December 21, 2014

Medical Device Cybersecurity Risks Are The Wrong Kind of Halloween Fright

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Well, Halloween is approaching boys and girls. And while it’s fun to don a Dracula (or Miley Cyrus) costume and get some yucks faux scaring folks, the FDA is acting like a responsible parent by setting up a medical device cybersecurity educational seminar later this month in Arlington, VA. It appears to have filled up already, but a webcast recording will be made available.

Getting a tiny adrenalin rush when a nine-year-old Frankenstein jumps out at you in the dark is one thing; finding out some nineteen-year-old hacker has infiltrated your proprietary product and customer information isn’t the right kind of fright.

Seems like someone out there in the bureaucracy has a little sense of humor, because October is National Cybersecurity Awareness Month. FDA, along with the Department of Health and Human Services and the Department of Homeland Security, hope to bring together a wide swath of stakeholders, including medical device makers, to their Oct. 20-21 “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.”

Participants will be encouraged to help regulators identify barriers to promoting medical device cybersecurity; discuss innovative strategies to address challenges that may jeopardize critical infrastructure; and enable proactive development of analytical tools, processes, and best practices by the stakeholder community in order to strengthen medical device cybersecurity. It’s shaping up to be a good agenda, but it’ll probably only be as strong as the attendees who show up to share war stories and discuss best practices with regulators and others.

iStock_000020037007SmallBroadly speaking, the symposium hopes to help advance medical device cybersecurity by swapping information about the most current online threats, identifying gaps, advancing usage of the feds’ “Framework for Improving Critical Infrastructure Cybersecurity”, and developing tools and standards to build robust, comprehensive protection programs, among other areas of focus.

One of the topics will be the FDA’s new guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” released Oct. 2. That guidance provides some helpful definitions (helpful in the sense that this is how the FDA views the world), and what kind of cybersecurity protection program the agency expects from medical device makers and their kin.

Some say the threat of medical device security hacks has been hyped up a bit. I’m no expert there. But a report issued earlier this year from a cyber expert at SANS Institute (sponsored by cybersecurity vendor Norse), says some 94% of medical institutions report being victims of some type of cyberattack. This isn’t a report specifically about medical device makers, and I’m certain the vast majority of the attacks were relatively small and easy to thwart. Regardless, those numbers deserve some attention.

Hyped or not, I don’t imagine you’ll see an attendee at FDA’s event getting a jump on Halloween and showing up dressed as a sophisticated hacker, though. That’s just too scary.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

FDA Proposals Take a Fresh Look at Some Stale Food Issues

Tamar June

Tamar June, VP, Strategic Marketing, AssurX, Inc.

That landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the FDA unveiled four proposed amendments that will likely make a tough law even tougher.

FSMA, signed into law in January 2011, is designed to tighten food safety regulations and shift the focus to a proactive mindset and away from FDA’s relatively reactive approach in years past. FDA has now proposed seven rules to implement FSMA. This new wave of proposed revisions target four areas: produce-safety; preventive controls for human food; preventive controls for animal food; and the foreign supplier verification program.

The action follows FDA’s May announcement it was engaging in the rule-making and guidance development process required to establish the new prevention-oriented standards. FDA implementation teams have developed a slew of ideas for how the agency can better oversee the food industry, strengthen the global food safety system, and enhance protection of public health. Planning has also begun for the next phase of FSMA implementation, which involves advancing new public health prevention standards and implementing the strategic and risk-based industry oversight framework at the heart of FSMA.

In just part of what could go into effect next year, FDA calls for revisions to the foreign-supplier verification proposed rule. It aims to give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.

Arguably, one of the more important FDA proposals is a new call to develop current Good Manufacturing Practices (cGMPs) more applicable to the animal food industry, provide flexibility for a wider diversity in the types of animal food facilities, and establish standards for producing safe animal food.

foodsafety570However, human food processors already complying with FDA human food safety requirements, such as brewers, would not need to implement additional preventive controls or cGMP regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed cGMPs to prevent physical and chemical contamination when holding and distributing the by-product (e.g., ensuring the by-product isn’t co-mingled with garbage). That noted, further processing a by-product for use as animal food (e.g., drying, pelleting, heat treatment) would still require compliance with the preventive controls for animal food rule.

