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 There A GROUP PURCHASING ORGANIZATION (GPO) Conspiracy?

Posted on May 18, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , |

AN ANALYSIS OF GROUP PURCHASING ORGANIZATIONS’
CONTRACTING PRACTICES UNDER THE ANTITRUST LAWS:

Group purchasing organizations (GPOs) play an important role in the provision of health care services in the United States. As hospitals and other health care providers have come under pressure to reduce expenses, they have turned increasingly to GPOs to reduce the costs of the products and services they purchase. Today, virtually every hospital in the U.S. belongs to at least one GPO. More than seventy percent of all hospital purchases are made through GPO contracts, and GPOs contract for purchases with an annual value in the range of $150 billion.

The fundamental purpose of a GPO is to allow its members to join together to leverage their purchasing strength in order to purchase goods and services at lower prices, which in turn should enable them to lower their costs and become more competitive in the provision of their own services. In its basic form, a GPO is a cooperative of buyers. Over time, however, GPOs have evolved significantly to offer other competition-enhancing programs such as networking, bench marking, and educational quality improvement programs. These functions are pro-competitive and consistent with antitrust policy – they offer GPO members increased efficiency, eliminate wasteful administrative duplication, and they increase competition between manufacturers/vendors, and within the hospital members’ own markets, which translate into lower prices and higher quality for consumers.

At a time when increasing health care costs are a major policy concern, one would expect GPOs to be seen as a major force in the health care industry for increased efficiency and cost containment. In fact, GPOs currently are under attack from several different directions. On the political front, GPOs have come under attack by some manufacturers of medical devices that claim GPO contracting practices, including “sole-source contracts,” percentage of purchase or “market share” discounts, and multi-product or “bundled” discounts, favor large established manufacturers with the result that smaller companies with “innovative” products are effectively foreclosed from selling to a large number of the nation’s hospitals. These concerns have attracted the attention of the U.S. Senate, which held hearings last year scrutinizing GPO contracting practices; the Senate may hold additional hearings on GPOs in 2003. Similarly, the Federal Trade Commission (FTC) held a workshop last fall at which GPO contracting practices were a topic of discussion, and the FTC, together with the Antitrust Division of the Department of Justice (DOJ), are holding health care hearings in 2003 at which GPO contracting practices also are being discussed. Finally, a 2002 preliminary study by the General Accounting Office (GAO) raised questions about whether GPO contracts actually save hospitals money.  GPO contracts also have been the subject of recent private litigation. In Kinetic Concepts, Inc. v. Hillenbrand Indus., Inc., a jury awarded more than $500 million in treble damages against a manufacturer of hospital beds that allegedly was using GPO contracts to exclude plaintiff, its competitor. In a suit more directly implicating GPO practices, Retractable Technologies, Inc. v. Becton Dickinson, et al., a manufacturer of safety syringes sued the two largest manufacturers of standard and safety syringes along with the two largest GPOs, alleging, among other things, a conspiracy between the GPOs and manufacturers to monopolize the needle and syringe market.

The important role GPOs play in the delivery of health care services, and the criticism that has been directed at them, raise important issues under the antitrust laws. Are GPOs the agents of efficiency they claim to be, or, as their critics charge, have GPOs become a vehicle for dominant manufacturers to achieve and/or maintain monopoly power? This article analyzes GPO contracting practices under the antitrust laws and whether these practices are likely to result in anti-competitive effects. As this analysis will show, in general, GPO contracts promote significant efficiencies and are unlikely to result in sufficient market foreclosure to injure competition. The policy implications of this conclusion are clear: instead of increasing competition, restrictions on GPO contracting practices are likely to result in less competition and higher prices for health care consumers.

I. History and Background of Group Purchasing Organizations Hospital GPOs trace their history back to the late 1800s, though the first known hospital GPO was the Hospital Bureau of New York, which appeared in 1910.  Over the next half century, the GPO concept grew slowly and by the early 1970s there were forty hospital GPOs in the United States. The next thirty years witnessed an explosion of GPOs. From 1974 to 1999,the number of GPOs grew from forty to 633.  Today, there are over 900 GPOs in the United States. While some of these are “child” GPOs that rely on contracts negotiated by larger “parent” GPOs, it is estimated that approximately 200 GPOs contract directly with suppliers, and that twenty-six of these operate on a national level.

It is not a coincidence that GPOs began to grow in popularity in the late 1970s and early 1980s. During this time, for-profit hospital chains began to expand and buy up not-for-profit hospitals, forcing not-for-profits to find ways to cut costs to remain competitive. In the early 1980s, Medicare instituted the Prospective Payment System through which hospitals were reimbursed a fixed rate based on a defined service rather than the cost to the hospital of providing that service. At the same time, growing pressure in the private sector to reduce health care costs in the form of Health Maintenance Organizations (HMOs) and other types of managed care also reduced hospital reimbursement. These external market factors made it important for hospitals to control costs. Part of this effort included forming or joining a GPO to lower the cost of goods and services that the hospitals purchased.

CONTINUE TO FULL ARTICLE WITH REFERENCES : http://www.ftc.gov/ogc/healthcarehearings/docs/030926bloch.pdf
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(202) 263-3000

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FDA – Approved SHARPS Disposable Containers

Posted on May 11, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , |

Sharps Disposal Containers – FDA APPROVED

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FDA-Cleared Sharps Containers

The FDA recommends that used needles and other sharps be immediately placed in FDA-cleared sharps disposal containers. FDA-cleared sharps disposal containers are generally available through pharmacies, medical supply companies, health care providers, and online.


The FDA has evaluated the safety and effectiveness of these containers and has cleared them for use by health care professionals and the public to help reduce the risk of injury and infections from sharps.

