to the holder. Even if it can be removed beforehand, as soon as the needle is threaded onto the holder, the shield cannot be removed anymore. The assembled combination therefore has an integrated safety mechanism. • The device must be easy to use and require little change of technique on the part of the health professional The assembly of both components and the activation of the safety mechanism should be trained, as stated in the Instructions of Use. The implementation of the combined products for blood collection is not different to the usual process, therefore not requiring major changes to the known procedure. • The activation of the safety mechanism must be convenient and allow the care-giver to maintain appropriate control over the procedure The safety mechanism is always controlled by the user himself. The required force for activation of the safety mechanism is high enough to prevent accidental activation, but the user has to push the shield over the needle after use until the safety mechanism is locked. • The device must not create other safety hazards or sources of blood exposure; The combination of VACUETTE® QUICKSHIELD Safety Tube Holder & VACUETTE® Multiple Use Drawing Needles or the VACUETTE® QUICKSHIELD Complete did not create additional safety hazards during examination. • A single-handed or automatic activation is preferable The shield of the VACUETTE® QUICKSHIELD Safety Tube Holder can be activated with one hand, either by using a free finger of the holding the holder/needle combination or by pressing it on a firm surface. • The activation of the safety mechanism must manifest itself by means of an audible, tactile or visual sign to the health professional The activation can be heard. • The safety mechanisms should not be easily reversible once activated For longer needles (1,5”) the safety mechanism could not be released again. The use of shorter needles (25 mm / 1”) is problematic if the product is not immediately disposed and if the shield with the enclosed needle is intentionally and / or forcefully bent backwards by more than 130°, as the needle will then slip out of the safety mechanism and the contaminated sharp is exposed for possible needle-stick injuries once again. If the user disposes the used equipment immediately, the safety mechanism is sufficient in reducing the risk of needle-stick injuries until disposal since the user should not force the safety shield completely open during this short period of time. VPA Prüf- und Zertifizierungs GmbH 4.4 TRBA 250 All requirements of TRBA 250 are met. • [Safety equipment] must put neither patients nor workers at risk The device can be used similar to normal blood collection equipment, therefore being no threat to either patient or user. • [Safety equipment] must be easy to use and application-oriented The usage is similar to usual equipment and can be easily adopted. The safety mechanism itself can be easily activated and does not hinder the procedure due to the possibility of repositioning of the shield. Training for safe handling should be required, to ensure right usage and disposal of the product. • The safety mechanism is an integral part of the system and is