FDA’s new amendments would also make exemptions a bit clearer, and raise the requirements defining a “very small business.” To be considered tiny, a firm must post less than $2.5 million in total annual sales of animal food, adjusted for inflation. FDA expects that exemption to apply to just over 4,000 facilities.

The proposed rules also address some supplier issues. FDA wants new controls addressing those occasions when the receiving facility’s hazard analysis identifies a significant hazard for a raw material or ingredient, and that hazard is controlled before the facility receives the raw material or ingredient from a supplier.

If these new FDA proposals become the law of the land, the facility would have flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing, review of supplier’s records) unless there is reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals.

Industry and any other interested parties have some time to weigh in on the FDA’s proposals. The FDA will accept comments on the proposed revisions of the four proposed rules for 75 days starting next week (September 29) while continuing to review comments already received on the sections of the proposed rules that are going to change. The agency will consider all comments before issuing final rules sometime next year.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

The FDA is Reading Your Facebook Page and They Don’t ‘Like’ What They See

Tamar June

Tamar June, VP, Strategic Marketing, AssurX, Inc.

In a previous post we looked at the FDA’s relatively ho-hum guidance on social media. Since then, the agency has issued an interesting warning letter to a Utah-based dietary supplement maker for, among other alleged infractions, “liking” off-label claims made about its product on Facebook.

In its warning letter, the FDA has determined that the supplement maker’s website promotes conditions that cause products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] and that the products are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of violation in the warning letter include:

  • “[C]linically supported to work fast and offer congestion relief so you can breathe better in every season”
  • “Proven congestion relief”

But it doesn’t stop there.

The FDA then continues with the company’s Twitter page, pointing out additional “evidence” that their products are indeed intended for use as drugs because the page has a direct link back to the company’s website where products can be purchased. The letter provides two examples of tweets that bolster the FDA’s case.

  • On February 7, 2014: “Try @Zarbees #naturalremedies for Cold and Cough Season…”
  • On January 30, 2014: “RT@MomCentral Have you tried #ZarbeesCough for cold and cough relief?”

And then there’s Facebook.

Once again, the letter points out the website link from their Facebook page where these products can be purchased. According to the FDA’s letter, “Your Facebook page also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease.”

The FDA also specifies nine instances of the company “liking” or replying to comments made by satisfied customers claiming various degrees of symptom relief or cures.

facebook Is this warning letter a blip, or could it be the start of a new FDA online enforcement trend? Because this one was sent to a dietary supplements maker, an industry segment that plays it pretty loosey goosey with claims in the first place, it’s not clear whether this kind of scrutiny will spill over into the medical device and drug market segments. We’ll keep an eye out and report back as newer warning letters emerge.

Customers can praise your products all they want, but don’t you dare “like” any of them.

As interactive technology and social media increasingly plays a prominent role in advertising and promotion, the FDA has attempted to issue several draft guidance documents at the request of industry. These include:

Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices is intended for using Twitter and sponsored links in Google or Yahoo that have character limitations.

Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices is intended to provide guidance regarding a manufacturer’s voluntary correction of misinformation that is “created or disseminated by an independent party.”

Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics extends guidance beyond traditional print media to websites, chat rooms, forums, etc.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

It’s Time to ‘Get’ IEC Before It ‘Gets’ You

Russ King, Managing Partner, Methodsense

Russ King, President, Methodsense

FDA medical device recalls are on the rise. An increasingly active FDA, coupled with the rise in software components for medical devices is adding up to new challenges for manufacturers. Given this reality, it’s important to understand how the FDA uses the IEC 62304, an international standard developed that, among other things, says product testing by itself is not enough to prove software is safe for patients using the medical device.