 

FDA-cleared sharps disposal containers are made from rigid plastic and come marked with a line that indicates when the container should be considered full, which means it’s time to dispose of the container. Below are examples of FDA-cleared sharps containers:

 

Group of sharps disposal containersSharps disposal container

 

Sharps disposal container

Sharps disposal container

 

 

FDA-cleared sharps disposal containers are available in a variety of sizes, including smaller travel sizes to use while away from home.

 

Large sharps disposal container

Small sharps disposal container

 

 

Alternative Sharps Disposal Containers

If an FDA-cleared container is not available, some organizations and community guidelines recommend using a heavy-duty plastic household container as an alternative. The container should be leak-resistant, remain upright during use and have a tight fitting, puncture-resistant lid, such as a

plastic laundry detergent container.

 

 

Hand putting a needle into a laundry detergent bottle

 

Household containers should also have the basic features of a good sharps disposal container described below.

 

All sharps disposal containers should be:

  • made of a heavy-duty plastic;
  • able to close with a tight-fitting, puncture-resistant lid, without sharps being able to come out;
  • upright and stable during use;
  • leak-resistant; and
  • properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is about three-quarters (3/4) full, follow your community guidelines for proper disposal methods.

 

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Low “Dead Space” Syringes Could Save Your Life

Posted on February 2, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , |

Another guest article from Jamie Bridge this week. This time he’s writing about some of the work of researcher Dr. William Zule, looking into how the type of syringe someone uses may have an inpact on their risk of getting the HIV virus. I have had this article a few weeks but it was embargoed until the AIDS2010 conference started as its finding are being presented there.

How syringe type effects HIV risk

New research being presented this week at the International AIDS Conference in Vienna has made a strong link between different types of syringe and levels of HIV transmission through sharing.

Every needle-syringe, when the plunger is fully depressed, retains some fluid or blood in what is termed “dead-space”. Some syringe designs have more of this “dead space” than others – especially those with detachable needles. Depending on the design, some syringes can retain 84 microlitres of fluid. This is a very, very small amount – but other syringe designs can retain as little as 2 microlitres.

So the hypothesis is simple: if you share a syringe with higher “dead-space”, then there will be more blood retained in the syringe and you will be more likely to become infected with blood-borne viruses. If you share a low “dead space” syringe, you are still putting yourself at risk – but perhaps less so, as there is less blood retained when the plunger is fully down.

Previous modelling work by Dr William Zule and colleagues in the USA tried to quantify what this could mean in the real world. The results suggested that injection-related HIV epidemics might not occur when most (95% or more) of injectors use syringes with low “dead space”. If everyone uses higher “dead space” syringes, then HIV prevalence can reach 50% among injectors in just seventeen years. When just one in ten sharing events involve high “dead space” syringes, then HIV prevalence can stabilise.

The findings, albeit theoretical, have clear implications for harm reduction programs. However, in Vienna, the research has been taken to the next level. Data from multi-year HIV prevalence studies were gathered from 35 cities in 20 countries, and local needle exchange workers were contacted to find out what types of syringe were mainly used.

In cities where high “dead space” syringes were mainly used, the average HIV prevalence among injectors was 32.6% (and went up as high as 73%). In cities where low “dead space” syringes were mainly used, the average was just 1.4%. When the data were analyzed, the type of syringe was the only factor closely associated with this pattern in HIV.

More research needs to be done on this topic, and expect to hear a lot more about this in the future – this is an important finding which could have a big impact on harm reduction and the advice given to injectors. Of course, the biggest message is that ALL needle-syringe sharing is a risk. However, if we could reduce HIV transmission simply by providing one kind of syringe over another, then this is something that must be rolled out as soon as possible. Do you know what kind of syringe your local exchange supplies?

A big thank you to Dr William Zule for sharing this research.

Jamie Bridge, MSc, currently works in the Technical Publications and Learning Team of the Global Fund to Fight AIDS, Tuberculosis and Malaria. Before moving to Geneva in 2010, he worked for the International Harm Reduction Association in London, coordinating the international harm reduction conferences. Before that, he also worked in a needle and syringe program in Bedford. Jamie also works voluntarily with UKHRA and the NNEF.

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Potentially dangerous needlestick injuries often go unreported

Posted on January 4, 2012. Filed under: Syringe Blog | Tags: , , , , , , |

Johns Hopkins research suggests least-skilled providers at risk for life-threatening infections

Medical students are commonly stuck by needles – putting them at risk of contracting potentially dangerous blood-borne diseases – and many of them fail to report the injuries to hospital authorities, according to a Johns Hopkins study published in the December issue of the journal Academic Medicine.

Researchers surveyed surgery residents at 17 medical centers and, of 699 respondents, 415 (or 59 percent) said they had sustained a needlestick injury as a medical student. Many said they were stuck more than once. Of the surgeons-in-training whose most recent needlestick occurred in medical school, nearly half of them did not report their injury to an employee health office, thereby avoiding an evaluation as to whether they needed treatment to prevent HIV or hepatitis C.

It is estimated that 600,000 to 800,000 needlesticks and other similar injuries are reported annually among U.S. health care workers and there is evidence of vast underreporting, says Martin A. Makary, M.D., M.P.H., an associate professor of surgery at the Johns Hopkins University School of Medicine and lead researcher for the study.”Medical schools are not doing enough to protect their students and hospitals are not doing enough to make medical school safe,” he says. “We, as a medical community, are putting our least skilled people on the front lines in the most high-risk situations. Most trainees are still forced to learn to sew and stitch on patients, which puts both providers and patients at risk.”

