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Changes to the EU MDR and IVDR and the future of the Medical Device Industry

[urlpreviewbox url=”https://www.youtube.com/watch?v=2oCV_82Y28E”/]

GA2 Medical shares a useful video about the changes to the EU MDR and IVDR.

Visit our website www.ga2medical.com to find out more about our range of single patient use and reusable medical devices and products.

TAKE ADVANTAGE OF WORKING WITH A COMPANY THAT TRULY LIVES BY ITS MOTTO – PERFORMANCE. BEYOND. EXPECTATIONS.

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Are you aware of EU MDR/IVDR deadlines? Explanations include a few surprises

[urlpreviewbox url=”http://mdi-europa.com/are-you-aware-of-eu-mdrivdr-deadlines-explanations-include-a-few-surprises/”/]

GA2 Medical shares a useful link about the changes to the EU MDR and IVDR deadlines.

Visit our website www.ga2medical.com to find out more about our range of single patient use and reusable medical devices and products.

TAKE ADVANTAGE OF WORKING WITH A COMPANY THAT TRULY LIVES BY ITS MOTTO – PERFORMANCE. BEYOND. EXPECTATIONS.

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Make the Switch

When health care facilities switch from reusable to single-use medical devices, the benefits extend beyond protecting patients from HACs. To realize the value of disposable medical supplies, here are the top reasons to make the switch from reusable to single-use devices:

Improved Patient Safety

Disposable devices can alleviate surgeon and health care provider concerns over the cleanliness of their surgical tools. With reduced risk of cross-contamination and increased infection control, single-use devices can improve overall patient safety and quality of care.

Save Time

Disposable medical devices relieve medical staff from the responsibility of properly cleaning, disinfecting and sterilizing instruments through extensive reprocessing cycles. When they arrive at the health care facility, single-use devices are ready for immediate use. And because they are disposed of after one use, hospital and medical practice staff do not have to spend time on decontamination or sterilization like they do for reusable devices. Plus, single-use devices are easily traceable and can eliminate the time spent tracking and accounting for reusable instruments.

With minimal preparation or post-procedure work, health care facilities can easily adhere to scheduling and avoid mishaps in medical procedures. Ultimately, single-use devices can significantly increase the facility’s efficiency.

Cut Down on Costs

While the upfront price of disposable supplies may be higher than reusable ones, providers can see significant long-term benefits. For instance, the initial savings on reusable tools can be offset by the outgoings associated with cross-contamination and infection complications. Plus, single-use devices eliminate the ongoing costs of reprocessing, which includes decontamination supplies, machine maintenance, utility use and employee time. With so many elements, it can be difficult to calculate the true costs of sterilizing and tracking reusable devices. Alternatively, single-use tools can simplify this process for health care providers.

Essentially, disposable supplies provide the same quality as reusable devices without the cost of upkeep. Over time, providers will likely see improved bottom line numbers after making the switch to single-use tools.

Reduce Environmental Impact

According to Practice Greenhealth’s Sustainability Report1, hospitals in the U.S. create more than 4.67 million tons of waste every year. It’s easy to assume that disposable devices would contribute far more to this number than reusable devices, but the opposite is actually true. The utilities and disinfecting solutions used when reprocessing reusable devices result in a much higher environmental impact. Plus, providers may also have to consider transport to decontamination facilities and landfill disposal. With single-use devices, there is no waste from these extraneous steps.

There are plenty of arguments on either side. However, when you strip away the reactionary scare tactics and look at some of the common sense information available in the single-use versus reprocessed medical devices debate, the traditionally-accepted arguments for choosing to reprocess lose their luster compared to the benefits of single-use medical devices.2

Ask GA2 Medical about making the switch or visit our website www.ga2medical.com to find out more about our range of single patient use and reusable medical devices and products.

References

1 https://practicegreenhealth.org/tools-resources/sustainability-benchmark-report-0

2 https://obpmedical.com/resource-center/blog/environmental-impact-single-use-vs-reusable/

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5 Strange and Ancient Medical Practices That Will Make You Gasp

Our ancestors relied on herbs, essential oils and other natural ways to stay well. On the flip side, their world included medical practices far more harmful than healing. These practices probably originated the phrase, “The cure is worse than the disease.”

