Procurement Of Medical Devices Research Articles

Value-based procurement of medical devices

Value-based procurement of medical devices

Procuring Medical Devices: Evidence from Italian Public Tenders

The public procurement of medical devices is increasingly relying on auction mechanisms to move toward more transparent procedures and to promote competition between suppliers in a market where the quality of the products matters enormously and an improper auction design could be very harmful. Based on Italian hospital data, we present new evidence on the performance of the public tenders to procure orthopaedic prosthesis for hips, knees and shoulders. Focusing on three main outcomes, the number of participants, the presence of a single firm bidding and the winning rebate, for the first time we describe how features related to the tender, hospital, region and bidders' competition all contribute to explain the functioning of the procurement auctions. The evidence we obtain can meaningfully help policy makers in designing and implementing better public procurement systems.

Legal Standing of Finance and Development Supervisory Agency (BPKP) in Calculating State Financial Losses in the Case of the Corruption Crime (Case Study of Decision Number: 31/Pid.Sus/TPK/2017/PN. Pdg)

Finance and Development Supervisory Agency (BPKP) is one of the institutions stipulated in Presidential Regulation of the Republic of Indonesia No. 192 of 2014 in charge of organizing government affairs in the field of state/ regional financial supervision and national development. This research raises several problems which include: First, what is the form of regulation of BPKP’s authority in legislation related to audits in calculating state financial losses in the case of corruption crime. Second, how is the legal standing of the BPKP Representative of West Sumatra Province in calculating state financial losses in the decision Number: 31/Pid.Sus/TPK/2017/PN Pdg on behalf of the defendant Vera Aldilla Roza, ST related to corruption crime in Padang District Court. This is a normative juridical research which applied an approach to legislation (statute approach) and to the case (case approach). This research used a technique in the form of a library study that utilized primary, secondary, and tertiary legal materials. The legal materials were then analyzed qualitatively to answer the problems discussed in this research. Based on the results of the research, it was concluded that the legal standing of BPKP was in the executive power. In this case, the regulation of authority related to calculating state financial losses contained in the legislation, i.e. Presidential Regulation No. 192 of 2014 concerning BPKP. In addition, this authority was strengthened by the Decision of the Constitutional Court Number: 31/PUU-X/2012 dated October 23, 2012. The legal standing of BPKP, in calculating state financial losses in the case of procurement of medical devices at Health Office of Pesisir Selatan Regency, was as auditor. The judge was guided by the calculation of state financial losses carried out by BPKP and used it as a basis for consideration of decisions.

The Implementation of the Government Goods and Services Procurement Policy at the General Hospital of Sanggau Regency West Kalimantan Province

This study is associated with the implementation of the government goods and services procurement policy at the General Hospital of Sanggau Regency, West Kalimantan Province. In this case, the procurement refers to the procurement causing legal problems namely the procurement of surgical medical devices in fiscal year 2014. The theoretical structure of the research consists of the grand theory (government science), middle range theory (public policy theory), and applied theory (the implementation theory of Van Meter and Van Horn Public Policies). This study was employed qualitative research approach. In addition, the secondary data collection was carried out by using library research. Meanwhile, the primary data collection was conducted by applying interview techniques and observation that involved 10 research informants determined by purposive sampling technique. The results of this study were analyzed by the researcher by entailing six variables of Van Meter and Van Horn. The results of this study indicated that there was an alleged criminalization by Government Internal Supervisory Apparatus (GISA) through the results of an audit on the procurement of surgical medical devices at the General Hospital of Sanggau regency in fiscal year 2014. Basically, the reason why the GISA stipulated the State losses is due to the emergence of an indication of a conspiracy among auction participants referring to the explanation of article 83, paragraph (1) the letter e on Presidential Regulation No. 70 Year 2012, without involving Procurement Service Unit (PSU) and/or the working groups of PSU, including the existence of contract value differences with the real value of provider purchases and VAT. The cause of the criminalization of the GISA audit results raising legal problems is presumably resulted from the fact that the audit carried out by GISA was not based on the GISA audit standards. Moreover it was not objective and unprofessional. The results demonstrated that the state losses determined by GISA were grounded on 1) the misinterpretation on the conspiracy indications in the explanation of article 83 paragraph (1), the letter e, Presidential Regulation No. 70 Year 2012 carried out by GISA; 2) incorrect assumptions which are not in accordance with the facts conveyed by GISA in the treatise of the audit results used as the basis for determining state losses; 3) GISA does not understand the mechanism and system for implementing procurement stipulated by the Government in which it should be carried out electronically/(e-procurement); 4) State Loss Calculation Method performed by GISA by finding out the difference between the value of the contract and the real value of the purchase of the provider based on the incorrect interpretation regarding the indications of conspiracy in the explanation of the article 83 paragraph (1) the letter e, Presidential Regulation No. 70 Year 2012. As a result, the State losses that GISA's stipulated become baseless; 5) The existence of the alleged GISA audit is carried out based on emotions, subjectivity, motives and certain interests. The researcher proposes several suggestions and the "SO&R by hari" model that can be analyzed by using 1 dimension/variable (variable policy standard, objective & resources) on new concepts obtained by the researcher regarding the Implementation of Government Goods and Services Procurement Policy, which is a simplification and refinement of the Van Meter and Van Horn theories on Public Policy Implementation, and a new framework which is specific and focused on the research related to government goods and services procurement.

