INTERPRETATION OF THE …
INTERPRETATION OF THE DIRECTIVE 2010/32/EU AND ITS IMPACT ON COMPETITIVENESS OF COMPANIES WHICH PRODUCE DEVICES FOR VACUUM BLOOD COLLECTION
Objavljeno: Economic and social development : 2nd international scientific conference, Paris. April 2013 .
Avtor: Anita Sluga
The council of the European Union has issued Directive 2010//32/EU, which speaks about the implementation of the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector. The aim of the Directive is to prevent injuries to workers caused by medical sharps. The recommendations are certainly welcome, however, is the interpretation of manufacturers of such products harmonized and what does the Directive bring to these companies in terms of competitiveness? The purpose of this study is to determine what impact the Directive will have after May 2013 when it comes into effect on the competitive advantage of companies that produce these products and whether the interpretations of individual companies, providing medical devices which incorporate safety-engineered protection mechanisms, vary from company to company. The aim of the research with the detailed view of three world famous brands and their products for blood vacuum system is to present their products which should ensure the compliancy with the Directive and to assess their impact on the competitiveness of individual companies. A qualitative method with the usage of case studies was use for this study. Based on a desktop research, we have found out that the companies indeed interpret the directive in a different way, giving them a competitive advantage, or otherwise competitive disadvantage, which depends on legal representatives and legislation in every country.
Keywords: Directive 2010/32/EU, competitive advantage, needlesticks, qualitative research, safety devices for vacuum blood collection
Thousands of years ago people started using discharge of blood to treat a variety of illnesses. Discharge of blood can be classified as one of the oldest forms of medicine, which was popular among physicians until the end of 19th century. The vein was cut and the blood was squeezed into containers. They thought this would make a sick person get well. Due to the excessive discharge of blood a president George Washington was supposed to die. A major turning point in philosophy of medicine began when people discovered more about a human body. Dr. Pravaz Charles Gabriel, a French surgeon, and Alexander Wood, a Scottish doctor invented a hypodermic syringes, which were first used for the injection of morphine and then for a drawing of blood. In 1897 the Maxwell Becton and Farleigh S. Dickson founded the company, which began producing glass syringes (following the example of French). In 1970, laboratory personnel started to take blood with steel needles and glass syringes. After analysis they washed syringes and test tubes, however, needles were washed and then re-sharpened and finally sterilized. In 1949, Kleiner Joshep invented the “Evacutainer”, which consisted of tubes and needles. The needle consisted of front part, which went in to a vein and a back part through which blood was dripping into a test tube due to the pressure in the vein. While replacing the tubes, the problem occurred how to stop the leakage of blood from the back part of the needle during switching of tubes. In 1973, Sinae Miyake found a solution for this problem by placing a multiple sample sleeve over the proximal needle. The existing glass tubes were replaced with plastic tubes containing vacuum (Stoker, 2009, pp. 1-2). As we can see, companies have always been looking for better solutions. They have been trying to manufacture a new innovative product to solve problems.
Nowadays blood is used for the analysis and diagnosis. There are several companies that manufacture devices for vacuum blood collection. Three of the most common systems are Vacutainer (Becton, Dickinson and company), Vacuette (Greiner Bio-One GmbH) and VenoSafe (Terumo), which follow the guidelines and demand in the sector and market. Compared with previous products, new products are user-friendly for the patient as well as for laboratory technician, but there is still a room for upgrading and improvement.
Among the 35 million health workers worldwide, about 3 million experience percutaneous exposures to blood borne pathogens each year; two million of those to HBV, 0.9 million to HCV and 170 000 to HIV. These injuries may result in 15 000 HCV, 70 000 HBV and 1 000 HIV infections. More than 90% of these infections occur in developing countries (Rapiti, Prüss-Üstün, Hutin, 2005, pp. 49). Estimates indicate that 600,000 to 800,000 needlestick injures occur each year. Unfortunately, about half of these injuries are not reported (NIOSH. Whatever workers should know – How to protect yourself from needlestick injuries, 2000, pp. 2).
Figure 1 shows that the most accidents with needlesticks injuries occur in patient’s rooms -66%, followed by other reasons – 19%, 9% occur in theatre/intensive care and the least accidents occur in a laboratory – 6%.