compatible with other accessories The safety mechanism is already attached to the holder. Even if it can be removed beforehand, as soon as the needle is threaded onto the holder, the shield cannot be removed anymore. The assembled combination therefore has an integrated safety mechanism. There is no need for other accessories near the safety mechanism. The safety mechanism of the pre-assembled product VACUETTE® QUICKSHIELD Complete therefore is already integrated in the product. • [The activation of the safety mechanism must] be self-triggering or allow single-handed operation The shield of the VACUETTE® QUICKSHIELD Safety Tube Holder can be pushed manually over the needle with one hand, either by using a free finger of the holding the holder/needle combination or by pressing it on a firm surface. • [The activation of the safety mechanism must] be possible immediately after use The shield can be pushed over the needle immediately after the retraction of the needle. • [The activation of the safety mechanism must] rule out subsequent use The safety mechanism usually encapsulates the contaminated needle, especially the 1,5” needles. In case the user forcefully bends the safety shield open for 1” needles, subsequent use is almost impossible due to the bent needle. • [The activation of the safety mechanism must] be indicated by a clear signal (tactile, visible or audible) The locking of the safety mechanism can be heard as well as (limited) felt. VPA Prüf- und Zertifizierungs GmbH 5 Expert opinion All combinations of VACUETTE® QUICKSHIELD Safety Tube Holder and VACUETTE® Multiple Use Drawing Needles as well as the pre-assembled VACUETTE® QUICKSHIELD Complete product line by Greiner Bio-One GmbH are meeting the requirements set by Clause 6 of the Annex of the European Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU, Number 5 of the Implementation Guidance for the EU Framework Agreement, Council Directive and Associated National Legislation by the European Biosafety Network and Number 4.5.2 (4) 3 of the German Technical Rule for Biological Agents (TRBA) 250. Therefore, the products are safety equipment with a safety-engineered mechanism appropriate to prevent needle-stick injuries for the process of blood collection. If the product is used according to the instructions for use of the manufacturer, the product is deemed safe for the intended application and can thereby reduce the risk of needle stick injuries of healthcare works during blood collection and disposal of medical waste. During the use of the product with shorter needles (25 mm or less) it is possible that an intentional misuse of the product could lead to the needle being exposed again. For the safe use of the product it is therefore essential for a user to follow the instructions for use of the manufacturer. VPA Prüf- und Zertifizierungs GmbH Remscheid, 17.12.2019 __________________________________ Dr.-Ing. Dipl.