Low Dead Space Syringe | QD Syringe

Posted on November 1, 2016. Filed under: Syringe Blog | Tags: , , , , , , , , , , |

QD Syringe Draw In - Attach QD Hub and Needle - Give Injection.jpg

The QD Syringe is the next generation of disposable syringes which are designed for greater safety and efficiency.  The patented QD Syringe with its one-piece glyflo tip is a ready to use draw syringe that reduces liabilities, hazardous waste, additional inventory and eliminates vial-caused needle dulling for sharper and less painful patient injections. The patented design of the QD Syringe includes several innovative concepts that also help make it one of the most versatile syringe products available.

The QD Hub and needle mates perfectly with the internal glyflo tip creating a low residual volume injection. The QD Syringe is compatible with existing luer lock hubs for seamless pre-slit injection receptacle injections and QD hubs are available up to 20+ needle gauge sizes.

The QD Syringe opens the door for detachable QD Nano needles for less painful injections. The QD Syringe hubs with needles are designed to be used in one single insertion action allowing our engineering team at QD Syringe Systems to create the most thin walled super sharp needles possible.

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High Dead Space Syringes with Dull Injection Needles

Posted on November 1, 2016. Filed under: Syringe Blog | Tags: , , , , , |

High Dead Space Syringes with Dull Injection Needles.jpg

Up to approx. 90 Microliters of residual volume remain in standard basic disposable syringes. This equates to massive medication waste and an encapsulated area where infectious pathogens can be encapsulated for weeks at a time.

The solution is the QD Syringe:

http://www.QDSyringe.com

http://www.QDSyringeSystems.com

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High Residual Volume Syringes with Unnecessary Draw Needles

Posted on November 1, 2016. Filed under: Syringe Blog | Tags: , , , , , , , |

High Residual Volume Syringes with Unnecessary Draw Needles.jpg

High Dead Space Syringes with dangerous draw needles. When drawing up medication into the syringe with a draw needle, residual medication is left within its chamber and ultimately thrown into the sharps container. Up to approx. 90 microliters of residual volume remains inside the lumen and hub of the basic disposable syringe. These high dead space syringes can harbor high residual infectious pathogens.

The Solution is the QD Syringe:

http://www.QDSyringe.com

http://www.QDSyringeSystems.com

http://www.Syringes.co

 

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QD Syringe | QD Syringe Systems®

Posted on October 1, 2016. Filed under: Syringe Blog | Tags: , , , , , , , , , , |

qd-syringe-systems-quick-draw-syringe-with-low-residual-volume

Low Dead Space QD Syringe with Low Residual Volume QD Hub with Needle.

 

qd-syringe-systems-low-dead-space-syringe

QD Syringe accessing BD Q-Syte and delivering low residual volume dose.

 

 qd-syringe-systems-low-dead-space-injection

QD Syringe giving low dead space intramuscular injection with QD hub and needle.

 

qd-syringe-systems-hep-lock-access

Hep Lock Accessed by low dead space QD Syringe with Integrated polycarbonate cannula.

 

qd-syringe-photo-low-dead-space-and-residual-volume-injection

QD Syringe injecting medication with low dead space, low residual volume. http://www.QDSyringe.com

 

qd-syringe-low-dead-space-injection-syringe

QD Syringe – Low Dead Space Injection Syringe – QD Syringe before patient injection with the low dead space syringe offering a virtually painless injection. – http://www.QDSyringe.com

 

qd-syringe-the-low-space-syringe

QD Syringe was designed as a low residual volume syringe with an integrated polycarbonate draw needle and an exclusive mating low dead space hub and needle. The next generation of basic disposable syringes. http://www.QDSyringeSystems.com

 

qd-syringe-suture-removal-assistance

The QD syringe can assist in removing embedded sutures by wedging beneath the sutures and the overgrown skin enabling the scalpel or scissors to cut the suture and not the patient. Note: There are suture removal kits but they are more costly than the disposable QD Syringe and a scalpel. http://www.QDSyringeSystems.com

 

qd-syringe-qd-hubs-and-needles

 

Low Dead Space QD Hubs and Sharp Steel Needles delivering virtually painless injections – http://www.QDSyringe.com

 

 

qd-syringe-qd-hubs

 

QD Syringe Systems – The low dead space QD Hubs with needles mate with the tip of the QD Syringe providing a low waste syringe.

