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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Safer Needle Devices

Safer Needle Devices

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Most needlestick injuries result from unsafe needle devices rather than carelessness by healthcare workers (JSHQ, 1998, Summer).

Safer needle devices have built-in safety control devices, such as those that use a self-sheathing needle, to help prevent injuries before, during, and after use through safer design features.

The Centers for Disease Control and Prevention (CDC) estimated in March of 2000 that 62 to 88 percent of sharps injuries in the hospital setting could be preventing by using safer medical devices.

Potential Hazard

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

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

• Examples of Safety Device Designs

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

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

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Needlestick Safety and Prevention Act and the requirement to include safety- engineered sharps devices in pre-packaged surgical kits and trays.

February 20, 2003

Ms. Wendy Gallart
Senior Marketing Manager
BD Advanced Protection Technologies
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417

Dear Ms. Gallart:

Thank you for your October 29, 2002 letter to the Occupational Safety and Health Administration (OSHA) regarding the requirement for employers to use engineering controls (e.g., safer medical devices) under the bloodborne pathogens standard [29 CFR 1910.1030]. Your question is restated below followed by OSHA's response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence.

Does compliance with the updated bloodborne pathogens directive enforced by the Needlestick Safety and Prevention Law require that pre-packaged kits include safety-engineered devices?

Note: These pre-packaged kits or trays may be prepared by outside vendors specifically for physician specialists in operating rooms and surgical centers.

The Needlestick Safety and Prevention Act (NSPA) was signed into law in November 2000. It mandated OSHA to revise its bloodborne pathogens standard to include specific additional definitions and requirements. OSHA published "Revision to OSHA's Bloodborne Pathogens Standard -- Technical Background and Summary -- Needlestick Fact Sheet (2001, May 9)," which clearly details the changes to the standard. We have attached it for your convenience. It is also available on our website, along with other informative outreach materials on the hazards associated with exposure to blood and other potentially infectious materials (OPIM), see [the Bloodborne Pathogens Technical Links Page].

The Needlestick Safety and Prevention Act is not enforceable on its own, but rather the Occupational Safety and Health Act of 1970, which requires compliance with OSHA standards. The OSHA bloodborne pathogens standard requires the institution of safety measures in workplaces where there is occupational exposure to blood or other potentially infectious materials (OPIM). Under the standard, as revised by the NSPA, employers are required to evaluate, select, and use engineering controls (e.g., sharps with engineered sharps injury protections or needleless systems) to eliminate or minimize exposure to contaminated sharps [29 CFR 1910.1030(d)(2)(i)].

In healthcare settings this requirement is easily interpreted to mean that employers must implement the use of "safety-engineered devices" or sharps with engineered sharps injury protection (SESIPs) when performing medical procedures with sharps, regardless how they are packaged or supplied. If, during surgical procedures, as your letter specifies, physician specialists or other healthcare personnel are using medical instruments supplied in pre-packaged kits, those packages must include engineering controls appropriate for the specific procedures being performed. Employees using these devices must have the opportunity to provide feedback on appropriate and effective safer devices [29 CFR 1910.1030(c)(1)(v)].

We understand that physician specialists (e.g., surgeons, anesthesiologists, etc.) often are not employees of healthcare facilities where they have staff privileges. Under OSHA's bloodborne pathogens compliance directive (OSHA Instruction CPL 02-02-069 [formerly CPL 2-2.69]) the status of the physician as an employer or employee is important to establish in order to determine the application of OSHA standards. According to the paragraph XI.D. in the directive, physicians "... may be cited if they create or control bloodborne pathogens hazards that expose employees at hospitals or other sites where they have staff privileges in accordance with the multi-employer worksite guidelines of CPL 02-00-124 [formerly CPL 2-0.124], Multi-Employer Citation Policy."

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,


Richard E. Fairfax, Director
Directorate of Enforcement Programs 

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