May 13, 2015

A conversation with the DOC and FDA

A conversation on device labels with friends identified by three letter abbreviations.

I have enjoyed being a go-between connecting friends in the DOC with friends at FDA for a conversation about device labeling. FDA reached out for some informal feedback. I in turn asked the DOC to share thoughts to help balance what I share. 

This essay is a summary of that conversation. My goal is simply to foster wider, open, and respectful conversation between all. 

Labels = Instructions
Labels are being used here to means the instructions for devices. Currently, it is an everyone creates their own kind of label world when it comes to the format of instructions.  So the question is would some standardization help? I was fairly sure I am not the best person to ask. Fortunately, I’m only one of a number of folks they called, and the hope was I would ask around. I am a fan of patient voices in the process. I think that FDA is a reaching out, for users views, is fantastic.  

My 2¢
My thoughts, based on no particular expertise, are that some flexible suggestions to design instructions may help. Particularly if it is more a template, which could ease developing, reviewing, and using device labels. 

Obviously focusing on simpler to write, review and use is better than harder to write, more time-consuming to regulate and difficult to sort through. I’m for well indexed, simple, effective language and clear illustrations. I don’t think anyone is looking for more onerous regulation.

I suspect that more complex tools need more detailed instructions, and simple stuff needs less. The risk of using the devices incorrectly matters, more risk needs better instructions (and better design up front.)  Syringes are fairly simple, pumps require a more complex set of user actions and artificial pancreas when it get here, I hope will bring sophistication AND simplicity of use - we will see.

What do people in the community think?

I informally polled the Diabetes Online Community (DOC) in three broad areas:
The process of considering instruction policy 
What is important in the label
How should the instruction be accessible

My hope was that asking these would also generate some thoughtful, open ended comments. The DOC did not let me down. Over a hundred folks took the survey and many shared detailed views. WoHoo! Still this is not a scientific survey. There are some obvious biases like it was done online, in English, it was quickly tossed together, etcetera. 

Still - It does help sift through ideas - what floats to the top and what sinks to the bottom. To do that, I used a weighted average.  I have listed all in the tables below. 

The top response had to do with what is in the label, specifically clear instructions for use and risk. Three of the remaining to 5 spots 3 were about how to get information suggesting folks see value in multiple ways to do that, phone support, a copy online and online support center. Lastly, the top five includes one item on the process: Keep the process simple enough to avoid fueling cost increases to comply with rules. The top 5 response are in various shades of green below.  

Clear easy, to access and don’t fuel costs with instruction processes. 

Next are, include patients, have image based instructions and have clear uniform instructions for reporting device errors to FDA.  Followed by including a printed copy with the device and standard format elements. 

The final five still all score in the range between important and more important than average, suggesting tall this stuff matters. Standardizing the formats of instructions with tables of contents, etc. is second to the bottom. Risk adjusting and FAQ seem less important to this group as well. Multi-language ranked last, and the comments maybe provide some insight why.

A number of comments spoke to the volume of labeling that consumers thrown away. One spoke directly to languages and paper use.

Comments
Each comment received is included below, unedited, because each individuals’ view matters. I have group individual comments into broad themes.

The most common theme of individual comments relates to accessing information:  
  • The very first item of these questions is most important - get input from end users - and not just college graduate level people - not everyone has a college degree or extensive knowledge even about Diabetes (like the people working for the manufacturers. They may know the product upside and backwards and how it works could be deep in their brain, but think about who your end users are - it may include children, and granted parents will likely be there helping them, but sometimes it's a school nurse who does not have extensive Diabetes device expertise. Almost anyone should be able to pick up the instructions and "get it" with relative ease.
  • An 'at a glance' version, like the one that came with our Dexcom is extremely helpful for devices which come with large instruction manuals. This is something that reviews the very basic instructions for use and the most common troubleshooting issues.
  • I wonder if this shouldn't apply to software, too. As apps become more common, users need ready access to manufacturers for comments, complaints and issues.
  • Yes I do. It's important people get educated on pumps and cgms. I know it seems low risk but you are pumping drugs into your body that could kill you if you don't check your blood sugar often!
  • Where is the line between the labeling and the user manual? The user guide needs to be pretty thorough. But they are never written well enough or thorough enough to cover every situation. Having access to online and, if possible, phone help is key for more complicated devices like insulin pumps. I am very much in favor of adjusting documentation requirements with device complexity, risk level, and even price point. Requiring a consistent table of contents sounds like specious precision that might actually inhibit the transmission of useful info.
  • You tube videos are a nice to have - I just do not have time to look at them. I completely rely on the manufacturer's documentation that accompanies the product. Instructive product videos generally should be clear - not someone blabbing and making jokes about the product (although humor always helps people learn better and gives the user a better memory of something that may not be so fun to deal with. (Last year Delta did a really cute pre-flight instruction video - everyone actually watched it. It was fun.) 
  • Visuals must be intuitive - photo pictures are better than drawings and it's ok to also include Words with the photos to explain the process. (e.g. I just looked at a visual guide for the Medtronic Mio and Quick Set pump tubing- they were so confusing (these entire products are confusing!) Quick start up guides and FAQs are also great. They should be based on actual user experience (e.g. obtained during clinical trials or general issues that people often encounter.)
  • Consistency helps us understand.
  • the data is ours and we should have a right to use it how we please
  • Publish "ingredients"-like list of materials that may have adverse interactions (i.e. adhesives -- what type is used? certain types are irritating for certain people. if wireless technology is used, what is the RF frequency (transmit and receive) and power level? also, don't make labeling so restrictive/subject to approval that it can't be modified over time with minimal effort to provide more details, troubleshooting FAQs, etc, that are discovered to be helpful after the device is on the market

