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U.S. Department of Health and Human Services

MedSun: Discussions with Healthcare Providers

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Discussions with Healthcare Providers

Here you will find information healthcare professionals have shared with MedSun about the safety and effectiveness of a variety of medical devices.

Discussions with Healthcare Providers

Respiratory Protective Devices: Small Sample Survey Summary

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Introduction

There are a number of respiratory protection devices (RPDs) used in hospitals in the United States to help protect healthcare providers and other staff who may be exposed to patients with airborne infectious diseases such as tuberculosis (TB) and influenza. One type of RPD that is commonly used is the N95, which is a type of air-purifying respirator (specifically a filtering facepiece respirator (FFR)) that protects by filtering particles out of the air the user is breathing in. These devices are generally single-use products and are inexpensive when compared to the other types of RPDs. The N95s which have been cleared by FDA for healthcare uses are labeled as surgical N95s.

Not all healthcare providers are candidates for using the N95. When staff have certain skin sensitivities, allergies, or facial hair, N95 use is generally not appropriate because of the inability to obtain good N95 respirator fit. In these cases, healthcare providers are often assigned to wear a powered air-purifying respirator, called a PAPR, which uses a blower to force the ambient air through air-purifying elements and requires rechargeable batteries. PAPRs have both disposable parts that are discarded after use and parts that may be reprocessed and reused. Like PAPRs, elastomeric respirators have parts that may be reprocessed and reused. Specifically, elastomerics have respirator facepieces made of a natural or synthetic elastic material.

Regardless of the type of RPD used, there are requirements for staff to have knowledgeable personnel evaluate their needs and fit them for the specific RPD type that is most appropriate for them (through a process known as fit testing). Training about how to put on, wear and discard the RPD is also necessary before these products are used, and the training is often accompanied by a short test. Hospitals report that fit testing and training should be repeated yearly in order to assess any changes in the size or type of RPD needed and to reinforce training. Fit testing is also done under certain conditions that may fall outside the annual schedule for the staff, such as in cases of substantial changes in weight or development of allergies. PAPRs do not require fit testing.

The FDA conducted a small sample survey using telephone interviews with infection control directors, members of their staff and other health care providers to learn about experiences with RPDs used by healthcare providers. The purpose of this survey was to help the FDA learn about the use of respiratory protective devices (RPDs) from health care providers involved in infection prevention and control in hospital settings. Specifically, this survey sought to better understand the factors that influence selection of different types of RPDs, specifically PAPRs, N95s and elastomeric respirators at any one healthcare institution. The FDA was also interested in learning about practices of extended use and reuse of surgical N95 respirators.

The survey questions focused specifically on the hospitals’ use of these products for routine and pandemic situations, staff training and fit testing programs, advantages and disadvantages of the products, standard protocols, end-user complaints, and suggestions for improvements. Information from the survey was intended to help FDA obtain a better understanding of users’ practices and perspectives in the hospital environment. In addition, the survey findings were intended to assist in preparing for the FDA’s 2014 summit for federal agencies and other stakeholders involved in infection prevention and control and/or in the regulation and certification of RPDs.

Methodology

Staff from a small sample of hospitals participating in FDA’s Medical Product Safety Network (MedSun) were interviewed by telephone to obtain information about their hospitals’ use of RPDs. Respondents from six different hospitals (located in the West, Midwest, Northeast, Mid-Atlantic, and Southwestern areas of the U.S.) participated in the voluntary survey. The sites were selected to provide geographic representation from hospitals in various parts of the U.S., a mix of university-based and non-university-based hospitals, and representation from both adult and pediatric hospitals.

Among the sites that responded, four hospitals have over 500 beds and two hospitals have between 100-500 beds. One of the hospitals serves only pediatric patients, while the other five provide care for either adults (3 hospitals) or for both adults and pediatric patients (2 hospitals). One of the respondents represented a major hospital system that includes both large and small hospitals as well as outpatient clinics. Half of the hospitals were university-based and the other half were not. All respondents had experience with respiratory protective device programs and knowledge about their hospitals’ policies and procedures.

The respondent sample included staff from infection control and prevention departments and, in some cases, staff from risk management, environmental health and safety, and/or respiratory therapy departments. For all six hospitals, the directors of hospital infection control, who were generally physicians, participated in the calls. In many cases, nurses who were specialists in infection control and prevention also participated.

Overview of Responses

History of RPD Use
Nearly all respondents indicate they have been using some form of RPD for at least 5 years. Many hospitals indicate that their RPD activities ramped up with the 2009 H1N1 influenza pandemic and that they continue to review and update their policies and procedures as needed. One hospital indicates that its staff has been using N95s since the 1990s when a regional outbreak of multi-strain TB increased awareness of the need for worker protection.

