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Needlestick Symposium

IMPACT OF THE NEEDLESTICK SAFETY AND PREVENTION ACT
ON THE PHARMACEUTICAL INDUSTRY

Symposium Summary

The main focus of the symposium was to raise awareness within the pharmaceutical sector, which utilizes advanced prefill devices, about how the new Needlestick Law will impact their customers and, therefore, the design of their products' delivery systems.

The symposium commenced with an overview of epidemiological data, which explained why the Needlestick Safety and Prevention Act was unanimously passed by Congress. The data show that although HIV receives most of the attention, infection rates with HCV and HBV, in particular, are much higher, according to the CDC. Also, the projected cost of treating an HCV infected population adds about $10 billion to U.S. medical expenditures each year. Although the new Needlestick Act is a federal law, almost 71% of all hospital beds in the U.S. will also be affected by legislation either passed or in the process of being passed on the State level.

A consensus emerged during the symposium that although the needlestick injury and occupational transmission of bloodborne pathogen problems have been clearly identified and are expected to persist, much of the pharmaceutical industry and, indeed, many of the healthcare providers have yet to become fully engaged in prevention via engineering control technologies. A number of barriers to the introduction of engineering control technologies to end users were identified, including the unavailability of the devices due to supply backlogs and the lack of access to the safety products by such nonhealthcare users of sharps as those who work in R&D and animal research.

Compliance pressures of the law will drive customers to demand prefills packaged with engineered sharps safety devices. These drug/device combination products present the opportunity to have integral safety "guaranteed" with every administered dose. Pharmaceutical companies that provide such "safety prefills" will have a concomitant competitive market advantage.
OSHA officials described how the Needlestick Safety and Prevention Act affects their jurisdiction. OSHA has been mandated to update the Bloodborne Pathogens Standard, first issued in December 1991. Some key new Standard requirements are:

• All employers must evaluate and implement new developments in safety devices
• Employers must solicit input from frontline healthcare workers in the identification, evaluation, and selection of engineering and work practice controls
• Employers with 10 or more employees must establish and maintain a sharps injury log

Representatives from the FDA detailed a new policy, setting up four pathways for the review of applications for prefill products, including those with additional safety features. These pathways are as follows:

• Add-on device has a 510K
• Add-on device does not have a 510K
• Immediate drug container has a 510K
• Immediate drug container does not have a 510K
  

For the end user safety controls are crucial to minimize sharps accidents in the health care workplace. However, the introduction of new devices or features requires much education, and compliance is always an issue. Therefore, safety devices with usage features that are readily apparent and that require minimal manipulation, such as prefills, are definitely preferred.

Based on all of the presentations, a list of ideal safety features for prefill products was compiled.

• Safety control is an integral part of the device
• Safety feature cannot be bypassed
• Safety feature does not interfere with the performance of the device
• Change in technique is not required
  
• Safety feature is simple and requires little or no user action or training to use it safely and effectively
  
• Safety feature is obvious to activate
  
• Instructions are clear
  
• Safety feature, is passive, requiring little or no user activation of device. Otherwise, can be activated with one hand
  
• Device can be used by right and left handed workers
  
• Hands remain behind sharp at all times
  
• Device has a visible or audible indicator of activation
  
• Safety device prevents needlestick injuries during and after use
  
• Sharp is covered permanently after device activation
  
• Add-on safety device is compatible with all brands and is available in all required sizes
  
• Device does not impact negatively on patient comfort or infection rates
  
• Feature should not introduce a sharp for a use where no sharp was previously needed

PROGRAM
(NOTE: This program was supported in part by an unrestricted educational grant provided by BD.)

Panel/Forum
Adjournment

FACULTY BIOGRAPHIES

Murray L. Cohen, PhD, MPH, CIH
Dr. Cohen is chairman of the Frontline Healthcare Workers Safety Foundation in Atlanta, GA., an organization dedicated to improving the working conditions of frontline healthcare workers through ongoing risk assessment, research, education and training programs. His career spans 20+ years in the United States Public Health Service including the National Institute for Occupational Safety and Health (NIOSH) and the national Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC).