The standard provides a common framework for medical device manufacturers to develop software. Conformance with this standard provides evidence that there is a software development process in place that fulfills the requirements of the Medical Device Directive. Because it has been harmonized with the Medical Device Directive in the EU and recognized as a Consensus Standard by the FDA in the US, IEC 62304 can be used as a benchmark to comply with regulatory requirements in both markets. To date, this standard has been recognized in most countries that use compliance standards to fulfill regulatory requirements.

Complying with 62304 enhances the reliability of your device’s software by requiring attention to detail in design, testing and verification, ultimately improving the overall safety of the medical device.

Here’s the $64,000, or usually much higher, question: Does your device have to meet IEC 60601-1 requirements?

The EU has been using IEC 62304 since 2008, but it has gained even more traction with its incorporation into the third edition of IEC 60601-1’s Amendment 1. The inclusion of Amendment 1 shifted the standard from a recommendation to a requirement if your device utilizes software.

For those who design or manufacture electromedical equipment, 60601-1 is one of the most important safety and performance standards to meet. The standard addresses critical safety issues, including electrical shocks and mechanical hazards, such as pinching, crushing, and breaking. Devices that must meet IEC 60601-1 requirements include those which:

  • Diagnose, treat, or monitor the patient under medical supervision
  • Make physical or electrical contact with the patient
  • Transfer energy to or from the patient; and/or
  • Detect such energy transfer to or from the patient.

60601-1 Clause 14 requires manufacturers to comply with IEC 62304 unless the device’s software has no role in providing basic safety or essential performance or risk analysis demonstrates that a failure of any Programmable Electronic Safety System (PESS) does not lead to an unacceptable risk.

insulin pumpBasic safety is the main focus of IEC 60601-1. It’s important that you conduct a risk analysis to identify your device’s level of unacceptable risk and determine the role of software in risk mitigation. This analysis will determine the applicable basic safety requirements for your device, and, for some requirements, the test parameters that need to be used by the test laboratory.

The most common mistake that medical device manufacturers make is that they do not always assess which elements of risk their software mitigates. These are the elements that must be addressed by IEC 62304. For example, what would happen if the creator of a hoist didn’t properly vet the software that signaled the hoist to lower the patient at a certain speed? If a patient were lowered to quickly–or not  at all –there would be a risk management nightmare. Since software plays a role in the Basic Safety functions of the hoist, it must comply with 62304’s requirements.

In conjunction with IEC 60601-1, 62304 is intended to minimize the occurrence of these situations. When device software is mitigating a known potential hazard, ensuring that the code is developed properly is critical for the management of patient safety, as well as liability to the manufacture.

It can be difficult to determine if a device’s software is tied to its Essential Performance (EP), especially because the definition of EP has been widely debated for years. Thankfully, the definition and requirements for Essential Performance changed with Amendment 1 of IEC 60601-1 to help provide more clarity.

Determining Essential Performance begins with a list of all functional aspects of your device, including accuracy, measurements and its capabilities. Once you identify these items, determine whether any of these are already covered by the Basic Safety requirements of IEC 60601-1 or whether any item is not part of the device’s intended use. Then, and this is key, every item remaining gets posed the question, “If this item degrades, will it create a risk for the patient?”If the answer is yes, you must identify how its functionality must be maintained so the risk is still acceptable. This is your Essential Performance.

A good example to help clarify the impact of Essential Performance on IEC 62304 is accuracy. Consider a device that claims its EP is accurate within 5%. If the device is relying on software to maintain that accuracy or provide an alert when outside of 5%, and that software fails, then the manufacturer will be unable to detect if the device’s Essential Performance is being met. This means the software is providing Essential Performance.

Once you know your device software is responsible for Essential Performance, you must comply with IEC 62304 to ensure there is no unacceptable risk to a patient.

There are several situations that manufacturers often don’t realize require compliance with IEC 62304. These product features can create major headaches and costly delays if they are not properly developed. These scenarios include:

Alarms & Alerts
Alarms are often an Essential Performance requirement because they are intended to detect abnormalities. If the alarm was removed, the device would no longer meet it’s performance requirements, making the risk unacceptable. Software is used to detect the issue, instigate the alarm and make the sound.