Makary says medical schools should take advantage of advances in simulation technology and do less training on actual human beings until they are more skilled.

The authors of the study believe that needlesticks go unreported due to cumbersome reporting procedures, fears about poor clinical evaluations by their by their superiors, or embarrassment. The most commonly given reason in the study for why the medical students didn’t report needle injuries was the amount of time involved in making a report.

The survey did find, however, that medical students were very likely (92 percent) to report the needlestick if the patient was at high risk for having a virus like HIV or hepatitis, compared with 47 percent of injuries involving low-risk patients. Still, prompt reporting of all needlestick injuries is critical to ensuring proper medical prophylaxis, counseling and legal precautions, Makary says. Very few people who follow proper protocol and seek treatment after a needlestick get sick, he says.

“Hospitals are not creating a culture of speaking up,” says Makary, who is also the Mark Ravitch Chair of Gastrointestinal Surgery and director of the Johns Hopkins Center for Surgical Outcomes Research. “If people are not speaking up regarding their own safety concerns, it’s probably a surrogate marker of people not speaking up about patient safety concerns.”

Most of the needlesticks among medical students were self-inflicted and occurred in the operating room when the student felt rushed.

Makary says that needlestick injuries in surgery can infect patients since the providers’ blood can enter the patient’s wound. He argues that hospitals need to create a culture of reporting errors and stop placing their newest trainees at the greatest risk for infection. He also says that since medical students are at significant risk of personal injury during clinical training, more needs to be done to educate them about the importance of reporting any needlesticks, the value of post-exposure treatment and on how to prevent future injuries.

At The Johns Hopkins Hospital, for example, a hotline has been instituted for all occupational blood exposures. After such a report is received, a rapid response team is activated to deliver appropriate care while preserving confidentiality. The study was supported by the Mr. and Mrs. Chad Richison Foundation and the Lotus Global Health Foundation.

Source: Johns Hopkins Medical Institutions

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An Act To Amend The Public Health Law, In Relation To Hypodermic Syringes

Posted on December 5, 2011. Filed under: Syringe Blog | Tags: , , , , , |

More than 3,000 pharmacies, health care facilities and practitioners have registered with the Department of Health (DOH) to sell or furnish syringes to those age 18 and over without a prescription under the ESAP.

This program makes syringes available without a prescription and promotes the safe disposal of used syringes. Research has shown this program effectively reduces transmission of blood-borne pathogens as a result of needle sharing and reuse and may increase safe disposal of used syringes. ESAP providers sell two to three million non-prescription syringes a year and the need for unrestricted access to syringes remains high. Only two states, Delaware and New Jersey, do not allow the sale of syringes without a prescription.

In a 2003 report, the New York Academy of Medicine (NYAM) stated that ESAP “has great potential to prevent transmission of blood-borne diseases without any detrimental effect on syringe disposal, drug use or crime.” NYAM’s recommendation included: (1) enacting legislation to allow the program to continue permanently (which occurred as part of the 2009-10 enacted budget); (2) lifting the restriction on pharmacy advertising; (3) continuing education and outreach; (4) continuing safe syringe disposal education; and (5) expanding disposal options. At the time of the program’s extension through 2007, NYAM again noted the importance of syringe access, indicating that expanded syringe access “is critically important to stemming the spread of infectious disease.” Numerous studies published in peer-reviewed journals have attested to the value of ESAP in reducing syringe sharing and re-use and preventing disease transmission.

This bill would eliminate two restrictions on the sale of syringes to further the objectives of ESAP. First, the bill would remove the restriction on the number of syringes that may be sold or furnished, leaving the matter to the discretion of the individual ESAP provider. The current limit of 10 syringes per transaction was first implemented when ESAP was a demonstration project. Removing the limitation would better serve individuals who use this program by ensuring that they have enough clean syringes to prevent reusing or sharing syringes. For individuals in rural regions of the State, removing this restriction will facilitate access, particularly when it may be difficult or time-consuming to get to a pharmacy to purchase or dispose of used syringes.

Second, the bill would permit pharmacies to advertise the availability of syringes to the public. Of the 3,300 pharmacies, health care facilities and practitioners that have registered with DOH as part of ESAP, more than 97 percent are pharmacies. The public health function that they serve is compromised if potential customers are unaware of which pharmacies are registered ESAP providers. Appropriate pharmacy advertising can supplement the efforts of DOH to promote ESAP and provide consumers with access to information that they need to make informed choices.

~ S5312-2011: Relates to hypodermic syringes


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Bloodborne Pathogens and Needlestick Prevention

Posted on November 25, 2011. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , |

Introduction

Needlestick injuries and other sharps-related injuries which expose workers to bloodborne pathogens continues to be an important public health concern. Workers in many different occupations are at risk of exposure to bloodborne pathogens, including Hepatitis B, Hepatitis C, and HIV/AIDS. First aid team members, housekeeping personnel in some settings, nurses and other healthcare providers are examples of workers who may be at risk of exposure.

Bloodborne Pathogens is addressed in standards specifically for the general industry.

OSHA Standards

This section highlights the OSHA standard requirements, preambles to final rules (background to final rules), directives (instructions for compliance officers), and standard interpretations (official letters of interpretation of the standards) related to bloodborne pathogens and needlestick prevention.

Note: Twenty-five states, Puerto Rico and the Virgin Islands have OSHA-approved State Plans and have adopted their own standards and enforcement policies. For the most part, these States adopt standards that are identical to Federal OSHA. However, some States have adopted different standards applicable to this topic or may have different enforcement policies.

