Keywords Kúcové slová: medical devices, spending of medical devices, reimbursed medical devices, direct sale of medical devices, groups of medical devices, effective treatment, cost savings zdravotnícke pomôcky, spotreba zdravotníckych pomôcok, hradené zdravotnícke pomôcky, priamy predaj zdravotníckych pomôcok, skupiny zdravotníckych pomôcok, efektívnos liecby, úspora nákladov INTRODUCTION MD are products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease likely to affect the structure or any function of the body of humans or other animals (Food and Drug Administration [FDA], 2014). * firstname.lastname@example.org © Acta Facultatis Pharmaceuticae Universitatis Comenianae MD work only if they are used correctly. Their effectiveness depends on the skills and experience of the physician using them, the quality of the hospital, and many other factors. The devices are by and large mechanical in nature and have an inert effect on the human body. There are more than 500,000 different types of MD produced globally. MD range from simple and everyday consumer products such as spectacles, dentures and sticking-plasters to incontinence and ostomy care products, syringes and bandages, hip implants, MRI and X-ray equipment, and pacemakers. The technologies concerned also extend far beyond those of pharmaceutical science to include materials science, bioengineering, engineering, electronics, software, information and communication technology, nuclear, aerospace, plastics technology, surface technology and many more, which are applied across all areas of clinical practice and homecare. Driven by technology, device improvements are typically available to users and patients within 1824 months of previous iterations (Eucomed, 2014). Over the past 2000 years, the materials used in MD have ranged from stone, wood, metal, ceramics, and most recently plastics. MD also have evolved in sophistication and complexity over time. With the formalization of the scientific method in the seventeenth century, such devices became more prevalent. Many MD were manufactured by doctors or small companies and sold directly to the public with no government standards or oversight. With the explosion of medical technology in the early twentieth century, several intermediaries evolved between the medical device industry and the public. In 1879, Dr. E. R. Squibb, in an address to the Medical Society of the State of New York, proposed the enactment of a national statute to regulate food and drugs. In 1906, the Food and Drug Act was signed into law. At that time, devices that were harmful to human safety and health proliferated the market, but regulation of MD by the Bureau of Chemistry (the precursor to the FDA) was limited to challenging commercial products only after they had been released into the market. The devices in the marketplace that were defective, adulterated, or misbranded were seized and the device manufacturers were prosecuted in the court of law, but only after the products were sold in the market and caused harm to the end users. Thus, there was a strong need for regulating the devices before they entered the marketplace (Sastri, 2014). Currently, in keeping with its mandate to provide the least burdensome means of product regulation, the US FDA's Center for Devices and Radiological Health uses many different standards to facilitate the review of premarket submissions of MD. The benefits of using standards in this manner include providing a set of common requirements and test protocols to the device manufacturer, thus reducing the manufacturer's need to "reinvent the wheel" for each new bench test to ensure safety and effectiveness of the device. With the current trend toward international harmonization of standards, tests performed in accordance with an international standard may be acceptable to several countries. However, there are instances in which FDA does not agree with certain provisions in a standard (Ho et al., 2005). In the European union the European Medicine Agency (EMA) Committee for Advanced Therapies (CAT) - Notified Body (NB) Collaboration Group, facilitates the implementation of the aspects of Regulation (EC) No. 1394/2007 when Advanced Therapy Medicinal Products (ATMP) are combined with Medical Devices (MD). The Mandate, objectives and the tasks of the EMA/CAT-NB Collaboration Group include the overview, coordination and the need for any update of any process and guidance for consultation of a notified body for medical devices during an assessment undertaken by the CAT of a combined ATMP/MD; at the request of the CAT, coordinate of the development of guidance on the standard information to be exchanged relating to the assessment of the NB for the CAT's assessment of a combined ATMP/MD; the coordination of the development of a process and guidance relating to postauthorisation activities for combined ATMPs/MD relating to variations/modifications