Article

Applicability of Food & Drug Act to AT Reuse

Program Operations

Webinar: Applicability of Food, Drug and Cosmetic Act

to the Reuse of Assistive Technology Devices Indicators of Quality for AT Reuse

3.4  Device Tracking (Inventory) The program uses an accurate and efficient method to track the inventory of available devices.

3.6  Device Recall Management The program has written procedures that are applied consistently to track device recalls and to identify and contact individuals who received recalled devices from the program.

  

 

 

 

This article is based on a Pass It on Center Policy Series Webinar from March 26, 2008. The presenter, Jessica Brodey, is an attorney and public policy consultant whose practice focuses on developing and implementing policies to improve access for persons with disabilities in education, work, community and daily living. She is a consultant to the Pass It on Center, and director of advocacy and governmental relations for the Assistive Technology Industry Association. The webinar transcript has been edited into article format.

 

Today I'll be talking about the Food, Drug and Cosmetics Act, and how that may or may not apply to assistive technology (AT) reutilization. This webinar is the first in a new policy series that will take place over the next several months.

 

We will discuss the Food and Drug Administration regulations and how those regulations impact reutilization activities. We have made specific recommendations for how to best handle reassignment, refurbishment and recycling programs. We have a separate but similar set of guidelines for exchange programs and some cautions to those who may be involved in remanufacturing.

 

The Food and Drug Administration, as many of you are aware, has jurisdiction over the manufacture and distribution of medical devices as defined in the Food, Drug and Cosmetic Act. Some AT devices fall within the definition of a medical device.

A medical device is, according to the law, "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar-related article which is recognized in the national formulary, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of man or other animals."

This definition is fairly broad. And everyone thinks, "I still am still not one hundred percent sure what a medical device is. What does that mean?"

 

And I'm here to tell you that the definition of a medical device is very broad. Many of the things that we deal with in our reutilization programs could, in fact, constitute medical devices. That is why we’re addressing the FDA and what something being classified as a medical device might mean to your program. When a medical device is regulated, there are a whole host of things that the FDA may require that you do. This is usually commercial distribution of medical devices, so many of you are not impacted by that.

 

Commercial distribution of medical devices requires registration. There's often a requirement of device listing. Certain types of devices need to have premarket notification or approval. You have to sometimes engage in studies for clinical studies to make sure that those devices are safe. There's quality system regulation. There are labeling requirements. And there are medical-device-reporting requirements.

And I know that all of us sitting here looking at this see this entire list, and we start to panic about how all these things are going to affect our programs.

 

One of the things that is important to note is that the guidelines that we are presenting here today are to help you avoid those activities that are going to trigger a situation in which you might be subject to all of these complex FDA regulations.

 

The FDA regulations are relevant to any entity using a medical device in a commercial activity. When we talk about activities, using a medical device, we mean manufacturing, remanufacturing, distributing, redistributing, packaging, repackaging, labeling relabeling. "What is the definition of 'commercial' for this purpose?"  I do not have a direct definition of "commercial" that came out of the regulations unfortunately. I think it is safe to say that "commercial" generally means distributed in commerce. And it usually indicates for a fee.

 

It is possible, however, that not-for-profit distribution could trigger the FDA regulations. In most cases, commercial is associated with a fee. Some of your organizations, however, do take voluntary contributions or do charge certain fees.

So in thinking about your organizations and how the FDA regulations apply, you do want to think about your own structure and if you are setting up your money systems in such a way that makes it appear that your organization is engaged in commercial distribution of a medical device.  Another important point is that the FDA also has some regulations about devices. It classifies them as either for prescription use or for over-the-counter use.

 

If a device is approved by the Food and Drug Administration, as for prescription purposes only, it is approved only for dispensing under the supervision of a licensed practitioner.  It is irrelevant to what kind of an activity or program you run.  So if a particular wheelchair is classified as a prescription wheelchair, and your program in any way touches that device, that device is only supposed to be distributed or utilized in any manner under the supervision of a licensed practitioner.  

 

We've created a set of basic guidelines to help your programs that are involved in reutilization activities navigate the pitfalls. These have been divided into three categories.  We lumped device reassignment, refurbishment and recycling activities into one category because there are very few differences in the actions these programs should take to steer clear of the FDA requirements.  Device exchange, however, is a little bit different because of the way devices pass through the program, so we put that in its own category. And we have dealt separately with device remanufacturing as well.