-Chem. Thomas Schochow Advokaadibüroo TRINITI OÜ Telefon: +372 6 850 950 Maakri 19/1 Faks: +372 6 850 951 10145 Tallinn, Eesti [email protected] www.triniti.ee VAIDLUSTAJA TÄIENDAVAD SEISUKOHAD, MENETLUSE PEATAMISE TAOTLUS JA MENETLUSKULUDE NIMEKIRI Adressaat: Riigihangete Vaidlustuskomisjon [email protected] Riigihanke 294368 viitenumber: Kuupäev: 09.06.2025 Vaidlustaja: ISIS Medical OÜ registrikood: 10958649 Vaidlustaja Toomas Pugri, advokaat esindaja: e-post: [email protected] Hankija: Aktsiaselts Lääne-Tallinna Keskhaigla registrikood: 10822269 Taotlused: 1. Peatada riigihange nr 294368. 1. VAIDLUSTAJA TÄIENDAVAD SEISUKOHAD 1.1 Vaidlustaja jääb kõigi vaidlustuses esitatud seisukohtade juurde. Vastuseks hankija 04.06.2025 menetlusdokumendile ja hankija poolt muudetud riigihanke alusdokumentidele selgitab vaidlustaja täiendavalt järgmist. 1.2 Kuigi hankija muutis vaidlustusmenetluse kestel alusdokumente, sh vaidlustaja poolt vaidlustatud Hanke osas 1 sätestatud hindamiskriteeriume (sh maksumuse osakaalu ja „täiendava funktsionaalsuse“ p-e 1 ja 2), on vaidlustaja hinnangul Hanke osa 1 hindamiskriteeriumi „täiendava funktsionaalsuse“ p-d 1-5 jätkuvalt vastuolus RHS-s sätestatuga vaidlustuses toodud põhjendustel. 1.3 Esiteks, vaidlustaja jääb seisukohale, et riigihanke osa 1 „Täiendava funktsionaalsuse“ hindamiskriteeriumid annavad (endiselt) ilmse ja põhjendamatu eelise üksnes ühele konkreetsele tootele („BD Vacutainer® Eclipse™ Blood Collection Needle“, edaspidi BD) ja seda toodet pakkuvale ettevõtjale. Vaidlustaja ei nõustu hankija väidetega, et (i) lisaks hankijale ja AS-le Surgitech oleks turul ka teisi pakkujaid ning (ii) et verevõtuvahendite turul oleks mitmeid brände, kelle tooted vastavad „täiendava funktsionaalsuse“ kriteeriumidele. (i) Hankija viitab teiste pakkujate olemasolu väites riigihankele nr 263595, mille verevõtuvahendite osas esitas pakkumuse ka Mediq Eesti OÜ (lisaks vaidlustajale ja AS-le Surgitech). Siiski, Mediq Eesti OÜ nimetatud hankesse ei kvalifitseerinud. Sealjuures ei ole  Mediq Eesti OÜ riigihangete registri andmetel sõlminud mitte ühtegi hankelepingut verevõtuvahendite osas (rääkimata verevõtuvahenditest, mis vastaksid Hanke osa 1 „täiendava funktsionaalsuse“ hindamiskriteeriumidele). Järelikult on hankija viide Mediq Eesti OÜ-le kui täiendavale konkureerivale ettevõtjale verevõtuvahendite soetusel asjakohatu ja tuleb tähelepanuta jätta. (ii) Niisamuti on vaidlustaja hinnangul asjakohatud hankija 04.06.2025 vastuse lisades 3-6 tootjate kataloogid. Esiti juba sellepärast, et hankija ei ole nimetatud dokumente esitanud eesti keeles (RHS § 195 lg 6), mistõttu tuleks jätta nimetatud dokumendid tähelepanuta. Lisaks ei vasta hankija viidatud tooted ka sisuliselt „täiendava funktsionaalsuse“ kriteeriumidele: b) Disera – hankija esitatud kataloogist nähtub, et tootel on küll olemas nõelahoidja, kus nõela kaitse asetseb nõela küljes, aga puudub mistahes informatsioon, et kas kaitsemehhanism keerleb või mitte (vastavalt p-le 1) ning kas kaitsemehhanism asetseb eelsätitult nõela ava suunas või mitte (vastavalt p-le 2); c) Metze Care – hankija esitatud kataloogist ei nähtu, kas nõela kaitsemehhanism keerleb või mitte ning kas kaitsemehhanism asetseb eelsätitult nõela ava suunas või mitte. Samuti ei ole hankija esitanud ühtegi viidet sellele, kes konkureerivatest ettevõtjatest niisugust toodet pakub (vaidlustajale teadaolevalt puudub Metze Care verevõtuvahenditel Eestis edasimüüja. Tegemist on