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UDI Costs: Long-Term Expenditures May Not Be Obvious

jon money UDI Costs: Long Term Expenditures May Not Be Obvious Our author says to expect UDI costs to be as much as 1%+ of annual sales. Ongoing costs and post market surveillance factors are also discussed. This new regulation is not without its costs. Some costs are significant–especially to small medical device labelers. There are the obvious implementation costs and ongoing maintenance. There are also “Post-market Surveillance Factors,” which may be a cost or benefit, but Post-Market Surveillance Factors certainly have long-term implications for your company.

UDI Costs to Industry

“The [UDI] final rule may have a significant economic impact on a substantial number of small entities that label medical devices.” (Federal Register – Cost and Benefits) Eastern Research Group, Inc. (ERG), under contract to FDA, “…estimated present value of the costs to domestic labelers is $620.4 million using a 7 percent discount rate and $713.2 million using a 3 percent rate…” over a 10-year period. Over the same time period, the annualized costs for domestic labelers are estimated to be $82.6 million at a 7 percent discount rate and $81.2 million at 3 percent. Medical device labelers will incur most of these costs. Labelers include manufacturers, reprocessors, specification developers, repackagers and relabelers that induce a label to be affixed to a medical device. ERG estimated costs would not eclipse 1% of revenues annually, except for a small percentage of companies required to directly mark certain devices. Some multi-use device manufacturers required to direct mark their Class I devices could benefit from reduced total costs if all of their device labels only require static barcodes, rather than more costly variable barcodes (DI +PI).  ERG also estimated 32 firms out of 5,234 domestic medical device labelers (5,010 are small businesses) will bear costs greater than 1% of revenues, due to needing costly laser direct marking equipment. Interestingly, all 32 firms are all considered small businesses.

Implementation Costs

Most of the costs associated with UDI are related to implementation. The following is a list of examples:

  • planning and integration of UDI throughout information systems
  • creation, review and approval of labeling changes
  • digital printers to print the new barcodes and date formats
  • increased printing due to variable barcodes
  • joining issuing agency and obtaining labeler ID
  • requesting Global Medical Device Nomenclature (GMDN) Preferred Term (PT) codes
  • registering new barcodes
  • laser-etching of UDI barcodes on devices for direct marketing
  • compliance with the FDA’s UDI data uploading requirements
  • review and approval of procedure changes

The first item on the above list, planning and integration, will be the largest cost of UDI implementation. The cost of planning and integration includes: installation, testing and validation of barcode printing software. You will also need to retrain almost every department to understand how UDI is being integrated with existing processes. You may also need to temporarily increase your workforce in order to help ensure timely implementation to ensure compliance with the data attributes required for each device entered into the Global UDI Database (GUDID).

Ongoing Costs

The largest annual ongoing cost include labor, operating, and maintenance associated with equipment for printing labels, and labor related to software maintenance and training needed to maintain the GUDID system. Other ongoing costs include paying initial and annual fees to the Issuing Agencies and/or the  GMDN agency (http://bit.ly/GMDN-Agency) for ongoing maintenance of the system. You will need to have additional personnel in most cases to manage these additional requirements.

Post-market Surveillance Factors

Post-market Surveillance Factors are either a cost or benefit to the labeler, and are directly related to the Patient Safety and transparency aspects of the UDI Regulation. The goals of FDA in enacting the UDI Regulation are:

  • reduce medical errors
  • simplify assimilation of device use information into database systems (such as Electronic Health Records and Personal Health Records)
  • provide for quicker identification of medical device adverse events; improve the speed of the development of solutions to reported problems
  • hasten and improve the efficient closure of device recalls
  • more focused and effective FDA Safety Communications
  • allow professionals and end-users access to additional product information via GUDID

In my opinion, there are other factors just as important which companies should pay attention to as they complete UDI requirements, including the ability to:

  • develop more complete safety and effectiveness profiles for devices
  • reduce waste by helping to eliminate duplicate inventory at healthcare facilities
  • identify new uses for devices, which will help increase value for shareholders, customers and end-users

Today, the identity of labelers is hidden from users and patients. Tomorrow, when the FDA’s goals are realized, labelers will be faced with increased transparency. You will need to address increased transparency by acting quickly to product performance trends. In today’s world of instant communication, you cannot afford to ignore safety issues brought to light by post-market surveillance factors. Anyone who does, does so at their own peril.