Types of RPDs Used

All of the respondents indicate that they use the following RPDs for protection of healthcare staff and others who could be exposed to patients with airborne infectious diseases as part of their work:

• N95 Respirators - which respondents describe as single-use RPDs used in the vast majority of cases;

• PAPRs - which respondents describe as being used for staff with facial hair, skin sensitivities, or difficulties with fit using N95s, and for staff who have not been fit tested for an N95 (such as for some physicians who have not been fit tested and are visiting one of their patients).

In all six hospitals, the majority of RPDs assigned to staff are N95s, supplemented by a much smaller number of PAPRs for specific staff requiring them. Some hospitals indicate that they also use other respirators such as the N99 when additional filtration is required.

Elastomerics have been considered for purchase at some of the hospitals surveyed. Hospital staff are generally aware of these products because of their use in protecting certain laboratory staff or because they are often on display at the professional conferences they attend. Respondents indicate that the hospitals that have reviewed or tried elastomerics consider them to be impractical for use at their hospitals, either because of their costs, the discomfort in wearing them, and/or because of the reprocessing needed for these products.

One respondent adds their hospital used elastomerics briefly during the H1N1 pandemic. However, they decided not to continue using them after that due to staff complaints that they were uncomfortable and because of the elastomerics’ reprocessing needs.

Types of Healthcare Providers and Other Staff Assigned to Use RPDs

The respondents indicate that staff who are likely to interact with patients with airborne infectious diseases such as TB or influenza are generally identified at the time of their staff orientation. These staff are then scheduled to be fit tested by trained staff in order to determine the specific type and size appropriate for them. They are also trained to use the type assigned to them, which may be done using self-study programs or group training sessions. There is often a short test associated with the training. Additional fit testing and training take place on a yearly schedule. Generally compliance with fit testing and associated training are monitored by supervisors, by a contractor hired for implementing the RPD program, or by the hospital’s human resources department. The types of healthcare providers assigned to wear RPDs generally include physicians, nurses, respiratory therapists, phlebotomists, emergency department staff, operating room staff, radiology staff and others.

In addition to healthcare providers, the types of staff who are fit tested and trained to use RPDs also include non-clinical staff. Examples include housekeeping staff, chaplains, students, security staff and “sitters” who stay in the hospital room with certain patients for day or night shifts when needed.

Amount of Time that Staff Wear an N95

Responses varied as to how long staff would wear each N95 respirator and when these products should be discarded. Some respondents indicate that one would be used “for each interaction with the patient, which could be a few minutes or as long as 2 hours.” Others report that the respirator would be used for the duration of the shift, as long as the respirator was not soiled/wet or had not otherwise lost its integrity. One respondent says that they follow the manufacturer’s guidelines, with up to 24 hours of wear allowed in some cases.

Respondents from several hospitals indicate that wear time would depend on the specific precautions in place for the patient (e.g., airborne, contact, droplet precautions or combinations of these). One hospital’s staff indicates that they would like more information about the wear times for RPDs and situations when they should be discarded.

Areas of the Hospital for RPD Use

The respondents generally indicate that RPDs would be needed for staff in any part of the hospital where patients with TB or other airborne infectious diseases could be located, and they generally included the following list of places:

• Patient rooms/general ward;

• Operating rooms and other procedures areas;

• Intensive care units;

• The emergency department; and,

• Isolation rooms (e.g., rooms designed for use with patients diagnosed with infections such as TB).

Protocols for Use of RPDs

The respondents for all hospitals indicate that they have at least one written protocol concerning the use of RPDs. These protocols have different names, such as respiratory protection plan, isolation plan, airborne isolation guidelines, and pandemic plan. Generally, the hospital staff indicate that they have separate protocols for routine use and pandemic use of RPDs.

Reprocessing for PAPRs

Respondents from all six hospitals indicate that they had procedures for reprocessing PAPRs. The procedures generally involve respiratory therapy staff and/or sterile processing staff. Often there is an initial wipe down of the devices done by the staff person who has used the PAPR before it goes to respiratory therapy and/or sterile processing for additional reprocessing including battery charging and testing. Respiratory therapy staff from some hospitals are responsible for the cleaning and reprocessing of their own PAPRs and may store them on their unit rather than at a more central location.