Eesti turul tundmatu tootega); d) KDL - vaidlustajale teadaolevalt puudub KDL verevõtuvahenditel Eestis edasimüüja ning tegemist on Eesti turul tundmatu tootega. Hankija esitatud kataloogist ei nähtu, kas nõela kaitsemehhanism keerleb või mitte ning kas kaitsemehhanism asetseb eelsätitult nõela ava suunas või mitte; e) Sol-Millennium Medical – viidatud tootjal on olemas küll nõelad, aga mitte katsutid (mis on samuti Hanke osas 1 nõutav, RHAD vorm 2, osa 1, p 1.1 ja RHAD TK p 1.2), mis välistab niisuguse toote pakkumise. Järelikult ei eksisteeri turul ühtegi teist ettevõtet peale vaidlustaja ja AS-i Surgitech, kes verevõtuvahendeid pakuvad ning hankija poolt abstraktselt viidatud toodete võõrkeelsetest kataloogidest ei nähtu, et ühegi teise tootja toode vastaks Hanke osa 1 “täiendava funktsionaalsuse” kriteeriumidele. Hankija väide laiemast konkurentsist kui 2 ettevõtjat (ja 2 toodet) on kunstlik, sest ühtegi hankija 04.06.2025 menetlusdokumendis käsitletud toodet ei ole varasemalt ühelgi hankel pakutud (ei hankija ega ka teiste Eesti haiglate hangetel, rääkimata hangetes edukaks osutumisest). Olukorras, kus reaalne konkurents verevõtuvahendite turul on üksnes kahe ettevõtja vahel, on ühe ettevõtja pakutava toote selge eelistamine vastuolus RHS § 85 lg-s 1 sätestatud reaalse konkurentsi tagamise nõudega ja RHS § 3 sätestatud põhimõtetega. 1.4 Teiseks, hankija on põhjendanud “täiendava funktsionaalsuse” p-des 1-2 sätestatud kriteeriumide lisamist sellega, et fikseeritud kaitsemehhanism ja selle paiknemine eelsätitult nõela ava suunas tagab väidetavalt patsiendi ja tervishoiutöötaja suurema ohutuse ning et töötajatel ei ole aega kontrollida, kas kaitsemehhanism on õiges asendis. Samuti väidab hankija üllatuslikult, et ei ole vaidlustaja tootega rahul ning et on hindamiskriteeriumid koostanud verevõtu töötajatelt saadud tagasiside põhjal. Vaidlustaja eeltooduga ei nõustu. Verevõtt ei ole liinitöö, et töötajal (õel) pole aega nõela sobivasse asendisse sättida. Vastupidi, verevõtuprotseduuri peab just eriti rahulikult ja ettevaatlikult tegema, vältimaks hankija poolt välja toodud nõelatorkevigastusi ja nakkushaiguste levikut. Ning just selleks, et ennetada nõelatorkevigastusi, ongi vaidlustaja pakutaval tootel nõela kaitsemehhanism liigutatav, et toodet oleks igas olukorras mugav kasutada. Tihtipeale ei ole patsiendid n-ö ideaalses asendis, 2  millisel juhul saab kaitsemehhanismi liigutada just sobivasse asendisse vastavalt vajadusele. Kaitsemehhanism, mis on liigutatav, ei saa olla seega objektiivselt toote puudus, mille hankimise välistamiseks „täiendava funktsionaalsuse“ p-des 1-2 teistsugust toodet soosivad kriteeriumid seada. Vastupidi, liigutatav kaitsemehhanism on nimelt arendatud selle universaalse mugavuse pärast, tagades igal üksikjuhtumil ohutu verevõtu. Vaidlustaja lisab käesolevale menetlusdokumendile sõltumatu eksperthinnangu, mille esemeks oli vaidlustaja poolt pakutava toote vastavuskontroll verevõtu ohutusstandarditele (lisa 1, lk 12). Eksperthinnangu tulemuseks oli, et vaidlustaja toode vastab kõikidele ohutusstandarditele. Veel enam, hankija on viimased 5 aastat kasutanud vaidlustaja tooteid ning vaidlustajale teadaolevalt ei