Kerugian Keuangan Negara Dalam Pengadaan Alat Kesehatan Di Indonesia

he financial loss of the state is determined by many factors leading the method of calculating the state financial loss to be unstandard and then causing uncertainty in calculation of the state financial loss, including in the procurement of medical devices. This study aims to (a) analyze the factors determining the financial loss of state in the procurement of medical devices and (b) to analyze the method used to calculate the financial loss of the state in the procurement of medical devices. This is a normative juridical research using a conceptual approach and a regulatory approach. The data used were secondary data collected through literature. From the research results, first, it can be concluded that the factors determining the fiancial loss of state in the procurement of medical devices were the factors of goods effectiveness as needed. The procurement of medical devices that has the nature of the goods is a unit to be utilized as needed, and then the method of calculating the financial loss of state used is the method of calculating the total loss, but if the medical devices that have properties can be utilized separately, the calculation of financial losses used is net loss. Another factor affecting was the price reasonableness if the procurement of medical devices can be utilized as needed but the price of medical devices exceeds the reasonableness. Second, the method of calculating financial loss of stated used due to the price reasonableness was the price reasonableness method.

Difficulties of the federal centers providing the profile medical assistance

The main goal of the Federal Center (FC), not dependent on its profile, is to assist specialized, including high-technology medical care using new, unique and resource-intensive technologies. This statement is legally enforced by Russian Federal Law № 323. However following the other regulatory laws, such as State Program of guaranteed free medical care, acts that provide hospitalization and out-patient assistance as well as legislation in the field of procurement of medications and medical devices, in reality the FC are financially and legally equated to clinics of other levels (for example, polyclinics, regional and municipal hospitals) despite the complex patients' population and the requirements to their treatment results. The basic organization difficulties that face the federal centers are considered on the example of Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology.

Tenders for the Procurement of Medical Devices: Adapting Cost-Effectiveness Rules to the Requirements of the European Public Procurement Directive

In evaluating 3 or more comparators, pharmacoeconomic analyses can be improved by using the methodology of net monetary benefit (NMB) as opposed to incremental cost-effectiveness ratio (ICER). NMB is particularly suitable for managing competitive tenders that evaluate 3 or more devices in the same lot. For scientific purposes, the methodology of NMB is perfectly adequate. However, when tenders are managed in European countries, the Public Procurement Directive states that the tender score for price should be kept separate from that of clinical benefits. As a result, the traditional mathematical approach of NMB must be rearranged to comply with this administrative requirement. In this report, we describe how the classic equations of NMB should be modified to achieve this purpose. The mathematical principle of proportionality, which is typical of the ICER, must be replaced by the principle of mathematical additivity, which is typical of NMB. Furthermore, to rearrange the scale of benefits according to the NMB, an estimate is needed of the minimum acceptable benefit converted into monetary units, which is associated with 0 in the benefit scale. A detailed example is presented to explain the practical application of these mathematical equations. These equations are widely applicable in the field of implantable devices. Since the expenditure for medical devices in European hospitals is close to that of hospital medicines, tenders for the in-hospital procurement of devices may represent a decisive tool to manage sustainability and ensure access to innovation. In this context, the methodology for managing clinical outcomes through tenders requires a specific mathematical approach that we have described in the present article.