Staff Complaints about RPDs (Use and Supply Concerns)

Most of the respondents indicate that they have not sent any complaints to RPD manufacturers. However, there have been some complaints from staff that were mentioned, including the following:

• An infection control nurse indicated that although staff did not experience substantial discomfort or headaches with the N95s when worn for routine use, N95s may be difficult to wear for extended periods of time as may be needed during pandemic flu.

• An infection control physician has found PAPRs difficult to use while communicating with patients because of the sounds coming from the PAPR. This physician has also experienced difficulty hearing over the sounds from the PAPR when listening for certain patient symptoms and conditions such as heart murmurs.

• One staff person suggests streamlining the PAPR design and reducing the size of the hood to make it easier for staff to wear.

• An infection control physician mentions that when PAPRs are indicated, the health care worker needs to go through a series of sequential steps successfully: find a PAPR with a clean hood, have it fit correctly, be able to turn it on, and ensure that the batteries are charged. Fulfilling all of these conditions has been a problem at this hospital from time to time.

• During the H1N1 event in 2009, many types of RPDs needed to be tried during staff fit testing. The hospital was conserving N95s by putting surgical masks over N95s. Some staff found it somewhat difficult to breathe when using a surgical mask over the N95 during that period.

• A physician mentions that PAPR batteries only last a limited time, and specifies the optimum battery time as about 8 hours according to the manufacturer’s instructions, with less time than that available once the battery has been worn down after recharges. This physician indicates that this could present challenges during situations when batteries cannot be recharged, such as during power outages. One respondent recommends that the PAPR should show the battery level, allowing the user to know how much charge is available.

• One staff person mentions that certain RPDs contain latex, making those products inappropriate for staff with latex allergies.

Fit Testing and Yearly Training

The hospital staff described their yearly fit testing/training programs and how they monitor these programs to ensure that the appropriate staff have received their initial and yearly follow-up training and fit testing. They also describe the procedures for additional, ad hoc fit testing for staff who may need a different size or type of RPD due to changes in skin sensitivities, substantial weight gains or losses, or facial hair changes (such as shaving off or growing a beard or sideburns).

As mentioned previously, the need for clinicians and other staff to undergo training and fit testing (as appropriate) for RPDs depends on the likelihood of their interacting with patients with airborne infectious diseases. These clinicians and staff are initially trained and fit tested during their orientation period. After that, they are put on a yearly schedule for additional training/fit testing (e.g., tied to their start date or birthday).

One infection prevention specialist indicates that the healthcare system has raised their staff compliance levels for training and fit testing to almost 100%. They did this by requiring that staff who didn’t have their fit testing/training renewal completed by a certain day (such as one week after their birthday) would not be allowed to report to work. The respondent indicates this policy works well for their hospital in increasing compliance.

Some hospitals use contractors to implement the training/fit testing, while others use hospital staff for this program. The environmental health and safety staff are often involved in this process, and human resources or occupational health staff are involved in some cases.

Two hospitals indicate that they are working on improvements to their monitoring programs to assure high levels of compliance with the training/fit testing, as well as with wearing the RPDs properly when they are needed. They indicate their compliance programs are undergoing some changes in an attempt to improve their compliance results.

Comments from some respondents indicate that they find the yearly fit testing requirements to be labor intensive and/or expensive for their hospitals. One hospital is in the process of analyzing the numbers and types of changes that had taken place for their staff during the recent yearly fit testing for an internal review.

One physician notes that nurses may often go into a TB patient’s room for what they think will be a very short time that can turn into an extended period once they see what the patient’s needs are. This respondent indicates that this situation could cause either TB exposure for the nurses if they did not wear the RPD when entering, or could lead some nurses to avoid interacting with infected patients as frequently as they would if they didn’t need to wear the RPD when entering the patient’s room.

Patient Perceptions
Hospital staff indicate that while they make concerted efforts to explain to patients and their families the reasons why some staff wore RPDs, they continue to have difficulties with patient and family perceptions. The following list shows some of their comments:

• RPDs (especially PAPRs) can seem frightening or upsetting to children and some adults, including family members as well as patients;

• Communications between patients and the staff wearing RPDs for respiratory protection can be more difficult than without an RPD; and,

• There may be cultural factors that influence reactions to staff wearing RPDs, with persons from certain areas of the world requiring additional information and reassurance about the reasons for using the protection.

The respondents mention that they have worked with patients and families to alleviate fears and concerns about RPDs (such as by putting signs on patients’ isolation room doors describing the reasons for the RPDs, having surgical masks with teddy bears for children to wear, and developing standard ways for addressing questions and concerns from patients and their families). One person also mentions the importance of steps her hospital has taken to inform family members and other visitors about their own needs for respiratory protection when visiting patients with certain infections.