ole hankija verevõtu töötajatel esinenud mitte ühtegi nõelatorkevigastust. Ka seetõttu jääb arusaamatuks, millest tulenevalt leiab hankija, et vaidlustaja pakutav toode oleks justkui „ohtlikum“ ja mille erinevate, kuid samaväärsete (ja sama ohutute) funktsioonide eest „täiendava funktsionaalsuse“ p-de 1-2 osas punkte saada ei ole võimalik. Samuti on arusaamatu hankija väide, justkui vaidlustaja toodet kasutades on verevõtu protseduuri ajakulu suurem kui BD toodet kasutades. Nimelt tuleb BD tootel erinevalt vaidlustaja tootest tõmmata füüsiliselt kaitsemehhanism sõrmega alla, et nõela saaks veeni sisestada. Eeltoodu illustreerimiseks lisab vaidlustaja piltliku võrdluse vaidlustaja tootest ja BD tootest (lisa 2). Viidatust nähtub, et ajaliselt pole vahet, kas verevõtu töötaja peab sõrmega kaitsemehhanismi alla tõmbama (BD toote puhul) või kaitsemehhanismi liigutama (vaidlustaja pakutava toote puhul). Lisaks, hankija väide, et töötajad pole vaidlustaja tootega rahul, on paljasõnaline ja üllatav. Vaidlustaja tooteesindaja on hankijalt regulaarselt uurinud toote rahulolu kohta ning hankija ei ole teinud vaidlustajale ühtegi etteheidet ega märkust (ei suuliselt ega kirjalikult), justkui vaidlustaja toode ei ole kvaliteetne või et seda on ebamugav kasutada. Pigem vastupidi, hankija tagasiside on olnud positiivne. Niisamuti jääb arusaamatuks ka hankija viide verevõtu töötajatelt saadud tagasisidele, mille põhjal on hankija väidetavalt hindamiskriteeriumid koostanud. Niisugune väide on paljasõnaline ning ei ole välistatud, et hankija on selle esitanud üksnes ühe ettevõtja pakutava toote eelistamise õigustamiseks, mitte reaalselt läbiviidud uuringu põhjal. Kokkuvõttes – Hankija poolt vaidlustusmenetluses esitatud väited suurema ohutuse, kiiruse või parema kasutusmugavuse tagamiseks on otsitud ning ei vasta tõele (samaväärse ohutuse, kiiruse ja kasutusmugavuse tagab ka vaidlustaja pakutav toode). Sätestatud „täiendava funktsionaalsuse“ hindamiskriteeriumide p-d 1-2 soodustavad seega ühte konkreetset toodet ilma mõistliku põhjenduseta. 1.5 Kolmandaks, hankija leiab, et kui Hanke osa 1 hindamiskriteeriumi p-des 3-5 sätestatud subjektiivsed kriteeriumid on pikalt lahti kirjutatud, on sellega ka tagatud pakkumuse läbipaistev ja kontrollitav hindamine. Vaidlustaja ei saa hankija niisuguse käsitlusega nõustuda. Hankija ajab segamini subjektiivse hindamiskriteeriumi kui sellise seadmise (mille lubatavuse üle iseenesest ju vaidlus puudub) ja subjektiivse hindamiskriteeriumi objektiivse kontrollimise. Vaidlustaja etteheide ei ole mitte selles, et subjektiivne tingimus oleks sõnastatud segaselt (mis omakorda tagaks hankijale piiramatu valikavabuse seda hiljem oma suva järgi sisustama hakata ning oleks samuti õigusvastane) või et vaidlustaja ei saa sellest aru, vaid Hanke osa 1 hindamiskriteeriumi p-de 3-5 õigusvastasuse tingib see, et hankija ei ole ette näinud objektiivset hindamise protseduuri, välistamaks sõnastuselt arusaadava subjektiivse kriteeriumi ühetaolise ja võrdse hindamise. Nii on näiteks RHS kommentaarides subjektiivse hindamiskriteeriumi kontrollimise osas leitud, et: „Hankija peab tagama subjektiivseid elemente sisaldavate kvaliteedikriteeriumide