The volume of printed material and ongoing use of devices and supplies.
  • I know it is impractical, but after the first few months of using the devices, I don't look at the printed information. Can there be a way to cut out the cost of printing labels on " refills"?
  • Please don't use this as an excuse to increase packaging.
  • I get very frustrated when i have pump sets coming with HUGE manuals every time i buy them. i have been using the same exact sets for a decade now, and they still give me the manual. it would be helpful and also more friendly for the environment if an educated patient (by the pump company or whatever) would not need to receive this every time. please also note that i am not from the U.S.
  • Minimize the paperwork that comes with the devices to essentials and include URLs to more in depth info. I never read all of the info that comes with my devices because there's too much of it. Ain't got no time for that!
  • Other languages are important for people speaking those languages but I'm in the US and I speak English and I think it's a waste of paper to include 10 different languages on instructions for me & my kid. But I realize it could be very challenging from a manufacturing and packaging perspective to differentiate which language to provide - maybe just include English ad Spanish in the US and perhaps a scanning code to quickly view other languages online? However, some people may not have the ability to to access this.) 

Cost and burden
  • I gave a slightly lower "importance level" on reporting device issues to the FDA on the actual product thinking that people can go to the FDA website for that information but even that can enormously confusing for an end user who is not familiar with all of the different areas of the FDA. So the FDA should have user-friendly standardized language including the appropriate website that all device manufacturer's use on their product labels.
  • Keep costs low so that more Type 1 diabetics have a chance at a somewhat "normal" life, with less testing and better BG control!!! It's all about dignity and the right to a healthy life! 
  • This isn't a real problem at present. Adding requirements here is a mistaken burdening of resources.
  • These are great as long as they don't further slow down the process of getting our devices. Hurry up with the artificial pancreas already!!!!!!!!!!!!

Usability
  • Minimum size, contrast of font color to make it easier to read. Size, quantity must be specified in metric units also.
  • Key word searchable DFUs should be available online.

Support
  • I have an Omnipod pump and Dexcom. I love the support from Dexcom, Omnipod is easy, but their online support has been condescending. Keeping it simple, with online info and support works for me.
  • Customer service reps - must have experience with the device (even better if they actually live with the disease and use the product but this may not always be feasible.) (E.g. On numerous occassions, I have called Omnipod (Insulet) Customer Service and most of the time they are clueless and it's like a battle getting information from them. Customers calling a manufacturer for help may be very upset, they not be feeling well or have a sick child to deal with. They should be trained on compassion skills.

Survey Results
The First table list the survey questions in the groups and order asked. People were asked to respond to each as Unimportant, Matters a Little, Important, More than Average, Very Important. 

The top 5 based on a weighted average are in descending shades of green. The rest are shade from yellow shifting to shades of to orange. All that color may make it confusing and a second table ranks all regardless of the group in descending average rank order. 




Group & Questions
Average Score
Rank
About the Process Making Device Label Rules - How important is it to:


Include patients in the process of creating label regulations.
4.16
6
Have standard formats for elements of device labels, like tables of contents.
3.94
10
Adjust label requirements for risk, less rules for low risk devices.
3.86
13
Keep process simple enough to avoid fueling cost increases to comply with rules.
4.46
4
About What is in Device Labels: How important are:


Clear instructions for use and risk.
4.64
1
Have standard formats for elements of device labels, like tables of contents.
3.85
14
Frequently Asked Questions.
3.87
12
Have clear uniform instructions for reporting device errors to FDA.
4.10
8
Outlining the information needed for a meaningful device event report.
3.93
11
About Accessing Device Labels: How important are:


There is a printed copy that comes with the devices.
3.94
9
Access to a customer support phone number
4.60
2
Make a copy available online
4.51
3
Provide online support center
4.39
5
Image based instructions
4.11
7
Multilingual resources
3.56
15




Question 
Average
Clear instructions for use and risk.
4.64
Access to a customer support phone number
4.60
Make a copy available online
4.51
Keep process simple enough to avoid fueling cost increases to comply with rules.
4.46
Provide online support center
4.39
Include patients in the process of creating label regulations.
4.16
Image based instructions
4.11
Have clear uniform instructions for reporting device errors to FDA.
4.10
There is a printed copy that comes with the devices.
3.94
Have standard formats for elements of device labels, like tables of contents.
3.94
Outlining the information needed for a meaningful device event report.
3.93
Frequently Asked Questions.
3.87
Adjust label requirements for risk, less rules for low risk devices.
3.86
Have standard formats for elements of device labels, like tables of contents.
3.85
Multilingual resources
3.56