Experts Speak Out

“Knowing Needle Position Is Essential to Safety”

By CATHIE GOSNELL – RN, MS, MBA
Safety Expert, Premier, Inc.

Needlestick injuries can occur at any time during the use or disposal of a needle or sharp device. While many injuries occur after device use and during disposal, up to 40 percent of injuries occur during use. During use injuries can be some of the most difficult to prevent. Most needlestick safety devices are designed to protect the sharp either before or after use; however a needle while in use is necessarily unprotected.

Needlestick safety devices or engineering controls; therefore, offer little protection against injuries that occur during a procedure. Work practice controls have been the primary method to reduce during procedure needlestick injuries. Such methods include:

• Implementing non-invasive techniques that do not require needles whenever possible
• Thorough training to develop practitioner confidence in the use of needles and other sharp devices Limiting interruptions during procedures
• Explaining the procedure to patients to gain their cooperation and avoid potential movement during the procedure
• Asking for assistance with patients that might be uncooperative, such as children

Strategies such as these remain the only method to prevent during the procedure injuries for most procedures. However, the recent availability of phlebotomy devices that include vein entry indication (VEI) technology could provide a reduction in needlestick injuries during blood drawing procedures.

…as a practitioner I am definitely more comfortable and confident using a product with VEI than one without.

—Cathie Gosnell

Most phlebotomy devices currently on the market consist of a blood collection needle, a tube holder and a vacuum tube. With the exception of the butterfly, the blood collection needle is a stainless steel, hollow bore needle that does not allow flashback of blood to be seen upon entering the vein until it is seen filling the vacuum tube that is attached once the vein has been entered. Addition of the tube results in a vacuum developing that begins extracting the blood from the vein; however, in the absence of vein entry indication (VEI) this occurs without the practitioner knowing for sure that they are actually in a vein. Newer devices that allow flashback to be viewed will allow the practitioner to determine that they are indeed in a vein before the vacuum tube is added.

IV catheters use a clear hub on the distal end of a stainless steel needle so the flashback of blood can be viewed and the practitioner can be confident they have entered a vein before hooking up IV fluids. Butterfly needles whether used for IVs or for blood collection, include a short length of clear tubing at the distal end of the needle that allows the practitioner to see the flashback of blood when the vein is entered. Why is it that we have accepted the inability to view this flashback when using blood collection needles to perform phlebotomy procedures?

As a pediatric nurse for more than 25 years, I have had many opportunities to perform venipuncture on patients with difficult to find and access veins. Some venipunctures were to start IVs, while others were for blood collection. When performing venipuncture procedures exclusively for the purpose of collecting blood, I routinely chose to perform the procedure using a butterfly. The ability to see the flashback of blood made me more comfortable and confident in performing the procedure, as I was certain that I was actually in a vein. VEI reduces the need for multiple sticks and unnecessary probing and manipulation to find a vein. Less attempts and less manipulation should also reduce the frequency of needlestick injury. Research is required to be certain of its impact on needlestick injury; however, as a practitioner I am definitely more comfortable and confident using a product with VEI than one without.

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Defining Passive in Safety-Engineered Medical Devices: A National Overview

By AMBER HOGAN MITCHELL – MPH, DrPH
Senior industrial hygienist at the U.S. Department of Labor OSHA
(specializing in national regulatory enforcement issues)
OSHA National Bloodborne Pathogens Coordinator.

Copyright 2009 by Virgo Publishing.
infectioncontroltoday.com

Occupational exposure to sharps contaminated with bloodborne pathogens continues to be an occupational health and safety concern among workers providing patient care. Sharps injuries have been substantially reduced in acute-care settings through increased awareness, thorough training, and technological advancement of safety engineered needles on syringes, blood collection devices, IV insertion sets and lancets. Within these families of devices, there have been multiple generations of safety designs that require the user to actively slide a sheath, flip a clip, advance a plunger, or add an extra aggressive push. Today, there are very few safety-engineered medical devices that require no active step to make a device safer during use, after use and prior to disposal. This brief report is an analysis of current national guidance for passivity in safety engineered medical devices.

FEDERAL COMPLIANCE AND GUIDANCE

Since the promulgation of the Occupational Safety and Health Administration (OSHA)’s Bloodborne Pathogens Standard requiring the use of safety-engineered medical devices there have been enforcement and guidance documents from federal agencies including OSHA, the Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH); as well as national, state, academic and private entities, including Training for Development of Innovative Control Technology Project (TDICT), University of Virginia International Healthcare Worker Safety Center, Massachusetts Department of Public Health, Premier Safety Institute and others. Device manufacturers, themselves, have published great pieces of information, forged ahead leaps and bounds on safer engineering design, and offered thousands of hours of training and assistance.

