Author: mpizzi25

New FDA Guidance on Gowns Intended for Use in Health Care Settings

By: Sarah Smit, Study Director

FDA recently released an updated guidance document to clarify regulatory requirements for gowns. This new guidance impacts manufacturers that currently sell gowns as well as manufacturers that intend to market gowns in the future. The guidance clarifies what types of gowns fall under the class of medical devices that require a 510k prior to being introduced into the market (Class II). Table 1 describes which class of medical device (Class I or Class II) a gown would belong to based on terminology used to describe the gowns on the market claims:

Table 1: Terms used to describe and market gowns by medical device classification
Table 1

Isolation gowns are generally Class I devices as they are intended to be used in general patient care situations where the exposure risk is low and the barrier performance is low or minimal. Isolation gowns can become Class II devices if additional claims are made that describe the gown as providing moderate or high barrier protection.

Gowns previously listed as Class I that now qualify as Class II must go through the 510(k) submission process and provide data to substantiate their claims. To determine which class a gown would belong, it is recommended to follow the 1993 and 2015 Guidance Documents for Surgical Gowns. These documents can be found at: and

The 510(k) should include barrier performance plus physical and safety testing with the recommendations shown in Table 2 and Table 3:

Table 2: Performance testing requirements as outlined in ANSI/AMMI PB70 for the classification of barrier performance of surgical gowns, isolation gowns, other protective apparel, surgical drapes, and drape accessories.
Table 2

Performance testing shall comply with the sampling requirements outlined in PB70. A statistical sampling plan is necessary to justify test quantity and test locations. Typically, 32 test samples from each test location are chosen. All critical and non-critical zones, including the back of the gown as outlined in PB70, must be tested. The back of the gown can also be classified as non-protective which warrants no testing. The labeling of the gown must identify the level of liquid barrier protection per ANSI/AMMI PB70.

Table 3 FDA recommended physical and safety testing to ensure gown performance.
Table 3

The deadlines for manufacturers proposing to market, or are currently marketing, Class II gowns under the new guidance are as follows:

Feb. 2, 2016: Submit a 510(k) request for the gown to FDA

Feb. 17, 2016: Obtain acceptance of the 510(k) by FDA

Jun, 1, 2016: Obtain 510(k) Clearance for the gown

Tribute to Dr. Scott Sutton; Review of Bioburden Contamination Control

Scott Sutton, PhD, was a well-respected and influential thought leader in the microbiology industry. He was a consultant and trainer in CGMP, investigations, environmental monitoring, and contamination control for pharmaceutical companies for over 30 years. He gave many presentations on these topics, and received multiple awards for his publications in microbiology journals and industry trade publications. For the past 22 years, Dr. Sutton served on the United States Pharmacopeia committee on Microbiology, serving as Vice-Chair from 2000 through 2010.

Dr. Sutton passed away on October 19, 2015. Shortly before his passing, Dr. Sutton published an article regarding the process of controlling bioburden contamination in a manufacturing facility. In memory of this great contributor to the microbiological and pharmaceutical industries, we have highlighted a few key points from this recent article. To read the full article by Dr. Sutton, please click here.

Bioburden contamination is an aspect of product manufacturing that must be considered for all medical devices and pharmaceuticals. Processes to attempt to control the contamination through validations and monitoring in each phase of production should be in place to ensure the bioburden contamination remain at an appropriate level. Maintaining control of the bioburden is far too complex for a single individual or even department to accomplish by themselves, so training and adherence to these processes is vital in ensuring any bioburden contamination stays at a manageable level.

Building Design & Control: Bioburden control in a facility should optimally begin with the design and construction of the building. Areas in a facility that are able to be tightly controlled should be surrounded by areas that are not as easily controlled. An important part of this design is the placement of air filters to ensure the pressure differential between areas allows the aseptic air to be pushed out. An argument can be made that the placement of filters in a terminal location allows for better air cleanliness, however, the ease of monitoring and maintenance should also be considered when placing filters. Facilities should also be designed to prevent personnel and materials from using the same paths to minimize cross-contamination. This type of building design works best when airlocks and pass-through chambers are put in place, as they help maintain bioburden barriers.

Water Systems: The water system of a facility also contributes to the control of bioburden contamination in a building. The properties of water make it an easy avenue for microbial contamination. Because water is often used as a raw material and a utility, frequent maintenance and monitoring are necessary to contain the bioburden resulting from the use of water. The last design element Dr. Sutton discusses is the location of the product when it will be at its most vulnerable point in the manufacturing process. Protection of the environment around the product at this point by an isolator or other environmental controls aids in maintaining control of the bioburden.

