The answer to that question in a word is yes, life sciences labeling is immeasurably complex. To provide you with an illustrative contrast based upon my decade of experience within the field of information security, life sciences labeling is a far more complex subject than an area such as Cyber-security technologies. If you think my previous statement is off-base, then keep reading. In addition to being exceptionally complex, labeling within the Life Sciences is also a mission critical function that is constantly changing as regulatory requirements are increasing exponentially around the world. Since the U.S. FDA considers the label to be part of the product, if products are not being properly labeled, those products must not be shipped. A product that is incorrectly labeled has the potential of causing injury or death. Labeling systems must also be extensible to accommodate new data in a flexible way as requirements will constantly continue to change.
Please enjoy this article in Innovatum’s continuing series containing timely content which is contributed by life sciences industry experts. Guest blog contributors will be presenting topics pertaining to labeling, regulatory management, and compliance considerations. The following article was submitted by…
Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer
Throughout its one hundred and ten year history, the Food and Drug Administration (FDA) has faced complex issues related to the labeling and packaging of products falling under their scope of influence. As early as 1912’s Sherley Amendment to the U.S. vs. Johnson ruling, regulations aimed at providing safe and effectively labeled products have been heavily woven into the fabric of FDA’s history. However, when compared to the extensive history of food and pharmaceutical law, legislation of labeling/packaging specific to medical devices is a relatively immature discipline. While the Agency has made numerous strides to counteract these problems, most notably 1978’s monumental Medical Device Amendments which enacted controls for manufacturers, the persistence of complications, such as class I recalls (a reasonable probability that the use or exposure to a product will cause serious adverse health consequences or death), have produced a difficult landscape for the FDA to traverse.
A recent analysis, conducted as part of continued research on recalls, utilized the FDA’s Center for Device Evaluation and Radiological Health’s (CDRH) recall repository to collect data and evaluate trends in both voluntary and involuntary recalls established between January 2010, and May 2016. This analysis demonstrates recall issues related to the labeling and packaging of medical devices are both continual and progressive, accounting for 15% of all recalls since 2010. (See Table 1: Labeling/Packaging Recalls by Year 2010-2014 for Raw Data) (Blue Lynx Consulting, 2015). The data also specifies a progressive yearly occurrence rate with trending indicating an upward swing in the following root causes as identified by the agency; labeling errors, design, mix-ups, false or misleading labeling, and change control.
2. Labeling/packaging Recall History By the Numbers
Since 2010, recalls related to device labeling/packaging account for an average of 488 issues annually. (Blue Lynx Consulting, 2015). Alone, this number is severe enough, however when juxtaposed with the major fluctuations in year to year growth percentages, a strong case begins to emerge which demonstrates an industry unable to predict the proper solutions to mitigate or control these adverse events. The data related to labeling/packaging recalls pulls back the curtain on an industry which is lives in a perpetual state of unrest. While recalls diminished moderately in both 2011 (-23%) and 2013 (-8%) (Blue Lynx Consulting, 2015), each year was followed by a wild upward fluctuation, +104 between FY 2011 and FY 2012 and +62% growth between FY 2013 and FY 2014 (Blue Lynx Consulting, 2015). (note: 2015 data provided by the FDA is incomplete, therefore the growth between 2013 and 2014 is the latest information available.) Over a five year period the cumulative growth percentage of recalls related to labeling/packaging grew +132%, reaching a five year high in 2014 with a total of 800 recalls. (Blue Lynx Consulting, 2015). For a complete overview of cumulative growth by labeling/packaging recall see (See Table 2: Labeling/Packaging Recalls Cumulative Growth % by Year 2010-2014)
In addition to being one of the most prevalent causes of medical device recalls, labeling related recalls are also one of the most likely to cause serious health problems or death to the end user. As defined by the Agency, Class I recalls are ones in which “dangerous or defective products could predictably could cause serious health problems or death.” Recalls correlated to labeling/packaging grew an average of 604% between FY 2010 and FY 2014, topping out at +1136% between FY 2013 and FY 2014. (Blue Lynx Consulting, 2015). For a complete overview of cumulative growth by labeling/packaging recall subcategory see (See Table 3: Labeling/Packaging Recalls % Growth Rate 2010-2014 (Subcategories))
