Monthly Archives: April 2015

Guidelines for reprocessing medical devices

Some devices in hospitals and offices are made for one-time use. These are used and then thrown away. But many of the high-price items are used repeatedly and for multiple patients. There are specific safety measures involved to ensure that such devices remain safe for use with multiple patients. Perhaps these measures include cleaning guidelines for protective covers. Whatever the specific case, there are countless devices that require users to closely follow instructions for reprocessing.

The U.S. Food and Drug Administration (FDA) recently made changes to their guidelines on reprocessing used medical devices. The final guidance clarifies testing protocols and which data should be submitted to the agency for a pre-market submission.

The six criteria for communicating reprocessing instructions to manufacturers are:

  1. Labeling should reflect the intended use of the device.
  2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
  3. Reprocessing instructions should indicate the appropriate microbicidal process for the device.
  4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
  5. Reprocessing instructions should be comprehensive.
  6. Reprocessing instructions should be understandable.

While Medical Device Depot does not sell used or pre-owned devices, a leasing program is available to offer a more affordable option. Leasing arrangements range from 24 months, where the equipment is generally depreciated, to up to 60 months, where the monthly payment is generally deducted as an operating expense. You can work with confidence knowing that you are using the best equipment available at a more affordable price.

Equipment Spotlight: Ultrasound Machines

Ultrasound machines allow radiologists to see inside the human body in a non-invasive, non-harming way. These high-frequency sound waves that are used to produce diagnostic images are also known as sonographies. They can be used in any number of procedures or diagnostic work, from detecting disease to checking the health of a baby in the womb. Although the ultrasound was first used for clinical purposes in 1956, it has gone through many updates and revisions.

As with most medical devices, ultrasound technology has only improved with age. Faster computers with more memory have the capacity to store more information and run more efficiently. As technologies continue to evolve, 3D ultrasounds will most likely become more highly developed as well.

Mindray is one of the leading manufacturers of ultrasound machines for in-vitro diagnostics and medical imaging, as well as veterinary medical imaging. Mindray, which can be purchased through Medical Device Depot, is committed to providing the most up-to-date and accurate equipment. Mindray has always given top priority to product quality and was one of the first medical equipment companies in China to obtain TUV ISO9001/13485 Certification, CE Mark and FDA Clearance.

Browse the selection of ultrasound machines at Medical Device Depot to find a machine for your practice.

5 key benefits of using a medical device supplier like Medical Device Depot

You need a new device for your practice but you’re unsure where to turn. A medical device supplier can help, and partnering with a supplier like Medical Device Depot offers numerous benefits. These include:

* Quality products. At Medical Device Depot, we carry only the highest-quality medical devices so you never need to worry that you’re choosing the right device. We’ve already done the investigating for you, and we guarantee the quality of everything we sell.

* Experienced customer service. Have a question about the products you need for your practice? Our experienced customer service team is ready and willing to help you anytime. Call us today at 877-646-3300.

* Multiple payment options. We have the payment solutions that work for your practice. We accept all major credit cards and offer financing for qualified customers as well.

* A warranty you can depend on. Because we have personally investigated the products we sell, we feel comfortable supporting every one of our products. All of our equipment is brand new and comes with a long-term warranty. If your device doesn’t work the first time, we’ll replace it with one that does.

* The best price every time. Our loyalty is to you, our customer, and because of that, we want to make sure you’re being offered the best price on every product. If you find a product we sell for a lower price somewhere else, let us know and we’ll beat that price immediately.

Shopping for the right medical device can be confusing, but partnering with a medical device supplier like Medical Device Depot can help. Contact us today to learn more about how we can provide your practice with everything it needs to succeed now and in the years ahead.

Cyber-attacks: How to protect your medical devices

Target, Neiman Marcus, Facebook, Microsoft and many more of the biggest companies in the world have fallen victim to hackers and cyber criminals. But is the comparatively smaller medical device industry too tiny to fall victim to cyber criminals? Hardly.

The security in obscurity mentality is not an effective shield. As cyber criminals expand their reach and target new potential victims, it is only a matter of time before they see the value of the medical device industry. So what can industry professionals do to protect themselves and their companies from cyber crime and hackers?

Many traditional security mechanisms that would work in other industries will not work for medical device companies because of a lack of additional processing resources. The industry is also too specialized to rely on standard PC security options.

Medical device companies are not without options, of course. Standard IT security practices such as authentication or encryption software, firewalls, security protocols and intrusion prevention or detection systems can all be helpful in staving off cyber criminals. Bump-in-the-wire options can also provide an effective way to upgrade existing security systems while ensuring platform independence. This solution also requires no new special software or hardware and configuration/maintenance is minimal.

The industry also has the unique opportunity to build security into the devices themselves. Building protection into the device itself means it is no longer solely dependent on the corporate firewall for its security. However, the security initiatives companies invest in must protect the firmware at all costs, and most also allow for the securing of stored data and communications both into and out of the device. Following these steps and building security measures into the company as a whole, as well as the individual devices, will help protect the medical device industry from the next wave of cyber-attacks.

Medical device recall numbers plummet in first quarter

The year 2015 is off to a great start in the medical device industry, with medical device recalls falling to near-record lows in Q1. That’s according to a review of the Food and Drug Administration’s (FDA) data conducted by Regulatory Focus.

Reviewing the FDA’s data shows that while 968 separate device recall events took place in the fourth quarter of 2014, only 426 recalls took place in the first quarter of 2015. This figure marks the lowest recall total since Q1 of 2013 when 367 recall events took place.

So why the big change between Q4 of 2014 and Q1 of 2015?

According to the Regulatory Affairs Professional Society (RAPS) three large incidents involving more than 721 recalled devices took place in 2014, making recall numbers especially high. In one instance, 233 devices were recalled because of packaging flaws. Even though the supplier and customer were the same for each device, it still counted as 233 recalls. The first quarter of 2015 represents a shift away from these previous outliers and a lower, more positive recall number.

It’s also important to point out that the recall numbers show only the number of different models recalled, not the total number of devices recalled. Some recalls may affect 10 or fewer devices while others can affect thousands or even millions. Each case is treated as one recall incident. It’s also worth noting that the FDA’s entrance of a recall reflects the date the FDA classified the recall, not the date when the recall actually occurred.

After recalls peaked at the end of 2014, a recall reduction of more than 50 percent last quarter is a great way to start the New Year. History shows recall numbers have fluctuated in Q2, being both higher or lower than their Q1 counterparts in 2013 and 2014. As the industry moves forward, it would prefer the latter.