Oversight of FDA recalls?

In a recent report by the GAO, it reported that between 2005 and 2009, 3510 recalls were initiated by medical device firms - an average of ~700 per year. Most of these recalls were Class II and involved Cardiovascular and Radiological devices. In fact, there were 532 Cardiovascular recalls during this time (15% of all recalls) and number of Class I recalls for this category was 31% of total Class I recalls. The largest number for Cardiovascular devices involved automatic external defibrillators.

The top reason for recalls in 2008 and 2009 was related to production/manufacturing processes. Here are the top 3 root causes in 2008 and 2009 for medical device recalls:
1. Process Control
2. Device Design
3. Component design/selection

Interestingly, in the "additional root causes"category (36% of all Class I recalls), all recalls related to label/labeling was in that bucket. In my experience with medical device companies, enterprise label management is a big challenge and can create major recalls for minor label/labeling errors.

Out of 101 Class I recalls, 74 of the recalls (73%) were for devices through the 510(K) process, 22% were for PMA. The report highlights that FDA has not analyzed recall data to identify systemic problems underlying device recalls. Instead of using RFS - the recall database to improve quality and safety, FDA has primarily used this database for processing and tracking the progress of individual recalls. In the final scathing remark against FDA, GAO identified one of the major gaps in the recall process -  ability to ensure that the highest-risk recalls were implemented in an effective and timely manner by the FDA.

Taking Control of the Engineering Change Management Process to Stay Competitive

Companies typically instigate engineering change management initiatives to control cost or improve efficiencies. However, in a recent research published by Aberdeen, 63 percent of respondents indicated "time to market" as the top driver to improve engineering change management performance.

An efficient engineering change process can cut up to 33 percent off the typical product development cycle; however, 54 percent of companies lack a single repository to review, analyze, approve and track engineering changes across products. Some of the key drivers to improve engineering change management performance today are increased regulations and compliance, global teams and outsourcing, product complexity and variations, global competition and cost pressure, higher cost of quality, and customer satisfaction and loyalty.....

Complete article can be found here.

EU includes Medical Devices in RoHS directive

As per my previous article I had outlined that EU was contemplating to include Medical Device as part of the RoHS directive. On July 4th, 2011, EU decided to include medical devices as part of the RoHS Directive (2002/95/EC). The deadline for medical devices to comply to this directive is 22 July 2014. More to come...

Fixing Labeling Issues - Low Hanging Fruit for Medical Device Companies?

There are two critical elements for governmental regulatory attention:

1. Product

2. Use of Product

The pre-market review focuses on the product control side of the equation, and post-market surveillance ensures that the devices in use continue to be safe and effective. However, there is an additional key element, which is the representation of the product to the user: labeling during the pre-market stage, and advertising of product.

Pre-market control is conducted to make sure that the product complies with regulatory requirements. Labeling and Advertisement control is maintained for correct product representation. However, in my experience working with medical device customers, the labeling process is typically very manual process supported by several home-grown or best of breed software systems. This makes the process inefficient, but most importantly prone to human error. If you search on FDA's recall website, in 2011 there are 87 recalls related to label/labeling issues. 3 of them are class 1 recalls by Medtronic.

In addition to product recalls, incorrect, inaccurate or incomplete label/labeling information can delay 501(k) approval process. FDA has clearly outlined what is required as part of pre-market approval process, such as instruction for use (IFU), etc. Typically, these IFU's are written towards the end of the project and have very small window to complete the required literature, such as complete instruction, maintenance instruction, cleaning/sterilization instructions, etc. to meet FDA requirements.

The best-practice will be to leverage an enterprise PLM system in conjunction with a Label management system to drive efficiency and lower "cost of compliance". The key will be to enable a process which leverages version controlled label templates with product content and workflow from a PLM system to deliver compliant labels on demand anywhere in the world.

New RoHS EU Directive Is Coming To A Medical Device Company Near You…

The RoHS directive is intended to restrict the use of certain hazardous substances in electrical and electronic equipment (EEE).  The EU Commission now plans to recast RoHS as part of its overall commitment for a better regulatory environment.   The work on the revision started in 2008 and the revision is ready to be presented as “RoHS Recast” because the current directive will be repealed or replaced. One of the major modifications to the directive will be inclusion of medical devices and monitoring and control instruments in its scope and to the adaptation of the list of restricted substances.

In the current EU RoHS directive, medical device (MDD) and IVDs are exempt from RoHS compliance requirements. However, in the new proposed RoHS directive, MDD and IVDD devices will be removed from the automatic RoHS compliance exclusion list, except active implants under AIMDD. This change will have significant impact on medical device companies.  The Commission expects higher costs for complex products that are produced in low numbers and have critical applications. However, the proposed changes will be staged to allow the conversion to take place. The medical device companies must comply within three years after the publication of the directive, whereas IVDs must comply within five years.

So MDD and IVD companies have two choices available to them after the publication of this directive

(1)    Apply for specific exemptions, which is granted for 7 years

(2)    If exemption is not approved or filed, companies must comply with the directive by setting up a self-declaration of conformity referring to the RoHS. This will require manufacturers to maintain technical documentation, cite relevant standards, implement internal production controls and keep a register of the nonconforming products.  In addition, EC declaration of conformity that accompanies the finished product should be in the local language.

It is also required that manufacturers  add CE mark on the finished product, as well as their name, trademark, contact address, and a type, batch or serial number on the product labeling.

The EU Commission website for recast of RoHS Directive http://ec.europa.eu/environment/waste/weee/index_en.htm

MDDI Industry Blog - Open for Business....

Welcome to my MDDI blog...

In my current professional role, I have been working with several medical device companies in the United States. As my interest has increased over the last few years about the MDDI industry, I decided to write about this industry and my thoughts. MDDI industry is going through several changes, including more regulatory oversight around the globe coupled with healthcare reforms in the US and Europe. But I also believe that this an exciting time to be part of this industry as product innovation is improving patient safety and care.

I recently wrote an article about "Delivering Innovation in the Medical Device Industry". You can read the article here. 

Ciao