3. Industry vs. the Agency?
It should come as very little surprise the FDA has begun to take notice of the unmitigated and ongoing failures related to device labeling/packaging. In fact, there is a growing recognition among FDA staff that a lack of device labeling standardization may be harming patients. (Gaffney, 2015). As the FDA noted in a 4 January 2013 Federal Register announcement regarding device labeling, there is a growing need for medical device labeling to be delivered in a clear, concise and readily accessible format so that patients, caregivers and healthcare providers may access and utilize device labeling as efficiently and effectively as possible,. Physicians may inadvertently skip over important information or be unable to find information in an emergency. (Federal Register, 2014)
Coupled with a 2013 public workshop the FDA held to discuss labeling issues, the Agency’s acknowledgement of the continuous and sometimes harmful events derived from device labeling represents a manner of thinking centered on the standardization of device labeling and the creation of an online labeling database. The proposed database would provide industry a central location for standardized medical device symbols used in labeling. Despite these efforts, response from industry has been mild at best, “with some characterizing the proposed solutions as solutions in search of a problem.” (Gaffney 2013)
As recalls continue, and trends pile up supporting the FDA’s thinking regarding the need for innovative mitigations in the area of device labeling/packaging, one must wonder if the temper of industry’s reaction will be altered by evidence, or if end users will continue to suffer from events which are readily preventable.
4. Statistical Evidence- Graphs
Table 1. Labeling/Packaging Recalls by Year Raw Data 2010-2014
Table 2. Labeling/Packaging Recalls Cumulative Growth by Year % 2010-2014
Table 3. Labeling/Packaging Recalls % Growth Rate 2010-2014 (Subcategories)
Joshua R. Dix is a Regulatory Affairs Specialist centered in the Western New York area. Joshua is the Global Regulatory Lead for multiple product platforms with responsibilities including Regulatory Strategy, Submissions, Product CAPA, and Audits. With extensive experience in both Regulatory Affairs and Quality Systems, Joshua has worked diligently to bring multiple medical devices to market in over twenty different countries. Joshua holds a Bachelor’s degree in English from the State University of New York.
Suraj Ramachandran, MS is a Regulatory Affairs Manager based in the Chicago Area. Suraj is involved primarily with managing the infusion pump platform and supporting all new product development and lifecycle maintenance activities including regulatory submissions, design control, audits, and CAPA’s. Suraj has also led many development efforts regarding medical device software, intended for both domestic and international markets. Suraj holds an undergraduate degree in Biomedical Engineering as well as a Master’s degree in Biomedical Engineering from the University of Michigan. In addition, Suraj holds a RAC certification from the Regulatory Affairs Professional Society.
Darin Oppenheimer, MS is a Regulatory Affairs Director based in New Jersey. Darin is involved in many facets of the Product Development Lifecycle including regulatory submissions, due diligence, and active participation on industry trade organizations and standards committees. Darin leads a team of regulatory professionals focusing on electromechanical devices and software. His prior background as a Research and Development Scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well as a graduate Certificate in Biotechnology Enterprise.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Health Care Practitioners for Device Labeling Format and Content, 79 Federal Register. 54727 (September 12th, 2014)
Gaffney, A. (2015, April 6). How can Medical Device Labeling be Standardized? FDA Study Aims to Find Out. Retrieved from http://www.raps.org/Regulatory-Focus/News/2015/04/06/21899/How-can-Medical-Device-Labeling-be-Standardized-FDA-Study-Aims-to-Find-Out/
Gaffney, A (2013, May 21) Industry to FDA: Give us Flexibility on Proposed Device Labeling Standards. Retrieved from http://www.raps.org/focus-online/news/news-article-view/article/3487/industry-to-fda-give-us-flexibility-on-proposed-device-labeling-standards.aspx
U.S. Food and Drug Administration, Food Drug and Cosmetic Act, July 1978
U.S. Food and Drug Administration, Sherley Amendment, 1912
Note: All supporting statistical information garnered from the FDA Recall Database in support of this article was compiled and provided by Blue Lynx Consulting.
Please enjoy this inaugural article in Innovatum’s new series containing timely content which is contributed by life sciences industry experts. Guest blog contributors will be presenting topics pertaining to labeling, regulatory management, and compliance considerations. The following article was submitted by Joshua R. Dix Regulatory Affairs Specialist Baxter Healthcare, Suraj Ramachandran Regulatory Affairs Manager Baxter Healthcare, Darin Oppenheimer Director Global Regulatory Affairs Baxter Healthcare.