läbipaistva ja kontrollitava hindamise. Näiteks 3  on soovitatav subjektiivseid omadusi puudutavate kriteeriumide hindamisel kasutada hankijast sõltumatuid eksperte, tagada pakkumuste anonüümsus hindamise ajal ja kõigi pakkumuste võrdlemine üksteisega lähedasel ajal ning sätestada hindamise protseduur nii, et kõik eksperdid lähtuksid ühtsest hindamisskaalast ja metoodikast. Kui hindamise tulemus ei ole üheselt mõistetavate väärtuste näol taasesitatav, tuleb vältida subjektiivsete kõrvaltunnuste häirivat mõju hindamisprotseduurile. Kui hindamiskomisjoni liikmete puhul ei ole tegemist hankijast sõltumatute ekspertidega, tuleb teha mõistlikke pingutusi, et vähendada hindamiskomisjoni liikmete teadmist sellest, millist toodet nad parasjagu hindavad“.1 Hankija ei ole käesoleval juhul näinud ette mistahes metoodikat pakkumuste läbipaistvaks ja kontrollitavaks hindamiseks. Hankija ei kasuta sõltumatuid eksperte, ei taga pakkumuste anonüümsust, ei taga pakkumuste võrdlust üheaegselt ega ole kehtestanud mistahes muud objektiivset hindamisskaalat „ohtlikkuse“ ja „sujuvuse“ (p 3), libistamise kerguse (p 4) ega käes hoidmise mugavuse (p 5) hindamiseks. Osundatud mõisted on kõik õiguslikult määratlemata ning nende sisustamine pole ilma ühetaolise hindamismetoodika kehtestamiseta objektiivselt võimalik. 2. MENETLUSE PEATAMISE TAOTLUS 2.1 RHS § 193 lg 1 sätestab, et vaidlustuskomisjon võib vaidlustaja põhjendatud taotluse alusel teha igas vaidlustusmenetluse staadiumis otsuse riigihanke peatamise kohta, võttes arvesse peatamisest tulenevaid võimalikke tagajärgi kõigile huvidele, mida võidakse kahjustada. 2.2 Vaidlustaja taotleb käesolevaga riigihanke nr 294368 peatamist, kuna peatamata jätmise korral ei oleks vaidlustajal võimalik vaidlustusega taotletud eesmärki (õiguspäraste hanketingimuste alusel raamlepingu sõlmimist) saavutada. Pakkumuste esitamise tähtaeg on 03.07.2025 11:00. Vaidlustuskomisjon on oma 04.06.2025 teates märkinud, et teeb otsuse 01.07.2025, mistõttu jääb vaidlustuskomisjoni otsuse ja pakkumuse esitamise tähtaja vahele vaid 1 tööpäev. Seega ei jää vaidlustajale mõistlikku aega pöörduda oma õiguste kaitseks halduskohtusse, kui see peaks osutuma vajalikuks. 2.3 Vaidlustajal ei pruugi olla võimalik hanke osa 1 hindamiskriteeriumide „Täiendava funktsionaalsuse“ tõttu konkureerivat pakkumust esitada. Seega kaotaks ta riigihanke peatamata jätmisel võimaluse oma õiguste edasiseks kaitseks halduskohtus. Pakkumuse mitteesitamise korral puuduks tal edasise riigihanke menetlusega õiguslik puutumus ning seega RHS § 185 lg 1 sätestatud eeldus hankija hilisemate otsuste vaidlustamiseks. 2.4 Vaidlustaja leiab, et riigihanke peatamisega ei rikuta hankija ega muude võimalike pakkujate huve, sest hankega taotletud eesmärke on võimalik saavutada ka hiljem, seadusega kooskõlla viidud RHAD alusel. 3. MENETLUSKULUDE NIMEKIRI 3.1 Vaidlustaja on seoses vaidlustusmenetlusega kandnud järgmisi menetluskulusid, mille väljamõistmist hankijalt vaidlustaja taotleb: (i) lepingulise esindaja tasu vastavalt Advokaadibüroo TRINITI OÜ arvetele nr 20251222 ja nr 20251437 summas 3 220 eurot ilma käibemaksuta (käesoleva menetlusdokumendi 1 Simovart, M.A, jt. Riigihangete seadus, kommenteeritud väljaanne, § 85, p 26. Juura, 2019. 