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FDA Hosts Medical Device Reprocessing Webinar



March 27, 2015 by David Lennarz

On March 24, 2015, the U.S. Food and Drug Administration (FDA) offered a webinar to review the agency’s guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” that was published last week.  The webinar was presented by Elaine Mayhall from FDA’s Office of Device Evaluation and Geetha Jayan from FDA’s Office of the Center Director.  Mayhall and Jayan said the purpose of the guidance was to provide recommendations to device manufacturers for developing reprocessing instructions that can be easily understood and followed by users because proper reprocessing plays an important role in reducing the risk of patient infections from reusing devices.

Mayhall and Jayan said the recommendations in the guidance are applicable to four types of devices:

  1. Reusable devices that are initially supplied sterile to a user and require the user to reprocess the device after each patient use
  2. Reusable devices that are initially supplied non-sterile to a user and requiring the user to process the device prior to initial use, as well as after each use
  3. Reusable devices that are intended for reuse by a single patient and need to be reprocessed between each use
  4. Single-use devices that are initially supplied non-sterile and require a user to process the device prior to its use

These devices must be cleaned and then either sterilized or disinfected, depending on their contact with patients. The processes used to clean, sterilize, or disinfect a particular device must be validated by FDA.  Cleaning, disinfecting, and sterilization are distinctly different processes and require separate validation.  FDA recommends that device manufacturers consider reprocessing needs in the early stages of designing a device and use designs that make it easy for users to affectively implement the process.

The new guidance replaces FDA’s 1996 guidance titled “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities.”  The guidance was expanded to include information regarding the validation of reprocessing methods and instructions and provides greater clarity on documentation to be provided in different premarket submissions (510(k), PMA,  de novo, etc.).  Mayhall and Jayan said the guidance puts specific emphasis on the importance of proper cleaning, testing worst-case scenarios, and designing devices that are less challenging to reprocess.

Mayhall and Jayan discussed FDA’s six criteria for writing reprocessing instructions:

1. Instructions should reflect the intended use of the device.

What constitutes appropriate instructions depends on many factors, such as if the device has direct or indirect contact with patient, the design of device, the  intended use of the device, if any toxic chemicals were used on the device, etc.

2. Instructions should advise users to thoroughly clean the device.

Adequate sterilization and disinfection depend on a thorough cleaning.

3. Instructions should indicate the appropriate microbicidal process for the device.

The appropriate microbicidal process for a device depends on the device’s Spaulding Classification.  A device can be critical, semi-critical, or non-critical.  Critical devices are introduced directly into the blood stream or contact a normally sterile tissue or body-space during use.  Critical devices should be thoroughly cleaned and sterilized after each use.  Semi-critical devices contact mucous membranes or non-intact skin.  They usually do not penetrate tissues or enter normally sterile areas of the body.  Semi-critical devices should be thoroughly cleaned and sterilized.  If sterilization is not possible, semi-critical devices can undergo high-level disinfection.  Non-critical devices only contact intact skin and do not penetrate it.  Non-critical devices should be thoroughly cleaned and then undergo either intermediate or low level disinfection, depending on the contamination.

4. The instructions should be feasible and only include legally marketed devices and accessories

Device manufacturers should consider the location where the device is likely to be used.  Disinfection and sterilization methods need to be feasible for users to implement, and the equipment and accessories needed to implement the instructions should be readily available to users.  A manufacturer should not suggest something like radiation sterilization, as this is usually only available at a manufacturing facility and therefore would not be readily available to users.

5. Instructions should be comprehensive

Mayhall and Jayan said the instructions should help the user understand precisely how to conduct the entire reprocessing procedure safely and productively.  The instructions should be so simple and specific that a lay person or patient could do it in their home.  The instructions need to cover every detail. For example, if a user needs to rinse the device, the instructions should indicate the necessary water quality and temperature and how long to continue rinsing.   The instructions should describe how and when to disassemble a device and should list the cleaning agents or the class of cleaning agents to use.

The instructions should instruct the user to inspect the device after reprocessing and, if the device does not appear clean, to repeat the process or dispose of the device.  Mayhall and Jayan said the instructions should always include the manufacturer’s contact information.

6. Instructions should be understandable

Instructions should use simple language and should be clear, logical, sufficiently detailed, and written in sequential order.  Mayhall and Jayan suggested including charts, diagrams, and pictures.

FDA will review the reprocessing procedures and instructions for a device when it conducts the pre-market review for the device.  All cleaning, disinfection, and sterilization validations should be completed before the pre-market application is submitted.   Mayhall and Jayan identified particular documentation required for specific pre-market submissions:

PMA, HDE, and de novo: Protocols and complete test reports of validation of reprocessing instructions

510(k): Manufacturers of a subset of devices should include data to validate their reprocessing instructions.  Validation data may also be requested for substantial equivalence.

