New Online Service Provides Consumer Access to FDA’s Recall Database

Today, the Wall Street Journal reported on two new websites that provide consumer access to FDA’s drug (AERS) and device (Maude) adverse event reporting databases. The story is here.

The site that reports on device events is Clarimed. According to Clarimed’s founder, Nora Iluri, the site’s purpose is to empower consumers and promote quality-based competition among manufacturers.

Although this information is interesting, I have my doubts about it’s ultimate usefulness in the device arena. Unlike drugs, physicians often have the ultimate say-so about which device they are using…my hip replacement is a Stryker because that’s what my doctor uses and was trained on…consumer preference is a secondary consideration. Will consumers start educating themselves about scalpels and IV pumps? Even if they did, would they be able to influence what gets used? That decision is largely in the hands of the hospital purchasing department. While some device decisions may be open to consumer input (e.g. hip, heart valve, pacemaker), the large majority are going to be beyond the patient’s immediate control. However, the launch of websites like Clarimed are interesting because they illustrate the democratization of information on the web…and a growing consumer awareness of the risks associated with medicines and medical devices.

A Rose is Not a Rose: All ISO 13485 Certifications Are Not Equal

The FDA just delivered a scathing 483 to device maker Pharmaceutical Innovations of New Jersey, citing, among other blatant violations:

Lack of calibration or maintenance of in-house sterilizers, lack of validated processes, lack of sterilization verification testing, no DMR/DHF, lack of sterilization batch information, and openly destroying legally required production records rather then permit FDA review (!) – the full text 483 is here.

The situation that set up the for-cause FDA inspection was particularly alarming. As stated in the letter, several infants in a neonate ICU (NICU) cultured positive for Pseudomonas (potentially lethal for immuno-compromised individuals, like premature infants!). The hospital’s investigation led to culturing the company’s ultrasound 8 oz bottles and 5 liter gel which tested positive for the Pseudomonas organism. You can see a company video touting their latest product, designed for (you guessed it)  infants is here.

Apart from the seeming lack of quality system rigor that seriously jeopardized some of the most vulnerable patients imaginable – it was especially alarming to see that this company was registered to ISO 13485…by Orion Registrar.

In fact, I’ve written before about the importance of ensuring that your suppliers are certified by a reputable registrar (e.g. DEKRA, BSI, etc) – and doing your own audit verification. For translation suppliers, this means examining Management Reports, CAPA records, project records, and other systems documentation to ensure that hazards are identified and mitigated.

Either that, or risk having a company like Pharmaceutical Innovations on your Approved Supplier List.

New Concern for Device Manufacturers: Whistleblowers

Last night’s 60 Minutes episode on the Glaxo SmithKline whistleblower, Cheryl Eckard, can be viewed here (see bottom of post) :
http://www.thepoptort.com/2011/01/60-minutes-and-glaxosmithklines-whistleblower.html

This is one of the largest whistleblower settlements ever and was based on quality systems violations – the same type of violations that can and do occur at medical device manufacturers. Ekard received a portion of the settlement ($90 million?) – and, even though this fact is not mentioned in many of the reports, you can be sure that QA employees at both pharma and device companies took notice when 60 Minutes reported it.

Interestingly, Eckard’s lawyers filed suit on behalf of the federal government claiming that Glaxo had defrauded the taxpayers. How is this fraud against the government? said Getnick , “Pharmaceutical drugs [and medical devices] are paid for by our Medicare program for the elderly, by our Medicaid program for the impoverished. And here we have a situation where hundreds of millions of dollars were paid for adulterated drugs through our Medicaid programs.”

FDA Enforcement Trends Evident in Infusion Pump Oversight

Evidence of a more muscular regulatory approach by FDA is easy to find – but a recent NY Times article on increased FDA oversight of infusion pumps is loaded with enforcement trends…

Thanks to the lower costs associated with in-home treatment, home healthcare is exploding – so is FDA’s concern about home healthcare devices and their potential impact on patient safety. As complex devices are employed, more and more, by average people, new risks are emerging. 

The potential for human error in using devices has been a particular source of concern for FDA for some time – in fact, Crimson recently hosted a webinar on “Device Safety through Human Factors Engineering” with the head of HFE at Abbott Laboratories. Human factors and use error becomes even more important in uncontrolled home-use environments.

Additional data requirments are part of FDA’s plan for infusion pumps – just as it is for many other medical devices. The Agency will require more and more manufacturers to submit clinical data to support their applications - even when manufacturers are claiming “substantial equivalence”.

Finally, beefed up requirements for software validation and testing are part of the Agency’s plan for infusion pumps. Last spring, I attended a Compliance Alliance event in Las Vegas that included Al Taylor from CDRH’s Division of Electrical & Software Engineering. At the time, Al promised that the Agency would begin using automated tools to better test device software – now, an open source version of testing software is available to manufacturers from the Agency.  

In a July, ’08 I wrote an article for Medical Product Outsourcing in which I predicted:

“Come November, we very well may have an activist executive branch— in which case we will get aggressive passed legislation… not to mention many important branch appointments”

Well, here we are, nearly two years later, and FDA is quite activist under its new leadership. New enforcement trends are all around us – many of which show up in recent activity for infusion pumps…

2010: Climate Change in the Medical Device Industry

There’s no doubt that medical device manufacturers will face a changing regulatory climate in 2010. A good overview article was written by Lloyd Benson (EVP of Schwartz Communications) and posted at massdevice.com (good ppt from Frost&Sullivan available here).

While many argue the relative impact of the proposed $20 billion tax on the medical device industry (12/14/09 amendment would exempt companies with less than $100 million of revenue, make payments tax-deductible, and move the implementation date to 2013), this highly-visible piece of legislation may only be the tip of the iceberg.

Lurking beneath the water, invisible but perhaps larger and more pervasive than the proposed industry tax, are the costs associated with increased regulation by FDA. Public safety issues with food, drugs and devices (both domestic and imported) have put the FDA on the hot seat…and heightened enforcement has been the result. Increased interaction between FDA and international authorities means a more muscular enforcement environment, world-wide.  Recent emphasis on supplier control is one obvious example.

Complying with enhanced enforcement can be costly – especially if a manufacturer is dealing with the cost of poor quality (in the form of rework or recall). Staff, processes, validation, audit preparation and response, all come at a cost – and it can be difficult to quantify. In the aggregate, however, the costs associated with heightened enforcement may represent a more substantial tax on industry than the one currently being debated in Congress.