4  lisadele 3-4). Lepingulise esindaja kulude koosseis ja nimekiri on nähtav arve lisaks olevast spetsifikatsioonist. Lepingulise esindaja tunnitasu on 200 EUR+km. (ii) riigilõiv vaidlustuse esitamiselt 1 280 eurot. (vaidlustuse lisa 3). 3.2 Vaidlustaja kinnitab, et kõik lepingulise esindaja kulude nimekirjast nähtuvad kulud on kantud seoses käesoleva vaidlustusmenetlusega. Lugupidamisega /allkirjastatud digitaalselt/ Toomas Pugri, advokaat Vaidlustaja lepinguline esindaja LISAD: 1. Eksperthinnang vaidlustaja pakutava Greiner Bio-one toote ohutusest 2. BD toote ja Greiner Bio-One toote võrdlus 3. Advokaadibüroo TRINITI OÜ arve nr 20251222 4. Advokaadibüroo TRINITI OÜ arve nr 20251437 5 5 Eksperdi arvamus Kõik VACUETTE® QUICKSHIELD ohutustoru hoidja ja VACUETTE® mitmekordse kasutusega verevõtun õel ade kombinatsioonid ning Greiner Bio-One GmbH eelmonteeritud VACUETTE® QUICKSHIELD täielik tootesari vastavad Euroopa Nõukogu 10. mai 2010. aasta direktiivi 2010/32/EL lisa punktis 6 sätestatud nõuetele. millega rakendatakse HOSPEEMi ja EPSU vahel sõlmitud raamkokkulepet teravate esemete põhjustatud vigastuste vältimise kohta haiglate ja tervishoiuasutustes, Euroopa bioloogilise ohutuse võrgustiku ELi raamkokkuleppe rakendamise juhendi punkt 5, nõukogu direktiiv ja sellega seotud riiklikud õigusaktid ning Saksamaa bioloogiliste mõjurite tehnilise eeskirja (TRBA) 250 punkt 4.5.2 (4) 3. Seega on tootel ohutusvarustus, millel on ohutuse tagamiseks spetsiaalne mehhanism, mis on sobiv verevõtu protsessi käigus tekkivate nõelatorkevigastuste vältimiseks. Kui toodet kasutatakse vastavalt tootja kasutusjuhendile, loetakse toode kavandatud kasutuseks ohutuks ja see võib seega vähendada tervishoiutöötajate nõelatorkevigastuste ohtu vere võtmise ja meditsiiniliste jäätmete kõrvaldamise käigus. <> greiner bio-one Your Power for Health Disadvantage of competitive product Application (BD) Application (BD) AELELELL Additional reguirement: Additional requirement: F move shield move out of shield out of way way Activation Activation only with only with thumb thumb Application (GBO) Shield already bent back – no Shield rotational – can be additional repositioning needed repositioned for ideal handling Two activation methods to suit individual preference ARVE Kuupäev Arve nr. ISIS Medical OÜ 31.05.2025 20251222 Maksetingimused Maksetähtaeg Kangru tee 6b 14 päeva 14.06.2025 75413 Kiili vald Viiviseprotsent 0,25 % Kliendi KMKR number Registrikood EE100850493 10958649 Ülesanne: Vaidlustusmenetlus riigihankes nr 294368 Spetsifikatsioon Neto KM Kokku Õigusteenuse tasu 1 900,00 418,00 2 318,00 Kulud ja lõivud 0,00 0,00 0,00 Kokku 1 900,00 418,00 2 318,00 Käibemaks Summa KM Kulud KM Neto KM Kokku VAT 22% 1 900,00 418,00 0,00 0,00 1 900,00 418,00 2 318,00 Kokku 1 900,00 418,00 0,00 0,00 1 900,00 418,00 2 318,00 Tasumisele kuuluv summa (EUR) 1 900,00 418,00 2 318,00 Täname meeldiva koostöö eest! Pangaülekande rekvisiidid Swedbank AS EE302200221069588766 IBAN: EE30 2200 2210 6958 8766 SWIFT / BIC: HABAEE2X Palun kasutage makse teostamisel arve numbrit. Arve nr. Maksetähtaeg Kokku 20251222 14.06.2025 2 318,00 EUR