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.

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!!!!!!!!!!!!

  • 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.

  • 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
About the Process Making Device Label Rules - How important is it to:

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

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

There is a printed copy that comes with the devices.
Access to a customer support phone number
Make a copy available online
Provide online support center
Image based instructions
Multilingual resources

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

April 27, 2015

What matters to you about device instructions?

Friends at the FDA called. 

Yes, I have friends there. 

They were looking for thoughts on device labeling and wondered if I could ask around. 

Sure, what are friends for? 

I would love to help funnel back thoughts to them from the DOC, not just my 2¢. It is all very informal but I hope, maybe, we can help them organize their thinking if they get to more formal asking. 

Willing to help?

Here is the little of what I know, labels are the instructions on how to use a device, what it is intended to do and what to do if there is a problem.  

RAPS aka Regulatory Affairs Professionals Society notes that unlike drugs devices do not have standardized labeling. “Under 21 CFR 801, medical device manufacturers are required to label their products with certain information, but the format and layout of that information is for the most part left up to the discretion of the manufacturer.” 1

Given that devices range from fairly simple to very complex it may make sense not to have a one size fits all standard. My BG meter is not the same level of sophistication as the CAT scanner at hospital, even if both are medial devices.

In this case FDA is asking about home-use devices. In the diabetes world that is a wide range of things from meters, insulin pens, pumps, CGMs, uploading software and more.

In a recent document FDA said this about home-use device labels:
Medical device labeling provides safety information, instructions for use, and/or other necessary information to the user. This labeling can be essential for home-use devices, which are much more likely to be used by lay users, who frequently have not been trained to use such medical devices and who are especially reliant on the instructions for use and other information provided by the device label and package insert.  2

AdvaMed the medical device association in 2013 said, "The development of a standardized Table of Contents (TOC) for device Instructions for Use (IFU) may be a useful tool if adequate allowances are made for the broad range of device types, users and environments."  3

So there we have the RAPS, FDA and AdvaMed, A.K.A. a bowl of Alphabits of regulatory professionals, regulators and industry. 

Notice a key group missing? Me too - Users, AKA patients. Maybe that is why they called. 

Here is my ask - take this quick survey. I made it up - none of it is their's. I’ll summarize the results for my friends at FDA and if you would like to see those too, share your contact information at the end of the survey and I send you what I send them.



Help a Dad asking for better education.

Tom Karlya, aka Diabetes Dad reached out and asked for help getting the word out on a North Carolina diabetes education ask.

I'm happy to help share.

The effort is to help provide education about the symptoms of diabetes so that kids are not sent home entering DKA with a suspected flu or other childhood bug. Tom outlines the issue better than I. Like so many advocacy issues this popped up at the last second. All the more reason we need a strong advocacy database.

April 24, 2015

From E&C, 21 Century Cures

Never to late to send a CGM message. Here

21st Century Cures Legislative Phase Continues

NIH and FDA to Testify at 21st Century Cures Legislative Hearing NEXT THURSDAY – Discussion Draft To Be Released Next Week

WASHINGTON, DC - After nearly a year of listening to patients, innovators, researchers, providers, and regulators, 21st Century Cures next week will take the next step in the legislative phase with a hearing, “Legislative Hearing on 21st Century Cures,” on Thursday, April 30, 2015, at 10:00 a.m. in room 2123 of the Rayburn House Office Building. Subcommittee members will discuss a forthcoming bipartisan discussion draft of this highly anticipated legislation, the product of a yearlong listening session and bipartisan negotiations. 
The committee has held eight hearings and issued several white papers in this initiative since its launch last year. Committee members, both in Washington, D.C., and across the country, have also hosted more than two-dozen roundtables to generate ideas for this initiative. Staff continues to work together around the clock as they have for the past several months and legislative text will be made available in the coming days.
Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy at the National Institutes of Health, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the Food and Drug Administration, and Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health at the FDA will testify. 
The Majority Memorandum, legislative text, and witness testimony will be available here as they are posted.

April 22, 2015

Two minute ask, How about CGM Coverage?

The House Energy and Commerce Committee is currently working on the bipartisan 21st Century Cures initiative. Help members of the Committee understand that CGM 21 is century technology that needs 21 century coverage. Now is the time, as Chair Rep Fred Upton says: “I am hopeful we’ll have an agreement by the end of the month.”

We are making it easy:

We have a list of Energy & Commerce Members and Tweet about CGM Coverage. 

News on the initiative:
Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) this week traveled to Southwest Michigan to talk about their nonpartisan 21st Century Cures initiative in Upton’s home district. The two launched 21st Century Cures last spring and have spent the past year gathering ideas from patients and experts across the country for how to improve the complete health care innovation infrastructure in the United States. 
“There is great excitement and anticipation building over the next phase of 21st Century Cures. Our teams have spent countless hours negotiating over the last few months on policy language and they continue to work by the hour in this landmark effort to provide folks more cures and treatments,” said Upton. “I am hopeful that we’ll have an agreement by the end of the month and the legislative phase can swiftly progress. This is an exciting time.”’s-next-cures2015

April 17, 2015

Testing Tuesday - Not Blood Testing (unless you have a better idea on how to that)

From my good friend Joyce Lee and our merry band of innovators:

Initiating a Collaborative Innovation Network for Healthcare Transformation in Type 1 Diabetes

We #makehealth!
We are a group of patients, caregivers, healthcare providers, designers, innovators, advocates, quality improvement specialists, technologists, and engineers who are passionate about transforming healthcare for type 1 diabetes.