1910.1030, Bloodborne pathogens.
Revisions to 1910.1030 as a result of the Needlestick Safety and Prevention Act:
Paragraph 1910.1030(d)(2)(i) requires the use of engineering and work practice controls to eliminate or minimize employee exposure to bloodborne pathogens.
Employers must keep a Sharps Injury Log for the recording of percutaneous injuries from contaminated sharps [1910.1030(h)(5)(i)].
The Exposure Control Plan (1910.1030(c)(1)(i)) shall:
Reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens [1910.1030(c)(1)(iv)(A)].
Document annually consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure [1910.1030(c)(1)(iv)(B)].
Solicit input from non-managerial employees responsible for direct patient care, who are potentially exposed to injuries from contaminated sharps, in the identification, evaluation, and selection of effective engineering and work practice controls and shall document the solicitation in the Exposure Control Plan [1910.1030(c)(1)(v)].
Appendix A, Hepatitis B vaccine declination (Mandatory).

The following information provides discussion on the revised standard.

Revision to OSHA’s Bloodborne Pathogens Standard – Technical Backgr…. OSHA, (2001, April). Includes revised information regarding the identification, evaluation, and selection of effective engineering controls, including safer medical devices.
Most frequently asked questions concerning the bloodborne pathogens…. OSHA Standard Interpretation, (1993, February 1; corrected 2003, August 13). Responses to common questions about the bloodborne pathogens standard.
Frequently Asked Questions. OSHA. Provides questions and answers to some commonly asked questions regarding needlestick hazards and prevention.
Frequently Asked Questions: Bloodborne Pathogens. OSHA. Provides answers and additional information to frequently asked questions regarding bloodborne pathogen hazards.
Frequently Asked Questions: OSHA’s Occupational Exposure to Bloodbo…. OSHA. Provides answers to questions concerning the safe administration of vaccines.
Occupational Exposure to Bloodborne Pathogens; Needlestick and Othe…. OSHA Federal Register Final Rules 66:5317-5325, (2001, January 18). Also available as a 450 KB PDF, 9 pages. OSHA revised the Bloodborne Pathogens standard in conformance with the requirements of the Needlestick Safety and Prevention Act.
OSHA’s Bloodborne Pathogens Standard [63 KB PDF*, 2 pages]. OSHA Fact Sheet, (2011, January).

Needlestick Legislation

Overview of State Needle Safety Legislation. National Institute for Occupational Safety and Health (NIOSH). As of June 2002, twenty-two states have enacted legislation related to needle safety.
Needlestick Prevention and Safety Act. 106th Congress – Public Law 106-430, (2000). The Needlestick Safety and Prevention Act became Public Law 106-430 on November 6, 2000.

Preambles to Final Rules

Occupational Exposure to Bloodborne Pathogens. (1991)
Search all available preambles to final rules.

Directives

Enforcement Procedures for the Occupational Exposure to Bloodborne …. CPL 02-02-069 [CPL 2-2.69], (2001, November 27). Includes revisions mandated by the Needlestick Safety and Prevention Act.
Appendix D, Model Exposure Control Plan. Includes a model exposure control plan that meets the requirements of OSHA’s Bloodborne Pathogens Standard and can be tailored to meet the specific requirements of an establishment.
Updated U.S. Public Health Service Guidelines for the Management of…. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) 50(RR11);1-42, (2001, June 29). Also available as a 333 KB PDF, 67 pages. Updates and consolidates recommendations for the management of health-care personnel (HCP). Serves as Appendix E for CPL 02-02-069.
Updated U.S. Public Health Service Guidelines for the Management of…. Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 54(RR09);1-17, (2005, September 30). Updates US Public Health Service recommendations for the management of health-care personnel (HCP) who have occupational exposure to blood and other body fluids that might contain human immunodeficiency virus (HIV).
Rules of agency practice and procedure concerning OSHA access to em…. CPL 02-02-072, (2007, August 22). Provides guidance concerning application of the rules of agency practice and procedure when accessing personally identifible employee medical records.
Multi-Employer Citation Policy. CPL 02-00-124 [CPL 2-0.124], (1999, December 10).
Search all available directives.

Standard Interpretations

Clarification of the use and selection of BBP safety devices. (2008, May 5).
Applicability of OSHA’s bloodborne pathogens standard to the contai…. (2008, January 2).
Clarification of PPE requirements for phlebotomists performing veni…. (2007, October 26).
The applicability of OSHA’s bloodborne pathogens standards to the u…. (2007, June 14).
Application of OSHA’s Bloodborne Pathogens standard to contractors …. (2007, May 22).
Requirements for safety-engineered sharps for stockpiled pandemic i…. (2007, March 2).
The use of safety-engineered devices and work practice controls in …. (2007, January 18).
Use of rapid HIV antibody testing on a source individual after an e…. (2007, January 8).
Periodic serologic testing to monitor antibody concentrations after…. (2005, November 9).
Safety precautions, PPE, and immunizations for workers in waste wat…. (2005, September 13).
Containment and disposal requirements for disposable razors used in…. (2005, March 28).
Needle removal procedures for situations where other methods of dis…. (2004, December 9).
Limiting factors for implementing the use of engineering controls, …. (2004, September 1).
Bloodborne Pathogens Standard application to bifurcated needles; ac…. (2004, May 27).
Employer’s responsibility to re-evaluate engineering controls, i.e….. (2004, January 20).
Acceptable use of antiseptic-hand cleansers for bloodborne pathogen…. (2003, March 31).
Needlestick Safety and Prevention Act and the requirement to includ…. (2003, February 20).
Evaluation of sutureless catheter securement devices to prevent nee…. (2003, January 23).
Safer medical devices must be selected based on employee feedback a…. (2002, November 21).
Application of the bloodborne pathogens standard to veterinary clinics. (2002, October 15).
Re-use of blood-tube holders. (2002, June 12).
Search all available standard interpretations.