Figure 2 shows that the most injures are caused with syringes and needles – 70%, followed by surgical instrument – 25%, 3% injures are caused by other object and the least accidents occur with glass object -2%.
According to statistic data it can be concluded that injures with needle-sticks in the medical field are really a reason for concern and that it is more than necessary to reduce them, therefore, Directives 2010//32/EU, which speaks about the implementation of the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector is more than welcome. In accordance with the Directive and 3 Article, Member States should adopt the laws, regulations and administrative provisions necessary to comply with it, or they have to ensure implementation of the measures required no later than by 11th May 2013 (Official Journal of the European Union, 2010, pp. 67). The purpose of this framework agreement is to achieve the safest possible working environment, to prevent workers injuries caused by all medical sharps (including needlesticks) and to prevent workers at risk. This agreement includes hospitals and health centers and appeals to all employees in these institutions. All employees are required to comply with this Directive.
The most important clause in the Directive, which includes safety vacuum blood draws is Clause 6: Elimination, prevention and protection, which in the second indent says: »Eliminating the unnecessary use of sharps by implementing changes in practice on the basis of results of risk assessment, providing medical devices incorporating safety – engineered protection mechanisms« (Offical Journal of the Eupropean Union, 2010, pp. 71).
Safety is a matter of different aspects. Who decides what safety devices with engineered protection mechanisms mean? An individual in an institution in a certain country will decide and consequently limit competitors by prejudicing the company that markets medical devices.
Market can be defined as individuals or companies where a certain need arises, which companies try to meet with their product or services (Kotler and Trias De Bes, 2004, pp. 23). It is true that companies are trying to adapt quickly to the demand of the market and be innovative, but innovation process includes research and interpretation for opportunities of new or improved products or processes, which are based on “know-how”, changes on the market or a combination of both (Fagerberg, Mowern and Nelson 2005, pp. 88). Companies must thoroughly consider their strengths and weakness and prepare the appropriate strategic plans. Strategic planning must include creativity and innovation. In order to make changes, managers must be one step ahead from the competition and think in a different way, find a different solution than the competition, consumers and their needs must be a center of their attention (Principles of general management, 2007, pp. 569). If they can recognize the signs, the theories of innovation can be a useful method for the future (Christensen, Anthony and Roth, 2004, pp. 243).
The purpose of this study is to determine what impact the Directive will have after May 2013, when it comes into effect, on the competitive advantage of companies that produce these products and whether the interpretations of individual companies, providing medical devices which incorporate safety-engineered protection mechanisms, vary from company to company. The aim of the research is with the detailed view of three world famous brands and their products for blood vacuum system, to present their products which should ensure the compliancy with the Directive and to assess their impact on the competitiveness of individual companies. On this basis, we set two hypotheses:
H1: Interpretation of the directive differs from company to company (a manufacturer of devices for vacuum blood collection).
H2: Interpretation of the directive will affect the competitive advantage of companies that manufacture and market products for vacuum collection.
2 METHODS SECTION
A qualitative method with the usage of case studies was use for this study. With desktop research, we want to find out how many sharps injuries were between health-care workers worldwide, what are the guidelines of WHO on drawing blood Safety-engineered devices, view the biggest risks for health worker between the blood drawn and examined how to decrease the risk. We examine in detail, tree the most common systems in the world Vacutainer (Becton, Dickinson and company), Vacuette (Greiner Bio-One GmbH) and VenoSafe (Terumo). We wanted to found, what the companies offer to meet the directive, which talks about using safety-engineered protection mechanisms.
3 BLOOD DRAWN AND NEEDLESTICKS
Phlebotomy – the drawing of blood – has been practiced for centuries and is still one of the most common invasive procedures in health care. Each step in the process of phlebotomy affects the quality of the specimen and is thus important for preventing laboratory error, patient injury and even death (WHO guidelines on drawing blood: best practices in phlebotomy, 2010, pp.13) Phlebotomy involves the use of large, hollow needles that have been in a blood vessel. The needles can carry a large volume of blood that, in the event of an accidental puncture, may be more likely to transmit disease than other sharps. Blood borne organisms that have been transmitted after needlesticks include viruses such as hepatitis B and human immunodeficiency virus (HIV), bacteria such as syphilis and parasites such as malaria. (WHO guidelines on drawing blood: best practices in phlebotomy, 13). In the year 2000, sharps injuries to health-care workers worldwide resulted in 16 000 HCV infections that will cause 145 (53−766) early deaths between the years 2000−2030; 66 000 HBV infections that will lead to 261 (86−923) early deaths by 2030; and 736 (129−3578) health-care workers will die prematurely from 1000 HIV infections by 2030 (Rapiti, Prüss-Üstün and Hutin, 2005, pp. 43). Accidental needlesticks per day – 2400; Estimated accidental needle-sticks injuries sustained by health workers worldwide per year is 1 million (Ernest, 2005, pp 244). Because all the above mention facts is definitely need to adopt guidelines / directives to avoid future stitches.