 

qd-syringe-low-residual-volume-syringe

 

The QD Syringe is the world’s first fully functional basic plastic syringe with low dead space.

 

 

qd-syringe-low-residual-volume-syringe-with-glyflo-technology

The QD Syringe incorporates a polypropylene syringe body and a contiguously integrated polycarbonate tip with GlyFlo Technology to deliver a low residual volume injection. The worlds first truly functional basic plastic syringe. The QD Syringe eliminates all draw needles which waste medications and contribute to inadvertent needle stick injuries by medical staff and patients. http://www.QDSyringe.comhttp://www.QDSyringeSystems.com

 

 

qd-syringe-low-dead-space-injection

QD Syringe giving low dead space, low residual volume injection. The QD syringe is a patented syringe which consists of a polypropylene syringe body and a polycarbonate tip designed with GlyFlo Technology. The QD Syringe tip mates with the low dead space QD hub with attached steel needle to deliver a precisely measured medication dose. the QD Syringe delivers virtually a pain free injection.

 

qd-syringe-glyflo-technology

 

QD Syringe giving low dead space, low residual volume injection. The QD syringe is a patented syringe which consists of a polypropylene syringe body and a polycarbonate tip designed with GlyFlo Technology. The QD Syringe tip mates with the low dead space QD hub with attached steel needle to deliver a precisely measured medication dose. the QD Syringe delivers virtually a pain free injection. http://www.QDSyringeSystems.comhttp://www.QDSyringe.com

 

 

qd-syringe-glyflo-technology-accessing-bd-q-syte-split-septum-luer

The QD Syringe with GlyFlo Technology is accessing BD QSyte Split Septum Luer with low residual volume, low dead space medication delivery. http://www.QDSyringeSystems.comhttp://www.QDSyringe.com

 

qd-syringe-accessing-hep-lock

QD Syringe Accessing Halkey-Roberts Needlefree Swabable Valve and delivering a low residual volume injection.

 

 

qd-syringe-systems-quick-draw-syringe

QD Syringe Systems – The Low Dead Space Multi-Functional Syringe.

 

 

qd-syringe-accessing-bd-q-syte-split-septum-luer

QD Syringe – accessing the BD Q-Syte™ Luer Access Split Septum and leaving low residual volume in syringe ~ http://www.QDSyringeSystems.com

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The QD Syringe has been touted as the next generation of safer and more effective syringes to enter the market – the Quick Draw Syringe™. The Quick Draw Syringe or the QD Syringe is a revolutionary product that will be the world’s first fully functional basic low dead space syringe with detachable and low residual volume QD hubs with needles.

Created by Christopher Green, CEO and co-founder of QD Syringe Systems Inc., this patented eco-friendly product is unique in the fact that it is fully functional out of its package, it is safer and easier for medical professionals to use and a low dead space syringe that tremendously reduces medication waste and residual volume. Headquartered in St. Petersburg, Florida, QD Syringe Systems, Inc. CEO says the design of basic syringe hasn’t been updated in decades. Until now. Introducing the QD Syringe.

http://www.QDSyringe.com
http://www.QDSyringeSystems.com

 

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QD Syringe – The Low Dead Space Syringe

Posted on September 29, 2016. Filed under: Syringe Blog | Tags: , , , , , , , , |

qd-syringe-with-bilateral-glyflo-technology-1

The QD Syringe drastically cuts the waste of costly medications down by over 89%, leaving just a scant 18 microliters of residual volume behind. This is a massive money-saving benefit to the healthcare industry and consumers.