The Food and Drug Administration (FDA)’s Supplementary Guidance for Premarket Notification 510 (k) for Medical Devices with Sharps Injury Prevention Features identifies safety features as features that provide barrier between hands and needle after use on patient; is integral part of the device and not an accessory; remains in effect after use and during disposal; and is as simple as possible, requiring little or no training to use effectively.¹

In the Bloodborne Pathogens Standard, OSHA requires the use of engineering controls where their use will reduce employee exposure to a contaminated sharp either by removing, eliminating, or isolating the hazard. In the OSHA Compliance Directive, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, it lists the specific design features that are recommended by the FDA and listed in a paragraph above, though within them there is no definition of “passive.”²

The TDICT Safety Feature Evaluation Sheets provide a useful tool for patient care employers and providers to evaluate sharps with engineered sharps injury protections (SESIPs) across major device categories; such as safety syringes, blood collection devices, IV catheters, etc.³ While these evaluation forms are quite comprehensive and very highly esteemed in OSHA circles, they do not currently define passivity.

No one safety device design is appropriate for all clinical procedures requiring needles or sharps.

The CDC and NIOSH have perhaps been the most proactive in attempting to define passivity in SESIPs. In the CDC’s Sharps Injury Prevention Workbook: Devices with Engineered Sharps Injury Prevention Features, it states that the “majority of safety features integrated into devices are active, i.e., they require some action on the part of the user to ensure that the needle or sharp is isolated after use.”⁴ Activation of the safety feature is typically done after use, meaning there is a risk window that opens after the needle is withdrawn from the patient and before the safety feature is activated, if in fact, it is activated at all prior to disposal. Safety devices pre-activated before clinical use that provide automatic or passive sharp encasement during the clinical risk window may be more effective. In the case of hollow-bore needles a device that protects during intermediary clinical steps, such as procedural interruptions due to patient instability may reduce risks. The CDC states, “A passive safety feature is one that requires no action by the user,” though they give a meager, low-risk infusion system example.

CDC and NIOSH both make vital points; because passive devices may be “intuitively more desirable, this does not mean that a safety feature that requires activation is poorly designed or not desirable. In certain situations it is not (currently) practical or feasible for the device of for the procedure to have a passive control.” In fact, OSHA requires that SESIPs be selected by employers, based on employee feedback, specifically for each procedure taking into account user safety, patient safety, and safety of the clinical procedure. No one safety device design is appropriate for all clinical procedures requiring needles or sharps.

SUGGESTIONS

There is an obvious and vast chasm extended among and across healthcare safety and health professionals, federal regulators, federal and state public health officers, device manufacturers and patient-care providers with regard to defining passivity. Each organization and the professionals within those organizations have done a grounded job over time defining and identifying the features needed in SESIPs and far above all else, they have each made a positive impact in reducing sharps injuries among those who care for patients. Since technology is moving ahead, it is important to begin defining the next generations of safety devices to the next generations of safety professionals and engineers.

National consensus for a “passive” definition needs to be created so that manufacturers have guidelines for which they can manufacture and label upcoming generations of passive devices. Consensus building will not be as arduous as it is typically in clinical settings; defining healthcare-associated infections (HAIs), clinical protocols for myocardial infarctions, safety specifications for pacemakers, etc. In this case, consensus building will include adding on to the work that NIOSH has already started; pulling together representatives from OSHA, NIOSH, CDC, FDA, the healthcare community, engineers and manufacturers to set parameters for safety medical device design passivity.

Passive protection is a newly emerging elemental engineering control that can eliminate exposure risk throughout the continuum of use — before, during, and after use of a sharp. It should involve no button pressing, no lever pushing, no needle shearing, no post clinical procedural activation, no “self” anything – the technological movement will involve the simple engineering of a smart device that activates itself during the course of normal clinical use and provides protection, ensuring worker and patient safety throughout – it will build on the guidelines and regulations set forth by OSHA, FDA, CDC, NIOSH, TDICT and others.^1-4

Amber Hogan Mitchell, MPH, is a full-time doctor of public health (DrPH) student in occupational injury prevention at the University of Texas School of Public Health in Houston, Texas. She is also a NIOSH doctoral trainee.

Prior to returning to school fulltime after 10 years in the field, she was manager of health affairs for Becton, Dickinson, and Company, a medical device and diagnostics manufacturer.

Before going to BD, Mitchell was a senior industrial hygienist at the U.S. Department of Labor, Occupational Safety and Health Administration (OSHA) in Washington, D.C. She specialized in regulatory and enforcement issues on the national level, specifically those relating to healthcare. She was also the OSHA national bloodborne pathogens coordinator.