4 SAFETY DEVICES
Definitions for Safe injection and for Sharp protection device, of WHO guideline are: »Safe injection – An injection that does no harm to the recipient, does not expose the health worker to any risk and does not result in waste that puts the community at risk, sharps protection device: A sharp or needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids. The device has a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident« (WHO guidelines on drawing blood: best practices in phlebotomy, 2010, pp. 109).
Table 1: Safety-engineered devices (WHO guidelines on drawing blood: best practices in phlebotomy, 2010, p. 71)
|Auto-disable (AD) syringes
NOT recommended for blood drawing.
|Not recommended for phlebotomy.
Designed to prevent reuse, does not reduce the risks of needlesticks.
|During probing, safety mechanism can be activated, requiring new venepuncture.
Requires blood transfer, creating risk of needle-stick injuries.
Difficult to draw large or multiple blood samples.
Does NOT offer needle-stick
Air in the syringe can affect test results.
Requires additional training.
Safety-engineered device should offers protection to health worker, but they should be suitable for the specific task. As we can see from the table above auto-disable syringes are not appropriate for phlebotomy. Let’s look the type of risk for health workers and how can they reduce the risk.
Figure/Chart 3: Summary of risks and risk-reduction strategies to health worker (WHO guidelines on drawing blood: best practices in phlebotomy, 2010, p.55)
4.1 Safety devices in accordance with Directive
Based on previous findings, we examined individual products of worldwide companies (Becton, Dickinson and company, Greiner Bio-One GmbH and Terumo) which should meet the Directive.
Becton, Dickinson and company
The company was established in 1897. BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures medical supplies, devices, laboratory equipment and diagnostic products and sells it in more than 50 countries worldwide.
Figure/Chart 4: BD Vacutainer® Eclipse™ without holder or with holder (http://catalog.bd.com/bdCat/search.doCustomer?searchText=368651)
»These sterile, safety-engineered, multi-sample blood collection needles offer a simple, effective way to collect blood while reducing the possibility of needlestick injuries« (https://us.vwr.com/store/catalog/product.jsp?product_id=4646701)
As we can see from the pictures BD Vacutainer Eclipse can be removed from the holder, which means that medical workers can remove them from the holder and reuse them. Because BD Vacutainer Eclipse is attached to the needle it can be used with BD Vacutainer* Pronto* Quick Release Needle Holder – reusable plastic holder, which can be used for multiple use.
Figure/Chart 5: Pronto* Quick Release Needle Holder http://www.cenmed.com/productDetail.php?productid=18189&catID=&category=5380&maincat=&cat=)
Greiner Bio One International AG
GBO started with as a small cork manufacturing company at the end of the 19th century. Today, Greiner Bio-One International AG is a world market leader in the field of biotechnology, diagnostics, pharmaceutical, medical and In Vitro diagnostics. The product range includes products for blood collections. The products are sold in over 100 countries worldwide.
Figure/Chart 6: VACUETTE® QUICKSHIELD Safety Tube Holder with needle or without needle (VACUETTE QUICKSHIELD Safety Tube Holder 2011, p. 3)
»The VACUETTE® QUICKSHIELD Safety Tube Holder is especially suitable for use in daily blood collection routines. Without the need to change collection techniques, the holder helps prevent needlestick injuries« (VACUETTE QUICKSHIELD Safety Tube Holder 2011, p. 3). Holder produced by GBO has a pre-assembled protective cap, which means that user can choose the thickness of the needle. All the needles have a thread, which means that they need to be tightened into the holder. After use, the entire set has to be discarded, because the needle is locked with a protective cap.
