Preparing for an Influenza Pandemic Personal Protective Equipment for Healthcare Workers (2008) / Chapter Skim
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5 Certifying and Regulating Healthcare PPE: Defining an Integrated System
5 Certifying and Regulating Healthcare PPE: Defining an Integrated System
Pages 147-168
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From page 147... ...
In this era of working toward preparedness for a pandemic, it is important to examine the level of rigor employed to ensure that all forms of PPE are safe and effective medical devices. This chapter examines the process by which healthcare PPE products are tested before entering the market to meet certification and approval requirements, the regulation of the use of PPE in the workplace, and the extent to which PPE products are found to be effective in the post-marketing phase (Table 5-1)
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From page 148... ...
. Manufacturing, performance, and testing standards are developed by voluntary standards-setting organizations including the International Organization for Standardization, ASTM International, and the Associa 1 N95 respirators that are approved by FDA for use in healthcare facilities (termed surgical respirators by FDA)
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From page 149... ...
Healthcare workers and others also need to be able to clearly identify and locate relevant PPE standards and the level of protection that the product can be expected to offer. Efforts should be made to provide easy access to the standards at minimal or no cost to the user so that the entire process is as open and transparent as possible.
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From page 150... ...
The responsibilities of the two agencies are interconnected in that FDA approval of respirators for use in healthcare settings requires that the respirators be NIOSH-certified. NIOSH Respirator Certification As described in Chapter 1, NIOSH has the legal authority to certify respirators; certification testing is conducted by the National Personal Protective Technology Laboratory (NPPTL)
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. FDA Medical Device Clearance and Approval Federal regulatory control of medical devices began in 1937 with legislation focused on the adulteration or misbranding of medical devices (Hutt, 1989)
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(510k exempt) II Intermediate 510k submission • Surgical gowns • Surgical masks • Surgical respirators III High Subject to pre-market None approvals must submit clinical evidence of safety and efficacy NOTE: FDA uses the terms surgical gowns, isolation gowns, surgical masks, and surgical respirators and defines each in guidance documents.
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From page 153... ...
More rigorous pre-market testing that includes field or field simulation tests of PPE products should be required in NIOSH certification of respirators and in FDA approval requirements for all healthcare PPE. Controlled field testing of PPE equipment under development would be conducted after the appropriate approvals from rele
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From page 154... ...
Just as NIOSH certification is a key criterion for FDA approval of respirators, one way to expedite FDA approval of other types of PPE would be to develop certification processes for gowns, gloves, eye protection, and other relevant PPE. Certification would raise the bar on requirements for pre-market testing and could be incorporated into FDA approval processes.
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From page 155... ...
OSHA regulations require the use of NIOSHcertified respirators and have explicit details about the responsibilities of employers to provide fit testing programs and ready access to respirators and other appropriate PPE on the worksite. Recently, OSHA released a report specifically focused on protecting healthcare workers during an influenza pandemic (OSHA, 2007b)
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From page 156... ...
Healthcare PPE is largely under the purview of the agencies and organizations that regulate occupational safety and health. In the event of an influenza pandemic, retail purchase may be a major route of acquiring PPE for home healthcare workers and others working in healthcare facilities.
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From page 157... ...
For products that assert NIOSH certification but have not received it, NIOSH can act against false or misleading advertising. In 2006, NIOSH revoked one respirator approval; two N95 respirator approvals were determined to be null and void because their issuance was based on the manufacturer's false and misleading statements; and 12 user notices were issued (3 of which involved devices misrepresented as N95 respirators)
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From page 158... ...
The MedWatch system and website are also used to disseminate medical product safety alerts, recalls, withdrawals, and major labeling changes. FDA receives more than 400,000 adverse reports annually, of which approximately 5 percent have been from individual healthcare workers through MedWatch (FDA, 2005)
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From page 159... ...
Other Medical Device Safety Reporting Efforts A range of additional incident-reporting programs through federal, state, and nonprofit agencies and organizations examine medical device safety and adverse events with a focus on patient safety issues. For example, in accrediting healthcare facilities, the Joint Commission examines sentinel events that may include the safe use of medical equipment.
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From page 160... ...
One of the challenges of post-marketing evaluation and surveillance is that PPE is only one component of the efforts needed to fully protect healthcare workers against exposure to infectious agents. Other controls (e.g., ventilation, vaccination)
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From page 161... ...
, with concomitant resources devoted to the research and development efforts essential for the comprehensive protection of healthcare workers. Additionally, this integrated approach will mean that a broader segment of the population should be considered in PPE planning, with attention given to ensuring that the general population will have access to and knowledge of certified respirators and other PPE.
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From page 162... ...
In a strengthened drug safety system, that juncture should mark the beginning of another important stage in the lifecycle, when regulators, sponsors, health in surers, health care providers, and independent researchers actively pursue and manage emerging knowledge about risk-benefit relationships and uncer tainty and they communicate that knowledge to patients, and health care or ganizations in a timely manner.
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From page 163... ...
• Pre-market testing -- Immediate attention needs to be devoted in the next 6 to 12 months to determining appropriate field testing parameters and methodologies for enhancing pre-market testing of healthcare PPE to focus the testing on efficacy against transmission of infectious disease and on enhancing wearability and other critical factors for use. Additional Challenges: PPE for the General Public In working on its charge to examine PPE for healthcare workers in the event of an influenza pandemic, the committee became aware of substantial gaps in knowledge regarding the design and implementation of PPE for family members and others who will provide care to influenza patients during a pandemic or who wish to use preventive measures to avoid influenza transmission.
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From page 164... ...
Greater coordination between federal agencies and other relevant organizations is needed, as is a means to fill gaps in responsibilities for PPE, particularly as related to home healthcare workers and others who may purchase their equipment in the consumer marketplace. An integrated life-cycle approach to healthcare PPE will ensure that this essential component of worker safety undergoes a rigorous testing and evaluation process that provides healthcare workers with the protection they need during an influenza pandemic.
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From page 165... ...
• Ensure oversight for PPE products sold commercially Post-Marketing Evaluation • Increase resources for post-market evaluation and surveillance Recommendation 10 Strengthen Pre-Market Testing of PPE for Healthcare Workers FDA, NIOSH, and other relevant agencies and organizations should strengthen pre-market testing requirements for healthcare PPE by requiring field testing of PPE prior to ap proval and by reevaluating the FDA medical device classifi cation for healthcare PPE. Testing requirements should use rigorous standards while also providing expeditious review of innovative approaches.
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From page 166... ...
Presentation at the Institute of Medicine Workshop on Personal Protective Equipment for Healthcare Workers in the Event of Pandemic Influenza: Next Steps and Research Directions. February 22, 2007.
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From page 167... ...
2005. Safe medical devices for children.
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From page 168... ...
2007b. Pandemic influenza preparedness and response guidance for healthcare workers and healthcare employers.
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