REFERENCES

¹ Supplementary Guidance for Premarket Notification 510 (k) for Medical Devices with Sharps Injury Prevention Features. FDA, 2005
² CPL 02-02-069 Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens. OSHA, 2001.
³ Guidelines for the Use of Safety Feature Evaluation Sheets. Training for Development of Innovative Control Technology (TDICT) Project. Rev 1998.
⁴ Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program. CDC/NIOSH, 2004.

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“As a Nurse for 35 Years…”

By ANNETTE M. BARRY – RN, BS, CCRP.

As a Nurse for 35 years I feel great pride to be a part of something so wondrous and ever changing as the medical field. The speed with which our medical science innovations have developed during my nursing career is extraordinary! It has also been wonderful to participate in the attitude changes that have taken place over the years. Patients have become much more active in their health care and thanks to the internet are much more informed when they see a physician. Patients are asking very detailed and intelligent questions and are now used to making information based decisions about their health and are active participants in their health care. Interestingly, we (I include myself) have never really questioned getting our blood drawn. None of us like it (some less than others) and none of us would let anyone poke a hole in us if we didn’t think it was absolutely necessary. So we each reluctantly stick our arms out and hope the person doing it knows what they are doing.

As a nurse I have spent a great deal of time accessing veins. My ego found joy in that I seemed to have the ability to get in a vein on the first try. I had a “visualization” technique I utilized. I was always a little nervous preparing to draw blood because I didn’t want to cause the patient any more discomfort than necessary. More importantly, I knew that once I missed the vein the patient would lose confidence in my ability as a nurse. Even worse, I would lose confidence in myself which would make the second attempt even more difficult. I developed a “3 strikes I’m out” policy. Some of my colleagues have developed the “if I can’t get it (the vein) then no one can” attitude and have stuck a patient many times to obtain a blood sample. As with most professions there are a lot of egos in the medical field.

As a patient I am very fearful of needles. Most blood draws leave me with a large hematoma, sometimes painful due to the clinician penetrating both sides of my vein. I have had a clinician put the tourniquet on my arm so tight it completely cut off my blood supply. On another occasion, the vacutainer tube exploded and my blood was everywhere. I have 2 “good” veins, I am comfortable in a health care setting and I am still fearful to have my blood drawn. I know for many others it can be a nightmare and some lose trust with the entire healthcare industry. The one “tip” I can pass on is that when it comes to blood drawing, credentials mean very little. Practice means everything. Most MD’s and RN’s rarely draw blood. It’s the Medical Assistants or Lab Tech’s that have developed a real talent due to constant practice.

As a nurse I would answer any question a patient would have about the blood drawing process. Most patients did not have any questions and would just stick their arm out to “get it over with”. As a patient I never had any questions because I knew all the terrible things that could happen but felt I had no choice and would just stick my arm out just wanting to “get it over with”. Knowledge, communication, confidence, trust, and proper equipment are all major factors affecting the outcome of the blood collection process. I feel that informing patients of the risks associated with the procedure can enhance the patient and the clinician’s relationship if the technology provides vein entry indication. To have this conversation with devices that do not offer this measure of safety is likely to cause more distress, and perhaps, danger as the patient is apt to make a sudden move when the vacuum tube is introduced and there is no blood flow.

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Nurses’ Champion to Congress: Update OSHA Regs

By GENE O’CONNELL – RN, MS
Past Chair of National Association of Public Hospitals and Health Systems
Past CEO of San Francisco General Hospital.

An open letter to:

Congressman Frank Pallone
Healthcare Sub-Committee Chair
2125 Rayburn House Office Building
Washington, D.C., 20515

Dear Congressman Pallone,

I commend Senator Waxman’s Sub-committee hearings on Medical Devices on June 18, 2009 as a critical component of healthcare reform to bring before Congress issues of regulatory oversight to ensure safe, cost effective medical devices that provide better healthcare.

Nowhere in the transcript of testimonies by the four prominent witnesses on June 18, 2009 was there mention of the historic U.S. Needlestick Safety and Prevention Act 2000. Internationally, this uniquely American legislation is the foundation for parliamentary discussions of healthcare reform around the world. The Needlestick Safety and Prevention Act is held as the highest standard of humanistic and wisdom-filled governance to ensure patient and healthcare safety.

Furthermore, the Act addresses the enormous hidden costs of needlestick injuries to society. Dr. William Maisel stated the case succinctly that healthcare reform in America would improve if we only implement current laws.¹

In the words of Elise Beltrami, medical epidemiologist at Contamination Disease Control, the CDC’s goal is to completely eliminate needlesticks. “We don’t give a time frame for doing that, and clearly it’s going to be a challenge. But with education, training, appropriate device development and implementation, and developing a culture of safety, it’s a potentially realistic goal.”² CDC’s national objective can only be achieved by fully supporting the U.S. Needlestick Safety & Prevention Act. The Act is groundbreaking and requires the involvement of frontline healthcare workers in the evaluation, selection and implementation of safer needle devices in particular during the routine blood draw.

