4

Options for Post-Market Surveillance

The workshop’s final panel session discussed various aspects of post-market surveillance and included the following:

• An overview of current processes for post-market surveillance of N95 respirators and other similar types of devices
• Discussion of suggested considerations for improving post-market surveillance

As an introduction to the one presentation in this session, Daniel Shipp from the International Safety Equipment Association explained that conformity assessment—the process of demonstrating that a product or process meets regulatory requirements—does not stop with regulatory clearance. Quality assurance monitoring is a critical aspect of post-market surveillance that aims to ensure that every item coming off a production line is exactly like the one that was approved. So, too, is assessing what happens to a product once it is in the hands of users and feeding that information back into testing and evaluation.

OVERVIEW OF THE NIOSH RESPIRATOR APPROVAL PROGRAM AND POST-MARKET ACTIVITIES

Jeffrey Peterson and James Harris, National Personal Protective Technology Laboratory

Under the provisions of 42 CFR 84, NIOSH is authorized to approve respirators. The regulatory specifications include performance requirements as well as the criteria for the quality assurance program relevant to manufacturing respirators. Peterson noted that because NIOSH is author-

ized to approve completely assembled respirators (and not respirator components or subassemblies), it is easy to track actual configurations and identify critical performance characteristics of NIOSH-approved N95s. In the approval process, NIOSH first conducts an initial engineering review to ensure that the request for certification matches all of the accompanying documentation, including product drawings and the quality assurance system specifications. The product is then sent to the laboratory for testing, and concurrently NIOSH conducts a quality assurance review that delves into the manufacturing processes and procedures. A final review includes comparing the manufacturer’s test results with those obtained by NIOSH’s laboratory and finalizing the labeling, which then leads to an issued approval. Currently, the respirator approval program deals with 98 approval holders comprising 119 manufacturing sites in more than 20 countries. In an average year, said Peterson, NIOSH receives approximately 400 approval requests and grants approximately 250 new approvals.

Post-marketing surveillance begins once a product is approved and it includes visiting every manufacturing site on a biennial basis to make sure the sites are complying with 42 CFR 84 requirements, their own quality assurance protocols, and the documentation that was submitted with the manufacturer’s application for respirator approval. Peterson said this inspection is important because inspectors do find changes in the product or manufacturing process that were not submitted to NIOSH after the initial approval, resulting in required corrective action. NIOSH also conducts audits on products it purchases on the open market or that it receives from manufacturers. Additionally, NIOSH can open an investigation in response to complaints.

Peterson explained that NIOSH is developing a new audit approach that will expand the number of product audits and will ensure that the agency tests at least one product from every manufacturer, rather than the prior process of testing 40 to 50 products selected by NIOSH from the certified equipment list. The new audit procedure will broaden the scope of the program so that the wide range of respirators are included.

Additional product audits and evaluations, he added, are conducted based on emerging issues and stakeholder needs, said Peterson. These include

• Increased filtering facepiece respirator audits during pandemics and other disease outbreaks,
• Evaluations of self-contained breathing apparatus to support the Fire Fighter Fatality Investigation and Prevention Program,

• Near-miss evaluations to support the International Association of Fire Fighters, and
• Evaluations of closed-circuit escape respirators to support the Mine Safety and Health Administration and the U.S. Navy.

Other point-of-use evaluations are also being explored, he said, and NIOSH has a new effort under way to evaluate stockpiled products to see if the agency can assist stockpile holders in making decisions on inventory that may be coming close to its expiration date or with other issues.

In the event of receiving a complaint about a respirator or failing an inspection, NIOSH initiates a certified product investigation process (CPIP). The purpose of this type of investigation, explained Peterson, is to ensure the quality of NIOSH-approved respirators by promptly investigating and resolving reports of product nonconformance issues. A CPIP also works with the manufacturer to understand and document the problem; assess any corrective actions that manufacturer has taken to correct the problem; and ensure the manufacturer takes steps to address inventory units, field units, and future production. In most cases, NIOSH wants the approval holder to conduct a failure modes and effects analysis. “Without that, it gets to be a bit tricky to really understand whether or not the root cause has been defined,” said Peterson.

Reports that trigger a CPIP come in to NIOSH via many routes, including self-reports from approval holders as well as from users and service organizations and during product audits. Examples of nonconformance issues include performance failures, a failure to maintain quality control requirements, misleading advertising, and manufacturing under a private label without prior approval from NIOSH. What is important about the CPIP, Peterson explained, is that NIOSH oversees the investigation but it does not conduct the investigation.

