Posted on July 29th, 2015
Posted on July 22nd, 2015
The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices…
Reprocessing vs Re-manufacturing
Presently, reprocessing single-use devices is not regulated at the EU level. Some individual countries, such as Germany, allow single-use devices to be reprocessed using the same standards that apply to reusable devices. Others countries, such as France, do not allow the practice, and many “do not have any specific regulations” on the subject.
The UK currently does not allow reprocessing of single-use devices; however, MHRA says that it has been approached by multiple manufacturers who “re-manufacture” and CE mark used single-use devices.
For the past two years, MHRA says it has been investigating re-manufacturers and “assessing their technical, regulatory and clinical processes.” Following its review, MHRA said it sees a distinction between re-manufactured and reprocessed single-use devices.
In its draft guidance, MHRA says re-manufactured single-use devices must conform to the relevant medical device directive(s), acquire a CE mark, and satisfy the requirements of a notified body assessing the product.
MHRA also says that Class I devices should not be re-manufactured as “there would be no external or independent assessment of CE-mark compliance.” When a device is re-manufactured multiple times, it should always be done by the same company. Remanufacturers must also validate the number of times a device can be re-manufactured before it must be disposed of.
Additionally, re-manufactured devices should retain all markings by the original manufacturer, as well as new markings by the re-manufacturer, including company name, address and serial number, and the “packaging and instructions for use must clearly state that this product has been re-manufactured from the original.
“The guidance also clarifies that the original manufacturer is not responsible for remanufactured products, and the re-manufacturer is responsible for post-market surveillance of any re-manufactured single-use device.
New EU Medical Device Legislation
MHRA also acknowledges that its guidance may need to be updated to reflect changes at the EU level related to single-use devices if new medical device legislation is adopted…
Posted on July 9th, 2015
The Council of the European Union has published a compromise text on medical device regulation, three years after the Commission first proposed reworking the legislation. Making the breakthrough has set the stage for a discussion of the draft at the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting this week.
Officials at the European Commission proposed changing the medical device regulations in 2012 to standardize approaches across the region, only to see the initiative to get stuck at the Council. After four presidencies tried and failed to advance the process, Latvia has reached a compromise in the form of a 676-page document. Health ministers will discuss the draft this week, after which it may advance to a trilogue in which the Council, Commission and Parliament will try to agree upon a final text.
The preliminary nature of the draft and range of interpretations that can be applied to some sections mean many questions remain unanswered. Lawyer Erik Vollebregt has a detailed analysis of what he sees as the standout points in the text on his MedicalDevicesLegal blog. Both Vollebregt and Politico pick out the draft’s stance on the reprocessing of medical devices as a hot topic. The draft allows for reprocessing to take place when permitted by national laws, a stipulation that represents a backing away from the commission’s initial ambition to harmonize standards across Europe.
Posted on July 8th, 2015
By pledging to support, we recognize that a set of nationally recognized environmental criteria are important to health care with a goal to:
- Reduce the negative environmental and health impacts of products and services across their lifecycle.
- Establish a standard for successfully purchasing environmentally preferable products, thereby encouraging other health care purchasers to adopt.
- Provide a tool for educating staff and others on the environmental priorities in health care.
- Create safer and healthier environments for patients, healthcare workers and local and global communities.
Posted on July 8th, 2015
[Practice Greenhealth] launched the Healthier Hospitals Initiative in 2012 to raise the bar in healthcare sustainability, challenging the entire healthcare sector to accelerate its progress as a whole. With the backing of 12 founding health systems, Health Care Without Harm, Practice Greenhealth and the Center for Health Design set out to reduce the environmental impact of hospitals and health systems across the country and lead out nation on a path to a healthier future.
More than 1,200 hospitals stepped up to the plate, reducing energy use and waste, serving healthier food and reducing the use of chemicals of concern. We feel strongly that the participation of these hospitals, outlined in our 2014 Milestone Report, shows significant progress in six “challenge” areas: engaged leadership, healthier food, leaner energy, less waste, safer chemicals and smarter purchasing…
Posted on July 2nd, 2015
This report covers the present scenario and the growth prospects of the global medical waste management market for the period 2015-2019. The market can be divided into two segments based on medical waste generation sources: large quantity generators and small quantity generators. To calculate the market size, the report considers the revenue generated from the two waste generation sources.
Reductions in federal reimbursements have helped healthcare facilities to optimize the sustainability of their operations and improve cost-cutting strategies. Hospitals are now assessing their departments and developing effective plans for the efficient utilization of water and energy and for the organized management of wastes. For instance, Spectrum Health launched a medical device reprocessing platform and implemented a reusable sharps container program in 2008, which helped it save about $1 million in waste management costs. The conversion of biogas (produced from waste) to electricity via the waste treatment process has not only helped in the efficient utilization of waste but it has also made healthcare facilities energy independent.
According to the report, medical consumables – catheters, syringes, saline needles, and reagents – are used in large quantities as ancillary devices in surgeries and laboratory research for sample analyses. Most of medical equipment suppliers, such as Thermo Fisher Scientific, Illumina, Roche Diagnostics, and Alere, invest extensively in the development of consumables, as these products generate higher return on investment than capital equipment. In addition, the National Institutes of Health provides quarterly reimbursements on the R&D of consumables. Medical waste handling companies make higher gross margins from the management of consumables, as they are dumped in bulk quantities. This has also shifted the sales mix – that is, from instruments to consumables – for medical equipment suppliers.
