Medical Device Quality Assurance

Another Class 1 Recall!

2010-09-16T09:19:00.000-07:00

From the FDA Medwatch on 9/15:

BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall

AUDIENCE: Risk Manager, Emergency Medicine

ISSUE: Westmed, Inc. is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. The BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation.

Recalls on the Rise?

2010-09-14T18:30:00.000-07:00

The Class I (and some II and III) device recalls listed by FDA have gone from 18 in 2008 to 31 in 2009 to 30 to date as of 09/08/10. That begs the question are recalls on the rise? It will be interesting to see how FDA reacts to this data. Stay tuned. We will be exploring this development in weeks to come.

Money Spent on Medical Devices

2009-06-03T05:15:00.000-07:00

If I told you from 1989 to 2006 money spent on medical devices increased at a slower rate than the consumer price index would you believe me? Are we not bombarded every day how healthcare costs are spiraling out of control? So shouldn't devices be spiraling out of control? Not exactly. A May 2009 study, prepared by Gerald Donahoe and Guy King, F.S.A., M.A.A.A., titled Estimates of Medical Device Spending in the United States concludes the following:

"During much of the eighteen year period, 1989--2006, a significant driver of changed medical practice has been the development of new medical devices—from stents to implantable defibrillators to artificial hips and knees to new imaging modalities to new diagnostic tests to new surgical tools. In view of the conventional wisdom about the role of medical technology in driving up costs, it is surprising that the
cost of medical devices has risen little as a share of total national health expenditures. It is also striking that, unlike most other areas of medicine, the prices of medical devices have actually been growing more slowly not only than the MCPI(medical CPI) but than the CPI as a whole."

This is so different from what I have been hearing from the media incessantly. Why isnt't a distinction being made and better yet if Medical Devices can keep costs in check what are the drivers of the total spend increase and how can those be controlled. We need more and better information on this very important topic not just calls for blanket solution that could seriously hamper innovation.

Now this is just a portion of healthcare total spend. However, the next time someone comes harping the evils of the healthcare industry make sure to tell them how devices have done their part and will continue to do their part in keeping healthcare costs in check. The study can be accessed at: http://www.fdanews.com/ext/files/king%20report.pdf

FDA Requests Budget Increase

2009-05-26T08:52:00.000-07:00

The FDA has requested a 19% increase for the its budget or $295.2MM budget increase and $215.4 MM in industry user fees. What do you think will this mean for the medical device industry?

The FY 2010 request, which covers the period of Oct. 1, 2009, through Sept. 30, 2010, includes increases of $295.2 million in budget authority and $215.4 million in industry user fees. The FDA budget proposes two major initiatives for FY 2010: Protecting America’s Food Supply and Safer Medical Products.

The following are the FDA's key proposed budget increases:

Protecting America’s Food Supply ($259.3 million) – The goal of this effort is to protect American consumers by preventing intentional and unintentional contamination. This effort invests in priorities that strengthen the safety and security of the supply chain for foods. Within this initiative, the FDA proposes to collect a total of $94.4 million in new user fees to register food facilities and increase food inspections, issue food and feed export certifications, and reinspect food facilities that fail to meet the FDA’s safety standards.

Safer Medical Products ($166.4 million) – This effort provides targeted resources to improve the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products. It will allow the FDA to strengthen safety and security of the supply chain for medical products. The initiative also includes $46.6 million in new user fees for generic drug review and new fees to reinspect medical product facilities that fail to meet safety standards.

Current Law User Fees ($74.4 million) – In addition to the new user fees proposed for FY 2010, the FDA request also includes inflationary and other authorized increases for fees that support FDA review of applications for new human drugs (+$67.5 million), animal drugs (+$2.3 million), and medical devices (+$4.5 million).

Follow-on Biologics & Drug Importation ($5 million) – Within the Safer Medical Products initiative, the budget proposes a new authority for the FDA to approve follow-on biologics through a regulatory pathway that protects patient safety and promotes innovation, and includes $5 million for the FDA to develop policies to allow Americans to buy drugs approved in other countries.

Does this mean more frequent audits, longer lasting audits or an improved compliance process or both? Will international audits increase? I do not know the answer to that what I do believe is that the compliance landscape will see significant changes. Medical Device quality professionals must be vigilant and continue thinking strategically as to how best to improveme our quality systems to ensure staying ahead of regulations and regulatory practices and improving product performance and compliance. This period resembles the changes occurred during 1992/1993. The industry emerged stronger from that period and I am confident we will also be strong when the economy gets better this time around.

For more information on the President's FY 2010 budget for the FDA, visit: http://www.fda.gov/oc/oms/ofm/budget/documentation.htm

The Future of Medical Devices

2009-03-09T15:31:00.000-07:00

According to a recent article in MD&DI the future of Medical Devices continues to be a strong one. How strong will be dependent on a series of important factors and/or trends:

1. Technology
2. Demographics
3. Franchise Building
4. Pricing

I want to focus on a particular area of the article that will be of key importance to what could turn out to be the biggest driver of growth in MedDev, clinical evidence. Particularly in the Neurological device market the key to growing the field will be the ability of companies to provide evidence that will support reimbursement of new devices in that field.

As quality assurance professionals we play a key role in ensuring devices not only meet specifications but also the user requirements. Both of these are key to the development of innovative devices. Focus on one only and you either have many headaches or very little sales. Balance both and do them well and you could positively affect the lives of many people. Read this great article and comment on the important topics with your organizations.

Medical Device Quality Assurance Job Trends

2009-01-30T12:16:00.000-08:00

This graph displays the percentage of jobs that contain the search term Medical Device Quality Assurance. Since May 2007, Medical Device Quality Assurance jobs have increased 10%. Given the current economic state that seems like a great performance. Look at the Medical Device Quality Assurance Engineering job trends a whopping 19% increase. Solid demand for quality professionals.

Medical Device Quality Assurance, Medical Device Quality Assurance Engineering trends

Medical Device Quality Assurance jobs | Medical Device Quality Assurance Engineering jobs

"Data provided by SimplyHired.com, a search engine for jobs."

Medical Device Quality Assurance

2009-01-30T11:28:00.000-08:00

This blog is dedicated to the issues, information and news that interests Medical Device Quality Assurance Professionals. Discussions will be opened in topics ranging from salary, statistics, reliability, compliance, New Product Development Quality Assurance and Risk Management among other topics. This is a technically oriented group to encourage exchange between professionals and live discussions of emerging, complex and heated topics in the Medical Device Quality Assurance communities.

I will have polls to get your feedback on the issues that interest the MDQA community the most. Please feel free to e-mail or comment on the topics and issues you want to discuss.

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