Speed & Position Sensors
These sensors are in place to address Basic Safety concerns. For example, a hospital bed has a position sensor to keep it from crushing the operator’s foot and mammography has sensors to gauge compression. Devices like these use software to limit range of motion, speed and force.

Algorithms
Algorithms are frequently used with physiological monitoring. If the software is removed, the device is no longer able to operate as intended, resulting in the algorithms being part of Essential Performance.

It is important to note that these situations apply to the patient, operator or service personnel.

Once you know you must comply with IEC 62304, how do you go about preparing for it? To start, know that compliance with this standard is defined as implementing all of the processes, activities and tasks identified in the standard in accordance with the software safety class. 62304 itself does not prescribe a particular organizational structure or specific format for documentation, however. Compliance is determined by a review of all required documentation, including the risk management file.

Editor’s Note: In Part Two, we’ll take a look at the best way to approach risk management.

About the author:

Russ King is President of MethodSense, a life science consulting firm with offices in the US and Europe. They guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions. Their services enable clients to operate more effectively during the commercialization process and beyond. As it relates to IEC 60601-1 and 62304, MethodSense provides expert guidance and interpretation, helping you with:

  • Reviewing the standard you must comply with
  • Conducting a gap analysis of your Risk Management Program against ISO 14971
  • Updating your Risk Management Documentation
  • Completing the IEC 60601-1 and other relevant tables
  • Submitting your documentation for review

MethodSense offers special thanks for the input of Medical Equipment Compliance Associates, LLC for information that significantly contributed to the content of this article. 

For questions and information, contact Russ King, rking@methodense.com

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

FDA IDE Guidance Offers Industry Important Clarity

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better outline its thought process for reviewing, accepting, accepting with conditions, or denying an IDE. It can literally be a matter of life and death for patients and trial subjects. Thus, the agency and industry continue to take it seriously.

FDA approval of an IDE allows the initiation of subject enrollment in a clinical investigation of a medical device that has potentially significant risks — widely defined as a device that could pose a serious health risk or death to the user, is used to support to prolong life, or is part of a diagnosis tool also being used to support or sustain life.

The guidance covers a number of important areas, some with new wrinkles, including:

IDE Decisions

FDAlogoFDA must inform sponsors or sponsor-investigator of its decision, or must notify the sponsor that the investigation may not begin, within 30 days from the date of receipt of the IDE application, or the IDE application will be deemed approved. If an IDE application is approved or approved with conditions, the sponsor may begin subject enrollment, up to the number of subjects and investigational sites specified in FDA’s decision letter, upon receipt of Institutional Review Board (IRB) approval, which may occur prior to FDA approval.

IDE Approval

An IDE application is approved if FDA has determined that: the sponsor has provided sufficient data to support initiation of a human clinical study; no subject protection concerns preclude initiation of the investigation; and no additional conditions must be met. 

IDE Approval with Conditions

FDA has clarified matters here somewhat, and appears to have given industry a touch more leeway if used wisely and safely.

If FDA approves an IDE application with conditions, the sponsor may begin subject enrollment upon receipt of IRB approval and in accordance with the limits described in FDA’s decision letter, including the maximum numbers of U.S. subjects and investigational sites, and must submit information addressing the issues identified as conditions of approval in FDA’s letter within 45 days.

An IDE application is approved with conditions if FDA has determined that: the sponsor has provided sufficient data to support initiation of subject enrollment in a human clinical study; no subject protection concerns preclude initiation of subject enrollment; but additional conditions must be met to address certain outstanding issues.

Previously known as “conditional approval,” the phrase “approval with conditions” is now used to convey that the outstanding issues do not raise concerns that preclude FDA from granting approval for initiation of subject enrollment in the clinical investigation. FDA now says resolution of those issues isn’t required prior to initiation of subject enrollment in the study, except for certain issues related to the informed consent document.

The guidance reiterates how seriously FDA takes clear, simply informed consent forms for trial participants, noting it “closely reviews” those as part of an IDE determination.

