In January of this year, we took a look at the overall numbers for electronic medical device reporting (eMDR) submissions to the CDRH/FDA. As we predicted, those numbers have risen significantly in the first half of 2010, even though the final rule still has not been published, and probably won’t happen before the end of the summer. Comparing the first six months of 2009 vs. 2010 [see chart below], electronic submissions are up dramatically.

The all-time monthly record was set in June 2010 with 7,755 electronic submissions, and for the first six months of this year they’re up 74% over total submissions in 2009 (21,296 total in 2009 vs. 36,962 first six months of 2010). Even without the eMDR final rule published, companies are taking advantage of paperless electronic submissions to FDA. As Indira Konduri, CDRH eSubmissions Program Manager once told us, it’s better to get on board with the FDA now, rather than wait. I’d take that advice and get it done now, before the final rule is published and everyone rushes to get on board.

It will be interesting to see what happens for the rest of the year.

We knew it was coming. FERC enforcement actions picked up significantly in 2009. But what surprised us most was the eye-popping 214 violations for PRC-005-1.

So, what exactly is PRC-005-1?

Simply put, the NERC PRC-005-1 standard says (but is not limited to the following – see below for link/download of standard):

• Owners of generation Protection Systems shall have a maintenance and testing program for all protection devices that affect the reliability of the Bulk Electric System (BES).
• The program must include a maintenance and testing interval for each type of device and the basis used for determining that interval.
• The owner must provide documentation of its system maintenance and testing program and the implementation of that program to its Regional Reliability Organization on request within 30 calendar days.
• The program must provide the evidence that each Protection System device was maintained and tested within the defined intervals including the last tested/maintained date.

You can download the NERC PRC-005-1 Standard here.

Why has complying with PRC-005-1 been such a challenge to utilities?

The legacy of the unregulated past of both small and large utilities has left them with islands of disconnected data related to physical devices and assets that have an affect on the BES. This data consists primarily of work orders, maintenance activities, test results and supporting evidentiary documentation. Unfortunately, all of this data tends to reside in disparate systems such as ERP, spreadsheets, hard copies, custom databases, test systems, etc., and are typically spread across various departments and facilities in the enterprise. If a utility is found in non-compliance with the NERC Standard during an audit, it can result in fines from the tens to hundreds of thousands of dollars.

Achieving compliance with PRC-005-1

As daunting a challenge this might sound, there is a cost effective and simple solution that provides a central hub for real-time visual compliance to NERC PRC Standards. CATSWeb ER seamlessly integrates data from dozens of differing sources into a single repository and creates logical relationships amongst this data to perform measurements and analytics in real-time dashboards. This provides a visual status of PRC compliance of all devices and assets across the enterprise. Users also get real-time alerts and notifications as trends towards non-compliance occur, well before a state of non-compliance happens. The system also maintains a complete auditable history that’s ready for an audit of all devices, issues and actions in maintaining control and compliance.

Visit the NERC website to view enforcement actions, settlements and penalties.

Ken Miles, a 28 year veteran of the FDA, is today a widely-respected industry consultant to the medical device industry. He draws on his extensive experience to help firms effectively and efficiently comply with FDA requirements. Ken’s expertise includes evaluating Good Manufacture Practice (GMP) and Good Laboratory Practice (GLP) compliance, Quality System Regulations, and QSIT certification inspections (Management, Design, Process Controls, and CAPA).

In this multi-part series, we talked with Ken about FDA medical device inspections, CAPA, quality systems, audits, training and more.

Q: Where do you think companies fall short when it comes to implementing CAPA systems?

A: Some companies have a great CAPA program that is tied in with metrics, management reviews, etc., but ultimately may be only looking at trend analysis studies of post-production products. Unfortunately, they neglect trends with suppliers and internal production operations, or visa versa.  Valuable data can be obtained for correcting problems in their factory by looking at all trends: suppliers’ and in-house non-conforming materials and components, scrap rates, training issues, complaints, competitors’ non conformances (ie Warning Letter), etc.  Sometimes they’ll discover ”a peak in noncomformance with a certain product line”, but they fail to break it down to reveal that the nonconformance(s) only involve one or two models within the product line which is often the real culprit.

Company managers need to ask themselves, is it one model or all models? A certain shift? A certain part of the plant? Finding the root cause is very important in order to effectively resolve the problem(s). Companies need to isolate the problem and find out if it’s widespread, model specific, or a component. The big picture of using metrics is great, however, if you can’t drill down to the specific problem and root cause, then it’s really not solving the problem.

Q: Can you give us some examples of what you saw as an FDA inspector?

A: One time I was at a large global manufacturer and they had a lot of returned motherboards for ultrasound systems (hundreds of boards returned per month.) Instead of analyzing and finding the root cause of the problem of all these returned boards, they would simply rework and repair them – over and over again. These boards had a very high rate of return, but they would all just go into a big hopper for rework. They should’ve taken the time to do a root cause analysis, but they didn’t, preferring to continue to fix them. None of this was logged into a system, and no failure investigations were ever conducted.  Think of the risk to consumers and to the companies’ reputation and earnings! Think of the enormous waste in time and funds and other resources used for fixing the same problems over and over again.

This firm ended up having a major investigation by the FDA with recalls and monetary fines in the millions of dollars. If they had an effective CAPA system in place with root cause and failure investigations, they could’ve fixed the problem once and for all instead of reworking hundreds of motherboards per month.

Q: Why do you think medical device companies have such a problem with CAPA?

A: The biggest problem I see has to do with a lack of human resources. Typically a person in charge of CAPA has too many tasks and things tend to fall through the cracks. This generally happens to smaller companies with growing pains. That said, it also happens with the biggest ones, too. Bottom-line: the failure is about not devoting enough resources to CAPA, and letting other issues distract them because they are overworked.

Click here to learn more about CAPA Systems.

In Washington, D.C., experts tracking the political shifting sands often advise you to watch what someone does, not what they say. Applying that to the FDA suggests the agency is starting to take risk management enforcement a bit more seriously.

Here’s a good example. Earlier this week (Feb. 16) the agency approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs) manufactured by Amgen Inc. The company’s risk management program or Risk Evaluation and Mitigation Strategy (REMS), requires health care professionals to provide their patients receiving an ESA with a Medication Guide that contains information for patients on how to safely use a drug.

And earlier this month, the agency requested a 23% hike in its budget to help it more aggressively pursue food, drug and device safety (plus its new tobacco initiative).

More action and more dollars could add up to a more active FDA in 2010.

Make sure to read our previous post: Risk Management Matures Beyond the Spreadsheet

Numbers don’t lie. Reviewing the year-end numbers for FDA’s CDRH electronic submissions (AS2 Electronic Submissions Gateway) provides some eye popping stats.  This is an early indicator that electronic medical device reporting submissions have significantly increased over 2008, and certainly suggests they’ll rise even faster this year after the final rule is published.

Comment period on the draft guidance ended November 2009. The final ruling is expected within weeks. According to some FDA insiders, many were relieved the agency wasn’t overwhelmed with comments (slightly over two dozen comments were filed), and the ones received were definitely “workable”.

So, what did 2009 numbers look like?

As the chart shows, early 2009 got off to a slow start, but picked up significantly in the fourth quarter of the year.

But when comparing 2008 vs. 2009, total submission numbers jumped from 4,619 to 21,296. It’s apparent that the device industry has picked up the pace when it comes to electronic submissions to FDA. And if this isn’t a wake up call for device companies to move away from paper 3500A submissions to eMDR, we don’t know what is.

We’ll be keeping a close eye on this through 2010.