Hazard Recognition

OSHA estimates that 5.6 million workers in the health care industry and related occupations are at risk of occupational exposure to bloodborne pathogens, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and others. All occupational exposure to blood or other potentially infectious materials (OPIM) place workers at risk for infection with bloodborne pathogens. OSHA defines blood to mean human blood, human blood components, and products made from human blood. Other potentially infectious materials (OPIM) means: (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. The following references aid in recognizing workplace hazards associated with bloodborne pathogens.

Bloodborne Pathogens

Hospital. OSHA eTool.
Bloodborne Pathogens
Bloodborne Infectious Diseases: HIV/AIDS, Hepatitis B Virus, and He…. National Institute for Occupational Safety and Health (NIOSH) Safety and Health Topic.
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. US Department of Health and Human Services (DHHS), Centers for Disease Control and Prevention (CDC).
Viral Hepatitis B
Viral Hepatitis C
HIV/AIDS
Healthcare-associated Infections (HAIs). Centers for Disease Control and Prevention (CDC).
Exposure to Blood: What Healthcare Personnel Need to Know [363 KB PDF, 10 pages]. Centers for Disease Control and Prevention (CDC), National Center for Infectious Diseases, (2003, July).
EPINet Data Reports. University of Virginia, International Health Care Worker Safety Center. The Center has used the Exposure Prevention Information Network (EPINet) since 1992 to collect data from approximately 70 hospitals on sharp object injury and blood and body fluid exposure patterns in the health care setting.

Needlestick

Sharps Injuries among Hospital Workers in Massachusetts, 2008 — F… [213 KB PDF, 32 pages]. Massachusetts Department of Public Health, (2010, March).
Medical & Dental Offices: A Guide to Compliance with OSHA Stand…. OSHA Publication 3187-09R, (2003). Also available as a 787 KB PDF, 2 pages. Provides a glimpse of the most frequently found hazards in medical and dental offices.
Disposal of Contaminated Needles and Blood Tube Holders Used for Ph…. OSHA Safety and Health Information Bulletin (SHIB), (2003, October 15). Also available as a 37 KB PDF, 4 pages. OSHA has concluded that the best practice for prevention of needlestick injuries following phlebotomy procedures is the use of a sharp with engineered sharps injury protection (SESIP), (e.g., safety needle), attached to the blood tube holder and the immediate disposal of the entire unit after each patient’s blood is drawn.
Potential for Occupational Exposure to Bloodborne Pathogens From Cl…. OSHA Health Information Bulletin (HIB), (1995, September 21).
Securing Medical Catheters [353 KB PDF*, 2 pages]. OSHA Fact Sheet.
Job Safety and Health Quarterly (JSHQ) [4 MB PDF*, 44 pages]. (2001, Summer).
Fleming, Susan. “Preventing Needlesticks [4 MB PDF*, 44 pages].” New rules affirm the need for safer devices to protect workers.
“Highlights of OSHA’s Bloodborne Pathogens Standard Revision [4 MB PDF*, 44 pages].” A toolbox discussion of the revision to OSHA’s bloodborne pathogens standard.
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 (Alert), (1999, November). NIOSH warns that health care workers who use or may be exposed to needles are at increased risk of needlestick injury.
Selecting, Evaluating, and Using Sharps Disposal Containers. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 97-111, (1998, January). Presents a comprehensive framework for selecting sharps disposal containers and evaluating their efficacy as part of an overall needlestick injury prevention plan, reviews the Occupational Safety and Health Administration (OSHA) bloodborne pathogens standard and recommends containers on the basis of a site-specific hazard analysis, and establishes criteria and provides tools for evaluating the performance of sharps disposal containers.
What Every Worker Should Know: How to Protect Yourself From Needles…. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2000-135, (1997, July). Discusses pathogens that pose the most serious health risks.

Possible Solutions

Studies show that nurses sustain the most needlestick injuries and that as many as one-third of all sharps injuries occur during disposal. The Centers for Disease Control and Prevention (CDC) estimates that 62 to 88 percent of sharps injuries can be prevented simply by using safer medical devices. The following references provide information regarding possible solutions for bloodborne pathogens and needlestick hazards.

Please Note: Articles/references that are dated before April 18, 2001 may not reflect the changes of the new Bloodborne Pathogens Standard but still provide relevant, general information.

Control Programs

Model Plans and Programs for the OSHA Bloodborne Pathogens and Haza…. OSHA Publication 3186-06N, (2003). Also available as a 521 KB PDF, 29 pages. Includes a model exposure control plan that meets the requirements of the OSHA Bloodborne Pathogens Standard and can be tailored to meet the specific requirements for an establishment.
Preventing Exposures to Bloodborne Pathogens among Paramedics. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2010-113, (2010, April).
Information for Employers Complying with OSHA’s Bloodborne Pathogen…. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2009-111, (2009, March).
Workbook for Designing, Implementing, and Evaluating a Sharps Injur… [2 MB PDF, 168 pages]. Centers for Disease Control and Prevention (CDC), (2008).
Preventing Occupational HIV Transmission to Healthcare Personnel. Centers for Disease Control and Prevention (CDC), (2002, February). Offers recommendations to prevent transmission of HIV to healthcare personnel in the workplace.
Checklist for Sharps Injury Prevention [21 KB PDF, 2 pages]. The University of Virginia, International Health Care Worker Safety Center. Provides a checklist intended to help facilities comply with the sharps safety requirements of OSHA’s Bloodborne Pathogens Standard.
A Best Practices Approach for Reducing Bloodborne Pathogens Exposure [3 MB PDF, 100 pages]. Cal/OSHA Consultation Service, Department of Industrial Relations, (2001).