Advokaadibüroo TRINITI OÜ Registrikood: 11984324 Tel. +372 685 0950 Swedbank AS: EE30 2200 2210 6958 8766 Maakri 19/1 KMKR number: EE101392248 [email protected] IBAN: EE30 2200 2210 6958 8766 10145 Tallinn www.triniti.ee SWIFT / BIC: HABAEE2X  2 (2) Spetsifikatsioon KONFIDENTSIAALNE Arve nr. 20251222 Ülesanne Vaidlustusmenetlus riigihankes nr 294368 Tehtud tööd Tunnid 21.05.2025 Dokumendi koostamine: Lääne-Tallinna Keskhaigla riigihankes hankevaidlustuse koostamine, materjalidega 2,40 tutvumine, õiguslik analüüs Dokumendi koostamine: vaidlustuse koostamine riigihankes nr 294368 1,60 22.05.2025 Dokumendi koostamine: vaidlustuse koostamine riigihankes nr 294368 (jätk) 4,50 25.05.2025 Dokumendi koostamine: vaidlustuse täiendamine riigihankes nr 294368 1,00 Kokku 9,50 Neto KM Kokku Kokku 1 900,00 418,00 2 318,00 Advokaadibüroo TRINITI OÜ Registrikood: 11984324 Tel. +372 685 0950 Swedbank AS: EE30 2200 2210 6958 8766 Maakri 19/1 KMKR number: EE101392248 [email protected] IBAN: EE30 2200 2210 6958 8766 10145 Tallinn www.triniti.ee SWIFT / BIC: HABAEE2X ARVE Kuupäev Arve nr. ISIS Medical OÜ 09.06.2025 20251437 Maksetingimused Maksetähtaeg Kangru tee 6b 14 päeva 23.06.2025 75413 Kiili vald Viiviseprotsent 0,25 % Kliendi KMKR number Registrikood EE100850493 10958649 Ülesanne: Vaidlustusmenetlus riigihankes nr 294368 Spetsifikatsioon Neto KM Kokku Õigusteenuse tasu 1 320,00 290,40 1 610,40 Kulud ja lõivud 0,00 0,00 0,00 Kokku 1 320,00 290,40 1 610,40 Käibemaks Summa KM Kulud KM Neto KM Kokku VAT 22% 1 320,00 290,40 0,00 0,00 1 320,00 290,40 1 610,40 Kokku 1 320,00 290,40 0,00 0,00 1 320,00 290,40 1 610,40 Tasumisele kuuluv summa (EUR) 1 320,00 290,40 1 610,40 Täname meeldiva koostöö eest! Pangaülekande rekvisiidid Swedbank AS EE302200221069588766 IBAN: EE30 2200 2210 6958 8766 SWIFT / BIC: HABAEE2X Palun kasutage makse teostamisel arve numbrit. Arve nr. Maksetähtaeg Kokku 20251437 23.06.2025 1 610,40 EUR Advokaadibüroo TRINITI OÜ Registrikood: 11984324 Tel. +372 685 0950 Swedbank AS: EE30 2200 2210 6958 8766 Maakri 19/1 KMKR number: EE101392248 [email protected] IBAN: EE30 2200 2210 6958 8766 10145 Tallinn www.triniti.ee SWIFT / BIC: HABAEE2X  2 (2) Spetsifikatsioon KONFIDENTSIAALNE Arve nr. 20251437 Ülesanne Vaidlustusmenetlus riigihankes nr 294368 Tehtud tööd Tunnid 05.06.2025 Vaidlustus riigihankes nr 294368: hankija vastuse ja tõenditega tutvumine ja analüüs, selgitavad 1,40 kommentaarid kliendile täiendava sisendi saamiseks 07.06.2025 Vaidlustus riigihankes nr 294368: vaidlustaja täiendava seisukoha ja menetluse peatamise taotluse 3,60 koostamine, menetluskulude nimekirja esitamine 08.06.2025 Vaidlustus riigihankes nr 294368: vaidlustaja täiendava seisukoha koostamine (jätk) 1,10 09.06.2025 Vaidlustus riigihankes nr 294368: vaidlustaja täiendava seisukoha täiendamine vastavalt kliendi 0,50 kommentaaridele, seisukoha esitamine vaidlustuskomisjonile ja hankijale Kokku 6,60 Neto KM Kokku Kokku 1 320,00 290,40 1 610,40 Advokaadibüroo TRINITI OÜ Registrikood: 11984324 Tel. +372 685 0950 Swedbank AS: EE30 2200 2210 6958 8766 Maakri 19/1 KMKR number: EE101392248 [email protected] IBAN: EE30 2200 2210 6958 8766 10145 Tallinn www.triniti.ee SWIFT / BIC: HABAEE2X