Spinal implants are tested according to several ASTM standards. ASTM F1717 is intended to provide a basis for the mechanical comparison among past, present and future spinal implant assemblies. Three static and one fatigue mechanical test of a spinal construct are governed by ASTM F1717. The three static tests are compression bending, tension bending and torsion. The fatigue test is a compression bending test. The mechanical tests are conducted in vitro using simplified loading schemes and do not attempt to mimic the complex loads of the spine.
It pays to remember an old adage: "Better to be safe than sorry." Indeed, many medical device manufacturers are re-evaluating their quality systems as a result of the Food & Drug Administration’s recent review of pre-market notifications and a FY 2011 budget request for additional funds to address product safety. Device makers should heed this advice and take the necessary steps to pro-actively — rather than reactively — address compliance issues.
There is a bit of holiday cheer going into 2010, as the Senate delayed the implementation of a healthcare reform tax on medical device makers to 2013. This amendment also provides an exemption to the small startups and companies with yearly revenues of less than $100 million. But those with revenues above that mark will see their tax burdens increase. This is perhaps a boost to the early-stage startups that are looking to raise funds to commercialize their products. The climate is difficult enough to find investors willing to fund an early-stage, pre-commercialization company.
What’s a woman to do? The latest health care reform is coming in the form of a report from an independent body of clinical specialists who have determined that mammography screening starting at 40 years old has lead to false positives, increased costs and other “risks” that are best handled by changing the time and number of mammograms mandated for women. According to the American College of Radiology, since regular mammography went into widespread use in 1990, the mortality rate from breast cancer has declined by 30 percent.
In TMJ Implants v. United States Department of Health and Human Services, the U.S. Court of Appeals for the 10th Circuit upheld the Food & Drug Administration’s imposition of $170,000 in civil money penalties against TMJ Implants and its president, Robert Christensen.
The Food & Drug Administration is asking the Institute of Medicine for a $1.3 million review of the 510(k) process. Is this a good or a bad way to review this agency’s work product?
Here we go again, taxing and spending, but now the theme is healthcare reform. We see this trend every eight to 10 years, so it’s really more of a cycle. It usually comes in lock-step with more regulation, because there are more funds to pay for the increased regulation. This “reform” is not shaping up to be all that different from the last attempt. If the Senate has its way, more fees and taxes will result to cover the $900 billion working price tag.
We watch to see the outcome of the hearings and discussions from the Congressional activities that have stemmed from the U.S. Supreme Court’s February 2008 decision in Riegel v. Medtronic Inc. Congress is rushing to enact the Medical Device Safety Act of 2009 to reverse the preemption bar for those injured by medical devices that have been approved for use via the pre-market approval process of the Food & Drug Administration.
Newly confirmed FDA commissioner Dr. Margaret Hamburg indicated In a recent speech ways that the agency will step up enforcement activities.
So put on your seatbelts. We’re going to see just how much the new mantra of “transparency” will help or further hinder the commercialization of medical products.
Hamburg announced several initiatives during her talk, including post-inspection deadlines of 15 working days for FDA to outline its issues for industry before a warning letter will be sent and limiting warning letter reviews to “significant legal issues.”
The world of medical devices is expanding. In the eyes of the consumer, medical devices are often lumped in with biotechnology and pharmaceuticals. The average medical products consumer does not distinguish between a drug, a face cream or a nail clipper. There is little consumer education, but if you watch TV, Stryker will recommend that you tell your surgeon to use their hip replacement.