to the combination and pharmacovigilance-vigilance legal provisions (EMA, 2014). MD and the materials they are composed of need to be assessed for their safety within the context of a risk management process. Safety issues related to toxicity can be evaluated using the ISO 10993 series of international standards for biological evaluation of MD. It provides an approach that combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, thus enabling a full evaluation to be made of the biological responses to each medical device, relevant to its safety in use. Various test methods, both in vitro and in vivo are used for this evaluation. In vitro cytotoxicity tests for genotoxicity, interaction with blood, and irritation. In vivo tests for irritation and sensitization, hemocompatibility, genotoxicity, implantation and systemic toxicity (De Jong et al., 2012). Plastics are one of the most used materials for MD production. Plastics used in medical device applications must meet stringent performance requirements through production, packaging, shipping, end use, and disposal. Many devices and device kits are sterilized before they are shipped for use. During manufacturing and during end use, they also come in contact with various chemicals, solvents, bodily fluids, skin, organs, and tissues. The materials used in such devices must be resistant to the sterilization methods, chemicals, and fluids that they encounter; be compatible with bodily fluids, skin, and tissues, and still maintain their safety, effectiveness, and functionality (Sastri, 2014). Strict safety regulation also applies to active implantable MD that are brought to the market, specifically the European Union and the United States of America. Proving that they are safe to use and indeed work as specified involves an extensive series of tests and trials, including bench testing, animal studies and human clinical trials. When the device finally reaches the market, its manufacturer still has obligations to maintain feedback from the market environment (Inmann and Spensley, 2013). Non-clinical functional studies are often needed to evaluate performance as well as safety of a medical device under conditions of use. The appropriate animal model mimicking the intended clinical use is selected. The definition of the objectives of the study based on the product characteristics, the use of appropriate evaluation tools, the definition of appropriate control groups and time-periods must be clearly selected and defined. Finally, strategies to incorporate requirements of other safety standards in the design of combined functional studies are involved as well (Clermont, 2012). Medical device systems have become increasingly complex, interconnected, and interoperating. A major challenge is how to ensure and improve the safety, security, and reliability of MD. An efficient human reliability analysis and assessment for MD is essential for improving the quality of medical treatment and preventing an accident (Lin et al., 2014). It can be done by using both qualitative and quantitative methods to analyze human reliability for MD. After placing MD on the market, the manufacturer runs postmarket medical product safety surveillance. It is a complex task requiring standardized data collection, prompt adverse event reporting mechanisms and appropriate methodologies to identify low-frequency safety threats and risk communication. The Data Extraction and Longitudinal Trend Analysis (DELTA) network study of the medical device safety surveillance fulfils this role (Vidi et al., 2011). Adverse event reporting after medical device implantation is essential to understand the safety and performance of a device. Standardization of reporting attains great importance when comparing different devices and for the ongoing surveillance of a marketed device. There are governmental guidelines and regulations for reporting adverse events that occur during a clinical trial as well as those that occur after a device has been introduced into the marketplace. These regulations are country specific, but several multinational nongovernmental organizations have taken the lead to achieve a level of international conformity and standardization (Ouriel et al., 2013). Description of medical device market and spending in Slovakia Slovakia is a small consumer of MD compared to USA where medical-device market is the world's largest with over $100 billion in sales in 2011 (Kampfrath, 2013). In 2005, Slovakia consumed 90 million worth of MD, which accounts for about 0.3% of the total EU consumption. (Emergo Group, 2014). According to Business Monitor in 2013, the Slovak medicaldevice market was estimated at US$545.0 million, or US$100 per capita. This market size is comparable to Hungary, while per capita expenditure is similar to Estonia. The 20082013 compound annual growth rate (CAGR) was estimated at 2.1%, but the market is