Toothaches

Ancient Egyptians also found medicinal value in dead mice. They would pulverize the bodies and make a paste, which, when slathered on the gums, was said to relieve toothache. For a really bad toothache, an entire dead mouse was applied.

Cocaine

Things go better with coke, according to many nineteenth-century physicians. Cocaine was recommended for all sorts of ailments, including depression, headaches and toothaches.

Heroin cough syrup

If your children are suffering from a cough, give them cough syrup containing heroin. That’s a concoction Bayer offered in 1920s Germany.

Birth control

There is no shortage of substances used in mankind’s endless quest to separate sex from reproduction. In ancient Egypt, women placed crocodile dung in their vaginas, an early variation of the diaphragm. Other methods included the following:

Lemons — the rind acted as a barrier and the juice killed off sperm.

Mercury — it would cause a miscarriage, but likely kill the mother.

Elephant dung — a variant on crocodile dung in countries where elephants roamed.

Elf sickness

Folks in medieval Europe were apparently prone to elf sickness, a disease caused by invisible elves shooting invisible arrows into them. Fortunately, there was a cure. Fresh dwarf elder made into a drink would cure the sickness and keep the elves at bay.

Ask GA2 Medical and visit our website www.ga2medical.com about our products that will make you gasp with excitement.

Visit our website www.ga2medical.com to find out more about our range of single patient use and reusable medical devices and products that will make you gasp with excitement!

Reference: https://www.thealternativedaily.com/horrifying-strange-ancient-medical-practices/

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Is your Consumables Supplier a Vendor or a Partner?

What kind of relationship do you have with your Medical Consumables supplier? Many organizations make the mistake of choosing a vendor and not a strategic partner. At GA2 Medical, we strive to build partnerships, not just a support relationship.

Medical Consumables suppliers, in the traditional sense, have been vendors. They provide a bill of goods for an agreed upon charge. More often than not, organizations choose their supplier based solely on tangible items such as cost, product specifications, location, supply terms and the like. Below, we’ll explore some of the intangibles needed to evaluate a Medical Consumables supplier.

Vendor relationship

The vendor/client relationship is two sided. Each party is advocating on their own behalf for their standards, structure, interests, and needs.

 

The engagement is very push/pull. Each party advocates for their own interests. In this relationship structure, the client and the supplier are not strategically aligned. While they may have similar interests, they are not having the ‘tactical’ discussions to create a “win/win” relationship.

Vendor relationships are often focused on the shorter term, where each party is working to meet their own current goals and initiatives. Rarely are parties engaging on how they may better align to create greater value to the business through the services and products.

Client (purchaser) objectives are to:

  • Ensure they’re getting a high ROI (return on investment)
  • Lower their spend
  • Provide a quality end user/business experience
  • Meet the business requirements
  • Align purchasing to business needs and roadmap

The supplier’s (sellers) objectives are to:

  • Minimize their cost of providing a product and/or service
  • Increase margins
  • Expand business development and sales
  • Leverage resources and standardize services across clients
  • Align services and/or products to business/sales opportunities

Partnered relationship

By building a partnership, two organizations can work closely together for common goals and mutual benefit. The Medical Consumables supplier establishes themselves as a trusted advisor and seeks to offer insights and guidance to the client. Throughout the engagement, the client should look to involve the supplier in strategic planning to ensure future alignment between the organizations.

Characteristics of a Partnership:

  • Both parties are transparent and open with their goals and initiatives
  • Each party seeks to find common ground on which they can engage
  • They create a mutually beneficial relationship
  • Both parties assist each other’s development

 

Each party will manage their own independent goals and objectives. Frequent and open dialogue can identify and overcome conflicts of interest. Occasionally, parties will need to concede their own specific interests to ensure overall, long-term health of the relationship. For example, a supplier might direct a client to a lower cost solution despite directly impacting the supplier, or the client might pay higher cost for a specific service to maintain a larger relationship. In the end, a partnership grows from ensuring both parties are meeting their objectives.

