Senators Introduce Legislation to Streamline de novo Process

Senators Introduce Legislation to Streamline de novo Process

12/07/2011

Senators Scott Brown (MA) and Kelly Ayotte (NH) introduced legislation this week to improve the de novo process for medical technology innovators, and to increase predictability in the regulatory environment.

 "This legislation would cut red tape for innovators and allow new products to reach patients faster," Senator Brown said.

"The United States leads the global medical device industry, and in order to stay on top and keep jobs in America, we have to make sure businesses can develop new, life-saving and life-improving technology by removing unnecessary regulations and increasing flexibility."

 Senator Brown's legislation mirrors a bill that was introduced earlier this year in the House of Representatives by Rep. Brian Bilbray (CA), and builds on a growing effort in Congress to restore predicitability and transparency to FDA.


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http://www.medicaldevices.org/node/1132
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SHARPS INJURY PREVENTION LIST and INFORMATION

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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What are bloodborne pathogens?

What are bloodborne pathogens?
 

Bloodborne pathogens are infectious microorganisms in human blood that can cause disease in humans. These pathogens include, but are not limited to, hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV). Needlesticks and other sharps-related injuries may expose workers to bloodborne pathogens. Workers in many occupations, including first aid team members, housekeeping personnel in some industries, nurses and other healthcare personnel may be at risk of exposure to bloodborne pathogens.

What can be done to control exposure to bloodborne pathogens?

In order to reduce or eliminate the hazards of occupational exposure to bloodborne pathogens, an employer must implement an exposure control plan for the worksite with details on employee protection measures. The plan must also describe how an employer will use a combination of engineering and work practice controls, ensure the use of personal protective clothing and equipment, provide training , medical surveillance, hepatitis B vaccinations, and signs and labels, among other provisions. Engineering controls are the primary means of eliminating or minimizing employee exposure and include the use of safer medical devices, such as needleless devices, shielded needle devices, and plastic capillary tubes.

How can OSHA Help?

OSHA has developed this webpage to provide workers and employers useful, up-to-date information on bloodborne pathogens. For other valuable worker protection information, such as Workers' Rights, Employer Responsibilities and other services OSHA offers, read OSHA's Workers page.

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