Possible follow-up actions include issuing a recall order, asking manufacturers to retrofit equipment, and issuing notices to users. Typically, such notices are issued by the manufacturer after review by NIOSH and a link to the notice is posted on the NIOSH website. On occasion, said Peterson, NIOSH will issue a notice that covers units from multiple approval holders or when it cannot agree with the approval holder that one is needed or on what the notice should say. If the CPIP involves a surgical N95 respirator, NIOSH also notifies FDA. In some instances, NIOSH will issue a stop sales notice so that the product is off the market while the CPIP is ongoing. In extreme cases where a resolution is not foreseeable, NIOSH will rescind an approval or the manufacturer will voluntarily request a rescission.

Before closing a CPIP, NIOSH poses the following questions:

• Has the approval holder properly identified the cause of the nonconformance?
• Has the approval holder developed effective corrective actions to resolve nonconformance?
• Has the approval holder successfully addressed inventory units, field units, and future production?

When NIOSH determines an investigation can be closed, it sends the approval holder a CPIP closing letter.

Aside from inspections and audits, NPPTL provides technical assistance to users, labor organizations, other government agencies, contractors, and the general public on questions, including expiration dates and proper selection and use of respirators. “We try to address each and every one of these within three days of receipt,” said Peterson. NPPTL disseminates information on standard test procedures through its website, issues letters to manufacturers on policy changes and clarifications, informs users about product failures or recalls, provides a certified equipment list and a trust source list through its website, informs all customers of new initiatives at NIOSH, and alerts stakeholders about other corrective measures that are under development.

DISCUSSION

A wide range of issues on post-market surveillance were discussed. Linda Hawes Clever asked if there have been any post-marketing surveillance complaints to FDA about surgical N95 respirators, and Peterson replied that there have been no more than two reported over the past 5 to 7 years. Over the same time period, there has been an increase in issues with manufacturers not following their quality assurance systems or having deficiencies in their system that have allowed products that are not in compliance with requirements to enter the market. There have been no reports, however, of any adverse consequences resulting from those deficiencies.

Responding to a question about stockpiling, Susan Moore from NPPTL said she is working on a project that will attempt to create a stockpile partnership for filtering facepiece respirators and surgical gowns. The partnership would include state hospital stockpiles, the CDC strategic national stockpile, manufacturing associations and manufactur-

ers, major suppliers, and distributors. Currently, she and her colleagues are examining the storage conditions for the stockpiled protective equipment in the United States as stockpile storage conditions can vary across states. The next step will be to initiate a study to test products from five facilities and multiple manufacturing models to determine how different products made from different materials perform over time in storage. One goal of this study is to give manufacturers more confidence in the shelf lives of their products. The availability of products that were initially stockpiled after September 11, 2001, will likely provide a wealth of information about product longevity.

Peterson responded to a question about NIOSH’s legal authority to take regulatory action against a manufacturer by noting that NIOSH does not have broad enforcement authority. When it issues a stop sell request, the manufacturer’s response is voluntary. NIOSH can move to revoke certification, triggering a legal process, if the problem proves to be large or if the manufacturer does not comply with NIOSH’s requests. Andrew Levinson said OSHA does have regulatory authority in that it can cite employers using non-NIOSH-certified respirators because that is a violation of OSHA standards and OSHA inspectors do enforce those standards. Elizabeth Claverie-Williams added that FDA has ongoing post-market surveillance for all regulated medical devices, including surgical N95s. The agency’s Office of Compliance investigates any post-marketing issues that arise regarding use of medical devices. Such issues can include outbreaks of infectious disease, although she noted there have been no such reports connected to surgical N95 use. If such an issue did arise, FDA would work with NIOSH, OSHA, CDC, the Joint Commission, and the affected hospitals to address the problem.

When asked for ideas on how post-market surveillance could be improved, Peterson said the main limitation today is one of resources. One suggestion, he said, would be to create an easy-to-use Web portal where users could report problems they experience with specific products. D’Alessandro said that NPPTL is looking into working with FDA’s MedWatch (a system where users can report issues with medical devices), and the laboratory has recently posted a standards database for personal protective equipment (PPE) as a first step toward becoming the nation’s PPE clearinghouse. The ultimate plan, she said, is to have an app or other vehicle that could link into this clearinghouse and enable users to submit reports that would be linked to specific products. Mark Shirley commented that MedWatch is the gold standard in health care for reporting incidents, one with which health care providers are quite familiar. He noted, though, that the challenge with disposable respirators is

that users are more likely to simply throw a defective one away and get a new one rather than report it. He suggested an effort to educate end users, safety professionals, and infection control practitioners on the need to report issues would be fruitful.