Figure/Chart 7: VACUETTE® PREMIUM Safety Needle System Tube-Touch (VACUETTE Safety brochure 2011, p. 19)
The user manual says: »When the user pushes in the tube, the pressure of the tube onto the back end of the needle releases the safety shield, automatically covering the needle which moves forward lightly resting against patient´s skin« (VACUETTE Safety brochure 2011, pp. 19-20).
Terumo foundation dates back to the year of 1921 as a manufacturer of clinical thermometers. Terumo Corporation has grown worldwide to a position of leading manufacturer of medical devices. They develop, manufacture, export, import, markets, distribute and sell a diverse portfolio of medical devices, supplies, and accessories. They have 13.000 employees worldwide.
Figure/Chart 8: Quick fit system holder with needle, needle (http://www.terumo- europe.com/laboratory/products/acc_holders.php)
From our pictures we can see that manufacturer Terumo is the only one on a market that produces needles without a thread, therefore the holder can be used only with Terumo needles (Quick – Fit), which means that after the needle has been inserted into the holder, it cannot be removed again. Their holders come with safety shields or without them.
Figure/Chart 9: Terusafe Disposal Boxes (http://www.terumo-europe.com/laboratory/products/acc_boxes.php)
Figure/Chart 10: VENOSAFE HOLDER (http://www.terumo- europe.com/laboratory/products/acc_holders.php)
The holder from Figure 10 is compatible with Quick fit needle from picture 8. Pressing the bayonet or by pushing the holder in the special QUICK FIT release aperture, disposes the needle safely into the TERUSAFE box, without touching the holder. (Terumo – Recommendation for use)
Based on a desktop research, we have found out that the companies indeed interpret the directive in different ways they manufacture various products which incorporate safety-engineered protection mechanisms in order to meet the Directives.
According to the purpose we examined the part of the directive, which applies to our case study. The aim of the research was achieved, as with a case study we found, that the companies produce a variety of products to provide devices with a built-in safety system.
Becton, Dickinson and company
They produce safety-engineered, multi-sample blood collection needles »Eclipse«, which go on a holder and can be reused. As we can see the »Eclipse« needles do not provide a product for single use, as a holder can be reused.
Greiner Bio One International AG
The company manufactures »VACUETTE QUICKSHIELD« Safety Tube Holder, which has a pre-assembled protective cap. User can choose the thickness of the needle. All the needles have a thread, which means that they need to be tightened into the holder. After use, the entire set has to be discarded because the needle is locked with a protective cap. This system is good as user can choose the size of the needle, disadvantage of this system is that the needle has to be threaded into the holder. We can say that this system meet the Directive.
The second product they offer, VACUETTE® PREMIUM Safety Needle System Tube-Touch is automatic product. If we look at Table 1: Safety-engineered devices, we can see that the WHO organization does not recommend automatics products because safety mechanism can be activated during blood drawn.
Terumo is the only manufacturer on the market that produces needles without a thread, therefore the holder can be used just only with a Terumo needle »Quick – Fit«, which means that after the needle has been inserted in the holder, it cannot be removed, which means it provides SAFETY for a user. Terumo produces holders with a safety shield for a single usage (Figure 10). To meet the Directive, Terumo recommends Quick-Fit needle with a holder for multiple usage together with Terusafe Disposal Boxes (Figure 9), Quick Fit release aperture on the cap for safety disposal needle.
On the basis of the above facts it can be said that the aim of the research was achieved. Companies offer a variety of products to meet the Directive, therefore we accept our H1 which says that the interpretation of the directive differs from company to company (manufacturer of devices for vacuum blood collection). Which of the above mentioned products are appropriate to meet the Directive, are decided by a clients. A restriction of competition starts here. We can say that a market share of the companies depends on the representatives in each country. If the brand is well represented and advertised the sales of these products will be successful. Based on the results we can also accept H2, which speaks about the interpretation of the Directive to affect competitive advantage of companies that manufacture and market products for vacuum collection. Based on a desktop research, we have found out that the companies indeed interpret the directive in different ways, giving them a competitive advantage, or otherwise competitive disadvantage, which depends on legal representatives and legislation in every country.
For further research we recommend the exploration of the interpretation of the Directive according to a client’s their response to the adoption of the Directive, which will drastically raise the cost of vacuum collection.
- BD Vacutainer® Eclipse™ without holder or with holder. Retrieved 01.12.2012 from http://www.catalog.bd.com/bdCat/search.doCustomer?searchText=368651.
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