What are the most common issues during FDA inspections of medical devices?

FDA inspections are par for the course in the medical device industry. Every medical device company class II or higher, in fact, should be inspected at least once every two years, according to existing bylaws.

Every medical device, medical device company and FDA inspection is different, but if you look at the applicable data from 2013 you can see some very clear trends in the most common features of these inspections.

FDA 483 Observational data for 2013 shows that more than 35 percent of the observations involved three areas: Design controls (13.25%), Corrective or Preventative Action (11.75%) and Complaint Handling (10.65%). These statistics are invaluable when it comes to focusing on your next FDA inspection.

To make sure your FDA inspections flow as smoothly as possible, ensure the protocols below are followed:

  • Properly document all design controls. Your lack of thoroughness will not go ignored.
  • Follow the proper corrective and preventive actions when responding to problems. It can be tempting to simply jump in and fix the problem, but moving forward with a controlled approach will pay dividends in the end.
  • Record all complaints. Operating with the “out of sight, out of mind” method can be tempting when dealing with complaints, but fixing the issue without following the proper investigative protocols will lead to future inspection questions.

FDA inspections are a common feature of the medical device industry and something companies should be prepared for every day. Adhering to strict guidelines throughout the year will lead to a smoother inspection process.

How medical device surveillance benefits clinicians

Patients deserve high-quality care options, thoroughly grounded in research to ensure the best possible outcomes. It sounds like an obvious staple of the health-care world, but this is not always the case.

Efforts exist to better understand the effects of prescription drugs – both benefits and risks – but no such efforts exist to discover the same in medical devices. In fact, many devices have little accompanying data pertaining to their effectiveness, reliability or quality once they are released to the market. Instead, these things are learned “in the field” when they are used in association with the treatment of patients. Rarely is that information shared.

This isn’t to say clinical trials are not done – far from it in fact. But the information these trials offer often fails to answer the questions that arise from in-practice situations.

Medical professionals are working to change this. A joint project from the Center for Health Policy at Brookings, the Food and Drug Administration and clinician, industry, payer and patient representatives will seek to outline the process for creating a national system that captures important device-related information as they are used in the field.

The medical device post market surveillance system, as it is being called, aims to improve safety surveillance while supporting device evaluation capabilities. The data gleaned here will further allow clinicians to analyze the device’s capabilities, overall quality and how it compares to other devices in the same space.

To succeed, however, the system will need to determine how to gather this information while minimizing the reporting required from clinicians. Research shows the average clinician may spend as little as four minutes with a patient, and most spend 8-15 minutes reporting afterward. It is not possible for these numbers to actually decrease if additional reporting time is required.

This new evidence must also be delivered in real time in order to offer any benefit. In a fast-paced industry such as health care, data that is reported late will likely be reported for a device that has already become obsolete.

While these are important challenges, the idea of a medical device post market surveillance system offers benefits to everyone involved in health care. Patients deserve high-quality options and such a system makes those options possible.

To find the medical devices your health-care facility needs, visit MedicalDeviceDepot.com.

How patient experience improves the medical device industry

This is an exciting time to work in the medical device industry. After decades of trying to determine the role of patient experience when creating regulatory policy, it appears answers may finally be coming.

The Medical Device Innovation Consortium released what it calls an “initial thought piece” in May, providing a guide for device makers seeking out information regarding patient preference when submitting data to obtain product approvals. The Consortium represents a joint effort of the device industry itself, the National Institute of Health and the Food and Drug Administration.

Ross Jaffe of Versant Ventures says that while patient preference is not required for a device manufacturer to obtain FDA approval, device manufacturers should consider it “an enhancement of a submission.”

In addition, device manufacturers benefit from the newly released FDA guidance that outlines just what patient preference information will be reviewed and considered by the FDA when weighing approval of any application for a new medical device.

For medical device manufacturers, these developments shed new light on an area that has always been frustratingly unclear. Device manufacturers can now use this information and these new guidelines to efficiently deliver proper applications to the FDA and get new, helpful medical devices on the market for the health-care facilities and patients in need, all more quickly than ever before.

To find all of the medical devices your health-care facility needs, contact Medical Device Depot today

What can 3D printing do for the medical device industry?

In industries all across the globe, 3D printers are getting attention for what they’re able to accomplish and how they seem to redefine what is possible. It is in the medical device world that 3D printed solutions have had perhaps the biggest impact.

Here are just a few ways 3D printing solutions have improved health care for consumers:

* Customization. Perhaps the strongest attribute of 3D printed products is their ability to support customization. By using bio-compatible and/or drug-contact materials, these printers can create medical devices perfectly designed to meet the needs of a certain individual. The printers can also be used to produce multiple individualized items at the same time, improving efficiency and ensuring that every device produced is a direct replica of the one that came before it.

* Quicker lead times. Dental offices are already using 3D printing technology to improve patient care. Today the denist can easily scan the patient’s mouth to obtain precise data. This data is then sent to the lab where the team can analyze it and immediately begin to create the necessary components for the patient. In some instances, this technology is being used to develop surgical drill guides to help dentists perform implant procedure for patients.

* Increased options. Perhaps no industry has benefited more from 3D printing thus far than the hearing-aid industry. 3D printers allow for the creation of numerous identical models, allowing patients to choose a hearing aid based not only on fit but color as well.

These are just a few of the ways health-care providers are using the medical devices created by 3D printers to improve patient care. As the technology continues to develop, you can expect the applications to increase as well. To find the right medical device solutions for your practice, visit MedicalDeviceDepot.com today.