The Supply Side to Procurement in a Health Market: Competition and Innovation in Hip Implants

Most research on procurement of medical devices focuses on buyer behaviour e.g. in the UK, purchasing strategies by the NHS. This paper is a rare case study of the other side of the market. We investigate competition in the artificial hip implant market in England and Wales, using National Joint Registry data for 2005-18. The analysis is in three parts. We first proceed as would a competition agency, by assessing the nature and structure of the market. We find a highly concentrated duopolistic market structure, in which there has been no significant entry or exit, except a merger between the much smaller 3rd and 4th largest suppliers. Viewed through the eyes of a competition economist, such a structure might be indicative of weak competition. However, concentration is not necessarily synonymous with low competition: it might be that technology dictates that only a small number of firms can survive profitably in the market, but that there is still the cut and thrust of competition leading to forever changing identities of the leading firms. In the second part of the paper, we address these possibilities in two ways, using a novel exploration of market share dynamics and an international comparison. On dynamics, we find an important difference between the two sectors of the market: in traditional cemented prostheses, there is little evidence of any share mobility amongst firms. Indeed, the only discernible change is that Stryker, already the dominant firm, has steadily further increased its market share over time. On the other hand, the uncemented sector has exhibited much more share mobility. Interpreting the uncemented sector as a comparator, this suggests the need for further investigation of the cemented sector. This conclusion is also indirectly reinforced by an international comparison of market structure, from which the most striking feature is the much larger market share of Stryker than in any other European country. In the third part of the paper, we explore the performance of the firms concerned, using innovation as the measure. We find only limited evidence of the emergence of new brands of implants - the smaller suppliers have had little success in introducing new brands and the two main suppliers appear to have concentrated on updating their existing brands. There is also little evidence of competition from generic brands, (in contrast to the picture in many parts of the pharmaceutical sector). Looking to the future, our findings are not necessarily conclusive evidence of a weakly performing, anti-competitive market, but they are sufficient to justify further more micro-survey research to identify the preferences and practices of the main players: surgeons, hospital procurement and the suppliers themselves. The need for such research is heightened by the fact that contemporary policy advice increasingly advocates that cemented prostheses should be preferred, especially for older patients.

Procuring Medical Devices: Evidence from Italian Public Tenders

The public procurement of medical devices is increasingly relying on auction mechanisms to move toward more transparent procedures and to promote competition between suppliers in a market where the quality of the products matters enormously and an improper auction design could be very harmful. Based on Italian hospital data, we present new evidence on the performance of the public tenders to procure orthopaedic prosthesis for hips, knees and shoulders. Focusing on three main outcomes, the number of participants, the presence of a single firm bidding and the winning rebate, for the first time we describe how features related to the tender, hospital, region and bidders' competition all contribute to explain the functioning of the procurement auctions. The evidence we obtain can meaningfully help policy makers in designing and implementing better public procurement systems.

PHP40 - European Experiences of Cross-Border Collaboration in Procurement of Health Technologies