Risk Based 510(k) Cumulative Review
Joshua R. Dix, Suraj Ramachandran, Darin S. Oppenheimer
April 15, 2016
Close to twenty years ago the FDA provided the Medical Device Industry with a unique guidance detailing their current thinking regarding when a company should submit a 510(k) for a change to an existing device. While the agency went to great lengths to provide a framework to industry professionals for their assessment of individual changes specific to labeling, technology/performance and materials, a caveat found in the guidance has left many companies looking for answers nearly two decades later.
Collective Assessment of Changes?
In releasing the guidance and providing visual tools for the assessment of changes to a legally marketed device, the FDA inched closer to creating a general consensus amongst industry professionals. Though the information was documented in a minimalistic sense as part of both 21 CFR Part 807.81(a)(3)(i)and 21 CFR Part 807.81(a)(3)(ii), the industry now had concrete and documentable evidence to demonstrate their decision points while assessing the impact of individual changes. Still, portions of the guidance, specifically information detailed in the Assumptions/Axioms section found on page six of the document, produced further division amongst companies’ ability to address the impact of changes to regulatory filings in the United States.
The guidance was clear and concise when detailing the impact of an individual change. Simply put, the FDA did not want a single change to affect a medical device’s indications for use, or cause new issues of safety and efficacy without the company filing a new premarket notification. However, the FDA was now asking companies to consider a more holistic approach when determining impact to filings. As described in the guidance document, the agency was asking the industry to consider a cumulative methodology when assessing changes: “because many changes occur in the evolution of a device, each change must be assessed individually and collectively with other changes made since the last 510(k) clearance.”
In reference to this, the FDA provided no visual aids or expansive definition, only going as far to state “When the effect of any one change, considered together with all previous changes since the last 510(k) clearance, leads a manufacturer to decide it is legally required to submit a new 510(k), then a 510(k) incorporating all the changes should be submitted.” But the question remains: how? The subjectivity of such a statement has resulted in a variety of disparities. Because the guidance document provides no measureable criteria for what would constitute the filing of a new 510(k) through a cumulative assessment process, many industry professionals have relied instead on the criteria provided for individual assessments.
Individual Assessment vs. Cumulative Assessment
When grappling with the question of how to comply with the FDA’s current thinking regarding when a manufacturer should file a new 510(k) for a change to an existing medical device, industry professionals appear to be battling the same uphill climb they encountered upon the guidance’s initial release. How can a cumulative review of changes be done in a consistent and presentable manner? The answer many manufacturers have turned to in light of this challenge is one which keeps in mind the totality of the changes, but focuses instead on the Agency’s direct path for the assessment of individual changes. While many manufacturers may theorize the correct criteria for cumulative review is looking at all the changes as if they were being made at the same time, the question remains: how is the final decision made? Furthermore, will the conditions for the company’s ultimate decision to file or not to file be consistent and complete?
While it may be enough for a manufacturer to organize their reassessment of standalone revisions as a catalogued cumulative review, this approach does not overtly consider the more complex affects a change can have on the device holistically. It is imperative the manufacturer provide a fully justifiable criterion to demonstrate why they did or did not file at the conclusion of their process. The simplistic approach of attempting to determine whether the totality of product changes have significantly altered the devices performance or intended use may be defendable in some cases, but again is not consistent, nor is the final decision specific to cumulative review of the product. Again, it can be argued the final decision when using this criterion will most likely rest upon the impact of one change, not the cumulative impact to the device. If this is the case, and the manufacturer ultimately decides to file because of a significant change to the device, wouldn’t they have already filed when the product change was initially made?
The variability in this theory creates gaps and weakens the manufacturer’s defense of their process. Is it feasible a manufacturer could argue the impact of over a thousand product changes didn’t significantly alter the device? Arguably yes, but the Agency likely will not agree. But how do we bridge the gap and alter this process so it is both consistent and defendable?