We recommend using these seven steps to rate your suppliers, track performance, and ultimately increase your company’s overall success:

  1. Define perceived value. Clarify key attributes you are seeking in the supplier relationship, such as delivery rate, return rate, corrective actions, and financial stability.
  2. Rank suppliers. Divide your suppliers into levels (one, two, and three) based on the impact they have on your business.
  3. Establish performance indicators. Determine what characteristics a supplier needs to have, demonstrate, or maintain to continue doing business with your company.
  4. Monitor results. Establish criteria for evaluating suppliers and, most importantly, define who in your company will be responsible for reviewing data.
  5. Build relationships. Consider your suppliers a partner with your business and treat them as such.
  6. Address the issues. Share the outputs from your performance indicators and issue a warning, providing the supplier with an opportunity to correct the problem. This creates a win-win situation by helping suppliers identify a pervasive issue that impacts you and other customers.
  7. Sever weak links. No one should tolerate ongoing bad products or service, and there may come a time when you have to let go of an underperforming supplier. However, make sure you fully understand ahead of time the impact of the termination on your business.

The relationship with your supplier should be a business partnership, with both parties working toward a common goal and enhancing the relationship. In the long run, a solid relationship with your suppliers creates a competitive advantage for your business.

If you are not happy with your current Medical Consumables Suppliers, we would be delighted to arrange a 15-minute telephone discussion with you, or an appropriate colleague, to show you that we are different and what that means to you and your business. Do you, or a recommended colleague, have a spare 15 minutes this week to chat on Skype?

Alternatively, visit our website www.ga2medical.com to find out more about our range of single patient use and reusable medical devices and products.

Reference: https://www.westmonroepartners.com/~/media/Files/White-Papers/Is-Your-IT-Service-Provider-a-Vendor-or-a-Partner.pdf

Reference: https://www.kmco.com/resource-center/article/looking-forward/vendor-vs-partner-are-your-suppliers-working-for-you-or-with-you/

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The Value of Single-Use Devices in the Emergency Department

From a business standpoint, what value do disposable medical devices offer over their reusable counterparts? How much do they save? What clinical benefits do they deliver? And most importantly, what kind of ROI can hospitals expect?

In this article, we’ll use a stainless steel kidney dish to illustrate the potential cost, cross contamination and convenience benefits that a typical ED might see as a result of switching from a traditional, metal kidney dish to a plastic disposable version.

Cost

To determine the true cost of a metal kidney dish, one has to consider not only the initial cost of purchasing the device, which can run anywhere from RM10 – RM50 per unit, but also costs associated with reprocessing and maintaining the device over its lifespan.

Because devices like the speculum are used on multiple patients on any given day, they have to be sterilized after each use, and that requires extensive equipment that, depending on a hospitals sterilization policies, can cost upwards of RM1,500. Add to that the annual cost of cleaning solution and ancillary items that also need to be purchased and cared for, as well as expenses associated with training staff, inspection and recordkeeping, and the per unit cost goes up significantly.

In addition, using a metal kidney dish slows down the process of caring for patients, and that time is money that hospitals need to allocate for. For example, it takes time for staff to clean the device, put it through disinfection, inspect it for potential damage, repackage it and put back in place for the next patient—and this should happen after each and every use. In a busy department, sterilization can take upwards of two hours out of the day; in a high-volume ED, it can eat up even more time. In an industry as resource sensitive as healthcare, all that time is money down the drain.

Single-use kidney dishes come out of the package ready for use and are disposed of after a single use. They allow hospitals to eliminate many of the costs, including maintenance and reprocessing, associated with reusable devices.

While reusable kidney dishes may be the more conventional choice for some providers, single-use devices, provide the same quality without any of the upkeep, resulting in true value for your facility.

Cross Contamination

There is a growing body of evidence—and countless real-world examples—that demonstrate how so-called “disinfected” medical devices are not as clean as we think. A study from the Journal of Hospital Infection for example recently found that 86 percent of “disinfected” laryngoscope handles in hospitals still had bacteria on them post sterilization. To put that finding in perspective, in March 2010, Dallas-based Parkland Memorial Hospital was forced to notify 73 female patients that they were potentially exposed to infectious agents—including HIV and hepatitis—due to both equipment failure and the reuse of an improperly sterilized vaginal speculum. Not only did the cross-contamination scare have the potential to significantly harm to those patients, as well as their partners, but it also caused significant reputational damage to the hospital.