Due to the high cost of pharmaceutical products, the European Union (EU) health care systems, particularly in low-resource settings, have begun to voluntarily enter cross-border collaborations in order to improve patient access to health technologies. The aim of this study was to identify and discuss the aims of the agreements and collaborations available across Europe as efforts made to address the challenges of the healthcare market. A literature review through PUBMED, EMBASE, and additional websites, was conducted to identify policy initiatives and opportunities in EU countries. Since 2012, 9 cross-border collaborations have been established in Europe: 4 collaborations focused on the procurement of innovative medicines: “Valletta Declaration” (2017), “Southern European initiative” (2016), “Nordic Pharmaceuticals Forum” (2015) and “BeNeLuxA” (2015), and five collaborations aimed to facilitate the procurement of pharmaceuticals and medical devices: “Declaration of Sofia” (2016), “Central Eastern European and South Eastern European Countries Initiative” (2016), “Romanian and Bulgarian Initiative” (2015), and “Baltic Partnership Agreement” (2012). Through these collaborations, EU countries tend to centralize medicines purchase in order to present a bigger patient pool to pharmaceutical companies to facilitate lower prices and to ensure continuity of access. Their principal objectives were horizon scanning, information sharing, enhancing transparency and price negotiation. The first Baltic States’ experience (Latvia, Lithuania and Estonia) in purchasing BCG vaccine failed in 2015 because no tender was submitted. Since 2015, there have been several successful joint purchasing of vaccines between Baltic countries (rotavirus vaccine, pneumococcal vaccine). Payers’ collaboration can lead to lower drug prices and to development and collaboration on patient registries. However, establishing and implementing sustainable cross-border collaborations in procurement seems to be challenging. Experiences in Europe are still limited and too recent to allow clear conclusions to be derived on these collaborations’ effectiveness and impact.

Life Cycle Assessment and Costing Methods for Device Procurement: Comparing Reusable and Single-Use Disposable Laryngoscopes.

Traditional medical device procurement criteria include efficacy and safety, ease of use and handling, and procurement costs. However, little information is available about life cycle environmental impacts of the production, use, and disposal of medical devices, or about costs incurred after purchase. Reusable and disposable laryngoscopes are of current interest to anesthesiologists. Facing mounting pressure to quickly meet or exceed conflicting infection prevention guidelines and oversight body recommendations, many institutions may be electively switching to single-use disposable (SUD) rigid laryngoscopes or overcleaning reusables, potentially increasing both costs and waste generation. This study provides quantitative comparisons of environmental impacts and total cost of ownership among laryngoscope options, which can aid procurement decision making to benefit facilities and public health. We describe cradle-to-grave life cycle assessment (LCA) and life cycle costing (LCC) methods and apply these to reusable and SUD metal and plastic laryngoscope handles and tongue blade alternatives at Yale-New Haven Hospital (YNHH). The US Environmental Protection Agency's Tool for the Reduction and Assessment of Chemical and other environmental Impacts (TRACI) life cycle impact assessment method was used to model environmental impacts of greenhouse gases and other pollutant emissions. The SUD plastic handle generates an estimated 16-18 times more life cycle carbon dioxide equivalents (CO2-eq) than traditional low-level disinfection of the reusable steel handle. The SUD plastic tongue blade generates an estimated 5-6 times more CO2-eq than the reusable steel blade treated with high-level disinfection. SUD metal components generated much higher emissions than all alternatives. Both the SUD handle and SUD blade increased life cycle costs compared to the various reusable cleaning scenarios at YNHH. When extrapolated over 1 year (60,000 intubations), estimated costs increased between $495,000 and $604,000 for SUD handles and between $180,000 and $265,000 for SUD blades, compared to reusables, depending on cleaning scenario and assuming 4000 (rated) uses. Considering device attrition, reusable handles would be more economical than SUDs if they last through 4-5 uses, and reusable blades 5-7 uses, before loss. LCA and LCC are feasible methods to ease interpretation of environmental impacts and facility costs when weighing device procurement options. While management practices vary between institutions, all standard methods of cleaning were evaluated and sensitivity analyses performed so that results are widely applicable. For YNHH, the reusable options presented a considerable cost advantage, in addition to offering a better option environmentally. Avoiding overcleaning reusable laryngoscope handles and blades is desirable from an environmental perspective. Costs may vary between facilities, and LCC methodology demonstrates the importance of time-motion labor analysis when comparing reusable and disposable device options.