Suggestions for the FDA Summit concerning RPDs

The respondents were asked to describe what they thought were important issues to be addressed at the 2014 FDA summit on RPDs. The following is a list of their comments:

• One respondent says that fit testing is difficult and expensive, and that there is a struggle with keeping up with the right product/right size annual fit and training requirements. Their staff indicate a desire for innovative products that could perhaps help with these and other limitations of the currently available products.

• One hospital’s staff indicates that they would like to see new products on the market that are more comfortable to wear and that address the concerns about costs and time needed for cleaning and reuse. On a related note, staff from a different hospital would like to see products on the market which are easier to reprocess and more acceptable to patients than those they use now. They also would like to see better instructions as to how long devices may be worn and when they should be discarded.

• One respondent expresses concern about the reliability of the supply of RPDs in high demand situations. A second respondent indicates interest in information about the reliability of the supply of RPDs during outbreaks.

• Respondents representing one healthcare system that has affiliated outpatient centers indicate that the manufacturers of the surgical N95s that are cleared for use by healthcare providers need to provide clearer information about the distinctions from other N95s so hospital purchasers select the right products for their staff. This comment applies to the electronic catalogs that purchasers use during the selection and ordering process and to the product labeling and packaging. The respondents mention that staff working for outpatient clinics may be less aware of the differences between the types of N95s than

• Many hospital staff are, and that there needs to be greater awareness about the differences in these products.


• One physician mentions the growth of RPDs used by scientists and students working on nanotechnology products, and indicates that those staff are very vigilant in their use of RPDs (primarily PAPRs). The physician recommends that FDA staff become very aware of this kind of use of RPDs since it could be expected to grow with increased use of nanotechnology products.

• One respondent indicates that it would be helpful to provide hospital staff with information designed to ensure that PAPRS are charged after use and are not left on the units. The respondent says that although PAPRs should be sent to the location for reprocessing and eventual reuse, they are often left on the units and therefore not available when needed.

• One infection control director expresses concern that TB is not suspected early enough, leaving unprotected staff subject to TB exposure. This respondent is interested in solutions to address this problem, and suggests that the FDA meeting in 2014 provide updates about the epidemiology of various respiratory infections and descriptions of other current related research.

• Another respondent asks for information about respiratory protection for staff who use shared work stations, especially in emergency room settings.

• A respondent suggested a review of the work of state regulators such as CAL-OSHA regarding respiratory infection prevention control.

Summary

The staff from the six hospitals included in the survey provided wide ranging and very useful insights about their experience, successes and challenges in implementing RPD programs with their staff and in developing information about RPD use for their patients. They were interested in RPD product enhancements and future innovations to make the products easier to use and more acceptable to staff and patients. They stated some concerns about the reliability of the supply of these products and about the costs of the annual fit testing programs compared to the benefits staff receive from annual testing. Respondents often had specific suggestions regarding the kinds of information they would like to have available about RPD products and programs. They were generally very engaged in the interviews and often acknowledged their hospitals’ progress in developing their RPD programs, especially over the past few years. In addition, they were interested in what they could learn from other hospitals, manufacturers, and epidemiologists, as well as from pertinent state and federal agencies.

Survey Limitations

Although the findings add to FDA’s knowledge of clinical experiences and provide perspectives about the use of RPDs, the small sample size of the survey limits the findings. In view of this limitation, the respondents’ perspectives may not represent the perspectives of all RPD users.

Therefore, these findings represent only one piece of information. No conclusions can be made about how RPDs are used in the broader clinical environment based on this report alone. Instead, the report should be considered along with other information that may include adverse event reports, scientific publications, enforcement/compliance information, and other data sources that are part of FDA’s monitoring of device performance.

Surveying device users is one of many tools the FDA uses to evaluate the public health impact of potential problems associated with the use of medical devices. Typically, small sample surveys are used to collect qualitative information on post-market experiences of clinicians or facilities with medical device performance or use. The FDA selects survey respondents based on their experience with the topic or device, their availability, and their willingness to participate.

The FDA makes our scientific, medical, nursing, and engineering staff aware of the survey results as needed. If the FDA believes there is a significant risk of adverse events as noted from the survey, we will combine those results with data gained from other sources. The FDA will work with the manufacturers and health care provider organizations to make important information known to the clinical community. Additionally, the FDA continues to work with manufacturers to ensure the development, testing, and promulgation of methods for reducing the risk associated with these devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these devices, the FDA may convene a group of clinical, scientific, and regulatory experts to discuss any necessary action.

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Updated August 22, 2014

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