 

Inform Consumers

 

We hope that our recommendations will aid in understanding the steps you should take to avoid liability and possibly falling under FDA regulations.  So the first recommendation we have for the first category of activities is to inform consumers. We encourage you to warn your buyers about the risks of acquiring reutilized devices; clarify what warranties, if any, are offered with the devices. Create and post a list of best practices for consumers who are acquiring reutilized devices to educate the consumers and to protect reutilization programs.  This is really critical because informed consumers understand what they're doing. It makes it more difficult for them to later come back and say, "We didn't know about this."

 

Know Your Inventory

 

We also encourage you to know your inventory, to be aware of all of the different types and brands of products available through your program.  This is critical, because if you are distributing prescription devices, you need to know that so that those devices are appropriate.

 

If you have only wheelchairs or only bedpans or a mix of things coming in, it is really critical that you just know what things are coming through. Your ability to understand what is passed through your program and what you have in stock will affect your ability to appropriately respond and address issues.

 

Follow Sanitization Guidelines

 

We encourage you to address sanitization guidelines. We will be posting some guidelines, and products should be sanitized according to the manufacturer's specifications. We strongly encourage you to stay on top of this because it is one of the things that can trigger potential liability.

 

I see a question posted regarding sanitizing: "Is it in the better interest to post and clearly state to the consumer that the item has been refurbished and sanitized or best to leave it as a silent acknowledgment?"

 

I think that it's always better to let people know what you are and aren't doing. If all you are doing is merely sanitizing the device and reassigning it, then that's an important thing to note and to inform consumers. If you are refurbishing it, you can let consumers know that this is, number one, not a new device; number two, that it has been restored to manufacturer's specifications, and that it has been sanitized.

 

Track Warnings, Bans and Recalls

 

Now, this is where knowing your inventory really comes in as well. We encourage you to track Class 1 FDA-issued warnings, bans, or recalls. So you need to know if the devices in your inventory are subject to warnings, bans, or recalls.  One way you could do that is to subscribe to the FDA alerts of medical device recalls or FDA e-mail notifications. So those of you who are interested can click on the link at the bottom of this article to view recalls and subscribe to the alerts.

 

If you have any recalled or banned medical devices, we strongly encourage you to immediately remove them from your inventory. If you have those devices in your possession, recalls generally ask you to send it back, and sometimes you get a new device, or it can be repaired.  If a device is banned, you should not be distributing it. Often there's either some compensation or some other corrective action that is taken so that you can turn that device back in and not have it as a loss to your program

 

If you distribute a recalled device and someone is later injured by that device, that is potential liability. We encourage you to try to identify the warnings, bans, and recalls. For those who refurbish, remanufacture, and recycle, you may be able to fix the problem identified in the recall to the manufacturer's specifications. You can simply recycle the parts not affected by the recall. You can utilize those links that are provided through the FDA to get the product fixed or replaced and then use that new product in your program.

 

Maintain Records of Customers and Inventory

 

We encourage you to maintain business records of your inventory and your customers. AT reutilization programs should keep ordinary business records of inventory and customers. A flexible database with search capacity will allow the program staff to locate medical devices that have been recalled that you suspect may be in your inventory.  Search capacity will enable a designated staff or volunteer to search for medical devices that appear on the FDA medical device recall alerts; notify customers who may have received these devices about the FDA alert; and advise customers about appropriate steps they can take to stop using the device, to dispose of them, or to have them replaced.

 

Disclose What You Have Done to the Device

 

Most of you know that you are not guaranteeing that your work is going to last and that the products won't break in the future. But one thing that you do, to some extent, is guarantee is that you haven't caused harm to the product through your repairs and that the repairs you have done are to the manufacturer's specifications and standards, that they have been done sufficiently and adequately.

 

But again, it's important to notify consumers what it is that they're getting and what they're not getting. If you're making assertions about what you've done, it's also important to know what warranties you are or are not providing. You may say, "It's given as is. We have done our best to restore these to manufacturer's specifications. We cannot guarantee how long these will continue to work," et cetera.

 

DC Shares includes a written disclaimer that equipment is in as-is condition.  It is  important to let people know what steps you have taken and what you haven't. Have they been inspected in some way? You can say, "These devices have not been inspected. They are being offered as is. We have sanitized them, but we have not done any tests to ensure how well they are functioning." That's an important disclosure to make because consumers then need to assess that and understand what promises you are making along with that delivery.