Value-based procurement of medical devices: Application to devices for mechanical thrombectomy in ischemic stroke

ObjectivesIn the acute ischemic stroke, endovascular devices have shown promising clinical results and are also likely to represent value for money, as several modeling studies have shown. Pharmacoeconomic evaluations in this field, however, have little impact on the procurement of these devices. The present study explored how complex pharmacoeconomic models that evaluate effectiveness and cost can be incorporated into the in-hospital procurement of thrombectomy devices. Patients and methodsAs regards clinical modeling, we extracted outcomes at three months from randomized trials conducted for four thrombectomy devices, and we projected long-term results using standard Markov modeling. In estimating QALYs, the same model was run for the four devices. As regards economic modeling, we firstly estimated for each device the net monetary benefit (NMB) per patient (threshold = $60,000 per QALY); then, we simulated a competitive tender across the four products by determining the tender-based score (on a 0-to-100 scale). Prices of individual devices were obtained from manufacturers. Extensive sensitivity testing was applied to our analyses. ResultsFor the four devices (Solitaire, Trevo, Penumbra, Solumbra), QALYs were 1.86, 1.52, 1,79, 1.35, NMB was $101,824, $83,546, $101,923, $69,440, and tender-based scores were 99.70, 43.43, 100, 0, respectively. Sensitivity analysis confirmed findings from base-case. ConclusionOur results indicate that, in the field of thrombectomy devices, incorporating the typical tools of cost-effectiveness into the processes of tenders and procurement is feasible. Bridging the methodology of cost-effectiveness with the every-day practice of in-hospital procurement can contribute to maximizing the health returns that are generated by in-hospital expenditures for medical devices.

Centralized Procurement of Medical Devices In Italy: A Methodology Towards Standardized Tender Dossier

Centralized Procurement of Medical Devices In Italy: A Methodology Towards Standardized Tender Dossier

Procurement of medical devices based on cost-effectiveness data.

The field of medical devices is characterized by a paucity of cost-effectiveness data that support their use. In this context, we have proposed a project based on the calculation of net monetary benefit (NMB) for each product subjected to procurement through tenders. This project consists of two steps: 1) calculation of NMB; 2) calculation of a value-based score to be used in the process of procurement and tendering. The NMB is defined as follows: NMB per patient= (monetary threshold of WTP) x (QALYs per patient) - (treatment cost per patient); WTP= willingness to pay]. Its main advantage is represented by the linear relation between NMB and unit price as opposed to the non-linear relationship that links the ICER to the unit price of the device. For all devices included in the same tender lot, our procedure firstly determines the valus of NMB and converts the NMB into a tender score determined on a 0-to-100 scale. The device with the worst pharmacoeconomic profile is assigned a tender score of 0 while the one with the best pharmacoeconomic profile is assigned a tender score of 100.

Methods for medical device and equipment procurement and prioritization within low- and middle-income countries: findings of a systematic literature review

BackgroundForty to 70 % of medical devices and equipment in low- and middle-income countries are broken, unused or unfit for purpose; this impairs service delivery to patients and results in lost resources. Undiscerning procurement processes are at the heart of this issue.We conducted a systematic review of the literature to August 2013 with no time or language restrictions to identify what product selection or prioritization methods are recommended or used for medical device and equipment procurement planning within low- and middle-income countries. We explore the factors/evidence-base proposed for consideration within such methods and identify prioritization criteria.ResultsWe included 217 documents (corresponding to 250 texts) in the narrative synthesis. Of these 111 featured in the meta-summary. We identify experience and needs-based methods used to reach procurement decisions. Equipment costs (including maintenance) and health needs are the dominant issues considered. Extracted data suggest that procurement officials should prioritize devices with low- and middle-income country appropriate technical specifications – i.e. devices and equipment that can be used given available human resources, infrastructure and maintenance capacity.ConclusionSuboptimal device use is directly linked to incomplete costing and inadequate consideration of maintenance services and user training during procurement planning. Accurate estimation of life-cycle costing and careful consideration of device servicing are of crucial importance.

How do health service professionals consider human factors when purchasing interactive medical devices? A qualitative interview study

We present findings of a UK study into how those involved in purchasing interactive medical devices go about evaluating usability, the challenges that arise, and opportunities for improvement. The study focused on procurement of infusion devices because these are used by various professionals across healthcare. A semi-structured interview study was carried out involving a range of stakeholders (20 in total) involved in or impacted by medical device procurement. Data was analysed using thematic analysis, a qualitative method designed to support the identification, analysis and reporting of patterns. In principle, health service purchasing was found to accommodate consideration of equipment usability. In practice, the evaluation process was driven primarily by engineering standards; assessment of local needs did not accommodate substantive assessment of usability; and choice was limited by the availability of equipment on the marketplace. We discuss ways in which purchasing could be improved through techniques that account for social circumstances.