In 2000, the Act specifically named the then existing ways to improve safety needles: blunting, sheathing, or retracting the needle for injection equipment (syringes,), IV access devices, lancets, and phlebotomy needles. The U.S. Needlestick Safety & Prevention Act proscribes that U.S. manufacturers offer the safest devices available, and acknowledged that in the future better devices would be invented:

In addition to the existing requirements concerning exposure control plans, the review and update of such plans shall be required to also–

(A) ‘Reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens’; and

(B) ‘Document 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)

Since the Act became effective and amended the OSHA Bloodborne Pathogens Standard, dozens of new device technologies are used daily across America, improving safety to both healthcare workers and patients, notably in reducing needlestick injuries and contamination. But we’re not out of the woods, as still hundreds of thousands of U.S. healthcare workers continue to receive accidental needlesticks annually.

I am not endorsing these products or companies, but by way of example, since 2000 market leaders, Greiner Bio-One and Becton-Dickinson, have introduced blood collection needles that inform the phlebotomist of needle placement before insertion of the vacuum tube, the current worldwide standard device used 3 billion times annually.³ These are medical breakthroughs, like other new technologies including soft tubing in the IV set, (reduces the potentially dangerous memory of the collection tubing), and medicine injection technologies with safety components that provide the safety of vein entry indication passively and without major additional cost to the procedure.

These safety devices represent issues that are responsible for tremendous hidden costs to our healthcare system. For example, in the U.S. alone, every year hundreds of thousands of healthcare workers are exposed to deadly viruses as a result of needlestick and sharps injuries, and before they can return to work, they must test to rule out HIV and Hepatitis at cost of $3,000 – $5,000 for each person,⁴ effectively costing hundreds of millions of dollars annually simply for testing due to the needlestick technology. Amber Hogan, MPH Manager, Health Affairs, Becton Dickinson, summed up the costs to society: “The real and immediate risk of exposure to healthcare facilities include days away from work, medical evaluation and follow up, counseling, emotional distress, side effects from drug prophylaxis, decrease staffing and workers’ compensation costs, to name a few.”

Please use America’s current interest in healthcare reform to shine a spotlight on the Needlestick Safety and Prevention Act 2000. OSHA should review the Act as part of the current healthcare reform legislation, and regarding the new safety devices now available, OSHA should be directed to amend its regulations to include the new available technologies. This is supporting standing U.S. law, and exactly in congruence with the fine testimony given to Congressman Waxman’s Sub-committee on Medical Devices.

I am the former chair of the National Association of Public Hospitals and Health Systems, and was the CEO of San Francisco General Hospital and Trauma Center for over a decade before retiring in March of this year. San Francisco General is one of the nation’s top tertiary academic medical centers and safety net institutions, and has received numerous national awards including the 2008 American Medical Association Ethical Force Programs Awards for its patient centered communications initiative as well as recognition for many advances in emergency care and HIV treatment and research.

It is in everyone’s best interest that our current healthcare reform insures that the United States has the most up-to-date and innovative technology that fully supports patient and health care worker’s safety. We must not let the gains of this historic legislation fall by the way side in our rush for health care reform. I urge you to include in your deliberations on medical device regulation the need to support the Needlestick Safety and Prevention Act towards continued oversight in safety, cost-effectiveness and quality control of all medical devices. Without such discussion, healthcare reform will have missed a valuable opportunity, and in so doing perhaps lead to the evisceration of the Act’s effectiveness.

Please enter this letter into the post-record of the June 18, 2009 hearings following Sub-committee discussions. I request that you keep me abreast of your receipt of this correspondence and further discussion how new legislation will support the U.S. Needlestick Safety and Prevention Act 2000.

Sincerely,

Gene Marie O’Connell, RN, MS

REFERENCES

¹ Marcia Crosse, Government Accountability Office, William H. Maisel, M.D. M.P.H, Director Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Phillip J. Phillips, Independent Consultant, Peter Lurie, M.D., M.P.H. Deputy Director, Health Research Group.
² General Accounting Office (GAO) 2000 Occupational Safety: Selected Cost and Benefit Implications of Needlestick Prevention Devices for Hospitals, GAO-01-60R. www.gao.gov/new.items/d0160r.pdf
³ See attached product literature from Greiner Bio-One and Becton Dickinson.
⁴ Wilburn, MPH, RN., Susan Q. “Needlestick and Sharps Injury Prevention”, Online Journal of Issues in Nursing, September 30, 2004.