 

Comply with Regulations for Prescription Devices

 

Earlier I had mentioned that some devices may be prescription, and it's important to know your inventory so that you can identify what devices are prescription, what devices may be regulated, what devices might be subject to recalls.  When you're doing all of this, part of this is also making sure that you are complying with prescription-use practices. If you are utilizing prescription medical devices in your program, you should ensure that you are only dispensing those devices under the supervision of a licensed practitioner.  Now, please note that this language -- "supervision of a licensed practitioner" -- is a little vague. It doesn't say it must be a medical doctor. It doesn't say who specifically is a licensed practitioner. It may be enough to just have the recommendation or a referral from an appropriate specialist.  But you need to make sure that you are taking steps that are consistent with what your program practices are -- to only distribute those prescription medical devices under the supervision of a licensed practitioner.  You need to determine what products you feel are appropriate and what level of supervision is also appropriate to your program. What that does is it allows you to say, "Yes, we were under the supervision of a licensed practitioner."

 

It may be sufficient that you have a note from a doctor, a conversation, or something that lets you know what particular type of device is needed by the user. If you have evaluations that have been done or "we have an evaluation," that may be sufficient for your program.  It's what your program, in consulting with others in your field, determines is appropriate and normal in your area. However, those devices are distributed the first time around, you should be engaging in similar practices to make sure that you are not giving out those devices in a manner that departs from the normal standard of care and subjects you to liability.

 

Have Qualified Technician Perform Repairs

 

This is really an important, important point for those engaging in refurbishment. All repairs or adjustments made to devices should be performed by a qualified technician who examines and understands the manufacturer’s specifications. So they should not be done by the kid who volunteers every once in a while who walks into the shop and who's never looked at the specifications before. It needs to be someone who has been trained in some manner, who knows how to look at these specifications, who can understand when it says a particular type of a bolt, if they found the correct bolt to place on that wheelchair or that device.  So again, a qualified technician should be used to safely service or repair the device.

 

Audience question: "Wheelchairs, AAC devices, standers, et cetera, all require a written script from a physician to approve the purchase of the device. Does that mean that they are all regarded as medical deviced and require approval the second time around by an SLP or physician?”

 

Here's an important distinction to make. Some things require a prescription so that insurance will pay for it. The device itself was not necessarily set up for a prescription use.  If a device merely needed a prescription the first time around so that insurance would pay for it, that's not what we're talking about. What we're looking for is when the FDA approves a particular medical device for persons with specific disorders or conditions. The device will say at the bottom of the approval application "for prescription use only" or "over-the-counter use." If it's over-the-counter use, you do not need to have any kind of a licensed supervisor, an SLP or a physician, to oversee or supervise that distribution.

 

If it says that this particular device is for prescription use only, then you need to have evidence from a qualified prescriber. It doesn't necessarily have to be a new SLP or physician evaluation. An old recommendation that had been written up by an SLP or a physician specifying the need for this particular type of device may be sufficient for you. The intent is to match the user to devices appropriate to his condition.

 

If you have some other person doing evaluations for seating and positioning who is appropriately licensed, those devices that are specifically specified as prescription use are the ones that you have to be concerned about.  Many wheelchairs are not for prescription use. I think pretty much all AAC devices are not marked as for prescription use. Not every device is a medical device.

 

Chris Brand has written that all DME mobility devices are allowed to be purchased by a private party in Georgia. I can only say that there are absolutely mobility devices that are marked by the FDA for prescription use only. It is not the majority of them, but there are some, particularly the ones that are electric and motorized. Most of the non-motorized wheelchairs are not for prescription use. However, some of them with highly specialized seating may be. What is critical is that you do check these devices. You cannot assume, that a prescription is not required. You should check.

 

Again, Chris is saying that electric wheelchairs can be bought without a prescription. That is true for some of them. There are absolutely some wheelchairs listed on the FDA Web site that are for prescription use only. And if you are found to be distributing those particular devices without the supervision of a licensed practitioner,  it is a violation of federal law. And that is a very important point to note. And so  everyone should be checking this and be on top of that.

 

Comment from Chris: He thinks that liability relates to the person's prescription matching correctly what was distributed. And if you are the person handing out the wheelchair and it is a prescription device, the supervision could be that you've taken a written prescription from the person or you have a reference by a doctor. That may be sufficient that those two things have matched up, but you have to in some way have integrated the process of supervision for the distribution of that prescription device.

 

Report Adverse Events

 

The FDA does not require that reutilizers report incidents of serious injury or death involving a device to the FDA or to the device manufacturer. However, reutilization programs should keep records of any complaints or reports of such incidents.  We encourage you to do more than just simply keep these reports. While there is no duty for you to report this either to the FDA or to the manufacturer, we strongly encourage you to report that to the manufacturer because the manufacturer, once notified, has an obligation to report that adverse event up to the FDA. And if adverse events aren't appropriately collected and reported, someone could be injured as a result.  If a faulty device design causes a serious injury or death, it is important that the manufacturer becomes aware of the danger.