IDE: Summary of the validation of reprocessing instructions

Mayhall and Jayan ended the webinar with three key messages of the guidance:

  1. Reusable device labeling should include instructions for reprocessing and reusing devices and accessories safely
  2. All cleaning, disinfection, and sterilization processes should be validated
  3. Labeling should provide sufficiently detailed reprocessing instructions

Registrar Corp is a U.S. FDA consulting firm that helps medical device establishments comply with FDA regulations.  Our Regulatory Specialists can help device manufacturers determine whether or not FDA’s reprocessing guidance applies to their products, as well as review their device labels for FDA compliance.  For questions or assistance with FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177 or receive help from a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

         

The U.S. Food and Drug Administration (FDA) recently evaluated two types of Okanagan Specialty Fruits, Inc.’s genetically engineered apples and six types of J. R. Simplot Company’s genetically engineered potatoes. Okanagan reduced the levels of enzymes in its apples that cause browning associated with cuts and bruises.  J.R. Simplot reduced enzymes in its potatoes to help resist black bruise spots, as well as engineered the potatoes to produce less acrylamide, a chemical found to be carcinogenic in rodents.  On March 20, 2015, FDA announced that it had “concluded that these foods are as safe and nutritious as their conventional counterparts.”

Genetic engineering, also known as biotechnology, refers to methods used by scientists to modify the traits or characteristics of an organism.  According to FDA, genetically engineered plants have been part of our food supply since the 1990s. Genetically engineered food and food ingredients must comply with the same FDA regulations and safety standards as other food.  FDA offers a voluntary biotechnology consultation process to help manufacturers ensure their genetically modified foods are safe and compliant.  According to Dennis Keefe, director of FDA’s Office of Food Additive Safety, “the consultation process includes a review of information provided by a company about the nature of the molecular changes and the nutritional composition of the food compared to traditionally bred varieties.”

FDA has completed approximately 166 biotechnology consultations to date.  FDA has found that, when compared to foods derived from traditionally bred plants, genetically engineered foods are generally equally nutritious and do not pose a greater risk for allergic or toxic reactions.

Currently, there is no FDA requirement for food manufacturers to indicate whether food has been genetically engineered on product labels.  FDA is in the process of reviewing two citizen petitions requesting that the agency change its labeling requirements for genetically engineered foods.  For the time being, food manufacturers can voluntarily include this information on labels.

In 2001, FDA published a voluntary labeling guidance to assist manufacturers of genetically engineered food in determining what information is required and what information is optional.  The guidance states that under section 201(n) of the Food, Drug, and Cosmetic Act (FD&C Act), FDA requires food labels to disclose all material facts about the food and thus:

  • If a bioengineered food is significantly different from its traditional counterpart such that the common or usual name no longer adequately describes the new food, the name must be changed to describe the difference.
  • If an issue exists for the food or a constituent of the food regarding how the food is used or consequences of its use, a statement must be made on the label to describe the issue.
  • If a bioengineered food has a significantly different nutritional property, its label must reflect the difference.
  • If a new food includes an allergen that consumers would not expect to be present based on the name of the food, the presence of that allergen must be disclosed on the label.

The guidance also helps manufacturers determine proper language for labeling their products as being genetically engineered as to not be misleading.  FDA has found that consumers prefer the term “biotechnology” over “genetic modification” or “genetic engineering”, and they prefer to know why genetic engineering was used on the product (increased nutrition, resistance to discoloration, etc.).  So, a preferable statement to identify a genetically engineered food could be: “This product contains corn developed using biotechnology to increase resistance to insects.”

FDA warns that the amount of a genetically engineered ingredient within a food item can determine whether a statement is misleading.  For example, FDA may consider it misleading to state that a food includes nutritionally improved soybeans if the soybeans make up only a small portion of the ingredients.

Registrar Corp helps food and beverage manufacturers comply with U.S. FDA regulations.  Registrar Corp’s Label and Ingredient Review Specialists can review food labels for FDA compliance, including identifying statements that could be considered misleading to consumers.  For assistance with labeling or any other FDA regulations for food and beverage companies, contact Registrar Corp at +1-757-224-0177 or speak to a Regulatory Advisor 24 hours a day at www.registrarcorp.com/LiveHelp.

         

On February 25, 2015, the U.S. Food and Drug Administration (FDA) announced that it is requiring multi-dose diabetes pen devices and their packaging to bear a warning label stating “For single patient use only.”   Sharing multi-dose diabetes pens between patients puts patients at serious risk for spreading infection, as blood may be present in the pens after use.  Over the past six years, FDA has been notified of multiple instances where a large number of patients were potentially exposed to bloodborne pathogens as a result of insulin pens beings used on more than one patient:

  • In 2008, a U.S. Army facility found that 2,114 patients were potentially exposed
  • In 2011, the Dean Clinic in Wisconsin found that 2,345 patients were potentially exposed
  • In 2013, the Veterans Health Administration found that 716 patients were potentially exposed

FDA feels that the large number of patients partaking in this risky activity is partially due to a lack of appropriate warning on labels.  In an attempt to spread awareness of the risk of sharing multi-dose diabetes pens, FDA is requiring the “For single patient use only” warning to appear in the following locations:

  • The label attached to the pens and
  • The pen cartons
  • The prescribing information
  • The patient Medication Guides
  • Patient Package Inserts
  • The Instructions for use

Registrar Corp assists medical device establishments with U.S. FDA regulation compliance.  Registrar Corp Label Review Specialists can review medical device labels for FDA compliance and help determine whether a specific product is required to bear the “For single patient use only” warning label.  For assistance with medical device labeling or other FDA regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/LiveHelp

diabetes, devices, fda, label

List of diabetes medicines with multi-dose pen devices (fda.gov)

         

On Sunday, March 15, 2015 at the Seafood Expo in Boston, Bruce H. Andrews, Deputy Secretary, U.S. Department of Commerce, announced a new Presidential Task Force plan to combat international seafood fraud and illegal, unreported, and unregulated (IUU) fishing.

According to the National Oceanic and Atmospheric Administration (NOAA), about 90% of seafood consumed in the United States is imported from abroad and about half of that is wild-caught.  A recent study by Oceana found that 20 to 32 percent of wild-caught seafood imported to the U.S. comes from illegal fishing, whether it is fish caught in closed areas, threatened or endangered fish, or fish caught with illegal gear that damages marine ecosystems.  Along with this, Oceana conducted DNA tests on seafood samples over the past two years and found that nearly a third of the tested seafood products were misrepresented and mislabeled according to U.S. Food and Drug Administration (FDA) regulations.  In 2014, Oceana released an interactive map to show the global reach of seafood fraud.

The Presidential Task Force, which includes the NOAA, FDA, and many other U.S. governmental agencies, plans to create a seafood tracking system that will track where, when, and how seafood is caught, as well as its path from capture to U.S. entry, such as where it is processed and stored.  At first the tracking system will be implemented for species with a high risk for fraud or illegal harvest.  The Task Force will then use what it learns from the implementation to expand the tracking system to all seafood. The Task Force would eventually like the tracking system to include a way of informing consumers about the seafood they purchase.

In addition to the tracking system, the Presidential Task Force will take measures to “create and expand domestic partnerships to detect black market fishing and seafood fraud” and strengthen enforcement, according to a White House blog post.

With increased governmental surveillance ahead for the international seafood industry, it’s prudent for industry professionals to take steps to ensure compliance with U.S. requirements.  Registrar Corp helps seafood companies comply with FDA regulations for exporting seafood to the USA.  Registrar Corp can help seafood companies create or review their required HACCP plan, review seafood labels for FDA compliance, and more.  Meet up with Registrar Corp at the Seafood Expo to learn more about FDA’s regulations for seafood companies and how we can assist.  Contact +1-757-224-0177 or tweet @RegistrarCorp.

Have questions, but can’t make it to the show?  Live help is available 24 hours a day at www.registrarcorp.com/LiveHelp.

         

Dunkin’ Donuts has decided to remove the whitening agent titanium dioxide from its powdered sugar donuts as a result of a shareholder proposal by As You Sow which expressed concern that titanium dioxide is commonly a source of nanomaterials.  According to As You Sow, an advocate group that promotes environmental and social corporate responsibility, nanomaterials may result in greater toxicity for human and environmental health.

A representative of Dunkin’ Brands told the Huffington Post that the ingredient used in Dunkin Donuts’ powdered donuts does not meet FDA’s definition of a nanomaterial. “Nevertheless, we began testing alternative formulations for this product in 2014 and we are in the process of rolling out a solution to the system that does not contain titanium dioxide,” the representative said.

Dunkin’ Brands Chief Communications Officer Karen Raskopf told USA Today that the decision to remove titanium dioxide was largely due to investor input on the matter.  According to CNN, about 19% of Dunkin’ Brands shareholders supported a resolution for the removal of titanium dioxide from products last year.

Titanium dioxide is a U.S. Food and Drug Administration (FDA) approved color additive.  FDA allows titanium dioxide to be used in food as long as the amount of the colorant in the food does not exceed 1 percent by weight.  Because titanium dioxide is exempt from certification, the specific name of the colorant does not have to be listed on labels of food that contain it. Instead, labels may list exempt color additives collectively as “artificial color”.

Titanium dioxide is also approved for use in cosmetics and is commonly used in personal products such as sunscreen and toothpaste.  Despite its frequent use, titanium dioxide is a suspected human carcinogen and is reportable under the California Safe Cosmetics Act of 2005. Cosmetic manufacturers must disclose any products intended for distribution in California that contain titanium dioxide to the California Department of Public Health (CDPH).  According to the California Safe Cosmetics Program Product Database, titanium dioxide has been reported as an ingredient in 48,863 products.

Registrar Corp assists food and cosmetic companies with FDA regulatory compliance.  Registrar Corp Label and Ingredient Review Specialists can help determine the regulatory status of specific additives and ingredients, as well as review product labels for FDA compliance.  For questions or assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/LiveHelp.

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