Safer Needle Devices

Use of Blunt-Tip Suture Needles to Decrease Percutaneous Injuries t…. OSHA and the National Institute for Occupational Safety and Health (NIOSH) Publication No. 2008-101, (2007, October). Supersedes NIOSH Publication 2007–132.
Evaluation of Blunt Suture Needles in Preventing Percutaneous Injur…. Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 46(02);25-29, (1997, January 17). Identifies the effectiveness of blunt needles in reducing percutaneous injuries (PIs) and suggests that they should be considered for more widespread use in surgical procedures.
List of Safety-Engineered Sharp Devices — and other products desig…. The University of Virginia Health System, International Health Care Worker Safety Center, (2003). Provides a list of devices designed to prevent percutaneous injury and exposure to bloodborne pathogens in the health care setting.
Sharps Disposal Containers with Needle Removal Features. OSHA Hazard Information Bulletin (HIB), (1993, March 12). Alerts field personnel to the risk of possible safety and health hazards that may arise with the use of some sharps disposal containers that incorporate an “unwinder” mechanism to accomplish needle removal.
Safer Medical Device Implementation in Health Care Facilities – Sha…. National Institute for Occupational Safety and Health (NIOSH). NIOSH developed this forum to assist health care facilities that are working through the process of implementing safer needle devices in their workplaces.
Evaluation of Safety Devices for Preventing Percutaneous Injuries A…. Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 46(02);21-25, (1997, January 17). Indicates that the use of phlebotomy safety devices significantly reduces phlebotomy-related percutaneous injury (PI) rates.
Needlestick and Other Risks from Hypodermic Needles on Secondary I…. Food and Drug Administration (FDA) Safety Alert, (1992, April 16). Urges the use of needleless systems or recessed needle systems to reduce the risk of needlestick injuries.

Decontamination

Selected EPA-registered Disinfectants. Environmental Protection Agency (EPA), (2009, January 9). Includes lists of EPA registered anti-microbial products to assist in choosing the appropriate decontaminant.

Post-exposure Evaluation

According to the NIOSH Alert Preventing Needlestick Injuries in Health Care Settings, it is estimated that 600,000 to 800,000 needlestick injuries (NSIs) and other percutaneous injuries (PIs) occur annually among health care workers. PIs are caused by sharp objects such as hypodermic needles, scalpels, suture needles, wires, trochanters, surgical pins, and saws. Additional exposure incidents include splashes and other contact with mucous membranes or non-intact skin. Post-exposure management is an integral part of a complete program for preventing infection following exposure incidents.

The following references provide useful information about the management of occupational exposure incidents to blood or other potentially infectious materials.

Rapid HIV Testing. Centers for Disease Control and Prevention (CDC). These pages include descriptions of the rapid HIV tests approved by the FDA, how the tests can be implemented in different settings and research on the effectiveness and possible uses of the tests.
A Comprehensive Immunization Strategy to Eliminate Transmission of …. Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 55(RR16);1-25, (2006, December 8).
Updated U.S. Public Health Service Guidelines for the Management of…. Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 54(RR09);1-17, (2005, September 30). Updates US Public Health Service recommendations for the management of health-care personnel (HCP) who have occupational exposure to blood and other body fluids that might contain human immunodeficiency virus (HIV).
Updated U.S. Public Health Service Guidelines for the Management of…. Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 50(RR11);1-42, (2001, June 29). Updates and consolidates recommendations for the management of health-care personnel (HCP).
Immunization of Health-Care Workers: Recommendations of the Advisor…. Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 46(RR-18);1-42, (1997, December 26). Summarizes recommendations of the ACIP concerning the use of certain immunizing agents in health-care workers (HCWs), and assists workers and administrators, in optimizing infection prevention and control programs.
EPINet. The University of Virginia, International Health Care Worker Safety Center. The Exposure Prevention Information Network (EPINet) system provides standardized methods for recording and tracking percutaneous injuries and blood and body fluid contacts. EPINet consists of a Needlestick and Sharp Injury Report, a Blood and Body Fluid Exposure Report, and software for entering, accessing, and analyzing the data from the forms.
National HIV/AIDS Clinicians’ Consultation Center. The University of California – San Francisco. Offers a post-exposure prophylaxis hotline called PEPline. PEPline offers health care providers around-the-clock advice about managing occupational exposures to HIV and Hepatitis B and C.

Additional Information

Related Safety and Health Topics Pages

Dentistry
Healthcare Facilities
Medical and First Aid
Nursing Homes and Personal Care Facilities

Training

Training Resources. OSHA. Contains training and reference materials related to bloodborne pathogens.
OSHA’s Revised Bloodborne Pathogens Standard. OSHA, (2001), 34 slides. Covers safe needle devices and provides new definitions from the revised standard.
Bloodborne Pathogens [1 MB ZIP*]. OSHA, (2001, December 17). Assists trainers conducting OSHA 10-hour general industry outreach training for workers. Since workers are the target audience, the material emphasizes hazard identification, avoidance, and control — not standards.
Public Health Training Network Catalog. Centers for Disease Control and Prevention (CDC), Public Health Training Network (PHTN). Browse for distance learning courses and resources.

OSHA Resources

Regional & Area Offices. Each Regional Office has a Bloodborne Pathogens Coordinator available to answer questions.
Small Business. OSHA.
On-site Consultation
Program Information and Benefits
Compliance Assistance Specialists (CASs). Provides general information about OSHA standards and compliance assistance resources.
Record Summary of the Request for Information on Occupational Expos…. (1999, May). Summarizes nearly 400 comments from health care facilities, workers and others who responded to OSHA’s request for information on engineering and work practice controls used to eliminate or minimize the risk of occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps.