Safety Assurance Cases and Risk Based Cumulative Review
One of the questions the FDA’s guidance on changes to an existing medical device asks assessors to consider while reviewing product changes is whether a modification will significantly impact the device’s safety and effectiveness Risk-based evidence, in the form of a Design Failure Mode Effects Analysis (DFMEA) or a Process Failure Mode Effects Analysis (PMFEA) may provide the assessor both an accurate baseline and the projected impact to patient risk based on an individual change, or multiple changes in same project. However, the same approach is not always readily available to assessors when considering the residual risk of multiple changes over the course of numerous engineering projects.
On December 2, 2014, the FDA released a final version of the Infusion Pumps Total Product Life Cycle Guidance. Most notably, this guidance solidified the agency’s current thinking around the use of Safety Assurance Cases as the framework for developing a device’s substantial equivalence to its predicate throughout the life cycle of the device, including residual risk of product changes. As described in section five of the guidance the agency states a Safety Assurance Case should be used to determine “whether a new, changed or modified infusion pump is substantially equivalent” to its predicate device.
Because Safety Assurance Cases are specific to medical devices, they provide a baseline for the complexities of modifications when assessed cumulatively. If revised, as suggested by the Agency, a Safety Assurance Case “will consider specified design requirements, associated hazards, design specifications and other design control documentation.” As such, the device’s Safety Assurance Case provides at measureable standard for the impact of cumulative changes on a cleared medical device. While assessment of incremental changes may help to measure impact to more clear changes such as the addition of a contraindication, or a change to the devices operating principles, the Safety Assurance Case risk approach goes beyond the simplistic and delivers a parallel assessment of both the impact to device as well as overall impact to the end user.
Medical Device Reporting (MDR)
Another important aspect of applying a risk-based approach to a product’s cumulative review is the inclusion of a manufacturer’s Medical Device Reporting (MDR) as a determining factor on whether a new 510(k) is necessary. The MDR regulation (21 CFR Part 803) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. When applied to a company’s risk profile, MDRs play a large role in determining both the Hazardous Situations documented in high-level risk documentation, for instance a Safety Assurance Case, as well as any resulting risk priority numbers applied to the device when the severities, occurrences and detections are considered.
As a company’s Medical Device Reporting plays an immeasurable role in how the safety and efficacy of a device is presented to the FDA, it is only reasonable to expect a company would consider reporting when formulating a decision during cumulative review. However, the practice of focusing solely on the “re-review” of individual changes can hamper a manufacturer’s ability to do so while completing this annual task. A change-centric approach may result in a company reviewing change documentation, but forgetting to determine how their reporting changed the patient risk of their product. To mitigate this issue, Risk Based Cumulative Review does not focus solely on the content of a single change to the device, or a “re-review” of all device changes at a scheduled interval; instead the review incorporates device reporting through a parallel revision to the devices risk profile. During this review the manufacturer may ask itself the following questions when determining if the device has changed from its cleared version.
- Does new information found through product surveillance alter the information documented in the device’s current risk profile?
- Has the cumulative impact of product and process changes led to new hazardous situations?
- Does the discovery of new hazardous situations impact the safety and efficacy of the device in a fashion which would significantly alter the residual risk of the device?
- Has the cumulative impact of product and process changes led to new questions of the device’s safety and efficacy?
Because of the Agency’s heavy interest in a manufacturer’s Medical Device Reporting, it is essential for product owners to develop a linkage between the information collected during product surveillance and processes used to demonstrate the sustained safety and efficacy of their device. Specifically, creating a link between Medical Device Reporting, Risk Management, and 510(k) Cumulative Review allows a manufacturer to create holistic assurances of safety for their patients and a more refined process to assist in making important regulatory actions for their company.
Risk Based Cumulative Review
Twenty years ago the FDA stepped forward and provided medical device manufacturers with an opportunity to be proactive in their pursuit of compliance. While the release of the K97 Deciding When to Submit a 510(k) for a Change to an Existing Device, provided new challenges to industry, specifically how to create a consistent theory of cumulative review, advances in risk based engineering have delivered a potential method of closing the divide between the assessment of incremental changes and the holistic assessment of changes to a cleared medical device.
The proposed method does not attempt to dissuade manufacturers from reassessing individual changes made to the product as an opposing factor, rather encourages the reassessment as a starting point of cumulative review, keeping in mind Agency regulations and considerations may change during the cycle. With this in mind, any change to the device which would result in a significant change (one which could significantly affect the safety and effectiveness of the device) to the intended use statement, contraindications, control mechanism, operating principle, or energy type should still result in the submission of a 510(k) for the device as the guidance suggests, regardless of impact to the risk profile.
However, the original methodology is furthered as industry professionals are also asked to assess the cumulative changes impact to the device’s risk profile, or Safety Assurance Case. The assessor should view any significant increase in residual risk to patient as new questions of the safety and efficacy of the device. As a result a new 510(k) would then be filed as the cumulative review of changes has led to new questions regarding the devices safety and efficacy as it relates to substantial equivalence to the cleared medical device.
As medical device technology advances it is imperative both manufacturers and the agencies regulating their industry search for progressive ways to measure risk and ensure the safety of patients. A cumulative review process bearing in mind the impact to the residual risk of a device should provide manufacturers a straightforward starting point in developing more involved methods to measure the substantial equivalence of their cleared device during a review cycle. This patient-centric approach adds more control and provides more assurance of safety to both the end user and business interest of the manufacturer, creating a stronger and more trusting relationship with government agencies.
Joshua R. Dix is a Regulatory Affairs Specialist with Baxter Healthcare. Centered in the Western New York area, Joshua is the Global Regulatory Lead for multiple product platforms with responsibilities including Regulatory Strategy, Submissions, Product CAPA, and Audits. With extensive experience in both Regulatory Affairs and Quality Systems, Joshua has worked diligently to bring multiple medical devices to market in over twenty different countries. Joshua holds a Bachelor’s degree in English from the State University of New York.
Suraj Ramachandran, MS is a Regulatory Affairs Manager at Baxter Healthcare. Based in the Chicago Area, Suraj is involved primarily with managing the infusion pump platform and supporting all new product development and lifecycle maintenance activities including regulatory submissions, design control, audits, and CAPA’s. Suraj has also led many development efforts regarding medical device software, intended for both domestic and international markets. Suraj holds an undergraduate degree in Biomedical Engineering as well as a Master’s degree in Biomedical Engineering from the University of Michigan. In addition, Suraj holds a RAC certification from the Regulatory Affairs Professional Society.
Darin Oppenheimer, MS is a Regulatory Affairs Director at Baxter Healthcare. Based in the Chicago Area, Darin is involved in many facets of the Product Development Lifecycle including regulatory submissions, due diligence, and active participation on industry trade organizations and standards committees. Darin leads a team of regulatory professionals focusing on electromechanical devices and software. His prior background as a Research and Development Scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well as a graduate Certificate in Biotechnology Enterprise.
U.S. Food and Drug Administration K97 Deciding When to Submit a 510(k) for a Change to an Existing Device: Office of Device Evaluation: January 10th 1997
U.S. Food and Drug Administration. Infusion Pumps Total Product Lifecycle Device: Office of Device Evaluation and Center for Device and Radiological Health, December 2nd, 2014
I was invited to speak at a UDI-centric conference a few weeks ago in which FDA made presentations and attended mine. Jay Crowley, Indira Konduri- (US FDA’s GUDID Program Manager) and representatives from GS1, ICCBBA and other organizations also presented. I was presenting on behalf of the AIM North America Healthcare Committee on the topic of UDI management software technologies, UDI Direct Part Marking Technologies, and Barcode validation and verification technologies. Since I was to answer audience questions that would tie into the things that were said in presentations that preceded mine, I was sure to pay close attention to the other presentations.
Key Take Aways:
- The FDA only has a staff of 10 on their UDI support desk yet they have thousands of companies to support.
- Indira said “If you send an email to FDA support desk and do not get a response within two months, please do not open another support request about the same topic.”
- The FDA has not granted any exceptions in response to any request for exclusion from Direct Part Marking requirements.
- A surprising number of people within the audience were not aware that since the FDA may reject a GUDID submission and require the medical device labeler to make changes it is prudent to make sure that UDI submissions are accepted by the FDA before labeling product.
- The complexity of UDI management will become exponentially harder for many companies in the near future as regulatory bodies outside of the United States introduce requirements for their own versions of UDI. Read the example below:
China is planning to develop their own MDN (Medical Device Nomenclature) system. This will require companies that label medical devices that ship to China and rest of world to manage GMDN codes in addition to the MDN that is specific to China.
- The most significant thing that I learned during this conference is that the majority of Medical Device Labelers are still managing regulatory data for UDI using spreadsheets.
At most, spreadsheets should be considered to be a stop-gap tool for collecting information for the achievement of initial UDI compliance. As the FDA said during the conference, post-GUDID submission data management will be a major ongoing challenge. Although it is possible to use multiple tabs, link spreadsheets, add drop-downs to improve data accuracy and consistency, add macros, add pivot tables, and VB scripts, spreadsheets are flat files. They are not relational databases. Spreadsheets are not designed for collaborative work. Therefore, copying and routing portions of spreadsheet for approvals, doing the same for trial uploads, managing spreadsheets for records that were not accepted by the GUDID, routing these for correction and re-approval by different departments, sending these out for upload again, receiving notification of acceptance for submitted records back in a spreadsheet format, is creating silos of related yet disconnected information in the form of multiple spreadsheets. Updating information from multiple spreadsheets into a master record is a manual process. Moreover, there is no audit trail as mandated by 21 CFR.
Although it is possible to use spreadsheets for regulatory data management—though it can be complex, largely manual and therefore risky—complexity will grow exponentially as other regulatory bodies come on-line with their own requirements. Subsets of the FDA listing of UDI attributes will likely be required along with some additions and some modifications. However, managing changes to records that are already in the FDA GUDID, is a more immediate challenge. As you know, medical device labelers are required to update information in the FDA GUDID by indicating when products are no longer being put into the supply chain. They also are required to upload and manage information in the GUDID for new products. Labelers are also required to update GMDN code information within the FDA GUDID as the GMDN code information changes. As the FDA reminded the conference attendees, labelers are also required to update changes to many other UDI attributes. As it is today, according to the GUDID_Data_Elements_Ref-Table_May1_2015.xls which may be found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396592.xls, the list of attributes which require maintenance or can trigger a need to create a new record with a new DI after the grace period is quite extensive. The information below is a condensed subset of the aforementioned spreadsheet that is tailored to illustrate the quantity of edit rules and or the need to create a new record with a new DI after the grace period (i.e. DI Triggers) for various GUDID attribute fields. This list includes:
A properly designed application running on a relational database delivers the ability to allow for the finding, filtering, mass updating and approval of regulatory information as well as pre-submission checking and final submission while maintaining useful audit history as required by 21 CFR. More importantly, it makes the on-going management of submitted records practicable. All of this can be done with information that was imported from spreadsheets or is derived from other systems. The main point is that people in various departments can work on the on-going management of UDI using browser based software in a collaborative way instead of sending, receiving and managing spreadsheets. Subsets of the list of UDI attributes for the US FDA GUDID can easily be combined with the new information that will be required by other regulatory bodies thereby making data reuse workable. The use of the right technology makes the efficient ongoing management of UDI requirements possible and practical.
Medical Device Manufacturers the world over are striving to stay abreast of developments as regulatory bodies other than the US FDA release details concerning their approach to Unique Device Identification for medical devices. Taiwan is progressing in the area of UDI, having produced a guidance document late last year.
Within this guidance information it is clear that Taiwan’s Unique Device Identification:
- References both the US FDA UDI Rule and the IMDRF UDI Guidance
- Will use a Taiwanese version of the FDA GUDID which will be called the UDID
- Provides guidance on combination products
- Targets Medical Devices that are manufactured in Taiwan and ones that are imported
- Allows various forms of AIDC and recommends the use of human readable characters
- References the use of GS1, HIBCC and ICCBBA
- Recommends direct marking for medical devices which are to be reprocessed
- Provides guidance that applies to software as a medical device (SaMD)
Although the tone has been set and many details are available, there is still much information that is yet to be put forth. Specifics about UDI attributes to uploaded and maintained as well as standards for the transfer of attribute information will go a long way towards helping the medical device manufacturing community assess the magnitude of the regulatory challenges that lie ahead.
Jack Mazur, Principal JMG Recruiting, Pete Ginkel, Vice President ID Integration, Inc., and Lisa Fohey, CMRP PMP Director of Supply Chain Children’s Hospital of Wisconsin will be conducting a UDI Webinar hosted by JMG Recruiting from 1:00 pm to 2:30 pm Eastern on Wednesday January 6, 2016.
Topics to be covered include Direct Part Marking technologies & application – The speaker will review the popular marking technologies for Direct Part Marking of Medical Devices. The technologies reviewed will include:
Electrochemical etching, Laser marking, and Dot peen marking
How can healthcare providers maximize the value of UDI in the healthcare supply chain? This presentation will explore the challenges providers encounter as they prepare to implement UDI: technology shortcomings, competing priorities for resources, difficulty in creating a sense of urgency.
Please join us https://jmgrecruiting.leadpages.co/udi-webinar/
The answer to this question is simple: have someone else do the work for you. Since there are two times (reasons) that validation is required there should be two approaches to making validation less onerous.
Software Validation Reason #1
The first reason that validation is required is unavoidable, e.g. moving to new software. But since validation is a significant effort associated with implementing any new system in a FDA regulated life sciences company, there has to be a better way than creating test scripts yourself.
Through the use of strict development methodologies such as GAMP5 with its risk-based validation approach and appropriate documentation, it is possible for a life sciences labeling vendor to pass vendor audits with excellent results. These audits, which include the review of software validation that is performed in-house is work that you will then be able to leverage to your advantage. Thus, your life sciences labeling software vendor should welcome regular customer inspections. When a company has served life sciences giants for over two decades, regular validation of their own product becomes part of their DNA.
The outcome of regularly scheduled audits should be a comprehensive validation documentation packet including: URS/FRS, functionality matrix, installation qualification (IQ), operational qualification (OQ), protocols, test cases, and test scripts for every function of the software system.
This exercise also needs to be performed whenever significant changes to the functionality of the software are introduced. Consequently, system users who have access to vendor supplied unexecuted test scripts will not have to create a validation plan from scratch. This can save hundreds of staff hours and accelerate implementation and go-live dramatically.
Moreover, the validation packet should be written by long-term veterans of the Life Sciences industry and should be successfully executed at multiple pharmaceutical, biopharma and medical device manufacturing facilities. This will ensure that the work is applicable within your company. Your life sciences labeling company should have a customer base that has been 100% successful with having their auditors accept this form of validation.
The activity and outcome that is described above should be available in two formats. The first is fully-executed test scripts in PDF form and the latter being test scripts which can be modified for your environment.
Software Validation Reason #2
I stated that the first reason why software validation is required is that the software is new to your organization and its unique environment. I went on to explain that you can make your validation less challenging by using the internal validation work of your vendor. The other reason why software validation is required is that the software has changed or the business process has changed.
While the latter is often necessary and therefore the validation is difficult to avoid, the former can be eliminated with smart software design. If part of the functionality of the software is its ability to allow user modification such as adding new fields of information for tracking (change by configuration), this functionality can be validated by the vendor. In this way, the user can make changes through configuration yet does not need to revalidate the software since the ability to make changes at the end-user level has already been validated.
Validation is considered a necessary but laborious task and the mere thought of it keeps many life sciences companies from realizing the benefits of new, good changes. It does not need to be this painful! Given the right approach, whether it may be vendor-driven validation efforts and material evidence or software that is designed in such a way that it minimizes or eliminates the need for revalidation, organizations can move on to realize the benefits of new approaches and technologies without the burdensome costs that are usually associated with them.
Innovatum Inc., a leading provider of labeling management and printing software as well as regulatory data upload solutions for the medical device and life sciences market, is a Silver sponsor at the 3rd Semi-Annual Medical Device & Diagnostic Labeling Conference taking place Sept. 24-25, 2015. The two-day event is being held at the, Hilton Del Mar Hotel in Del Mar, CA.
In his case study presentation entitled, “A Unified Systems Approach To UDI” on Thursday September 24, Ardi Batmanghelidj, President and CEO of Innovatum will be discussing a software technology approach to reducing duplication of effort and leveraging labeling data along with its associated regulatory data to the utmost. Essentially, manifesting a realization of Single Source Of Truth (SSOT) theory and design as applied to the various elements that support “labeling and labeling related functions” thereby offering undeniable benefits. The discussion will include, housing data that did not previously have a good home, updating data in its primary location, eliminating the possibility of duplicates, maintaining quality data history and ensuring 21 CFR Part 11 compliance. In short, a realization of the goals of Master Data Management initiatives with re-use of the same data for various forms of regulatory upload, label management and production and also for eIFU management.
As part of its presentation, Innovatum will be demonstrating its industry leading and UDI-ready ROBAR Labeling, solution that enables end-to-end label life cycle management as well as its companion product, ROBAR MDM/COM regulatory data management and upload. The conference is set to be attended by industry leaders and will focus on a wide range of topics ranging from Maximizing Corporate UDI Strategies, Optimizing Label Translation & Content Localization Strategies all while Streamlining Label Approval Operations & Minimizing Human Errors.
Let’s face it, there are still those amongst us who grumble at the mention of having to comply with the UDI regulations. To them, it’s simply a matter of having to comply to stay in business. There are those of us however, who are advocates of the regulation and appreciate the benefits of UDI. We believe in its overall benefit for patient health and safety, and also as a means of facilitating business and reducing cost and errors.
The AIM North America Healthcare Committee recently presented a webinar to investigate the functionality of a system which makes extensive use of the UDI as a means of identifying medical devices in the operating room and associating those devices with patients’ medical health records. Through the use of in-line scanning technology during production, each device is entered into the chain of custody process where it is controlled throughout the supply chain from production to patient implantation. Part of this control includes anti-counterfeiting through confirmation of the pedigree at multiple checkpoints. Combatting counterfeit product is one of the benefits of UDI as counterfeit medical devices have wreaked havoc in the lives of patients, caregivers and others in the medical device community. Although the challenge in UDI is that multiple agencies and multiple barcodes can be used, there are differentiators that can allow a scanning device to be pointed at any barcode and in turn determine the agency and barcode type.
NOTE: The presentation below does contain some product marketing from the company which created the software however, it is a good demonstration of what a central device database can provide to the entire medical device industry. Capabilities include the ability to:
- Identify which items are used and generate an invoice, thereby eliminating manual data entry
- Compare costs, revisions, waste, and recalls, by manufacturer device, hospital and/or surgeon through real-time analytics
- Identify and measure outcomes by physician, hospital and/or implants
- Cross-reference devices, allowing stakeholders to alert patients when a recall occurs.
- Deliver access to member information by recalled device
- Provide member access to master implant database
- Identify prior implantations by member/surgeon/payer
- Eliminate overbilling by ensuring accurate device utilization by case
- Identify actual device implants as opposed to paying for wasted or defective implants
- Know exactly where each implant has been placed, targeting devices that need to be replaced because of a recall
- Identify the responsible party when a revision or replacement is required
With AIM focused on AIDC matters, about 30 minutes into the presentation, focus shifts to the AIDC implications and the use of bar codes and issuing agencies and complexities that go along with it. You can view the presentation at this location: https://youtu.be/VaPZPVYI_cg. This is not an endorsement of the company or product, just a means of whetting the appetite for all of the possibilities that UDI provides.
Innovatum and QuickLabel Systems leading providers of labeling management and printing software (Innovatum) and printing technologies (QuickLabel Systems) for the medical device and life sciences market, are silver sponsors at the 3rd Annual Medical Device Global Labeling Strategies Conference taking place Aug. 12-13, 2015. The two-day event is held at the Double Tree, Hilton Hotel in St. Paul, MN.
Innovatum will be showcasing its UDI-ready ROBAR Labeling, a market-leading solution that enables end-to-end label life cycle management as well as ROBAR MDM/COM regulatory data management and upload. QuickLabel Systems will be highlighting it’s Kiaro! Fast Inkjet Color Label Printer. The conference is set to be attended by industry leaders and will focus on topics ranging from UDI compliance to regulatory data management.
Together with, QuickLabel Systems, Innovatum will also be giving a presentation on how medical device organizations can centralize the design and control of labels within a global enterprise labeling system to manage centrally and print globally.
On Aug. 13, Ardi Batmanghelidj, President of Innovatum, Inc., along with Eric Anderson, Field Sales Engineer for QuickLabel Systems, will lead a presentation titled “Designing a Streamlined Approach to Label Standardization, Development and Printing.”
Together, Mr. Batmanghelidj and Mr. Anderson will explore the topic of a global enterprise labeling system having the ability to centralize the design and control of labels to thereby ensure consistent adherence to corporate labeling standards worldwide. A close examination of capabilities that must be accounted for in system design and implementation will be discussed. The path to maximization of efficiencies and process optimization as the desired outcome will be analyzed.