 

We also encourage you to consider partners. If you work closely with local vendors, those vendors could be a great asset in helping you to identify what devices might be prescription medical devices. They can help you if you're seeking supervision from licensed practitioners, if you're trying to track FDA recalls and report medical device incidents.

 

Understand and Apply State Statutes and Regulations.

 

Some states have chosen to regulate the reutilization of medical devices. This is an additional layer on top of what the FDA is doing. You should consult your applicable state statutes and regulations to be sure that you are in compliance with your state and local laws.

 

Comply with End-of-Life Disposal Regulations

 

End-of-life recycling is often a part of the recycling and reutilization process. If you are refurbishing, many times you will break down old devices, you'll use some parts that are still good in refurbishing other units, and you'll want to dispose of what’s left.

 

If a program is recycling parts to use them to refurbish or remanufacture devices, you should be aware of and comply with the state's solid waste and e-waste laws and regulations when disposing of the parts that cannot be reutilized. Many states have electronic-waste laws and laws regarding waste in general. There are standards about where and how you can dispose of different types of waste, and whether or not you have to pay charges. Look into those and make sure that you comply.

 

Applicability to Exchange Programs

 

Again, we separated out the guidelines for exchange programs. We felt that there were slight differences for exchange programs because they are not directly distributing to consumers. The focus is on educating consumers of the risks.  The devices made available for exchange continue to be subject to any warnings, bans, or recalls issued by the FDA. Therefore, a program that facilitates the exchange of a device subject to a warning, ban, or recall, might be subject to liability.  What we encourage you to do is to place that obligation or that risk on the consumers by educating them.

 

As you can see, many of these recommendations are the same. We encourage you to inform your consumers, warn them about the risks of acquiring devices, clarify what warranties are being offered, and follow a list of best practices and guidelines for consumers.  For example, you can encourage them to get the serial numbers off the products and then check those with the manufacturers to find out the last state that they were aware that that device was in. You can determine whether its still possible to get replacement batteries for those devices.

 

You can request that sellers clarify what warranties, if any, are offered with the device. And you should also encourage the consumers to ask about the warranties and for copies of user guides.

 

Once again, we encourage you to know your inventory. This time it's a little bit different. We're not encouraging you to know your inventory so that you can track every little thing that's happening.  But if there are some obvious issues.  If there's a very large ban or if there's a big recall that's happened and you have a lot of those devices going through the program, you may want to flag your system in some way to let people know that they should not be distributing these devices, that they should be subjecting them to the recalls. You also want to inform your consumers about particular devices that may have passed through your Web site, that these are subject to recall and to be careful about certain model numbers or model years. If you are aware that a banned device is available for exchange or something has been recalled because it was dangerous, that device should be removed from the exchange site.

 

Joy Kniskern wrote that seller agreements might be good. And I think what she is suggesting is that you  encourage some sort of a seller agreement; that they state that this is not a prescription device; that they state that they own the device; that they do not believe it's subject to any bans or recalls.  You can give them a series of questions that they have to check off and assert before they are allowed to post that device to your site.

 

Again, address sanitization guidelines. Because none of the exchange programs actually put their hands on these products, you cannot sanitize the products yourself. What we are suggesting is that you inform both buyers and sellers about appropriate steps that they should take to sanitize devices. You can encourage your sellers to sanitize. Maybe you can encourage them to have a little box checked about whether or not the device has been sanitized prior to distribution.

 

Once these devices are received, the sanitization guidelines are something that can help buyers know what they should do with their devices before utilizing them. We do think that it's a good idea that you encourage your sellers to sanitize all devices that they exchange and that you post sanitization guidelines as a notice to both the sellers and the buyers.

 

Once again, we encourage you to keep an eye on and track Class 1 FDA-issued warnings, bans, or recalls. For this particular effort, this is really not so that you're going to be following and pulling every little thing that might be posted. But this is something that you may want to post on your Web site, have a hot-button area of the latest recalls that you think might be relevant to the exchange Web site and post them there. You should have a mechanism for removing medical devices from your listing if you're notified that the listed product is recalled or banned. You should have a procedure for accepting customer complaints. If a consumer calls and tells you that one person is repeatedly doing this over and over again, you need a policy for addressing that concern.