expected to expand at a CAGR of 3.9% over the 20132018 period, reaching US$659.9 million, or US$121 per capita by 2018. Around 88% of the medical device market is supplied by imports. Slovakia imported MD valued at US$482.1 million in 2013; this represented an increase of 7.6% over 2012 and a 20082013 CAGR of 1.5%. Imports grew every year between 2004 and 2013, except for 2009. Slovakia exported MD worth US$221.5 million in 2013, representing a decrease of 7.7% compared to 2012 and a 20082013 CAGR of -2.4%. The trade deficit increased from US$208.0 million in 2012 to US$260.5 million in 2013, due to import growth. Slovakia has an established medical device manufacturing sector, although domestic companies struggle to compete with Western manufacturers with regard to product quality or innovation. Areas of specialty include X-ray and dental products. Domestic medical device production is estimated to be in excess of US$300 million. The Slovakian medical device market is expected to grow by a CAGR of 3.9% over the 20132018 period, as the economy grows and health spending remains at a high level. Slovakia is heavily reliant on imported MD despite the presence of an established medicaldevice industry. Health spending is high for the region, in per capita terms and as a percentage of GDP. If the government is successful in creating a single health insurer, the amount of funding within the health system should increase (Business Monitor, 2014). In Slovakia, MD are sold in community pharmacy, branch of community pharmacy, dispenser of MD, dispenser of orthopaedic devices and dispenser of audioprosthetic devices. MD are reimbursed from public health insurance funds entirely; for others, particularly advanced functional types of MD, there must be patient participation on price or he or she can buy them according to their own decision (known as direct sale). MD are grouped into several groups according to the purposes intended such as MD for incontinence, ostomies, diabetics, for compression therapy, for eye disorder, bandaging material, physiotherapy equipment, MD for patients with mobility problems, individually prepared MD, breast prosthesis, orthopaedic MD and others. AIMS AND OBJECTIVES The target of this study is to analyse the data from paid database of National Center for Healh Information (NCHI) in Slovakia that collects the outputs of provided healthcare. Data were focused on MD in the time span from 1.1.2013 to 30.9.2013. METHODOLOGY AND RESEARCH METHODS The methodology conducted relies on monitoring, calculation and assessment of data related to spending on MD. The most recent data about spending on MD were evaluated according quality (groups of MD) and quantity characteristics (packages and value) from the point of reimbursed MD by health insurance funds and direct sales realized by patients in cash. We used basic statistical method of evaluation to present average monthly spending of MD. This type of assessment is very rare. That confirms our scientific literature research made before evaluation. There is little evidence to indicate assessment of MD both in Slovakia and the world. RESULTS According to NCHI, apart from community pharmacies and branches of community pharmacy, there were 226 registered establishments that sold MD until 30.9.2013. Their specialization were dispenser of MD (n=163), dispenser of orthopaedic devices (n=48) and dispenser of audioprosthetic devices (n=15). In the observed period, average monthly spending on MD was 10.1 million packages and 14 million . Average monthly spending on reimbursed MD amounted to 8.8 million packages and 12.9 million . The groups with the highest shares were MD for incontinence and urinary retention 7.7 million packages per month (86.9%) and 3.9 million per month (30.7%), followed by plasters and bandaging materials 0.5 million packages per month (6.0%) and 1.3 million per month (10.1%), MD for ostomies 0.4 million packages per month (4.5%) and 1 million per month (8.0%), and MD for diabetics 0.1 million packages per month (1.4%) and 1.6 million per month (12.8%). Rest of the results are present in the Table 1. Average monthly spending on MD through direct sales reached 1.3 million packages and 1.1 million . The groups with the highest shares were MD for incontinence and urinary retention 629,660 packages per month (50.3%) and 291,919 per month (26.2%), followed by plasters and bandaging materials 388,111 packages per month (31.0%) and 227,119 per month (20.4%) and MD for diabetics 56,014 packages per month (4.5%) and 81,721 per month (7.3%). The highspending group also included "other MD", 135,396 packages per month (10.8%) and 327,668 per month (29.4%). Rest of the results are present in the Table 2. DISCUSSION Spending on MD can be influenced by many factors. One of them is high quality, well-designed MD are necessary to provide safe and effective clinical care for patients as