Be part of this crowd sourced effort!

This collaboration was inspired by the work we have been doing for the T1D Exchange and the C3N Project. See Storify #1; see Storify #2 to take a peek at what we have been up to!

Why is the page called Testing Tuesday? (

Testing Tuesday Projects are projects, collaborations, improvements in healthcare that we can do to start the transformation now! Watch this video by Mike Evans to learn about how we chose the name!

April 14, 2015

IBM Watson Teaming up With Medtronic. Will Your Pump Kick Butt at Chess?

... or maybe Jeopardy? 

Medtronic is teaming up with IMB's Watson. The full press release is here. I thought these comments were the most interesting part:

"Devices alone cannot transform diabetes care. The combination of leadership technologies, big data, informatics and world-class patient management are all required to drive effective results in diabetes care," said Hooman Hakami, executive vice president and president of the Diabetes Group at Medtronic. "Medtronic and IBM intend to bring these capabilities together to pioneer a new level of care that will improve outcomes and lower cost so people living with diabetes can enjoy greater freedom and better health." 

"We are building a secure, open innovation platform that could change the face of diabetes management," said John E. Kelly III, IBM senior vice president, solutions portfolio and research. "Medtronic and IBM can marry the power of analytics, cognitive computing and patient engagement with the world's most sophisticated diabetes management devices to truly change how people with diabetes live."

Maybe it will be DEWY.

See: Of Fantasy Diabetes Devices, Sheldon & Dewy.


April 7, 2015

PRESS RELEASE: DreaMed Diabetes and Medtronic Enter Strategic Collaboration

PETAH TIKVA, Israel, Apr 06, 2015 (BUSINESS WIRE) -- DreaMed Diabetes, developer of diabetes treatment and management solutions, announced today that it had signed an exclusive worldwide development and license agreement with Medtronic, the world's premier medical technology and services company, for the development and marketing of products incorporating DreaMed’s MD-Logic Artificial Pancreas algorithm in Medtronic’s insulin pumps.
Under the terms of the agreement, DreaMed Diabetes will receive undisclosed royalties from future sales of each device utilizing MD-Logic. Medtronic will be responsible for all development and marketing of such devices. In addition, Medtronic has made a minority investment in DreaMed Diabetes of $2 million.
DreaMed Diabetes’s CE approved GlucoSitter™, which is based on the MD-Logic Artificial Pancreas algorithm, is a fully-automated, artificial-pancreas system for controlling glucose levels. The system links the glucose sensor with the insulin pump through computerized control algorithms. It uses data of glucose levels from a continuous glucose sensor, analyzes them and directs the insulin pump to deliver the correct dose of insulin that should be released to the body in order to maintain balanced blood glucose. In effect, the software continuously monitors glucose levels, and defines precisely when and how to adjust insulin levels. more:

March 26, 2015

SGR is on Congress’ Agenda This week: What is It? A Primer for Diabetes Advocacy

SGR is in health news. MedPage Today ran a piece March 25 by Joyce Frieden titled, "Bill to Kill SGR Likely to Pass House, but Fate in Senate Less Certain." Her opening sentence is:

WASHINGTON -- Negotiators are working feverishly and President Obama has a pen at the ready, but whether a permanent repeal of the widely disliked "sustainable growth rate" (SGR) formula for Medicare reimbursement can happen this week is still up in the air.
Wait. The house and the President are interested in the same thing passing. In health. What the... is SGR.

SGR is a process Congress created in 1997, to restrain the cost Medicare pays doctors. The idea is that growth in Medicare cost should be linked to the growth rate in the US economy. SRG triggers cuts in physician payments if doctor costs exceed targets. It is very formula heavy. Congress has to March 31 to step in before there are cuts to doctors for seeing Medicare patients. Those cuts would be over 20%. The fear is then that doctors would stop seeing Medicare patients.

For the last decade, Congress has prevented these cuts with short term fixes. The Brookings Institute says, “However, since 2002, Congress has stepped in with short-term legislation (often referred to as the “doc fix”) to avert the payment reduction. These patches have kept increases in physician payments below inflation over time.” There are voices calling for a longer term process as well as those less concerned with regular consideration congressional action.

There are concerns over the SGR patch process as well. For example, since payments are on a fee for service basis they encourage volume of services billable Medicare over quantity of care. The process does not consider doctors or practices based on performance. Cuts may limit seniors access to care.

Because Congress has consistently passed SGR patches, the legislation often attracts other issues as riders. CHIP programs for children and  funding for the Special Diabetes Program are advocacy priorities of the American Diabetes Association and JDRF.

Here are some resources to learn more about SGR:

The Brooking Institute:
A primer on Medicare physician payment reform and the SGR

MedPage Today
Bill to Kill SGR Likely to Pass House, but Fate in Senate Less Certain

Internal Medicin News
FAQ: What’s in the House proposal to fix the SGR?

American Diabetes Asscocation Call to Action

JDRF Call to Action