Medical Device Regulation Dilemma

Spotlight on Medical Device Regulation Policies

On 7 February, President Obama gave a speech to the Chamber of Commerce during which he addressed some issues regarding regulations, such as:

We’re improving the way FDA evaluates things like medical devices, to get innovative and life-saving treatments to market faster.

According to the FDA’s device regulation and guidance, medical devices are classified into Class I, II, and III.  Most Class I devices do not require notification.  Most Class II devices require premarket notification 510(k) and most Class III devices must have both 510(k) clearance and receive premarket approval.  In other words, the higher the class, the more stringent the regulatory requirement.  Recent news about medical devices is centered on 510(k).  So what is 510(k)?  From FDA’s website:

The 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

Medical Device Review Standard Challenged

Recently, the FDA has reviewed its 510(k) approval actions, aiming to streamline and shortening review processes.  But there were alarming signs that past review processes already existed flaws that could potentially challenge the FDA’s attempt to simplify medical device review processes. For instance, the New York Times reported that in the past five year there were over 68 recalls and more than 22,000 reports of malfunctioning external defibrillator devices.  This prompted the FDA’s advisory panel to request tighter oversights.  A study also found that about 70% of the recalled devices received FDA abbreviated agency protocol review, which again alerts current regulatory processes.  Despite these seemly increasing numbers of recalls and defective devices, medical device makers complained that the FDA’s stricter and prolonged regulatory scrutiny had already forced them to move operations to overseas, like China, Brazil, India, and Europe.  Again FDA is sandwitched between medical device makers who prefer simpler approval processes and consumers who demand stricter standards and safer devices.  A tough role.

Greenlights on Recent Medical Devices

From my Google Alert notice, at least four companies received greenlight on their 510(k) clearance and approval, here they are (and hope more to come):

1. Diazyme’s 25-Hydroxy Vitamin D Assay (January 24, 2011)

2. Pacific Consolidated Industries’s On-Site Oxygen Generators (February 7, 2011)

3. Depuy Orthopaedics’s New Titanium Foam Implants and revision hip system (February 15, 2011)

4. Allergan’s Lap-Band Device (February 16, 2011)

Until next post, keep on reading and writing!!

When CT Scan Fails to be a Cool Tool

Radiation on Spotlight

Hot, hot, and hot!  Wait, I am not referring to weather.  For those who may not know, in science community “hot” refers to “high” when it comes to radiation dose.  Recent full-body X-ray scan in the airport-screening procedure, increasing usages of the cone-beam CT scanners in dentists and orthodontists’ clinics, and damages caused by the CT head scan are all become news headlines.   With the advancement of radiation technologies in security and medical devices, more and more people start to worry about the trade-off between speed and scale of radiation scanners and dose and time of radiation exposure one receives.

Good News to Cheer

Lung cancer, one of the leading deadly cancers, causes ~157,300 deaths in the US alone.  Early discovery of small cancer tissue formation and surgical removal can prolong the lives of patients.  Recent good news revealed by the National Cancer Institute-sponsored clinical trial with over 53,000 participants (mainly smokers and ex-smokers) has shown that a 20 % reduction of mortality in participants screened by low dose helical CT scan instead of conventional chest X-ray.  Computed tomography (CT) scan utilizes radioactive atoms that emit X-rays to image detailed structures of a body.  The CT scan apparently has higher sensitivity, so it can lead to early detection and treatment.  However, CT scan is potentially a double-edged sword, warrant further study.

Bad News to Pay Attention

Although the CT scan has higher sensitivity than conventional X-ray, it also has high false positive (for lung abnormality) alarms, leading to unnecessary medical procedures and medication.  The CT scan is expensive with a price tag of at least $300 per screening.  The huge CT scan machine produces ~400 times higher dose of radiation compared with conventional X-ray.  In fact, experts have long been warning the FDA to regulate the CT scan on colon cancer screening due to its high radiation dose.  Now, there are several incidences whereby patients were severely hurt after high dose of radiation exposure, causing a variety of ailments, including hair loss, confusion and memory problems.

Proper Use of CT Scan is Crucial

What is the safest way to use CT scan and how?  There are many controversies among different interest groups, e.g. medical device makers, radiologists, patient advocate groups, insurance companies, and governmental regulators.  Each has its own stance on the risks and benefits of CT scan in prevention and diagnosis of various cancers.  Is there any ways to improve the safety of CT scan?  According to the FDA’s new release on preventing radiation overdose during CT scans, “education” becomes a key.  The CT scan manufactures need to better train the operators, because most overdose is a result of improper use of the scanner (i.e. operator error) not the machine malfunction.  When CT scan is properly used, it did not result radiation overdose.  I wonder why CT scan, such a sophisticated and expensive machine, was used with no clear and strict rules in the first place.  Now the FDA has stepped up to the investigation and followed up the cases of overdose, hopefully medical community is able to learn from past mistakes and seriously improve education, so the benefits of CT scan could outweigh risks of radiation exposure.

Until next post, keep on reading and writing!!