well as to ensure the health and safety of professional and lay device users. Capturing the requirements of users and incorporating these into design is an essential component. The field of ergonomics has an opportunity to assist not only with this area, but also to encourage a more general consideration of the user during medical device development (Martin et al., 2008). Otherwise, spending on MD can be influenced when they are reused. MD such as surgical instruments and endoscopes are multiuse devices designed to be used on multiple patients over a prolonged period of time. Devices designated by manufacturers as single-use devices are intended to be used on a single patient for one procedure. Many single-use devices, including needles and syringes used for injection, are truly intended for single use. However, complex single-use devices that are frequently used in surgical, endoscopic, and intravascular procedures are often reused for economic reasons. In resource-limited settings throughout the developing world, reuse of single-use devices is especially common because of cost constraints. Reprocessing of single-use devices is often problematic because of lack of standardized procedures, and adverse events related to device contamination or damage do occur. Such events can potentially offset any cost savings gained through reuse (Shuman et al., 2012). In many developing and transitional countries, reuse of cheap single-use devices (needles, syringes, surgical gloves) is common, leading to large numbers of unsafe interventions, Table 1. Average monthly spending on reimbursed MD paid by health insurance funds in packages and value (). Average monthly packages 533,305 7,671,341 123,567 399,069 10,276 692 20,036 34,459 20,885 1107 3121 6575 10,803 8,830,303 Average reimbursed monthly value 1,298,247 3,943,731 1,642,229 1,032,520 196,534 18,468 2,596,299 838,811 381,438 341,937 376,430 154,512 872,879 12,859,304 Group Plasters, bandaging material MD for incontinence, urinary retention MD for diabetics MD for ostomies MD for compression therapy Breast prosthesis MD individually prepared Orthopaedic MD Physiotherapy equipment MD for patients with mobility problems MD for ear disorder MD for eye disorder Other MD Sum MD: Medical devices. 38 % 6.04 86.88 1.40 4.52 0.12 0.01 0.23 0.39 0.24 0.01 0.04 0.07 0.12 100.00 % 10.10 30.67 12.77 8.03 1.53 0.14 20.19 6.52 2.97 2.66 2.93 1.20 6.79 100.00 Table 2. Average monthly spending on MD on direct sale realized by patients in cash in packages and value (). Average monthly packages 388,111 629,660 56,014 887 4455 200 794 6417 6283 411 559 23,732 135,396 1,252,919 Average monthly value 227,119 291,919 81,721 2252 12,177 2405 1434 46,976 25,263 6387 5683 84,090 327,668 1,115,093 Group Plasters, bandaging material MD for incontinence, urinary retention MD for diabetics MD for ostomies MD for compression therapy Breast prosthesis MD individually prepared Orthopaedic MD Physiotherapy equipment MD for patients with mobility problems MD for ear disorder MD for eye disorder Other MD Sum MD: Medical devices. % 30.98 50.26 4.47 0.07 0.36 0.02 0.06 0.51 0.50 0.03 0.04 1.89 10.81 100.00 % 20.37 26.18 7.33 0.20 1.09 0.22 0.13 4.21 2.27 0.57 0.51 7.54 29.38 100.00 specifically injections, and, as a consequence, infection with hepatitis B, C or HIV. There are various reasons for reuse: limited resources, insufficient knowledge of healthcare workers and the belief of patients that injection is more beneficial compared to oral medication. Reuse of cheap single-use devices should cease and both medical staff and the public should be informed about potential safety risks associated with injection. In developed countries, reuse of single-use items is less common, but may include expensive technical products. Reuse is regulated in many countries (e.g. US, Canada, some European countries) demanding ethical and legal considerations, high standards of reprocessing and training of staff, risk assessment, management and validation of reprocessing. Well regulated reprocessing can decrease the number of single-use devices reprocessed. In developing as well as developed countries, the decision to reprocess singleuse devices should only be made after a careful consideration of the advantages and disadvantages (Popp et al., 2010). The other factor that influences the spending on MD is their safety. The recent scandals involving the sale and manufacture of defective MD such as the PIP breast implants and the DePuy implants have resulted in the long-awaited modernization of the Medical Device Directive. Taking cognizance of the increasing integration of MD and technology, as well as the importance of electronic information, the proposed EU Regulation on Medical Devices promises greater European control on Notifying Bodies and more transparency to ensure patients' safety (Kierkegaard and Kierkegaard, 2013). Analysis by Niederländer