Christopher Green designed the Bilateral QD GlyfloTechnology™ for the QD Syringe. The uniquely patented cone-shaped tip has bilateral fluid flow channels and a bilateral orifice. This new design also greatly reduces the risks of needle sticks by medical professionals, reduces the spread of infectious diseases, and saves tremendously on medication waste with its low residual volume design and guarantees delivering a less painful injection to the patient.

The Low Dead Space Syringe – Low Residual Volume Syringe

Syringe with Integrated Cannula – Patent # 9,295,788

 

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FDA Guide On Approving Medical Devices

Posted on July 30, 2016. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , , , , , |

FDA Guidance On Approving Medical Devices

ImageNew FDA guidance on considerations used in device approval, de novo decisions

Clinical data, risks, benefits and patient risk tolerance outlined in process


The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.

Premarket approval (PMA) is the FDA process of scientific and regulatory review used to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury. The de novo process is available for low- and moderate-risk devices that have been found not substantially equivalent (NSE) to existing devices.

When evaluating PMA applications or de novo petitions, the FDA relies upon valid scientific evidence to assess safety and effectiveness. Both clinical and non-clinical data play a role in FDA’s benefit-risk determinations.

The guidance includes a worksheet for device reviewers that incorporates the principal factors that influence benefit-risk determinations, such as the type, magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability of alternative treatments, and the value the patient places on treatment.

The guidance:
  • outlines the systematic approach FDA device reviewers take when making benefit-risk determinations during the premarket review process
  • provides manufacturers a helpful tool that explains the various principal factors considered by the agency during the review of PMA applications, the regulatory pathway for high-risk medical devices, and de novo petitions, a regulatory pathway available for novel, low- to moderate-risk devices
  • describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the novelty of the device.

“This guidance clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations,“ said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health (CDRH).

The FDA will also increase the transparency of the decision-making processes by describing the worksheet analysis in the Summary of Safety and Effectiveness Data for PMAs and the decision summary review memos for de novo decisions.

“In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Shuren.

CDRH will train medical officers, review staff managers and device reviewers on the guidance to assure the guidance is applied consistently to submissions and petitions.  CDRH reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.

The FDA is also developing external training modules to help industry and device sponsors understand how CRDH will apply the guidance.

For more information:
Medical Device Guidance Documents

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Media Inquiries: Michelle Bolek, 301-796-2973, Michelle.Bolek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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What does it mean when FDA “clears” or “approves” a medical device?

Posted on June 10, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , |


When FDA review is needed prior to marketing a medical device, FDA will either:

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  1. “clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or
  2. “approve” the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.

Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.

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.

To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.

FOR PHOTOS OF 12 COMMON DEADLY MISCONNECTIONS CLICK HERE

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(Source: fda.gov)

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510k Premarket Notification Fees

Posted on June 5, 2012. Filed under: Syringe Blog | Tags: , , , , , , |

Premarket Notification 510k Review Fees

Overview

On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 signed into law. This law authorizes FDA to charge a fee for medical device Premarket Notification 510(k) reviews. This application fee applies to most 510(k)s including Traditional, Abbreviated, and Special 510(k)s, but not those exempted or waived as noted below.

Small businesses may qualify for a reduced fee. Payment must be received on or before the time the 510(k) submission is submitted. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing.

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Fees

The review fees for 510(k) submissions are below:

FY 2012 Device Review User Fees (U.S. Dollars)
Submission Standard Fee Small Business Fee
(≤$100 million in gross receipts or sales)
510(k) $4,049 $2,024
513(g) $2,971 $1,485

The applicable fee corresponds with the date of receipt of the submission by FDA. Please note that FDA will consider the 510(k) submission incomplete and will not accept it for filing until the fee is paid in full. That is, the date of receipt is the date that the submission has been received AND the fee is paid in full.

FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. The small business fee is 50% of the standard fee. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.

 Exemptions and Waivers

The following exemptions or waivers apply:

Fee Exemptions and Waivers (No Fee for These)
Category Exemption or Waiver
Third-party 510(k) Exempt from any FDA fee; however, the third-party does charge a fee for its review.
Any application for a device intended solely for pediatric use. Exempt from user fee. Please note that changing the intended use from pediatric use to adult use requires the submission of a new 510(k). The new 510(k) is subject to the 510(k) review fee at the time of submission.
Any application from a State or Federal Government entity. Exempt from any fee unless the device is to be distributed commercially.

When to Pay

Payment must be received at or before the time the 510(k) submission is submitted. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing.

 How/Where to Send Payment

Submit the information and payment in the following order
  1. If you believe you qualify as a Small Business and would like to qualify for reduced fees, submit a Small Business Qualification Certification. If you qualify, you will receive a Small Business Decision number. You must provide your Small Business Decision number on the Medical Device User Fee Cover Sheet at the time of submission to be eligible for reduced fees. FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.
  2. Complete the Medical Device User Fee Cover Sheet and send a completed copy with your payment.
  3. Submit your Premarket Notification 510(k) and include a copy of the Medical Device User Fee Cover Sheet with your submission.
  4.  Complete the Medical Device User Fee Cover Sheet
 

You should complete the Medical Device User Fee Cover Sheet (Form FDA-3601). The Medical Device User Fee Cover Sheet and instructions are available online.

You will need to register to create a Medical Device User Fee Cover Sheet. Please note that the User Fee Cover Sheet website was enhanced on March 1, 2005. Even if you have registered in the User Fee Cover Sheet system previously to March 1, 2005, you will need to follow the instructions as a “New User.”

You will need one of the following pieces of information to complete the registration process.

Organization #: 123456
Dun and Bradstreet Number (DUNS) # 123456789
Employer Identification Number (EIN) #  123456789

Additionally, you will need to identify a Principal Point of Contact (PPOC) in your organization who will be responsible for validating users for security purposes.

After you have registered and have created a user name and password, you will receive a confirmation email. You may then access the cover sheet creation page. A unique user fee Payment Identification Number will be generated on your cover sheet upon completion. You will need three copies of your completed User Fee Cover Sheet: one copy for your payment, one copy for your 510(k) submission, and one copy for your records.

Frequently Asked Questions addresses common questions regarding the Medical Device User Fee Cover Sheet.

Submit Your Payment

Send a printed copy of your User Fee Cover Sheet with your payment. Be sure to include the Payment Identification Number (beginning with MD) and the FDA P.O. Box on your check, bank draft, or U.S. Postal Money Order. The review fee may be submitted by mail, courier, or wire transfer.

Send your payment to:

By Mail:
Food and Drug Administration
P.O. Box 956733
St. Louis, MO 63195-6733By Courier: If the check is sent by a courier, the courier may deliver the checks to:
US Bank
Attn: Government Lockbox 956733
1005 Convention Plaza
St. Louis, MO 63101
(Note: This address is for courier delivery only. Contact the US Bank at (314) 418-4821 if you have any questions concerning courier delivery.)

By Wire Transfer:

“As of 1/31/10 US Bank will no longer accept Wire Transfers”
Wire transfers are now processed through the Federal Reserve Bank of New York. You will need the following information to remit a payment:

FDA Deposit Account Number: 75060099
US Department of Treasury Routing/Transit Number or ABA: 021030004
Address:
Federal Reserve Bank of New York
TREAS NYC
33 Liberty Street
New York, NY 10045
Tel (212) 720-5000
Also include your User Fee Payment Identification Number from your Medical Device User Fee Cover sheet when you send payment by wire transfer.Note: Your bank or financial institution may assess a fee for sending a wire transfer.
If needed for accounting purposes, FDA’s tax identification number is 53-0196965.
Fees should arrive at the bank at least 1 day before the application arrives at FDA. FDA recommends that you send the payment to the bank 4-5 business days before the application arrives at FDA so there is no delay in starting the review of your application. FDA records as the submission receipt date the latter of the following:1. The date the submission was received by FDA; or
2. The date Bank notifies FDA that payment has been received.
Bank is required to notify FDA within 1-working day, using the Payment Identification Number.

 Qualification for Small Business Fees

In FY2012 (October 1, 2011 through September 30, 2012), firms with annual gross sales and revenues with $100 million or less, including gross sales and revenues of all affiliates, partners, and parent firms, may qualify for lower rates for Premarket Notification 510(k) submissions.

An affiliate is defined by §737(8) of the FD&C Act: An affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly,

  1. one business entity controls, or has the power to control, the other business entity; or
  2. a third party controls, or has power to control, both of the business entities.

 

To qualify, you must submit the MDUFMA Small Business Qualification Certification (Form FDA 3602). In addition, certified copies of your firm’s Federal Income Tax Return for the most recent taxable year, including certified copies of the income tax returns of all affiliates, partners, and parent firms must be provided.

The following guidance and form should be used.

FY2012 MDUFMA Small Business Qualification Worksheet and Certification

The Certification should be sent to:

MDUFMA Small Business Qualification
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
10903 New Hampshire Avenue, WO66-4613
Silver Spring, MD 20993

FDA will review the Certification within 60 days and send its decision that the firm is, or is not, a small business eligible for reduced or waived fees. If your firm qualifies as a small business, the decision letter will include a Small Business Decision number. The Small Business Decision number is used on the Medical Device User Fee Cover Sheet (Form FDA 3601) to demonstrate that your firm is entitled to a reduced fee. If you submit a reduced fee to FDA without a Small Business Decision number, the submission will not be accepted for filing.

The small business status expires at the end of each fiscal year (September 30th). A new MDUFMA Small Business Qualification Certification must be submitted each year to qualify as a small business.

Questions concerning Small Business Qualification should be directed to Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at 301-796-7100 (800-638-2041).

_____________________

(Source: www.FDA.gov)
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How Human Factors Lead to Medical Device Adverse Events

Posted on June 1, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , |

Medical Device Adverse Events

By Suzanne Rich, RN, CT, MA                                                                                                                                              FOLLOW US ON TWITTER
ADVERSE EVENTS involving medical devices or equipment can lead to serious problems, including incorrect or delayed diagnosis and treatment or patient injuries. When errors involving medical devices recur repeatedly, people typically blame the users instead of the real culprit, which is often a poorly designed interface between the medical device and the user. Human factors is the science that focuses on understanding and supporting how people interact with technology.
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In health care, the objective of human factors is to improve human performance with medical products, including medical devices, and to reduce the likelihood of error or injury, thus improving patient and workplace safety.1 In this article, I’ll discuss some common problems and steps you can take to prevent them.

Design considerations

The complexity and diversity of medical devices used simultaneously contribute to human factors errors. A key objective of human factors in medical device design is to enhance the likelihood of good performance under less-than-ideal conditions. To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the design of the device’s user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device.
Good design should include:
  • operation that’s intuitive and doesn’t require frequent reference to an instruction manual
  • easy-to-read displays
  • easy-to-use controls
  • appropriate connections of device-to-device and device-to-outlet for safe use
  • effective alarms
  • easy repair and maintenance.2
Consider three major areas when evaluating medical-device-related adverse events from a human factors perspective:
  1. user characteristics, including the person’s abilities and training and her expectations of the device
  2. device design considerations, which focus on the device-user interface, including
    instructions for use
  3. the environment in which the device
    is used, including the lighting, noise,
    distractions, and time constraints.1 , 2
Let’s examine these elements in more detail, starting with the device user. For examples of errors in each major area, see Troubling human factors problems.

Training and expectations

Make sure everyone using a device has received training on it. Then consider a less obvious factor, the user’s expectations of how the device works. Whether a user is a health care professional or a patient, she may expect a device to work like another device that looks similar. For example, based on her experience, she may expect a device to deliver the same prescribed treatment or dose as a similar device, or expect the alarms to be in a specific sequence or pattern of sounds. Many reported I.V. fluid pump programming errors resulted when the actual device function wasn’t what the user expected.3

Looking at design

A user’s ability to interpret or understand device communication is often impaired by incomplete, confusing, or misleading labeling and instructions for use. Ambiguity about the sequence of steps required for device setup and operation can also be a factor.
Sometimes the instructions for use aren’t easily accessible, which prompts users to operate devices based on previous experience instead of on the requirements found in the labeling. An example of this problem is when the text or numeric font is difficult to find in the device’s display panel.
When similar devices are made by different manufacturers, the vocabulary in text displays may be inconsistent. For example, adverse events have involved devices that used different units of measure, such as cubic centimeters instead of milliliters. When devices display unfamiliar text abbreviations or words, this may further compound difficult or confusing navigation through menus to set up the device, leading to errors.
Make sure that when your facility chooses devices, it takes into account the following visual, auditory, and tactile features of the interface between user and device.

Visual considerations:

 

  • The user can see the device displays, labels, or markings.
  • Display screens are easy to see, have clear contrast, and are bright enough to be seen without glare.
  • The font is large enough to be read by all users.

Auditory considerations:

 

  • The user can easily hear and interpret alarms.
  • The sequence of sounds is appropriate in volume, frequency, tone, and pitch.
  • The alarm’s timing clearly defines the acuity of the warning and gives the user enough time to make adjustments and corrections.

Tactile considerations:

 

  • The device’s components can be connected easily.
  • The device’s components can’t be easily disconnected or connected by mistake. (Problems have been reported with some electrodes, cables, and I.V. tubing.)
  • The device’s components can be connected so that the user feels a “click” to help ensure a proper connection.
  • The user can feel the controls of knobs, buttons, switches, and keypads.
Instructions for maintaining and cleaning the device should be clear and include what compounds can and can’t be used. Some devices, such as electronic medical devices, shouldn’t be cleaned with fluids, which can leak into the device housing and cause performance problems and even fires. Some cleaning agents may degrade or otherwise affect a device’s plastic casings, impairing performance.

Consider the environment

Both user and device performance can be influenced by physical characteristics of the environment, such as adequate lighting, clear and unobstructed views of devices (especially those used for monitoring), and controls for temperature and humidity.
These workplace constraints can contribute to medical device errors or
adverse events:
  • staff with heavy workloads, such as multiple high-acuity patients
  • staff working double shifts
  • float and temporary staff who may be unfamiliar with the unit’s equipment
  • different brands or models of the same type of equipment within the same facility.
Some organizations have moved to using a single brand or model throughout their facilities.

Reporting problems

If an error or an adverse event occurs despite your best efforts, take action. Medical-device-related adverse events involving death or serious injury must be reported. Reporting near misses or events that could cause patient harm can help identify system improvements that can prevent similar adverse events in the future. Follow your facility’s policies and procedures. You can report events to MedWatch.  See the nearby link to MedWatch.
Addressing human factors in both the design and clinical use of medical devices mitigates risk, improves patient safety, and improves workplace safety.

 TROUBLING HUMAN FACTORS PROBLEMS

Adverse events reported to the Food and Drug Administration involving human factors errors range from the simple to the complex. Here are examples of errors in each major area involving human factors:4
User expectations. One error involved an otoscope and transilluminator that look similar but have different light intensities. During an urgent intervention, the health care provider picked up an otoscope, thinking it was a transilluminator. When he tried to use it to locate a child’s vein for an I.V. catheter insertion, the patient experienced a second-degree burn.
 
Device design. Another error concerned noninvasive blood pressure (BP) tubing that was mistakenly connected to I.V. tubing. The patient, who was being monitored in the ED with a noninvasive automatic BP device, also had an I.V. catheter. The BP cuff tubing was disconnected when the patient went to the bathroom, and it was reconnected upon his return. The patient’s wife found the patient “blue from the neck up.” Despite resuscitation efforts, he died. The BP cuff tubing had been connected to the I.V. catheter and had delivered about 15 mL of air. An autopsy confirmed a fatal air embolus.5
Environment. A safety issue was reported when newly purchased ventilators were placed into service in a trauma ICU. Staff immediately noted that the ventilators had an alarm that wasn’t audible when the patient-room door was closed. Although the devices weren’t defective, they weren’t suited to the environment where they were being used.

REFERENCES
1. FDA’s Human Factors Program: Promoting safety in medical device use. http://www.fda.gov/cdrh/humanfactors/index.html. Accessed March
27, 2008.
2. Sawyer D. Do it by design: An introduction to human factors. http://www.fda.gov/cdrh/humfac/doit.html. Accessed March 27, 2008.
3. Rich S. Medical devices and patient safety: The role of human factors. Association for Vascular Access Pre-Conference, Indianapolis, Ind., September 8, 2006.
4. Food and Drug Administration. Manufacturer and User Facility Device Experience (MAUDE). http://www.fda.gov/cdrh/maude.html. Accessed March 27, 2008.
5. Eakle M, et al. Luer-lock misconnects can be deadly. Nursing2005. 35(9):73, September 2005.

Suzanne Rich is a senior project manager of the patient safety staff at the Office of Surveillance and Biometrics, Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md. (Article reprinted from June Nursing2008, Volume 38, Number 6, Pages 62-63)

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Source ~ www.FDA.org
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Medical Device Fellowship Program

Posted on May 27, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , , , , , , , , , |

Medical Device Fellowship Program

(EEP, OCD, CDRH) 

Introduction

 

The Center for Devices and Radiological Health (CDRH) Medical Device Fellowship Program (MDFP) provides opportunities for health professionals to participate in the FDA regulatory process for medical devices. MDFP is part of External Expertise and Partnerships (EEP) in the Office of the Center Director (OCD) in CDRH.  In addition to MDFP, other components of EEP include Technology Transfer and Partnerships, and the Critical Path Initiative.

CDRH regulates a wide array of medical devices and is involved with the latest medical device cutting-edge technology areas such as genomics, proteomics, diagnostics for personalized medicine, percutaneous heart valves, artificial hearts, tissue engineered wound dressing with cells, and bone void fillers with growth factors, and many others.

To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely consults with experts in the academic community, other government entities, clinical practice, and the military. By filling gaps in expertise for a finite period of time, EEP enhances the efficiency and effectiveness of CDRH operations. EEP is the focal point of all CDRH fellowships and interorganizational partnerships. EEP also fosters scientific innovation by helping offices form partnerships with academia, private sector organizations, and government agencies.

CDRH established MDFP to increase the range and depth of collaborations between CDRH and the outside scientific community. The MDFP offers short and long-term fellowship opportunities for individuals interested in learning about the regulatory process and sharing their knowledge and experience with medical devices from the relatively simple to the highly complex.

Physicians with clinical or surgical expertise, engineers in biomedical, mechanical, electrical and software areas, and individuals from many other scientific disciplines have participated in the fellowship program. Opportunities are available for students in many areas as well.

Career Development

Learn about the FDA approval process for medical devices:

  • medical device design
  • clinical trial design and data
  • safety and efficacy evaluation
  • materials, performance, bioeffects and standards
  • adverse events

  

Public Service

  • Join CDRH’s mission to protect the public health by ensuring that medical devices are safe and effective
  • Share your expertise on complex device issues
  • Make a difference in the lives of patients and consumers

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