 

Again, we encourage you to maintain business records of inventory and customers. Exchange programs should know whether or not a particular type of device passed through the program, which consumer possesses the device, and how to contact that consumer to inform him or her of the recall or warning.  Again, this is not always something that is feasible or possible. We do encourage you do this to whatever extent it is possible. If there's a way for you to track it, if this information is being passed through your program, then we encourage you to maintain that as a normal business record.  If any of that information is strictly individual to individual, whatever information you can capture about who the seller was and what the device was, this may be relevant to then pass along because perhaps the seller can reach out and contact people. You could put a link on the exchange site to FDA Class 1 alerts listing.

 

Sample language for things like seller agreements or best-practice documents will be added to the PIOC web site.

 

Once again, comply with prescription-use practices. This is not something that is incumbent upon the exchange program because they are not the ones doing the distribution. But you should be informing consumers that prescription medical devices should only be dispensed under the supervision of a licensed practitioner.  If you ask those listing products for sale to verify that the device being listed is not a prescription device, that is one way to minimize risk to the consumer. We're not suggesting that you double-check all of these assertions. You can say, "We asked. They said it was not prescription. That's what we understood it to be. We only allow things that are not for prescription to be listed." And if someone checks "yes" it's for prescription, you may want to have some kind of a flag that disables that from listing in your system.

 

Report adverse events. Again, this is not a situation in which the programs that are engaged in exchange activities should be doing all the reporting or worried about all of these things that are happening.  However, if you get any complaints or reports of incidents, we encourage you to keep records of those. And if a faulty device design causes a serious injury or death or really anything that you think is relevant or important, we do encourage you to reach out to the manufacturer and pass on that complaint so that they are aware of that danger. Once things are reported to the manufacturer, they are obligated to report to the FDA.

 

Again, understand and apply state statutes and regulations. There may be no applicable FDA regulations or statutes governing reutilization activities. But some states have chosen to regulate the reutilization of medical devices.

 

State statutes and regulations may also govern contract relationships and warranty promises for the exchanges that happen through your program. Exchange programs should understand how these laws may impact exchanges and inform consumers of these laws.  So if you're in a state that's always ‘buyer beware’, you may want to put a warning up there for your consumers that says, "When you buy this device, understand that no warranties are being given, that you're buying this ‘as is’."

 

Reutilization programs should also consult the applicable state statutes and regulations to be sure that they are in compliance with state or local laws for doing business. Are you properly licensed to conduct your activities over the web?

 

Guidelines for Device Remanufacturing.

 

We broke this out as a separate category because basically what we have to say is that, if you are engaged in remanufacturing, that means taking a device and building it to a new specification that's different from the original manufacturer's specification, this is absolutely not a recommended activity. It becomes a new device.  Because of the complexities involved in remanufacturing, we encourage AT reutilization programs to avoid remanufacturing. If you choose to remanufacture, it will be critical to identify and comply with the FDA regulations for remanufacturers, including registration, device listing, premarket notification or approval as appropriate, labeling guidelines, quality system regulations, and reporting.

 

Question from Joanne Willis, Touch the Future, ReBoot. "Is adding a switch to a radio considered remanufacturing?" No, it is not. There is a definition of remanufacturing out there. Again, things that are considered accessories to the original device that that aid in the operation of the device, such as mounting things, adding switches, et cetera -- that would not be considered remanufacturing if the original underlying device is built to the original manufacturer specifications.  You're looking at the underlying device, not accessory add-ons that are to help with the operation of the device. Swapping out wheels could be considered remanufacturing. And again, using completely different size wheels and different screws to attach those wheels, that would be perhaps an example of remanufacturing.

 

 

RESOURCES

 

View recalls or subscribe to the Class One alerts at

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm

 

INTERNET LINK WARNING

Please note that by selecting an Internet link you will be directed to an external site, and the Pass It on Center does not control the content of the site.

 

DISCLAIMER

This work is supported under a five-year cooperative agreement # H235V060016 awarded by the U.S. Department of Education, Office of Special Education and Rehabilitative Services, and is administered by the Pass It On Center of the Georgia Department of Labor – Tools for Life.  However, the contents of this publication do not necessarily represent the policy or opinions of the Department of Education, or the Georgia Department of Labor, and you should not assume endorsements of this document by the Federal government or the Georgia Department of Labor.

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Title: Applicability of Food & Drug Act to AT Reuse
Module: Program Operations
Author: Jessica Brodey
Audience: Administrator
Sub Title:
Procedure:
Organization Source: Pass It On Center
Last Reviewed: 05-05-2010 4:24 PM