Staged Approval, Staged Approval with Conditions

In the guidance, FDA says it may grant IDE approval or approval with conditions for a portion of the intended study cohort, enabling certain outstanding questions to be answered concurrently with enrollment in this cohort. Staged approval permits the clinical investigation to begin in a timely manner while maintaining appropriate subject protections. In some cases, the sponsor proposes a staged enrollment in the IDE application. In other cases, the sponsor requests approval for the full subject cohort but the agency may decide to grant staged approval for a limited number of subjects as an alternative to outright disapproving the IDE.

IDE Disapproval

Broadly speaking, little has changed here in regards to what the FDA deems most important in an IDE request. If the agency raises patient risk issues the device company cannot adequately address, and/or if the device maker is unable to persuade the FDA that the product is important enough (e.g. life-saving) to quality for IDE designation, it will get the thumbs down.

FDA Communications

The agency says it will send a letter discussing any rejection or question about an IDE request. The letter should include the agency’s thoughts on how the study design assessment, considerations, and other suggested improvements the device maker should consider if it plans to try again.

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

FDA Guidance Advises Device Makers to Think About Home-Use

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Medical device manufacturers would be well-advised to address any potential home-use products risk at the design state, says an August guidance from the FDA.

As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home use devices may result in inappropriate use, use error, or incompatibilities between the use environment, the user, and the device. This could cause the device to malfunction, possibly contributing to death or serious injury.”

It could also make the FDA really angry.

The guidance offers advice designed to address then entire manufacturing process — and beyond. It covers environmental issues, user issues, design issues, human factors, labeling challenges, postmarket considerations, and the always fun human factor

Digging a little deeper into the guidance, FDA covers many layers of these topics, including:

  • Environmental considers such as location, contaminants, water supply, temperature, dampness and humidity, atmospheric pressure changes, air flow, travel and international use, fluid exposure and storage.
  • User considerations such as physical location, sensor/perception requirements, plus cognitive and emotional product demand.
  • Design issues, including lock-out mechanisms, maintenance and calibration, mechanical issues and special emphasis of electrical issues. As noted earlier, this is probably the section deserving the closest examination by medical device makers.
  • Human factors ranging from user training to certifications.
  • Labeling issues including describing the basic handling of the device, how to dispose of it in an emergency, disposal, and hygienic maintenance.
  • Post-market considerations such as robust customer service and medical device reporting.

electronic document managementFDA’s Medical Device Reporting (MDR) regulation requires manufacturers to submit reports to the FDA whenever it becomes aware of information that reasonably suggests that a device it sells may have caused or contributed to a reportable death or serious injury, or has malfunctioned and the malfunction would be likely to cause or contribute to a reportable death or serious injury should it recur.

For the FDA Form 3500A, instructions for completing specific items on the form, and the coding manual see MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

For additional guidance on the MDR regulation and the reporting requirements refer to FDA’s guidance Medical Device Reporting for Manufacturers (March, 1997). FDA advises medical device manufacturers to also take a look at its draft guidance Medical Device Reporting for Manufacturers (July 9, 2013).

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

FDA Spreads Regulatory Love Nationwide

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Detroit may be struggling with bankruptcy, but in a flurry of activity that would make industrialist Henry Ford proud, the local FDA office has been active in our latest warning letter round-up.

Indiana-based Med-Mizer, manufacturer of AC powered, adjustable and bariatric hospital beds, was hit by FDA’s Detroit office with a 12-point letter dated July 21.

Among FDA’s accusations, Med-Miser failed to:

  • Establish procedures for reviewing and evaluating incoming complaints
  • Develop, conduct and control and monitor its production process
  • Establish and maintain design controls
  • Validate a manufacturing process
  • Ensure its products meet acceptance criteria

Ventilab LLC, a manufacturer of manual resuscitation bags based in Grand Rapids, was also dinged by the Detroit office for CAPA shortcomings, inadequate complaint management, and failing to establish an acceptable risk management plan.

warning640Moving east to the City of Brotherly Love, FDA’s Philadelphia District office sent a warning letter to the maker of a sleep apnea monitor citing it for failure to ensure its device conformed to specifications and requirements. That June 30 letter was the result of a series of April 2014 inspections.