Posted on June 24th, 2015
Brussels, 19 June 2015
MedTech Europe, the alliance of Eucomed and EDMA, welcomes the fact that the Council has opted to move forward with its proposal. At the same time, MedTech Europe notes that Council also recognises a number of areas that still raise concern and thus warrant further work.
It is apparent that Council found it important to make progress on discussions to achieve a balanced regulation for medical devices and in vitro diagnostics. But at the same time a significant number of Member States voiced concern over the unnecessary complexity of the scrutiny mechanism, the approach on reprocessing of single-use devices, the performance evaluation of in vitro diagnostic medical devices and the overall unnecessary additional administrative burden that would still need to be addressed. Industry shares these concerns.
Regarding medical devices, MedTech Europe believes that at least two issues merit particular attention and must be addressed if the EU is serious about providing equal levels of patient safety and treatment across Europe:
- The ‘scrutiny’ mechanism: The newly added “scrutiny” mechanism to bring products to the European market creates heavy procedures that will lead to unnecessary delay in the availability of devices to patients, as well as legal uncertainty in the innovation process. The proposed Regulation has other robust safety controls that strengthen the patient safety net, i.e. by enhancing the quality and expertise of notified bodies. These added controls render the additional ‘scrutiny’ procedure redundant in terms of patient safety and only serve to adversely impact the innovation and growth of the medical device industry. Moreover, the proposed ‘scrutiny’ procedure comes too late in the process and is based on a random selection of products.
- Reprocessing of Single Use devices: Patient safety is a crucial concern when it comes to reusing single use devices. The Regulation should therefore strive to ensure equal levels of safety for all products, regardless of who, in fact, is the reprocessing entity (original manufacturer, commercial reprocessor or hospital reprocessor). Council’s proposal, however, introduces three levels of patient safety depending on the entity who reprocesses. In addition, a non-harmonised approach allowing Member States to decide on national rules means that patients across the EU will not be equally treated. None of this is conducive to improved overall patient safety.
Other key areas that need additional attention include provisions on clinical evidence, hazardous substances and unnecessary bureaucratic burden.
Concerning in vitro diagnostics (IVD), the five-year transition period is in line with the initial proposal from the European Commission and is viewed positively while being in line with experience by other jurisdictions making similar changes to IVD legislation.
- Clinical Evidence: This has always been the aspect of the new IVD regulation that will be having the most impact for the IVD industry. Member States are considering extensive changes to the section of the proposed Regulation on clinical evidence. Overall, the proposal of the council greatly increases the burden of the new clinical evidence requirement for IVDs with unclear benefits for patients, while at the same time breaking the alignment with the international consensus which would have mitigated the impact of the clinical evidence requirements.
- On Companion Diagnostics: the proposed definition is too broad to be functional – too many assays fall under the new definition, creating an almost insurmountable barrier for some of the simpler assays such as cholesterol tests which will fall under the new definition.
Serge Bernasconi, MedTech Europe CEO says, “It is critically important that in the future discussions between Council, Parliament and Commission shortcomings on the key issues such as scrutiny and reprocessing for Medical devices and clinical requirements and Companion diagnostic definition for In Vitro Diagnostics be addressed. The current Council texts as it stands still fail to ensure that every proposed measure consistently meets the two overarching objectives of these Regulations, namely to increase patient safety and to foster innovation in medical technology in Europe bolstering a dynamic part of the European economy.”
Posted on June 23rd, 2015
The health and economic benefits of global climate change policies outweigh the impacts of taking no action, the Obama administration said Monday in a new report, which was released as Congress tries to weaken some of those policies this week.
The new report by the Environmental Protection Agency makes the first attempt to quantify the benefits of global action on climate change by examining 20 key sectors from water to electricity to infrastructure, EPA Administrator Gina McCarthy told reporters Monday.
“The report finds that we can save tens of thousands of American lives, and hundreds of billions of dollars, annually in the United States by the end of this century, and the sooner we act, the better off America and future generations of Americans will be,” McCarthy said.
The EPA is at the center of President Barack Obama’s Climate Action Plan, which he first announced nearly two years ago, which aims to tackle greenhouse gas emissions across different sectors using mainly executive actions and existing authority under federal law.
Posted on June 23rd, 2015
Lower-than-expected use of medical supplies and pharmaceuticals is linked to lower rates of mortality, lower 30-day readmission rates and higher patient-satisfaction scores at hospitals that score well in Truven Health Analytics’ 100 Top Hospitals study, according to an exclusive study conducted for Modern Healthcare by the Ann Arbor, Mich.-based data and research firm.
Truven found that hospitals with less waste—and therefore lower-than-expected supply and pharmacy costs per discharge—outperformed others on multiple quality measures used by Medicare.
The study included 2,560 hospitals from Truven’s flagship 100 Top Hospitals study for which pharmacy and supply data were available from Medicare. Together, the hospitals reported nearly 5.3 million discharges.
Posted on June 11th, 2015
Healthcare Facilities Focus on Recycling & Safer Chemicals
US hospitals are making an effort to use safer chemicals and reduce waste, and they’re seeing results, according to a report released by the Healthier Hospitals Initiative. The study demonstrates the results of initiatives designed to improve both operating efficiency and patient outcomes, such as safer chemicals, waste reduction, and energy efficiency.
The purchasing program seeks to transition facilities to using PVC- and DEHP-free devices, greener cleaning products, and furnishings that do not contain halogenated flame retardants, formaldehyde, perfluorinated compounds, or PVC. According to the report, the program has been responsible for an 11% increase in spending on certified cleaning products, 172 hospitals reporting to have made at least one product-line DEHP and PVC-free, and fourteen facilities meeting the goal of purchasing over 25% healthy furnishings.