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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The use of safety-engineered devices and work practice controls in operating rooms; hospital responsibility to protect independent practitioners under BBP standard

January 18, 2007

Mr. Erik Frederick
Director of Safety
Baptist Medical Center
111 Dallas Street
San Antonio, Texas 78224

Dear Mr. Frederick:

Thank you for your letter to the United States Occupational Safety and Health Administration (OSHA). Your letter was forwarded to the Directorate of Enforcement Programs (DEP) for a response. You have questions about the use of safety-engineered devices and work practice controls, such as implementing safe zones in operating rooms. 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. For clarification, your specific questions are paraphrased below, followed by OSHA's response. We apologize for the delay in addressing your concerns.

Question 1: Members of our hospital operating room (OR) committee, including surgeons, nurses, and technicians, are requesting an interpretation of what the hospital's responsibility is in evaluating and implementing the use of sharps with engineered sharps injury protections (SESIPs) and safe zones for hands-free passing of sharps in the surgical suite. What does the bloodborne pathogens standard at 29 CFR §1910.1030 require in this regard?

Reply 1: OSHA's bloodborne pathogens standard requires that employers use engineering and work practice controls to eliminate occupational exposure or reduce it to the lowest feasible extent [29 CFR §1910.1030(d)(2)(i)]. One type of engineering control is a SESIP. 29 CFR §1910.1030(b) (definition of "[e]ngineering controls"). Therefore, where feasible, hospitals must implement the use of SESIPs and proper work practices, such as designated neutral or safe zones, which allow hands-free passing of sharps, to prevent sharps injuries in operating rooms. See CPL 2-2.69, XIII D.2 (2001) ("eliminating hand-to-hand instrument passing in the operating room" noted as engineering control in directive implementing the standard). The practitioner's preference is not an excuse for failure to use engineering controls and work practices. In many cases, surgeons may simply need additional practice or training to feel comfortable using a new and different device or work practice. However, if the use of a particular device or work practice could adversely affect the performance of a particular procedure and, ultimately, the safety of a patient, the device or practice does not have to be used. A determination not to use a particular device or work practice must be documented in the facility's exposure control plan (ECP), 29 CFR §1910.1030(c)(1)(iv).

if a hospital-selected safety device or work practice would adversely affect patient safety, the hospital must ensure that an alternative safe device or practice is implemented for the handling of sharps in the OR. For example, in a situation where all practicable engineering devices have been implemented and it is not feasible to perform the surgical procedure safely using a neutral zone, the hospital must ensure that surgeons and other staff in the operating room do not perform "hand-to-hand" passing of devices without first verbally notifying each other. In this way, operating room nurses, technicians, and surgeons will not be caught off-guard and will thus avoid "blind" retrieval of contaminated sharps.

Question 2: The surgeons in our facility are independent practitioners and are not employees of the hospital. What are the responsibilities of the hospital and the surgeons to protect hospital personnel in the OR under the bloodborne pathogens standard in this situation?

Reply 2: The hospital is responsible under the OSH Act for affording the protections of the bloodborne pathogens standard to its employees, regardless of the independent practitioners performing surgery in its operating rooms. It may not absolve itself of these responsibilities. We assume that the independent practitioners you discuss are surgeons with staff privileges at the hospital. The relationship between a hospital and a surgeon or other physician with staff privileges at the hospital is contractual. Therefore, the practitioner has a contractual responsibility to comply with hospital procedures as set forth in the contract, and the surgeon has an obligation to follow them. Hospitals have the right to make a practitioner's adherence to the hospital's procedures a condition of staff privileges.

Furthermore, the practitioner or the medical practice with which he or she is associated, like a partnership or a professional corporation, usually would also be obligated to comply with the OSH Act and its standards, like the bloodborne pathogens standard, so as to protect employees. Surgeons or their medical practices usually employ at least one employee, such as a secretary or receptionist, and thus are employers under the OSH Act. 29 USC §652(5). Under the OSHA multi-employer worksite doctrine, an employer (here, the practitioner or his or her medical practice), that creates or controls a hazard, is obligated to comply with the standard so as not to endanger hospital employees.¹ See CPL 2-2.69 XI D (2001), which refers to CPL 2-0.124, Multi-Employer Citation Policy. These directives are available on OSHA's web site, http://www.osha.gov.

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. Also, from time to time we update our guidance in response to new information. 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 General Industry Enforcement at (202) 693-1850.

Sincerely,



Richard E. Fairfax, Director
Directorate of Enforcement Programs


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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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Employer's Responsibility To Re-evaluate Engineering Controls, i.e., Safer Needle Devices, At Least Annually

January 20, 2004

Mr. Marty Salanger
Manager of Safety, Policy and Government Relations
BD Advanced Protection Technologies
1 Becton Drive
Franklin Lakes, NJ 07417

Dear Mr. Salanger:

Thank you for your October 29, 2003 letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question(s) not delineated within your original correspondence. You had specific questions regarding an employer's responsibility to re-evaluate engineering controls under OSHA's bloodborne pathogens standard (29 CFR 1910.1030). Your question is restated below followed by OSHA's response. We apologize for the delay in responding.

Question: If an employer has selected a particular safety-engineered device based on employee feedback, and a reduction in needlestick injuries can be shown as a result of the adoption of the current device, to what extent does an employer need to re-evaluate their chosen device?

Reply: As you are aware, OSHA's bloodborne pathogens standard requires employers to review and update their Exposure Control Plan (ECP) at least annually [29 CFR 1910.1030(c)(1)(iv)]. It is also a requirement that: 1) annual reviews and updates of ECPs reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens; and 2) employers document annually their consideration and implementation of appropriate commercially available and effective safer medical devices [29 CFR 1910.1030(c)(1)(iv)(A-B)].

If, after employee input, an employer selects an engineering control that is effective in reducing needlestick injuries, it is not necessary to evaluate all newly emerging engineering controls each year. The employer must simply keep abreast of new and emerging technologies and solicit input from non-managerial employees to determine if the facility's chosen device remains preferable to any newly developed products. This should be documented in the ECP.

Since the requirements of the standard are performance-based, OSHA determines compliance with the standard on a facility-by-facility, instance-by-instance basis, based on the employer's consideration of safer medical devices, solicitation of input from employees, documentation in an employer's ECP, and employee interviews.

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. Also, from time to time we update our guidance in response to new information. 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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