et al. on safety issues and monitoring implant MD found that there is lack of surveillance of MD. They detected and classified 101 implant registries and their distribution showed variation in Europe. For a lot of implant categories, none or very few registries could be identified. Some countries run more registries than others. There are a lot of differences in aim and structure among the registries. Niederländer reveals lack of transparency concerning number, aim, structure and quality of registries. This is crucial, as registries work as early warning systems for identifying and notifying patients at risk. (Niederländer et al., 2013). The next factor influencing the spending on MD has been described in an analysis carried out in a hospital by Cruiz. He revealed problems in users' training (errors in operating procedures), intrinsic failures in MD, and badly scheduled maintenance policies. Clustering techniques uncovered the main causes of failures. With the evidence obtained, corrective actions were taken. The service request average dropped dramatically from 6.4 to 0.4 during the analyzed period (Cruiz, 2013). During the 1990s, economic evaluation of costly new pharmaceuticals and MD became increasingly widespread and systematic throughout the developed world. However, serious concerns remain about the validity and relevance of this economic evidence, and about the transparency and accountability of its use in public sector reimbursement decisions. Cookson and Hutton summarize current concerns in Europe, based on interviews with European health economists from industry, universities, research institutes and consulting firms. They identify five challenges for European policymakers and conclude that there is considerable scope for improving decision-making without damaging incentives to innovate. The challenges are full publication of the economic evidence used in reimbursement decisions; the redesign of licensing laws to improve the relevance of economic data available at product launch; harmonization of economic evaluation methodologies; development of methodologies for evaluation of health inequality impacts; and negotiation of priceperformance deals to facilitate the use of economic evidence in post-launch pricing review decisions, as information is gathered from studies of product performance in routine use (Cookson and Hutton, 2003). MD are a component of healthcare technology (Waller, 2014). The role of medical technology in healthcare costs has long been a source of debate. It has been widely asserted that healthcare technology can be cost increasing due to price and volume effects both for medical technologies themselves and related services (See Fuchs, 1996). Other findings have suggested that returns on spending on medical technologies can far exceed their costs, particularly when long-term benefits are measured in terms of productivity and reduced disability (Cutler and McClellan, 2001). Yet, surprisingly, very little analysis has been conducted on the direct costs to the health system of MD themselves. A review of the literature for MD-related studies did not find a single, empirical study on systemic spending on all types of MD (INhealth, 2006). A large share of financial resources in the Slovak healthcare system are absorbed by pharmaceutical spending (28% in 2008), which is 2-times higher than the OECD average. In contrast, spending on MD is 3%, which is lower compared to the EU, OECD averages and USA (6%) (Danahoe and King, 2012). Having achieved the goal of decreased spending on pharmaceuticals, an appropriate portion of the resulting savings must consequently be reinvested into supporting new modern medical technologies, which would lead to more effective treatment, faster patient recovery and a reduced risk of complications. Reducing pharmaceutical consumption, investing into modern medical technologies, and focusing on the care pathway will help the Slovak healthcare system achieve both financial stability and sustainability (Micieta, 2012). CONCLUSIONS When an aging population creates an increased financial demand on the healthcare system, Slovakia must further focus on efficiency and sustainability. Medical technologies (including MD) represent the best approach because improvements in medical technologies are not a driver of cost. Medical technologies represent a small portion of overall spending and offer limited potential cost savings in procurement. In the context of the above, the pharmacists play an important role. Providing MD brings benefits not only for the patients, but also for the pharmacists. Such character of the provision of pharmaceutical care bring community pharmacies additional revenue and enable them to retain in a sufficient network of healthcare providers among which community pharmacies belong.
Acta Facultatis Pharmaceuticae Universitatis Comenianae – de Gruyter
Published: Dec 30, 2014