Featured Products From Medical Device Depot

With such a large inventory of products, it is challenging to become familiar with every piece offered at Medical Device Depot. From office furniture to veterinary care equipment and urology to dental, we run the gamut of medical supplies. We understand it is no easy task to run a medical office of any kind, and because you are busy enough we have placed our featured devices right on our homepage so you don’t have to dig through the website to find the latest and greatest in the medical world.

The Medical Device depot website is neatly sorted by both product and specialty categories. If you know what you are looking for, it should be very simple to immediately get to your desired product; you can even use the search bar. And just like you would browse for new items being showcased in a brick-and-mortar store, you will want to take a look at the featured products every time you visit. This will keep you up to date regarding all of our newest products.

Whether the devices are big or small, we offer some of the best prices you can find. You can get great savings on EKGs, dopplers and autoclaves. And, as always, we offer leasing options on many of our products so you don’t have to worry about coming up with the full ticket price right away.

Medical Device Tax: Will it be Repealed?

The Medical Device Tax has been a long debated aspect of the ObamaCare plan. The medical device tax went into effect January 1, 2013, and has been a hot topic ever since. The medical device tax adds 2.3 percent of taxes on manufacturers who profit under the law. It has been made clear time and time again that the Obama administration is likely to oppose the repeal unless lawmakers can find a way to make up the cost that would be lost without the tax. According to a report by the Center on Budget and Policy Priorities, repealing the tax would cost $26 billion over the 2015-2024 period.

House democrats were aiming to pressure the House to repeal the medical device tax before Memorial Day, but that day has come and gone. Rep. Scott Peters led 17 House Democrats in a letter to Speaker John Boehner and Minority Leader Nancy Pelosi urging a timely passage of the bill.

As Memorial Day weekend has come and gone, the timeline is no longer possible. But will Democrats and Republicans come together to press for this issue? While there are many issues being debated in the house, ObamaCare remains a hot topic that will certainly come back up again.

What you need to know about vision tests and vision screeners?

A vision screening remains a cost-effective, efficient way to discover visual impairments and assess eye conditions that may cause them. The information attained from the visual screening can then be sent to the proper eye-care professionals for further evaluation and expanded treatment options.

If your practice is looking to improve its vision-screening services, the right vision screeners are essential. Some vision tests you will need vision screeners for include:

* Inspecting the eye, pupils and red reflex. The examiner uses a flashlight to inspect the eyes when looking for abnormalities in shape or structure, as well as pupil shape irregularity. An ophthalmoscope is used to detect red reflex by measuring the red appearance that reflects from the eye. Both eyes should look bright red and equally so in this test.

* Photo screening. This test can identify problems through the red reflex, and modern photo screeners deliver instant results for this quick test.

* Cover testing. Used to detect eye misalignment, the patient is asked to focus on a target while each eye is covered one at a time to check for a shift in the alignment.

* Glaucoma testing. Using a tool like the Diaton Tonometer, this test can be used to spot glaucoma through a simple, noninvasive procedure that measures intraocular pressure through the eyelid. The latest technology has not only increased the simplicity of the test but its safety as well.

To find all of the right vision screeners for any vision test, contact Medical Device Depot today or review our complete product line here.

What you need to know about spirometers?

If you have a patient who may be suffering from asthma, bronchitis or emphysema, a spirometer is an essential tool for conducting Pulmonary Function Tests (PFTs).

Spirometers measure the air that is entering and leaving the lungs and allow medical professionals to identify both obstructive and restrictive breathing patterns in patients. Most of these tests are handheld, allowing the patient to blow into the spirometer, and feature direct-to-printer or even built-in printer options. Peak-flow meters can also be used to monitor airway obstruction and breath exhalation.

Once the test is complete, medical professionals can use the readouts generated by the spirometer to monitor breathing patterns and identify possible cases of the diseases mentioned above. In addition, spirometers can also be useful in cases where it is necessary to measure the effect of working in close proximity to chemicals has had on a person’s lung function. Many medical facilities also use spirometers to assess a person’s lung function before they undergo surgery. Measuring a patient’s progress in treatment for a disease or assessing the affect of a certain medication are other tasks that health-care professionals can use spirometers to accomplish.

At Medical Device Depot, we carry a full line of spirometers and mouthpieces featuring the latest technology. We offer products from all the major manufacturers, too, such as Welch Allyn, MIR, Micro Direct, Midmark, SDI and ndd, so you know you’re getting a quality medical device that you can count on time and time again.

If your facility is in need of a spirometer, call us today at 1-877-646-3300 and we can help you find the right device for your medical practice.

What magnesium is doing for products in the cardiovascular and trauma fixation?

The medical device industry is always changing. As the industry continues to grow, you can expect more and more of those future changes to tie to magnesium. That’s in part because of a recent certification that has opened the door for magnesium to play a vital role in cardiovascular and trauma fixation.

Magnesium Elektron, which develops and manufactures high-performance magnesium alloys, was recently awarded ISO 13485:2012 certification for the company’s SynerMag Technology Center, located in Swinton, Manchester. ISO 13485:2012 represents an internationally recognized standard in the medical device industry.

The certification represents a victory of Magnesium Elektron, which has been working for years with medical device manufacturers in an attempt to use its SynerMag magnesium alloy in cardiovascular and/or trauma fixation implants. While the use of metal implants in these areas is already commonplace today, the advantage of using a magnesium alloy in such a situation instead is that it can be absorbed completely by the human body.

For the medical device industry, this represents an intriguing step forward as magnesium combines the benefits of a metallic implant but is also bioabsorbable. It will be intriguing to watch the development of medical devices using the alloy to see how it affects future industry growth.

To keep up with the latest news in the medical device industry and to find the right medical device options for your health-care facility, visit www.MedicalDeviceDepot.com.