A June 27 letter called out Zynex Medical, manufacturer of the NexWave multiple mode electrical stimulator and the IF8000 electrical stimulator for perceived CAPA and design control and verification shortcomings. Zynex, baed in Lone Tree, Colorado, was also hit for failure to have adequate device master records and internal audit procedures.

Out in Napa, California where the weather is lovely and the wine flows, June 25 was probably not a day to celebrate for Dexta Corporation, manufacturer of medical chairs used for Lasik surgery and other procedures. FDA hit them for, among other things, failure to adequately train personnel, inability to verify test results, CAPA issues, and process controls problems.

Henry Ford, a man who tried to build his own utopian city in the jungles of the Amazon and modestly name it Fordlandia, would be proud of the FDA’s devotion to hard work these past few months. Perhaps there is an FDAlandia on some city planners drawing board just waiting for the green light. You never know.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

Time to Take a Closer Look at FDA MDDS Moves

Russ King, Managing Partner, Methodsense

Russ King, Managing Partner, Methodsense

The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify the data, and it does not control the functions or parameters of any connected medical device. MDDS are not intended to be used in connection with active patient monitoring.”

The core issue it raises, I believe, is one of data integrity. More on that later.

The new draft guidance cites the growing trend “that many medical devices be interoperable with other types of medical devices and with various types of health information technology.” And further “[s]ince down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public,” the FDA wrote. “Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices and medical image communications devices.”

The FDA’s interest in this kind of risk based approach has pleased a great many. On the one hand, the draft guidance demonstrates a proactive approach by the FDA for addressing the explosion of mobile health applications in the light of pending legislation on the same topic in the US Congress. It frees application developers to innovate without the additional burden of regulatory compliance, and it dovetails with the rapidly expanding electronic health ecosystem servicing the informational appetites of healthcare providers and patients alike.

Driving this trend are advances in mobile networks and the proliferation of smart phones and tablet devices, which the Cisco Visual Networking index projects will result in 10 billion mobile devices around the world by 2016. This revolutionary expansion constitutes a global service delivery platform for many industries, including health care. Creating affordable and efficient health care systems is a critical challenge for everyone, and mobile health solutions offer tremendous potential by improving and lowering the cost of health care interactions for everyone.

But, there are also some complications to consider with this overall approach. Creating mobile medical device applications is relatively easy and inexpensive, which enables developers inexperienced with the medical device industry to quickly develop applications that are, in fact, medical devices. This ranges from hospital software developers creating interfaces that network device data to Electronic Health Records to college students with a basic understanding of iOS for iPhone applications.

mobile health appRegardless of whether the applications are distributed to clinicians by hospital IT staff or available as a download from iTunes to clinicians and patients alike, once in the hands of the user, the data from MDDS applications will be used for diagnostic purposes –even if the expressed intended use of such applications is to the contrary. We would be naïve at best to believe otherwise.

The use of a device “off label”or contrary to its intended use, however, is not the concern here. Reconciling the conflicts between the intended use of devices and the intentions of end users is a different kind of problem more properly framed by the argument between those advocating stronger more far reaching government controls and those advocating more personal responsibility. Instead, the issue here is one of data integrity and the risks associated with compromising that data.

The draft guidance for MDDS, in essence, proposes a lifting of controls that are otherwise designed to ensure data integrity of MDDS software applications. In the absence of those controls, what assurances will we have that the data stored, transferred or converted was done so in a way that did not create an unintended change in the data? At this point, advocates for the draft guidance might remind us that the FDA “has determined that these devices pose a low risk to the public.”

Here is the rub: however simple the application, there is very little credibility in claiming that a particular software application is “bug free.” Simply ask “how frequently does your iTunes Store app alert you to application updates for bug fixes?” This gives you a sense for the state of software development in the absence of strong quality controls and the rigorous software lifecycle planning that are part of medical device regulations and standards, such as 21 CFR Part 11 and IEC 62304.

