FDA Information on EKG Machines

The U.S. Food and Drug Administration is in charge of protecting public health by assuring the safety, efficacy and security of medical devices, among many other things. With their thorough monitoring, the FDA ensures that medical devices do their intended job. When a device or drug is approved, patients understand that they will be receiving quality health care that has been proven effective through numerous tests. The FDA either denies the device, approves the device after reviewing a premarket approval (PMA) application that has been submitted, or it “clears” a device after reviewing a premarket notification, otherwise known as a 510(k).

According to the FDA, “In order to acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is ‘substantially equivalent’ to a device that is already legally marketed for the same use.” After thorough performance testing, the FDA will determine whether the machine is suitable for widespread use.

If you are in the market for a new EKG machine for your office, check out the large selection of FDA-approved EKG machinesEKG cables and sensors and a wide variety of other medical devices at Medical Device Depot to help enhance your practice and your patient experience.

5 Top EKG Machine Manufacturers

Researching the best machine to replace your office’s old EKG machine? Take a look at these 5 popular manufacturers and see if they have a model that would be right for your practice:

  • Bionet – This manufacturer was established in 1999. With a Bionet EKG, you get free access to EKG Plus II Software, which allows users to preview, store and transfer EKG readings. There is a typical 4-year warranty on all EKGs. The company continues to develop new products and models based on your needs, as well as findings from their research and development center.
  • Midmark – Starting as the Cummings Machine Company in 1915, the company produced concrete mixers. In 1974, the company changed its name to Midmark, and then in the ’90s it transitioned into the world of medical equipment.
  • Schiller – This manufacturer was founded in 1974 and really made a name for itself with the creation of their portable, compact EKG devices. The company plans to grow by acquiring, applying and integrating scientific findings.
  • Philips – This vast company does much more than just produce health-care equipment. Starting back in 1891, the manufacturer had not even thought of working with health-care equipment. Today they combine their unique clinical expertise with human insights. With the combination of the machines and data-management software they offer, you will be able to ensure an accurate reading with the whole bundle from Philips.
  • GE Healthcare – Another company that reaches far past health-care devices, GE has made an impact in medical imaging and information technologies, medical diagnostics, patient-monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions.

If you are ready to invest in an EKG machine from one of these top manufacturers, browse the selection available at Medical Device Depot. The experienced customer service representatives will be able to work with you to answer any questions you may have to ensure that you get the best piece of equipment for your office. No matter which manufacturer you choose, you will have peace of mind.

When is it Time for a New EKG Machine?

You want your office to provide nothing but the best care available to patients, and in order to do that you must have up-to-date equipment. Gaining the trust of your patients requires that you provide the best possible care to every person who walks through your door. While there is nothing wrong with using older equipment, you want to ensure that all of your equipment does the job it is supposed to do so you can do yours.

With an electrocardiogram (EKG) machine, it is important to verify that it is giving accurate readings of a patient’s heart activity. If your machine is not giving accurate readings, try these steps to troubleshoot:

  • Recalibrate the machine.
  • Ensure the electrodes are properly placed on the skin.
  • Unhook and reattach leads to ensure they’re securely attached.
  • If the leads are damaged, replace them.

If none of these fix steps the issue, it may be time to look for a new EKG machine. Rather than looking to repair the old one, consider all of the new features that would be available with a new machine to help better serve your patients.

If you need to replace an old EKG machine or you want to update your office before your old machine calls it quits, check out the selection of EKG machines at Medical Device Depot. Your office will be able to give accurate readings in which your patients will feel confident.

Equipment Spotlight: What is an EKG machine?

An electrocardiogram machine, which is also known as an EKG or ECG, is used to check a heart’s electrical activity. Whether the patient visits the office with unexplained chest pains, symptoms of heart disease like palpitations, dizziness and fainting, to check the effectiveness of a pacemaker, or to monitor high blood pressure, an EKG machine can quickly provide a clear picture of the patient’s heart health.

Types of EKG machines

Different types of machines are often distinguished by the number of leads, or electrical cables, that attach the electrodes to the skin. Some of these include:

  • Portable or handheld machines – Simply uses the pulse of a patient’s finger. No leads.
  • 3-lead – Shows waves on a screen.
  • 5-lead – Used for continual monitoring and shows waves on a screen.
  • 12-lead – Prints readings on a paper copy.

The machine translates the heart’s electrical activity into line tracings of spikes and dips that are easy to decipher. You may choose to use an EKG machine in a variety of ways. Depending on your practice, you may use it as part of a physical examination, during specialized tests or for continual monitoring. Because it is important that this type of information is correct so you can best treat your patients, it is vital to have a high-quality EKG machine in your office that you can depend on for accurate readings.

Certain variables may affect the test, but they do not mean you have a faulty machine. To ensure you get an accurate reading, make sure the electrodes are securely attached to the patient’s skin. Also be certain that the patient does not move around or talk during the test, and restrict exercise prior to testing. Additionally, try to provide a calm environment so the patient is not anxious during the test.

If you are unsure of the accuracy of your EKG machine, you don’t have to proper type for its particular use or yours is out of date, check out the selection of EKG machines at Medical Device Depot to update your practice.

Medical Device Depot, Inc. Donates EKG Machines to Promise for Haiti

Medical Device Depot recently donated two GE Mac 1200 EKG Machines to Promise for Haiti. These EKG machines will be used to assist daily services at the Hopital Bienfaisance de Pignon in Haiti.

Dr. Omer L. Shedd has these words to say regarding the donation:

 


I wanted to write a note of my sincerest appreciation for your kind donation of ekg machines for Promise for Haiti.  This hospital mission is truly unique in that it requires Haitians to have an active role in their health care and is not just another donation driven facility giving solely handouts.  Their mission is to teach the Haitians skills to eventually become self sustaining.

I will be going back down later this year and will try to get some pictures to you.  We look to start implanting pacemakers in early 2015 and could not have done this without your help!!!

Thank you again,
Omer L. Shedd, MD, FACC, FHRS


 

For more information on EKG Machines, visit Medical Device Depot.

Medical Device Depot is now an Authorized MedAssets Distributor

MedAssets Performance Management Solutions, Inc.
DATE: April 17, 2014
RE: Authorization of Medical Device Depot, MedAssets Medical/Surgical Distribution

Medical Device Depot is contracted as an authorized distributor with MedAssets.
Please recognize Medical Device Depot as an authorized MedAssets Distributor. Where appropriate, please send all contract information pricing to Medical Device Depot at the address below:

Medical Device Depot
3230 Bethany Lane Ste. 8
Ellicott City MD 21042
877-646-3300

Please call or email if you have any questions or need additional information.

Click here for a copy of the original letter.

http://www.medicaldevicedepot.com/

Medical Device Depot, Inc. Donates EKG Machine to Preventive Medicine Research Center

Medical Device Depot was pleased to donate an EKG machine to Preventive Medicine Research Center. This EKG machine will be used to assist in the cardiovascular and preventive health screening of non-insured minorities.

For more information about ekg machines, call 877-646-3300 or visit www.medicaldevicedepot.com.