Syringe Blog

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.

www.QDSyringe.com

www.QDSyringeSystems.com

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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

http://www.Syringes.co

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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

 

 

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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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The ULTIMATE Sharps Safety Manual

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

The Ultimate Guide To Sharps Safety

Healthcare Wide Hazards
Needlestick/Sharps Injuries


Needlesticks and other sharps-related injuries which expose workers to bloodborne pathogens continue to be a significant hazard for hospital employees. OSHA estimates that 5.6 million workers in the healthcare industry and related occupations are at risk of occupational exposure to bloodborne pathogens. Bloodborne pathogens are pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include Human Immunodeficiency Virus (HIV), Hepatitis B Virus(HBV), Hepatitis C Virus (HCV), and others.

Any worker handling sharp devices or equipment such as scalpels, sutures, hypodermic needles, blood collection devices, or phlebotomy devices is at risk. Nursing staff are most frequently injured. Exposure Prevention Information Network (EPINET) data shows that needlestick injuries occur most frequently in the operating room and in patient rooms.
Syringe with a Retractable Needle.

Common safety and health topics:

Syringe with a Retractable Needle - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.

  • Bloodborne Pathogens
  • Needlestick/Sharps Injuries
  • Other Sharps Injury
  • Safer Needle Devices

Bloodborne Pathogens


Definitions for bloodborne pathogens, other potentially infectious materials (OPIM), and occupational exposure are found in the Bloodborne Pathogens Standard, Definitions 29 CFR 1910.1030(b).Potential HazardExposure to blood and OPIM from contaminated sharps injuries.

Possible Solutions

Follow the requirements of the Bloodborne Pathogens Standard and implement engineering and work practice controls to minimize exposure to blood and bloodborne pathogens.

  • Engineering and Work Practice Controls must be the primary means used to eliminate or minimize exposure to bloodborne pathogens. Where engineering controls will reduce employee exposure either by removing, eliminating, or isolating the hazard, they must be used, and documented in the Exposure Control Plan (ECP). [29 CFR 1910.1030(c)(1)(iv), 29 CFR 1910.1030(c)(1)(iv)(B), 29 CFR 1910.1030(d)(2)(i), OSHA Directive CPL 02-02-069[CPL 2-2.69].
    • Engineering Controls are measures (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace [29 CFR 1910.1030(b)].
      • NOTE: The exposure control plan must document consideration and implementation of appropriate commercially available and effective engineering controls designed to eliminate or minimize exposure [OSHA Directive OSHA Directive CPL 02-02-069 [CPL 2-2.69]], and revised Standard Exposure Control Plan [29 CFR 1910.1030(c)(1)(iv)(B)].
    • Work Practice Controls are measures that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique).
  • The revised Bloodborne Pathogens and NeedleStick Prevention Standard requirements (effective date April 18, 2001) include:
    • The review and update of the Exposure Control Plan must reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens and document annually consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure [29 CFR 1910.1030(c)(1)(iv)(A), 29 CFR 1910.1030(c)(1)(iv)(B)].
      • Employers must get input in the identification, evaluation and selection of engineering and work practice controls from employees responsible for direct patient care in [29 CFR 1910.1030(c)(1)(v)]. This input must be documented.
    • Employers must maintain a log of injuries from contaminated sharps 29 CFR 1910.1030(h)(5)(i).
  • The Recordkeeping Standard 29 CFR 1904.8 also requires needlestick injuries to be recorded on the OSHA 300 Log. This includes all work related needlestick injuries and cuts from sharp objects that are contaminated with another person’s blood or other potentially infectious materials (OPIM).
    • If this recorded employee injury is later diagnosed with an infectious bloodborne disease the OSHA 300 log must be updated.
Other Bloodborne Pathogens Standard requirements include:
  • Compliance with Universal Precautions (an infection control principle that treats all human blood and other potentially infectious materials (OPIM) as infectious) [29 CFR 1910.1030(d)(1)].
  • Personal Protective Equipment (PPE). Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, PPE shall also be used [29 CFR 1910.1030(d)(2)(i)].
  • Worker training in appropriate engineering controls and work practices, to eliminate or minimize worker exposure. [29 CFR 1910.1030(g)(2)].
  • Proper handling and containerization of sharps.
  • Hepatitis B vaccine and vaccination series made available to all employees with occupational exposure.
  • Post-exposure evaluation and follow-up, including post-exposure prophylaxis when appropriate [29 CFR 1910.1030(f)(3)].
books For additional information, see Healthcare Wide Hazards – Bloodborne Pathogens.
Needlestick/Sharps Injuries

According to the Centers for Disease Control and Prevention (CDC), about 385,000 sharps injuries occur annually to hospital employees.

Potential Hazard

Exposure to blood and other potentially infectious materials (OPIM) because of:

  • Unsafe needle devices.
  • Improper handling and disposal of needles and other sharps.

Possible Solutions

  • Use safer needle devices and needleless devices to decrease needlestick or other sharps exposures. See Safer Needle Devices.
  • Properly handle and dispose of needles and other sharps according to the Bloodborne Pathogens Standard.
    • Handling Needles/Sharps:
      • Do not bend, recap, or remove contaminated needles and other sharps unless such an act is required by a specific procedure or has no feasible alternative [29 CFR 1910.1030(d)(2)(vii)].
      • Do not shear or break contaminated sharps. (OSHA defines contaminated as the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface) [29 CFR 1910.1030(d)(2)(vii)].
    • Containerization:

Needle Container

Additional Information:

  • Exposure Prevention Information Network (EPINET). International Healthcare Worker Safety Center, U.Va. Health System. Conducts epidemiological research on needlesticks and blood exposures, advocates for a safer health care workplace and provides resources:
    • Fact Sheet: Percutaneous Injuries From Suture Needles [83 KB PDF, 1 page]. (2006, June). Identifies suture needles are the main source of needlesticks to OR personnel, causing 51% of all sharps injuries in surgical settings.
    • Checklist for Sharps Injury Prevention [23 KB PDF, 2 pages].
Other Sharps Injury

“Contaminated Sharps” means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires [29 CFR 1910.1030(b)].
Potential HazardExposure to blood and other potentially infectious materials (OPIM), from contaminated sharps for example:
  • Used Disposable Razors that could be contaminated with blood.
  • I.V. Connector Systems that use needles to connect I.V. setups.
Possible SolutionsFollow the requirements of the Bloodborne Pathogens Standard 1910.1030 and implement engineering and work practice controls to help prevent needlesticks or other sharps exposures.
  • Used Disposable Razors should be considered contaminated waste and disposed of properly in appropriate sharps containers.
  • I.V. connector systems: Use needleless connector systems with I.V. setups to minimize occupational exposure to needles and bloodborne pathogens. Avoid using needles where safe and effective alternatives are available.
Needleless I.V. Connector - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
(Figure 1) Needleless I.V. Connector.The FDA urges using needleless systems, or recessed needle systems to reduce the risk of needlestick injuries.These connectors use devices other than needles to connect one I.V. to another. This example shows the plunger-type s.

Safer Needle Devices


Most needlestick injuries result from unsafe needle devices rather than carelessness by healthcare workers (JSHQ, 1998, Summer).Safer needle devices have built-in safety control devices, such as those that use a self-sheathing needle, to help prevent injuries before, during, and after use through safer design features.The Centers for Disease Control and Prevention (CDC) estimated in March of 2000 that 62 to 88 percent of sharps injuries in the hospital setting could be preventing by using safer medical devices.

Potential Hazard

According to the Bloodborne Pathogens Standard, employers with the help of employees, must select safer needle devices to use in work environments.

  • There are different types of safety features that are available for safer needle devices such as:
    • Needleless devices
    • Passive safety features:remain in effect before, during and after use.
      • Integrated safety design: have a safety feature that is built in as an integral part of the device and cannot be removed. This design feature is usually preferred.
    • Active devices:require the worker to activate the safety mechanism.
      • Accessory safety devices: have safety features that are external to the device and must be carried to, or be temporarily or permanently fixed to, the point of use. This design is dependent on employee compliance and according to some researchers, is less desirable.
  • Desirable Characteristics of Safety Devices include:
    • The device is needleless.
    • The safety feature is an integral part of the device.
    • The device is easy to use and practical.
    • The device performs reliably.
    • The safety feature cannot be deactivated and remains protective through disposal.
    • The devices work effectively and reliably, and are acceptable to the healthcare worker, and do not adversely affect patient care.
    • The Food and Drug Administration (FDA) is responsible for clearing medical devices for marketing in the US. It recommends safer needle devices with a fixed safety feature that:
      • Provides a barrier between the hands and the needle after use; the safety feature should allow or require the worker’s hands to remain behind the needle at all times.
      • Is an integral part of the device and not an accessory.
      • Is in effect before disassembly and remains in effect after disposal to protect users and trash handlers, and for environmental safety.
      • Is as simple as possible, and requires little or no training to use effectively.
  • Examples of Safety Device Designs

There are many types of safety devices. Some examples of safety device designs include:

  • Needleless Connector Systems: Needleless connectors for IV delivery systems (e.g., blunt cannula for use with pre-pierced ports and valved connectors that accept tapered or luer ends of IV tubing) (Figure 1).
  • Self-Sheathing Safety Feature:Sliding needle shields attached to disposable syringes and vacuum tube holders (Figures 2A and 2B).
    • Disposable scalpels with safety features such as a sliding blade shield (Figure 6).
  • Retractable Technology:Needles or sharps that retract into a syringe, vacuum tube holder, or back into the device.
    • Syringe with a retractable needle (Figure 3).
    • Retractable finger/heel-stick lancets (Figure 8).
  • Self Blunting Technology: Self-blunting phlebotomy and winged-steel “butterfly” needles (a blunt cannula seated inside the phlebotomy needle is advanced beyond the needle tip before the needle is withdrawn from the vein (Figure 4), (Figure 5).
  • Hinged Safety Feature: Hinged or sliding shields attached to phlebotomy needles, winged steel needles, and blood gas needles (Figure 7).

Example Devices with Safety Features
Self Re-sheathing Needles. Before Use.
(Figure 2A) Self Re-sheathing Needles. Before Use.

Self Re-sheathing Needles. After Use.
**(Figure 2B) Self Re-sheathing Needles. After Use.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only. Self Re-sheathing Needles
As seen in this animation, initially the sleeve is located over the barrel of the syringe with the needle exposed for use.

  • After the device is used, the user slides the sleeve forward over the needle where it locks in place and provides a guard around the used needle.

Syringe with Retractable Needles - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 3) Syringe with Retractable Needles. The used needle retracts into the barrel of the syringe.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only.
Syringe with Retractable Needles
As seen in this animation, after the needle is used, an extra push on the plunger retracts the needle into the syringe, removing the hazard of needle exposure.

Blunt-Tipped Blood Drawing Needles - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 4) Blunt-Tipped Blood Drawing Needles. Blood collection tube and blood drawing syringe.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only. Blunt-Tipped Blood Drawing Needles
As seen in this animation, after blood is drawn, a push on the collection tube moves the blunt tip needle forward through the needle and past the sharp needle point.

The blunt point tip of this needle can be activated before it is removed from the vein or artery.
Winged Steel Needles - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 5) Winged Steel Needles. Blunt-tipped winged steel needle.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only. Winged Steel Needles
As seen in this animation, after placement, the third wing is rotated to flat position which blunts the needle point before it is removed from the patient.
Re-sheathing Disposable Scapel - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 6) Re-sheathing Disposable Scalpels. Re-sheathing scalpel.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only. Re-sheathing Disposable Scalpels
As seen in this animation, single-use disposable scalpels have a shield that is advanced forward over the blade after use, containing and removing the hazard.
"Add on" Safety Feature - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 7) “Add on” Safety Feature.
“Add on” sliding shield.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only. “Add on” Safety Feature
As seen in this animation, hinged or sliding shields attached to phlebotomy needles, winged steel needles, and blood gas needles, act as an “add on” safety feature.
Retracting Finger Prick Lancets - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 8) Retracting Finger Prick Lancets.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only. Retracting Finger Prick Lancets
As seen in this animation, this single use lancet retracts automatically after use, containing and removing the hazard.