If MDDS application developers are not required to have a competent software development lifecycle, not required to test or validate their software, not required to manage their quality…what assurances does the user have that the software operates as intended, and the data is not compromised in some fashion due to software bugs? And, if we take for granted that the data from MDDS applications will be used for diagnostic purposes despite their stated intended use, what risks are we accepting on behalf of patients?

In short, the risk of misdiagnosis, either by the clinician or the patient themselves, increases as do the consequences for misdiagnosis. The more widely distributed mobile health care monitoring and treatment options become and the fewer requirements for ensuring data integrity, the more likely patients will be exposed to such risks.

Russ King is President of Methodsense, a consulting firm that helps clients deliver medical and technological breakthroughs by effectively meeting the requirements needed to bring their products to market.   He can be reached at (919) 313-3962 or rking@methodsense.com.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

FDA Lets MDDS Off The Regulatory Hook

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

FDA won’t enforce compliance with regulatory controls that apply to medical image storage devices (MDDS) and medical image communications devices recognizing the “low risk” they pose to patient safety and the importance they play in advancing digital health.

The good news came in a guidance released June 20, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.”

Specifically off the hook are MDDS’ subject to 21 CFR 880.6310, medical image storage devices subject to 21 CFR 892.2010, and medical image communications devices subject to 21 CFR 892.2020. Devices in these categories won’t be subject to FDA regulatory enforcement regarding registration and listing, premarket review, postmarket reporting and quality system regulations.

As defined by the FDA, MDDS is a medical device intended to store and/or move edata without controlling or altering the functions or parameters of any connected medical device.

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

Charles Darwin, Social Media & The FDA’s New Guidance

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

If someone out in there in the wild wonderful world of the Web takes a potshot at your drug or device, the first thing to do is take a deep breath and think. Any crisis communications executive worth his or her salt will tell you it’s often best to let the attacker eat silence rather than draw more attention to their criticism or cheap shot.

But if the criticism is relentless, or damaging and unfair, if it looks to be gaining traction, then a measured response can be part of the solution.

The FDA just released a guidance it says “responds to (among other things) stakeholder requests for specific guidance regarding a firm’s voluntary correction of misinformation when that misinformation is created or disseminated by an independent third party.” In other words, how to fight back fairly.

But the short guidance is vague on specifics, though it does give us a “helpful” reminder that the Internet makes it much easier for third-parties to easily disseminate information about your products and your company. The agency calls it User-Generated Content (UCG). I don’t mean to sound like an elitist snob, but this sounds kind of obvious to me.

“I wouldn’t call this guidance useless…well, yes I would,” a device industry consultant told us. He asked to remain anonymous on the off chance anyone at the FDA ever reads this blog.

Is the guidance helpful? You be the judge. Here’s how the FDA advises a drug or device company to address negative and or inaccurate claims online:

  • Be relevant and responsive to the misinformation;
  • Be limited and tailored to the misinformation;
  • Be non-promotional in nature, tone, and presentation;
  • Be accurate;
  • Be consistent with the FDA-required labeling for the product;
  • Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
  • Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
  • Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

I suppose writing all of this down somewhere doesn’t hurt anything except the trees killed when it is printed out. Still, it feels a bit like FDA is talking down to future winners of the Darwin Awards. That’s the “prize” named in honor of Charles Darwin, the father of evolution. The Darwin Awards commemorate those who “improve our gene pool by removing themselves from it.”

Here’s a good example of a Darwin Award: In 2000, a motorcycle taxi driver challenged his neighbor to stand beneath a hornets’ nest, while two men pelted it with stones. The 53-year old man should have known better, but he had a local reputation as a strong man to uphold. He stood beneath the nest and the pelting commenced. The man endured the pain of countless stinging hornets before expiring from the toxic injections.

To be fair, if you need an FDA guidance to tell you to “be accurate,” I’d also say you may need a reminder to stay away from hornets or men holding stones. Otherwise, there’s no harm bookmarking this new guidance in your computer.

But don’t print it out, please. It’s not fair to the trees.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare