Archive for January, 2012

Congressional Letter Urges FDA to Improve Med Tech Pathway

Posted on January 30, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , |

Congressional Letter Urges FDA to Improve Med Tech Pathway
11/08/2011

A bipartisan, bicameral letter was sent to FDA Commissioner Margaret Hamburg recently urging her to improve the agency’s handling of medical technologies.

“Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system,” stated the letter.

The signers are asking FDA to:

  •     Recognize and correct the disparity between “FDA time” versus real time when tracking device approvals;
  •     Consider potential benefits of harmonization with international testing standards;
  •     Address the unintended consequences of the conflict of interest rules for advisory panels; and,
  •     Create a transparent tracking and review system for applications and clearance decisions.

A hearing will be held in the U.S. Senate next week taking a closer look at efforts FDA is working on to improve the regulatory environment,  and examining the impact that today’s challenges are having on patient care and innovation.

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http://www.medicaldevices.org/node/1118

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SHARPS INJURY PREVENTION LIST and INFORMATION

Posted on January 28, 2012. Filed under: Syringe Blog | Tags: , , , , , , |

SHARPS INJURY PREVENTION LIST and INFORMATION

In all workplaces where employees are exposed to contaminated needles or other contaminated sharps, the employer shall comply with 29CFR 1910.1030, Tennessee Code Annotated 50-3-203(e)(1)-(e)(4) and Tennessee Rule 0800-1-10 as follows:

  • Evaluate available engineered sharps injury prevention devices for all sharps
  • Solicit input from employees directly involved in patient care in the evaluation and selection of devices and document this in the Exposure Control Plan
  • Select the devices most appropriate to your procedures
  • Train employees to use the devices,
  • Require use of the safer devices and use of safer work practices when handling and passing contaminated sharps
  • Update the Exposure Control Plan at least annually or when needed to document the devices evaluated and those placed into use
  • Justify the use of any sharps without sharps injury protection & document in the Exposure Control Plan
  • Maintain a Sharps Injury Log with:
  1. Type and brand of device involved in the exposure incident
  2. Department or work area of occurrence
  3. Explanation of how it occurred

The list below is to assist employers in complying with changes in Tennessee Code Annotated Section 50-3-203 (Senate Bill 1023/House Bill 634). Inclusion of types of devices does not represent or imply any evaluation, endorsement, or approval by The Tennessee Department of Labor and Workforce Development, the Tennessee Department of Health, or any other agency. This list is not all inclusive.

Types of Devices and Engineering Controls

Injection Equipment

  • Hypodermic needles and syringes- sliding sheath/sleeve, needle guards
  • Needleless jet injection
  • Retractable needles

Medication Vial Adaptors (used to access ports of medication vials)
IV Medication Delivery Systems

  • Needle guards for pre-filled medication cartridges
  • Needleless IV access-blunted cannulas
  • Needleless valve/access ports and connectors
  • Prefilled medication cartridge with safety needles
  • Recessed/protected needle
  • Needle guards for pre-filled medication cartridges

IV Insertion Devices

  • Shielded or retracting peripheral IV catheters
  • Shielded midline IV catheters

IV Catheter Securement Devices
Epidural/Spinal Needles
Blood Collection Devices

  • Arterial blood gas syringes
  • Phlebotomy needles
  • Safety-engineered blood collection needles
  • Blood tube holders
  • Closed venous sampling systems
  • Plastic blood collection tubes
  • Butterfly blood collection needles
  • Blood Donor Plebotomy Devices

Other Catheter Equipment

  • Guidewire Introducers-for venous and arterial access
  • Central Venous Catheters
  • Peripheral Inserted Central Catheters
  • Radial Artery Catheters

Umbilical cord sampling devices
Lancets

  • Laser lancet
  • Retracting Lancet
  • Strip Lancet

Laboratory Devices

  • Hemoglobin reader
  • Mylar-wrapped glass capillary tubes
  • Plastic capillary tubes
  • Protected needles for blood culture vial access
  • Vacuum tube stopper
  • Plastic fingerstick sampling blood collection tube
  • Slide preparation devices

Surgical Devices

  • Scalpels (disposable safety, retracting, shielded)
  • Ultrasonic scalpel

Blunted Suture Needles (for internal suturing- fascia/muscles)
Surgical Glues & Adhesives
Alternative Skin Closure Devices
Surgical Sharps Protection and Other Surgical Sharps Protection

  • Hands free transfer disposable magnetic drapes
  • Sharps counting and disposal system
  • Magnetic floor sweep
  • Scalpel blade removal system

Hemodialysis and Apheresis Devices
Fluid Sampling Devices
Sharps Disposal or Destruction Containers
Irrigation Splash Shield (Eliminates use of needles in debridement procedures)
Blood Bank Devices

  • Segment sampling devices

Nuclear Medicine Devices
Cut or puncture-resistant barrier products (gloves, liners or pads)
Huber Needle and related devices
Smallpox Vaccination Needles
Vaginal Retractors
Surgical Prep Razors
Bone Marrow Collection Systems
Dental Safety Devices
To access this fact sheet online: www.state.tn.us/labor-wfd/sharpslist.pdf

The next list below contains web site resources that can be used for the purposes of information and research. The examples of effective engineering controls in this list do not include all those on the market, but are simply representative of the devices available. Neither the Tennessee Department of Labor and Workforce Development nor the Tennessee Department of Health approve, endorse, register or certify any medical devices. Inclusion on this list does not indicate approval, endorsement, registration or certification.

International Health Care Worker Safety Center, University of Virginia:
Available: Features a list of safety devices with manufacturers and specific product names: http://www.healthsystem.virginia.edu/internet/epinet/safetydevicene… and Safety in Surgery : http://healthsystem.virginia.edu/internet/safetycenter/internetsafe…

International Sharps Injury Prevention Society:
Available: http://www.isips.org/
ISIPS is an international group of medical device and pharmaceutical manufacturers, health organizations, healthcare professionals, medical waste disposal experts and others that are joining forces to provide education, information, and product knowledge that will help reduce the number of sharps injuries that occur each year. This website features a list of safety product categories with a description of the category and a list of safety products that fit under that category : http://www.isips.org/safetyproductlist.php
Food and Drug Administration (FDA) Safety Alert: Needlestick and Other Risks from Hypodermic Needles on Secondary IV Administration Sets – Piggyback and Intermittent IV: http://www.osha.gov/SLTC/bloodbornepathogens/fdaletter.html
Warns of the risk of needlestick injuries from the use of hypodermic needles as a connection between two pieces of intravenous (IV) equipment. Describes characteristics of devices which have the potential to decrease the risk.
Occupational Safety and Health Administration (OSHA) Glass Capillary Tubes: Joint Safety Advisory About Potential Risks : http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTER…
Describes safer alternatives to conventional glass capillary tubes.
Occupational Safety and Health Administration (OSHA) Needlestick Injuries Available: http://www.osha.gov/SLTC/bloodbornepathogens/index.html
Features recent news, recognition, evaluation, controls, compliance, and links to information on effective engineering controls.
Needle Safety http://www1.va.gov/vasafety/page.cfm?pg=119
Features needle safety information from the US Department of Veterans Affairs (VA).
Training for Development of Innovative Control Technologies (TDICT) Project Available: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIREC…
TDICT “Safety Feature Evaluation Forms” in Appendix B of this directive.
OSHA Instruction CPL 2-2.69 Enforcement procedures for the Occupational Exposure to Bloodborne Pathogens
Available: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIREC…
Instruction that establishes policies and provides clarification to ensure uniform inspection procedures are followed when conducting inspections to enforce the Occupational Exposure to Bloodborne Pathogens Standard (29 CFR 1910.1030).
Service Employees International Union (SEIU) Guide List
Available: http://www.seiu.org

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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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