Posted in: Unique Device Identification (UDI)

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How to Prepare for an ISO 13485 Certification Stage 2 Audit-Part 1

last prep How to Prepare for an ISO 13485 Certification Stage 2 Audit Part 1

This blog, How to Prepare For an ISO 13485 Certification Stage 2 Audit-Part 1, reviews CAPA records, design controls and production process controls.

ISO 13485 certification is required by Health Canada as a requirement for all Medical Device License Applications, and most companies choose ISO 13485 certification as their method for demonstrating conformity to the requirements of the Medical Device Directive (MDD)–instead of a special MDD audit.

In order to achieve ISO 13485 certification, you must successfully complete a Stage 1 and Stage 2 certification audit with your chosen certification body (http://bit.ly/SelectingRegistrar). If you are interested in an overview of this certification process, you can download Medical Device Academy’s white paper on this topic (http://bit.ly/wpiso13485), or you can watch a webinar we recorded recently on ISO 13485 Certification (http://bit.ly/6-steps-to-ISO13485).

Management Processes

The Stage 1 audit is typically a one-day audit where the auditor is evaluating your readiness for the Stage 2 audit. The auditor will review your Quality Manual and your procedures (19 are required) to ensure compliance with ISO 13485. In addition, the auditor will sample records from critical processes to assess your readiness for the Stage 2 audit. Typically, these processes will be:

  1. Management Review
  2. CAPA
  3. Internal Auditing

After you complete the Stage 1 audit, you may have a few nonconformities identified by the auditor. Responding to these nonconformities is the first step in preparing for your Stage 2 certification audit. You need to initiate a CAPA for each of the auditor’s findings and begin implementation before the Stage 2 audit. Typically, you will have about six weeks to implement these actions. This is not typically enough time to complete your CAPAs, because you need more time before you can verify effectiveness of corrective actions (http://bit.ly/CAPA-effectiveness-checks).

Preparing CAPA Records

In preparation for your Stage 2 audit, prepare for the auditor to review any CAPAs that you completed since the Stage 1 audit–especially if you have evidence of completing an effectiveness check. You may think this is unnecessary, because the auditor previously reviewed CAPAs during Stage 1. However, you probably received a nonconformity related to your CAPA process (almost everyone does), and you should expect auditors to review your CAPA process during every audit.

CAPA Effectiveness Graph 300x218 How to Prepare for an ISO 13485 Certification Stage 2 Audit Part 1 Each CAPA record you present should be provided in a separate folder as a paper, hardcopy. The paper, hardcopy makes it easier for the auditor to review. The folder should include documentation of the investigation, a concise statement of root cause, and copies of records for all corrections and corrective actions implemented. Corrective actions include procedure revisions and training records. If there is quantitative measurement of effectiveness, include a graph of current progress with the record. Ideally, the graph will be one of your quality objectives. The graph to the right is an example.

Production Process Controls

Every company has at least some production and process controls implemented prior to the Stage 2 certification audit. Most auditors and inspectors spend too much time in conference rooms reviewing paperwork, and too little time interviewing people that are performing work. However, many companies also outsource production activities. Therefore, unless you have a software product, you can expect your auditor to review incoming inspection activities. The auditor is also likely to review finished device inspection, storage and distribution. If the auditor is thorough, they will also follow the trail from inspection activities to calibration activities, nonconforming materials and data analysis.

Design Controls

If your company is a contract manufacturer, then you probably are excluding design controls (ISO 13485, Section 7.3) from the scope of your Quality System. However, if you are a manufacturer that performs design and development, then  is an element of the quality system that warrants special attention. During the Stage 1 certification audit, the auditor reviewed only your Design Control procedure. During Stage 2, the auditor will look for evidence of implementing design controls. Therefore, even if your company has not completed your first design project, the auditor will still want to see some evidence of implementation. The auditor will expect at least one design plan to be written and at least one design review should be completed.

If you are familiar with the FDA Quality System Inspection Technique (QSIT) process for inspection, you might have noticed that this blog is divided into the same subsections identified in the QSIT Manual (http://bit.ly/QSITManual). You should also consider downloading Medical Device Academy’s free webinar recording on the topic of FDA inspection (http://bit.ly/QSIT-Preparation).

Posted in: ISO Certification

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