Equipment: Once the design of the facility is in place, the next factor to analyze is the equipment being used. In addition to the tasks the equipment is required to perform, the ability to clean and sanitize the equipment should also be considered. Choosing equipment and placing it in locations that allow for easy cleaning and sanitation aids in the exclusion of microorganisms from coming in contact with the product. Fill lines and equipment should also be organized in a way that will not allow for mix-ups or cross contamination between filled products and raw materials. One way to minimize contamination is to eliminate the human factor, and utilize equipment to fill the product.

Cleaning Processes: The sporicides and sanitizers that are used in bioburden control processes need to be tested to show their efficacy against the microorganisms in a facility; generally, this is a four-step process. The first step is a suspension test. This test analyzes the effectiveness of a sanitizer against indicator organisms as well as other organisms found in a facility. This test aids in selecting the best sanitizer for your product and also determines the most resistant microorganism. The second step is a coupon study, performed on materials present in the facility. This study evaluates the effectiveness of the chosen sanitizer against the organisms found in the suspension test. The third step is a “mock” sanitation study to provide real-world analysis of the effectiveness of the sanitizer. The last step of testing the sanitizer is ongoing environmental monitoring. This is usually done by the annual trending of the environmental monitoring to show the bioburden is being adequately controlled.

Personnel: The main source of bioburden contamination during manufacturing process comes from the personnel involved. It is estimated that an individual at complete rest sheds about 10,000 particles per cubic meter. Any movement or activity increases this number exponentially. Because of this, it is important to be careful in selecting gown material and also gowning methods. Simulated trainings, proficiency testing, and monitoring of the operators and their involvement in the manufacturing process are vital to make sure human contamination of the product is limited. Use automation in manufacturing to avoid the chance of mix-ups causing cross-contamination and limit the need for human intervention. To assist in monitoring the bioburden in these processes, bioburden testing should be performed on all material coming into a facility, and checked against existing bioburden acceptance criteria prior to use.

Process Monitoring: Monitoring activities and processes to control bioburden are indirect, so it is important to partner with a reputable testing facility that is knowledgeable on current industry standards in creating and carrying out these procedures. USP has recently released a chapter to help break down laboratory operations into a series of systems, that when paired with other USP chapters are useful in determining the best practices for a facility.

Thank you, Dr. Scott Sutton, for your contribution to the microbiology community.


Need Additional Guidance? Nelson Labs employs many scientists who actively participate in the creation and modification of industry standards who can help interpret the standards and apply them to specific products and facilities.


Updates to the Bioburden Standard ISO 11737-1; Significant Additional Guidance. P.S. What Happened to the Microbiologists?

Did you miss MD&M Texas? Check out the Tech Theater presentation given by Nelson Laboratories scientist Martell Winters. As biological and tissue products and combination products become more prevalent, new questions are often asked related to microbiology that are different from those asked for traditional medical devices.  As these questions become more common, additional guidance is necessary for the industry.  Much of this additional guidance will be added to the new version of the ISO bioburden standard, 11737-1.  Some of this information must be added due to the lack of microbiological expertise in the industry.  However, when the information is added it will not be easily understood by non-microbiologists, meaning that some understanding must be present to fully appreciate it. Following are some main points to be added to the standard which will be discussed in the Tech Theater presentation.  Also some discussion will be provided regarding the microbiological expertise in the medical device industry.

  • Low bioburden products
    • How low is low?
    • Why are they different?
  • How should the bioburden test be performed?
    • Review of raw materials/manufacturing process
  • Optimization of bioburden testing
    • Increasing sensitivity (e.g. volume factors)
    • Pooling of bioburden samples
  • Reviewing bioburden data
    • Addressing TNTC values
    • Addressing spreaders/lawns

EN14683 Harmonizes Bacterial Filtration Efficiency and Differential Pressure with ASTM F2100

Over the past several years the European Committee for Standardization (CEN), has been working to align the Bacterial Filtration Efficiency (BFE) test requirements for medical facemasks (EN 14683) with its counterpart committee requirements in the U.S. (ASTM F2101).  The goal was to update the standard and align the pre-conditioning parameters in both Europe and the U.S. so that manufacturers would only need to test their facemasks once to meet both requirements.  The good news is that the CEN committee has recently released their latest revision of EN 14683 standard aligning these requirements.

Previously, manufacturers had to conduct tests using two methods for BFE and Differential Pressure to comply with the standards in Europe and the U.S. This was due to the difference in preconditioning requirements as shown in Table 1. Needing to conduct two very similar tests ultimately cost manufacturers both time and money.  As a result of the 2014 revision for EN 14683, which aligned preconditioning requirements to the ASTM F2100 standard, manufacturers can now use one, combined BFE and Differential Pressure testing method.