Publications

Model Plans and Programs for the OSHA Bloodborne Pathogens and Haza…. Publication 3186-06N, (2003). Also available as a 521 KB PDF, 29 pages. Includes a model exposure control plan to meet the requirements of the OSHA bloodborne pathogens standard and a model hazard communication plan to meet the requirements of the hazard communication standard.
Access to Medical and Exposure Records. Publication 3110, (2001). Also available as a 1 MB PDF, 8 pages. Provides information for employees who have had possible exposure to or use toxic substances or harmful physical agents at their work site or employers who have employees who may be exposed.
Medical & Dental Offices: A Guide to Compliance with OSHA Stand…. Publication 3187-09R, (2003). Also available as a 787 KB PDF, 2 pages. Provides a glimpse of the most frequently found hazards in medical and dental offices.
OSHA Forms for Recording Work-Related Injuries and Illnesses. Forms 300, 300A, and 301.
Personal Protective Equipment. Publication 3151-12R, (2003). Also available as a 629 KB PDF, 46 pages. Helps both employers and employees understand the types of PPE, know the basics of conducting a “hazard assessment” of the workplace, select appropriate PPE for a variety of circumstances, and understand what kind of training is needed in the proper use and care of PPE.
RECORDKEEPING – It’s new, it’s improved, and it’s easier… Publication 3169, (2001). Also available as a 2 MB PDF, 7 pages. Provides information on the new rule.
Publications, Posters, and Online Order Forms

OSHA Alliances

American Biological Safety Association (ABSA). Signed September 23, 2002; renewed October 13, 2004; renewed January 29, 2007; renewed March 3, 2009).
Association of periOperative Registered Nurses (AORN). Signed December 15, 2006; renewed April 1, 2009.
Association of Occupational Health Professionals in Healthcare (AOHP). Signed February 19, 2004; renewed August 27, 2006; renewed April 28, 2008.
The Joint Commission and Joint Commission Resources (JCR). Signed July 27, 2004; renewed November 8, 2006; renewed January 14, 2009.

Other Resources

Information for Employers Complying with OSHA’s Bloodborne Pathogen…. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2009-111, (2009, March).
Worker Health Chartbook 2004. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2004-146, (2004, September).
Fatal and Nonfatal Injuries, and Selected Illnesses and Conditions
First Responders: Protect Your Employees with an Exposure Control Plan. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2008-115, (2008, July). First Responders face unique scenarios due to uncontrolled settings and the possible presence of large volumes of blood at the scene. A comprehensive bloodborne pathogens exposure prevention program will help protect your employees.
First Responders: Encourage Your Workers to Report Bloodborne Patho…. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2008-118, (2008, July). Encourage your employees to report all exposures. This way, you can carry out your responsibility to take appropriate post-exposure actions to protect your workers, their families, and the public against infection from bloodborne pathogens.
First Responders: Informational Poster on Bloodborne Pathogen Expos…. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2008-116, (2008, July).
Protect Your Employees with an Exposure Control Plan. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2007-158, (2007, September). NIOSH researches visited a number of prisons and jails to learn more about current practices and procedures being used to protect health care workers from bloodborne diseases. This brochure provides information to medical service administrators and supervisors about common problems with facility Exposure Control Plans.
2007 Guideline for Isolation Precautions: Preventing Transmission o…. Centers for Disease Control and Prevention (CDC), Division of Healthcare Quality Promotion (DHQP). Provides an outline of a single set of standard precautions to be used for the care of all patients in hospitals regardless of their presumed infection status.
The CDC Prevention Guidelines Database. Centers for Disease Control and Prevention (CDC). Provides a comprehensive compendium of all of the official guidelines and recommendations published by the Centers for Disease Control and Prevention (CDC) prior to October 1998 for the prevention of diseases, injuries, and disabilities.
Cardo, Denise M., et al. “.” The New England Journal of Medicine (NEJM) 337(1997, November 20): 1485-1490. Abstract only.

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Safe Syringes For Injection Safety

Posted on November 13, 2011. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , |

World Health Organization

World Health Organization

There are four types of syringes currently used around the globe. The first two categories are cheaper but less safe. The two newer and safer devices are more expensive. Simpler disposable syringes cost on average 12 to 15 cents less than devices that prevent reuse and needle stick injuries. In industrialized countries, the injection systems are firmly established and well resourced, with the most advanced syringes broadly available. The vast majority of developing countries cannot afford the most recent technologies.

Group One: Reuse Prevention Feature

• Auto-disable (AD) syringes are designed to prevent reuse by patients and health care workers. After being utilized once, the syringes are put out of action due to an internal mechanism which blocks the plunger once it is fully pressed.

• Breaking Plunger syringes contain the same purpose and a similar functioning as the AD syringes. Once the plunger is fully pressed, an internal mechanism cracks it completely, impeding any possibility of reuse.

Group Two: Reuse and Needle Stick Prevention Features

• Needle Stick Prevention syringes, apart from having a mechanism to avoid reuse, also protect health care workers and patients from needle related injuries and infections. The syringes contain a shield, made either of paperboard or plastic, which covers the needle creating a protective cap.

• Retractable syringes, apart from preventing reuse and needle sticks, also avoid hazardous sharps waste. After being used, the needle is pulled back inside the syringe barrel upon retraction of the plunger.

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Injury and Hazards in Home Healthcare Nursing are a Growing Concern

Posted on November 13, 2011. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , |

“Although professionally and personally rewarding for many, home care nursing can be both physically and emotionally demanding. Our study findings suggest that home healthcare work may be dangerous for nurses who work in this setting. These types of injuries are serious as they can result in infection with bloodborne pathogens, such as hepatitis and HIV.”