How does the knowledge environment shape procurement practices for orthopaedic medical devices in Mexico?

BackgroundIn organisational theory there is an assumption that knowledge is used effectively in healthcare systems that perform well. Actors in healthcare systems focus on managing knowledge of clinical processes like, for example, clinical decision-making to improve patient care. We know little about connecting that knowledge to administrative processes like high-risk medical device procurement. We analysed knowledge-related factors that influence procurement and clinical procedures for orthopaedic medical devices in Mexico.MethodsWe based our qualitative study on 48 semi-structured interviews with various stakeholders in Mexico: orthopaedic specialists, government officials, and social security system managers or administrators. We took a knowledge-management related perspective (i) to analyse factors of managing knowledge of clinical procedures, (ii) to assess the role of this knowledge and in relation to procurement of orthopaedic medical devices, and (iii) to determine how to improve the situation.ResultsThe results of this study are primarily relevant for Mexico but may also give impulsion to other health systems with highly standardized procurement practices. We found that knowledge of clinical procedures in orthopaedics is generated inconsistently and not always efficiently managed. Its support for procuring orthopaedic medical devices is insufficient. Identified deficiencies: leaders who lack guidance and direction and thus use knowledge poorly; failure to share knowledge; insufficiently defined formal structures and processes for collecting information and making it available to actors of health system; lack of strategies to benefit from synergies created by information and knowledge exchange. Many factors are related directly or indirectly to technological aspects, which are insufficiently developed.ConclusionsThe content of this manuscript is novel as it analyses knowledge-related factors that influence procurement of orthopaedic medical devices in Mexico. Based on our results we recommend that the procurement mechanism should integrate knowledge from clinical procedures adequately in their decision-making. Without strong guidance, organisational changes, and support by technological solutions to improve the generation and management of knowledge, procurement processes for orthopaedic high-risk medical devices will remain sub-optimal.

Reconsidering Planning and Management of Medical Devices Procurement in Public Health Services in Cyprus.

Hospital procurement is a crucial field for any health care system, not only for economic reasons but also for reasons related to the quality and safety of the services provided. That is why the process of procurement is, in most countries, governed by a strict legal framework and policy mechanisms. This study investigates the problems and inefficiencies associated with the procurement of medical devices in public hospitals in Cyprus and formulates empirically documented proposals for improvement. Using the Delphi method, a group of 38 experts approach the procurement system in Cyprus from different angles, achieving high rates of consensus on 35 different statements on the weaknesses and problems of the current medical device procurement system, as well as presenting proposals and recommendations for improvement. The findings are highly valuable for future policy initiatives in Cyprus in the light of the economic crisis and the expected implementation of the new General Health Insurance System (GeSY), which the Government of the Republic of Cyprus and the Troika has agreed.

Public Procurement of Healthcare in Europe: The Case of Medical Devices

This paper analyzes the public procurement of orthopaedic implants and related medical devices in Europe. We analyze the legal framework laid down by the EU Procurement Directives, especially with regard to awarding procedures and contractual forms. We then use data covering the universe of EU public tenders for the period 2009-2014 to describe the key empirical features of the market with regard to awarding procedures and contractual forms. We discuss implications for quality, competition, corruption and product innovation in light of both our data and the new Directive 2014/24/EU.

An approach to prioritization of medical devices in low-income countries: an example based on the Republic of South Sudan.

BackgroundEfficient and evidence-based medical device and equipment prioritization is of particular importance in low-income countries due to constraints in financing capacity, physical infrastructure and human resource capabilities.MethodsThis paper outlines a medical device prioritization method developed in first instance for the Republic of South Sudan. The simple algorithm offered here is a starting point for procurement and selection of medical devices and can be regarded as a screening test for those that require more labour intensive health economic modelling.ConclusionsA heuristic method, such as the one presented here, is appropriate for reaching many medical device prioritization decisions in low-income settings. Further investment and purchasing decisions that cannot be reached so simply require more complex health economic modelling approaches.Electronic supplementary materialThe online version of this article (doi:10.1186/s12962-014-0027-3) contains supplementary material, which is available to authorized users.