EN14683 Harmonization Preconditioning Requirements

Table 1: EN14683 Harmonization Preconditioning Requirements

Because of this revision which aligns the method of preconditioning, manufacturers  can now perform BFE and Differential Pressure testing at Nelson Labs using one test code, one testing method, and only one test report will be generated. The final report will list both standards and all results required such as, both mmH2O/cm2 and Pa/cm2 units for Differential Pressure.

One important note, although the preconditioning requirements align the BFE and Differential Pressure testing methods, the tests that are necessary to perform will remain different between the two standards. Depending on your mask claim, the performance results required will also remain different between the two standards as shown in Table 2 below.

EN14683 Harmonization: Test Requirements and Performance Requirements by Type in EN14683:2014 and Level Barrier in ASTM F2100-11

Table 2: Test Requirements and Performance Requirements by Type in EN14683:2014 and Level Barrier in ASTM F2100-11

Manufacturers who wish to market their medical face masks in both the United States and Europe will still need to perform the tests required by both standards and meet the differing performance requirements—listed in Table 2.

Nelson Labs will continue to be able to provide all testing required by both standards.  Please contact your Nelson Laboratories sales representative if you have any questions.

Visit Nelson Laboratories at OMTEC 2014

Nelson Laboratories will be exhibiting at the OMTEC 2014 show, June 11-12, 2014, at the Donald E. Stephens Convention Burst-TestCenter (Chicago) in booth #812.

Presentation: Sterile Barrier Packaging: Common Causes of Failures and How to Correct Them 

During the two-day conference and showcase Wendy Mach, Packaging Section Leader at Nelson Laboratories, will be presenting in the Knowledge Center on Sterile Barrier Packaging: Common Causes of Failures and How to Correct Them on Wednesday June 11th from 1:30- 3:30 pm.

This presentation will provide a brief overview of the types of tests that are available to validate a Sterile Barrier System. Though it is not expected, failures can happen while performing these tests. The presentation will take a look at common failures within these tests, provide some understanding behind why they happen, and suggest ways to correct and avoid them.

Nelson Laboratories will have technical representatives available in their booth ready to assist orthopedic device manufacturers with any questions about testing their devices and packaging.

Discussions may include:

– Validating the manufacturing residue cleanliness for orthopedic devices
– Biocompatibility testing for medical devices
– Reusable device sterilization and cleaning validations for medical devices
– Packaging validations
– Lot release testing
– And more

Don’t forget to stop by booth #812 to speak with Nelson representatives.


Donald E. Stephens Convention Center
5555 North River Road, Chicago, IL 60018
Booth #812

ISO Meeting and Biocompatibility Standards Update, Mishima, Japan

by Thor Rollins, Biocompatibility Expert, Nelson LaboratoriesGC

I recently attended ISO (International Organization of Standardization) meetings in Mishima, Japan to participate in updating various biocompatibility testing standards. These updates are intended to reflect the best care and safety possible, regarding biocompatibility, for any given device. The updates discussed at this series of ISO meetings included the following:

  • Compound Limits: Safety limits need to be determined for each compound that can come off of a medical device during use. Currently, Ethylene Oxide (EO) gas is the only compound listed in an ISO standard that has a residual limit. However, the plasticizer diethylhexyl phthalate (DEHP), a plastic compound used in medical devices such as tubing, will likely have a limit set in the future.
  • Cytotoxicity Test: A test wherein a device, or portion of a device, is applied to living cells to see how the cells react to the materials used in the manufacture of the device. This is considered the most sensitive biocompatibility test and is a great screening tool for medical devices. The current cytotoxicity tests are qualitative; however the standard is now emphasizing the use of a quantitative version of the cytotoxicity test.   The early results from these quantitative methods have shown an increased sensitivity over the qualitative methods. A series of round robin tests are being planned to verify that the quantitative test method is consistently more sensitive.  These tests will then be followed by a discussion of clinical relevance of making the test more sensitive.
  • Different Population Limits of Chemicals: A person’s healthy limits for chemical exposure from using a medical device can vary depending on body size. For this reason, new standards for these limits are being discussed to introduce new limits according to the physical characteristics of the target population of the intended recipient. Currently, the industry standard is set for an average person weighing 70 kilograms (154 pounds), much higher than the weight of a child or infant. The new standard will consider the weights of intended populations, such as small children and infants.
  • Gas Path Devices: When using delivery systems that are intended to supply gases needed for medical purposes, compounds from those devices can come off and enter the human body. For this reason, it is necessary to standardize the effects of these compounds, in addition to the amount of compounds that will be allowed to be released during use.

Standards are reached through global consensus and serve to make the industry more efficient and effective, in addition to providing additional safety. As these standards are implemented, Nelson Laboratories will ensure the standards are met with the same quality as before.