As these examples highlight, cleaning devices does not always mean that they are truly clean. The reality is that even when staff follow manufacturer recommendations for cleaning, contaminants can still exist deep in the equipment because cleaning protocols aren’t always sufficient, devices aren’t cleaned in a timely fashion or they simply weren’t designed with optimal cleaning in mind.

It isn’t hard to imagine that if reprocessing doesn’t get a reusable device truly clean—or if potential sources of contamination, such as handles or even plug-in light sources, are overlooked when considering potential risk factors and developing institutional decontamination protocols—devices, their components and even the seemingly benign items you see in an exam room, all can easily become vehicles for cross contamination.

By comparison, when a product is opened, used on a single patient and then thrown out, the risk of cross contamination from one patient to another drops to almost zero. So making this simple change from reusable to single-use enables organizations to minimize cross contamination, maximize infection control and focus on what’s really important: delivering high-quality care to patients.

Convenience and Care

For a patient in need of urgent evaluation or an immediate procedure, the single-use kidney dish means less time waiting. A single-use device eliminates all of the prep and post exam or procedure work and allow clinicians to deliver great care in less time.

As this article has outlined, for hospitals looking to increase resource utilization and cut costs while also reducing the risk of cross contamination and enhancing the experience for providers and patients alike, medical devices that are designed for single-use offer a high return on investment that should put them high on the list for any healthcare organizations, and for acute care environments in particular.

Ask GA2 Medical about the value of single-use products or visit our website www.ga2medical.com to find out more about our range of single patient use and reusable medical devices and products.

Reference: https://medicaldesign.com/components/value-single-use-devices-emergency-department

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Reduce the Risks

There is currently a very large international focus on hospital-acquired infections, which can be associated with reusable medical devices that are difficult to clean, disinfect and sterilize. HAI’s are caused by viral, bacterial, and fungal pathogens. The most common types are bloodstream infection (BSI), pneumonia, urinary tract infection (UTI), and surgical site infection (SSI).

The UK National Audit Office estimated that in 2004 the rate of HAI in the UK ran at 9%, including some 5000 deaths. The cost to the UK NHS is over €1.5 billion/£1 billion each year. They also compared the UK with other countries and found the rate of HAI to be between 4% and 10%1, and the incidences of HAI’s is increasing. There is a renewed, industry-wide focus on implementing methods to reduce these risks. One method for reducing rates of HAI’s is using single-use medical devices.

Single-use, or disposable, medical devices as those strictly intended for use on one patient during only one procedure. These devices should not be reprocessed and instead are properly disposed of immediately after use.

Single-use medical supplies are a reliable option for ensuring all devices are decontaminated. They can protect patients from developing life-threatening infections from cross-contamination or unsafe conditions during medical procedures and treatment regimens.

Single use medical devices simplify processes within hospitals. They eliminate the need for complicated guidelines setting out procedures for cleaning, sterilizing, checking functionality, labelling and tracking.2

Single use medical devices also make it possible to create innovative designs, which in turn lead to faster, more efficacious, and less risky procedures. In other words, single use medical devices provide treatment that would not otherwise be available.2

Often claims are made that waste generated by the disposal of single use devices could be considered as environmentally unfriendly. However, any analyses of the environmental impact of single use devices should also consider the significant resources (e.g. chemicals and packaging) needed and the energy consumed during the cleaning, disinfection and sterilization of devices.2

Ask GA2 Medical about reducing the risks or visit our website www.ga2medical.com to find out more about our range of single patient use and reusable medical devices and products.

Reference: 1 National Audit Office Report (HC 876, 2003-2004) Improving patient care by reducing the risk of Hospital Acquired Infections. http://web.nao.org.uk/search/search.aspx?Schema=&terms=HC+876,+20032004 (accessed 8th December 2009).

Reference: 2 Eucomed White Paper on the reuse of single use devices, December 15, 2009.