— Robyn Gershon, DrPH, professor of clinical Sociomedical Sciences

Injury and Hazards in Home Healthcare Nursing are a Growing Concern

October 1, 2009 — Patients continue to enter home healthcare ‘‘sicker and quicker,” often with complex health problems that may require extensive nursing care. This increases the risk of needlestick injuries in home healthcare nurses. While very few studies have focused on the risks of home healthcare, it is the fastest growing healthcare sector in the U.S. In a recent study, led by researchers at Columbia University Mailman School of Public Health, the rate of needlestick-type injuries was 7.6 per 100 nurses. At this rate, the scientists estimate that there are nearly 10,000 such injuries each year in home care nurses. The findings, reported in the paper, “The Prevalence and Risk Factors for Percutaneous Injuries in Registered Nurses in the Home Health Care Sector,” were published in the September 2009 issue of American Journal of Infection Control.

According to lead author Robyn Gershon, DrPH, professor of clinical Sociomedical Sciences at the Mailman School of Public Health and principal investigator, “although professionally and personally rewarding for many, home care nursing can be both physically and emotionally demanding. Our study findings suggest that home healthcare work may be dangerous for nurses who work in this setting. These types of injuries are serious as they can result in infection with bloodborne pathogens, such as hepatitis and HIV.”

A critical finding of this study was the statistical correlation between needlesticks and exposure to stressful conditions in the patients’ household. Nurses reporting household stressors, such as cigarette smoke, unsanitary conditions, air pollution, and vermin, were nearly twice as likely to report needlestick injuries. Most significant was the fact that home healthcare nurses exposed to violence in their patients’ households were nearly three and a half times more likely to also report needlestick injuries, according to the study.

The home healthcare sector is a very important part of the nation’s healthcare infrastructure with over 1.3 million workers in the field, including roughly 125,000 RNs. Many procedures previously performed only in the hospital are now routinely performed in the home.

Over 700 home healthcare RNs from across New York State were recruited for this study, which was funded by the National Institute for Occupational Safety and Health (NIOSH), the Centers for Disease Control and Prevention (CDC).

The provision of a safe work environment in the home healthcare sector is complicated by the fact that worker safety in this setting is largely unregulated. Certain OSHA regulations do not apply to workers employed in individual households. However, home healthcare agencies accredited by the Joint Commission must be in compliance with certain infection control and other standards. Protecting workers from violence in the healthcare setting is an ongoing and well recognized challenge according to Dr. Gershon, “These results indicate that household hazards in general, and home care violence in particular, needs addressing.”

We Must Find Safer Ways To Deliver Medications To Patients

“Many of the unsafe conditions identified in this study can also increase risk of harm to patients,” said Dr. Gershon. She further noted that as healthcare increasingly moves out from the acute care setting and into the home setting, efforts to improve the health and safety of workers in this sector is critical, with benefits to home health care workers and patients alike.

“Dr. Gershon’s research on home healthcare and how it affects elderly patients and caregivers alike is key to helping us evaluate the ways to ensure that both frail older adults and their home health providers remain as safe and healthy in the home setting as possible,” says Linda Fried, MD, MPH, dean of the Mailman School of Public Health. “This research is especially important since we know that 20% of the U.S. population will be over 65 years old by the year 2030.” Dr. Fried is an epidemiologist and geriatrician whose career has been dedicated to the science of healthy aging.

The study was supported by Centers for Disease Control and Prevention/National Institute of Occupational Safety and Health (5 R01 OH008215-03).

About the Mailman School of Public Health

The only accredited school of public health in New York City and among the first in the nation, Columbia University Mailman School of Public Health pursues an agenda of research, education, and service to address the critical and complex public health issues affecting millions of people locally and globally. The Mailman School is the recipient of some of the largest government and private grants in Columbia University’s history. Its more than 1000 graduate students pursue master’s and doctoral degrees, and the School’s 300 multi-disciplinary faculty members work in more than 100 countries around the world, addressing such issues as infectious and chronic diseases, health promotion and disease prevention, environmental health, maternal and child health, health over the life course, health policy, and public health preparedness. http://www.mailman.columbia.edu Contact: Stephanie Berger, Mailman School of Public Health, 212-305-4372, sb2247@columbia.edu

 

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We had a needle stick. What do we do now?

Posted on November 13, 2011. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , |

 

Coping with OSHA

We had a needle stick.
What do we do now?

HARRISBIOMEDICAL can help.

When your employee has an exposure incident, you must respond immediately. Exposure incidents include injuries from contaminated sharps or any blood, saliva or other potentially infectious material contact with eye, mucous membrane or non-intact skin.

For any exposure incident, you must:

* Provide immediate post-exposure medical evaluation to the employee. The treatment offered must include a medical evaluation for Post-Exposure Prophylaxis (PEP) for HIV. Document whether or not the employee chooses to pursue immediate medical evaluation.
* Request consent to test the source patient (if known). The consent must be in writing and must include consent to test for HBV, HCV and HIV and to disclose the test results to the exposed employee. Document whether or not the source patient gives consent to test and disclose.
* Investigate and document the exposure incident. You must document the circumstances that led to the exposure. You must also provide a copy of the documentation to the employee’s treating health care professional if the employee seeks medical evaluation and/or treatment.
* Provide a copy of the Bloodborne Pathogens standard to the treating health care professional if the employee seeks medical treatment and/or evaluation.

 

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Tags: OSHA, CDC, needles, syringes, needlestick, safety syringe

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