(These drawings are presented for educational purposes and do not imply endorsement of a particular product).

According to NIOSH’s Preventing Needlestick Injuries in Health Care Settings the process for selecting and evaluating needle devices with safety features includes:

  • Form a multidisciplinary team that includes workers to (1) develop, implement, and evaluate a plan to reduce needlestick injuries in the institution, and (2) evaluate needle devices with safety features.
  • Identify priorities based on assessments of how needlestick injuries are occurring, patterns of device use in the institution, and local and national data on injury and disease transmission trends. Give the highest priority to needle devices with safety features that will have the greatest impact on preventing occupational infection (e.g., hollow-bore needles used in veins and arteries).
  • When selecting a safer device, identify its intended scope of use in the healthcare facility and any special technique or design factors that will influence its safety, efficiency, and user acceptability. Seek published, Internet, or other sources of data on the safety and overall performance of the device.
  • Conduct a product evaluation, making sure that the participants represent the scope of eventual product users. The following steps will contribute to a successful product evaluation:
    • Train healthcare workers in the correct use of the new device.
    • Establish clear criteria and measures to evaluate the device with regard to both healthcare worker safety and patient care. (Safety feature evaluation forms are available from the references cited earlier.)
    • Conduct onsite follow-up to obtain informal feedback, identify problems, and provide additional guidance.
  • Monitor the use of a new device after it is implemented to determine the need for additional training, solicit informal feedback on healthcare worker experience with the device (e.g., using a suggestion box), and identify possible adverse effects of the device on patient care.

OSHA Directive CPL 02-02-069 [CPL 2-2.69] provides suggested non-mandatory forms to help employers evaluate engineering controls such as safety syringes, I.V. access devices, and sharps containers.

  • The appendix includes the sample evaluation form [18 KB PDF*, 1 page] developed by the Emergency Care Research Institute (ECRI). [Appendix B, OSHA Directive CPL 02-02-069 [CPL 2-2.69].

Additional Information:

  • Bloodborne Pathogens and Needlestick Prevention. OSHA Safety and Health Topics Page.
  • Preventing Needlestick Injuries in Health Care Settings. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2000-108, (1999, November).
  • What Every Worker Should Know—How to Protect Yourself From Needlestick Injuries. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2000-135, (2000, August 11).

~ Article by www.osha.gov

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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.

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(Source: fda.gov)

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Is A New 510k Required For A Modification To Your Medical Device?

Posted on June 6, 2012. Filed under: Syringe Blog | Tags: , , |

Is a new 510k required for a modification to the device? 

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As described in 21 CFR 807.81(a)(3), a new complete 510(k) application is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication.
When a 510(k) holder decides to modify an existing device, the holder must decide whether the proposed device modification(s) requires submission of a 510(k). It is not FDA’s intent that a 510(k) must be submitted for every modification. However, all changes in indications for use require the submission of a 510(k). A change in indication for use includes prescription use to over the counter use. Deciding When to Submit a 510(k) for a Change to an Existing Device provides guidance to 510(k) holders on deciding when to submit a 510(k) for a change to an existing device.
Examples of modifications that may require a 510(k) submission include, but are not limited to, the following:
  • Sterilization method
  • Structural material
  • Manufacturing method
  • Operating parameters or conditions for use
  • Patient or user safety features
  • Sterile barrier packaging material
  • Stability or expiration claims
  • Design
FDA believes that the 510(k) holder is best qualified to determine when modifications to their device could significantly affect safety or effectiveness. Therefore, every modification to the device should be reviewed by appropriate personnel to determine if it affects safety or efficacy. Any design or labeling change to a device should be evaluated and documented in accordance with the 21 CFR 820, Quality System regulation. If it is determined that the modification is not significant, the basis for this decision should be documented with supporting data in the 510(k) holder’s device master file. If it is determined that the modification is significant, a new 510(k) must be submitted to FDA.
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There are no provisions for a 510(k) amendment or supplement to the existing 510(k). A new 510(k) must be submitted. However, FDA developed a streamlined 510(k) process for modifications to a device cleared under 510(k), called the Special 510(k).

Source ~ www.FDA.org
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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).

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(Source: www.FDA.gov)
________________

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