Dr. Cohen specializes in bloodborne pathogen control and related occupational injury prevention. He is a diplomate in the American Academy of Industrial Hygiene, serves on the editorial board of Advances in Exposure Prevention, and is a member of multiple professional organizations. Dr. Cohen holds a PhD in occupational and environmental health sciences from the University of Illinois Medical Centers at Chicago and is a frequent lecturer and presenter on healthcare and safety issues. Dr. Cohen is also President of CDIC, Inc., Consultants in Disease and Injury Control.

Patricia M. Cricenti
Patricia Cricenti is the Branch Chief for the General Hospital Devices Branch, Division of Dental, Infection Control and General Hospital Devices, Office of Device Evaluation, Center for Devices and Radiological Health FDA.

The General Hospital Branch reviews medical devices that have sharps injury prevention features (safety or antineedlestick). Prior to assuming the Branch Chief position Ms Cricenti was a reviewer in the Microbiology Devices Branch and the Infection Control Devices Branch.

Barbara DeBaun, RN, BSN, CIC
Barbara DeBaun is a certified Infection Control Practitioner who has worked in the field of Infection control for the past 23 years. She is currently the Director of the Infection Control Program at California Pacific Medical Center (CPMC) in San Francisco, California. She has lectured nationally and internationally on many Infection Control issues, particularly on topics related to healthcare worker safety. Barbara has chaired the CPMC Needlestick Prevention Task Force since it's inception in 1989. Her articles on needlestick prevention have been published in Infection Control and Hospital Epidemiology and Infection Control Today.

Amber Hogan, MPH
Amber Hogan is an Industrial Hygienist for the Directorate of Compliance Programs in the U.S. Department of Labor, Occupational Safety and Health Administration (OSHA). Amber specializes in regulatory and enforcement issues on the national level with specific regard to the Bloodborne
Pathogens and Laboratory Standards. She functions as the national liaison for OSHA's Regional Bloodborne Pathogens Coordinators.

Amber has an educational and practical background in clinical public health, injury prevention, occupational and environmental health, epidemiology, and military public health. She holds a Master of Public Health degree from The George Washington University. Before coming to OSHA, she worked as an
environmental health specialist for the U.S. Army and U.S. Public Health Service. View Presentation

Steven Koepke, PhD
Steven Koepke is the Deputy Director of the Division of New Drug Chemistry II, Office of New Drug Chemistry, Office of Pharmaceutical Sciences. Dr. Koepke received his Bachelors degree from Oberlin College in 1973 and his Ph.D. from the University of Nebraska in 1978. Dr. Koepke joined the National Cancer Institute in 1978 where he worked as a contract researcher exploring the mechanisms of chemical carcinogenesis. In 1990, he joined the Environmental Protection Agency as a reviewer in the Office of Pesticide Programs where he reviewed new pesticides prior to their approval for the US markets. In 1992, Dr. Koepke joined the Food and Drug Administration as a reviewer in the Division of Oncology and Pulmonary Drug Products. During his tenure as a reviewer, Dr. Koepke has served on various committees including Biotech Reagents and the Office of Pharmaceutical Sciences Information Technology Committees. Dr. Koepke joined the Division of New Drug Chemistry II as Deputy Director in 1997.

Melody Sands, MS
Melody Sands is Director of the Occupational Safety and Health Administration's (OSHA's) Office of Health Compliance Assistance, part of the OSHA Directorate of Compliance Programs. The Office of Health Compliance Assistance is responsible for planning and directing OSHA's comprehensive, nation-wide occupational health compliance program and for developing policies and inspection procedures to ensure uniform enforcement of occupational health standards. Prior to holding this position, Ms. Sands served for five years as Chief of OSHA's Division of Consultation Programs, which oversees the development and continued operation of the Agency's nation-wide, on-site Consultation Program. Previous to this appointment, Ms. Sands served as a Senior Industrial Hygienist within OSHA Compliance Programs, and was responsible for the coordination and interpretation of complex Agency enforcement and compliance issues. Other positions held include work as an industrial hygienist in OSHA's Directorates of Technical Support, Field Coordination, and Training and Education. She received her Master of Science (M.S.) degree in Occupational and Environmental Health from Wayne State University School of Medicine in 1977.