Capitol Comments

INDA Submits Comments To FDA On Antiseptic Skin Preparation Products

By Jessica Franken, Director of Government Affairs & Dawnee Giammittorio, Associate Director of Government Affairs | March 11, 2013

Major patent reform becomes effective March 16; Industrial wiper rule is delayed until October 2013.

INDA submitted comments February 12 responding to the U.S. Food and Drug Administration’s (FDA) request for input on preventing microbial contamination in antiseptic patient preoperative skin preparation products. These products, used in hospital or clinical settings and available for purchase over the counter include single-use pads, wipes and swabs often containing alcohol, poyodone iodine or chlorhexidine gluconate (CHG). While designed to prevent pathogens from entering the body through surgical incisions, medical procedures and injections, sometimes these products themselves become contaminated with the infection-causing microbes they are designed to protect against.

After several product recalls and reports of infection outbreaks involving these products, FDA last November announced it would hold a public hearing in December and collect stakeholder comments to get more information about contamination issues. The agency requested input on a range of issues related to intrinsic and extrinsic contamination, with one of the primary questions being whether these products should be required to be manufactured sterile. 

INDA’s comments stressed the importance of these products in combating surgical site infections, which account for more than 30% of all hospital acquired infections. INDA cited several studies demonstrating the significant cost savings and infection prevention benefits from using APPSPPs and noted that various healthcare agencies and professional organizations including the CDC, Association of Perioperative Registered Nurses (AORN) and others recommend the use APPSPPs as part of standard patient preoperative protocols.

INDA emphasized the need for an evidence-based approach when evaluating the risks of these products versus their proven benefits and queried whether sterility requirements could actually make matters worse. INDA noted that only 40 incidents involving contaminated antiseptics have been recorded during the last 50 years, despite more than 48 million procedures performed in the U.S. each year. Of these, more than 70% involved contamination caused by improper usage, which sterile manufacturing would not address. 

INDA also questioned whether manufacturing these products sterile would offer any meaningful benefit, pointing to studies and reference materials that show no difference in the efficacy of clean versus sterile products. Further, INDA pointed out, while some of these products are used in the operating room environment, a large percentage are utilized in non-sterile environments, using non-sterile application practices on non-sterile patient skin, and thus would negate any benefits that sterility would confer.

INDA also raised concerns about the technical challenges manufacturers would face in meeting such a standard. Making these products under sterile conditions could prove insurmountable, INDA noted, with existing sterilization methods either degrading the active ingredients or requiring major redesigns of production facilities and equipment. Such a requirement would increase costs so significantly that some manufacturers would be forced to withdraw from the market altogether, INDA stated. This would lead to a scarcity of products that have been shown to reduce SSIs and drive up rates of infection and healthcare costs at a time when the government is trying to reduce both. In other words, it would exacerbate the problem that the agency hoped to eradicate.

Major patent reform becomes effective March 16, 2013

Mark your calendars inventors and patent seekers. On March 16, 2013, one of the most significant changes to U.S. patent law in the last 50 years will go into effect. That is the day when the U.S. will switch from a “first to invent” to a “first inventor to file” patent system.

The change is one of the key provisions included in the Leahy-Smith American Invents Act (AIA) patent reform law signed by President Obama in 2011. Currently, under the “first to invent” rule, patents are awarded to the first inventor to conceive and reduce the technology or invention to practice. After March 16, however, the inventor with the earliest filed application will be entitled to claim a patent over other inventors, regardless of who invented the claimed subject matter first. Critics argue the change will simply reward the winner of the race to the Patent Office, but proponents say it will bring the U.S. in line with the rest of the world and eliminate costly and time-consuming fights over who invented something first. 

The law includes a number of other changes, among them, an expansion of the “prior user rights” infringement defense and a new post-grant review procedure that allows for challenges on any ground within nine months of an issued patent. It also provides for a new  “prioritized examination” procedure, enabling those willing to plunk down $4800 ($2400 for small businesses) the chance to expedite the patent review process from the current three-year average to within one year of the application filing date.

Industrial Wiper Rule timeline pushed back to October 2013

Just when it seemed things in Washington couldn’t get any worse, it was revealed that the timeline for completing the Environmental Protection Agency’s 28-year-old “industrial wiper rule” has been delayed once again, with a recent federal regulatory agenda citing October 2013 as the agency’s target completion date.

As readers may recall, this rule would revise the hazardous waste regulations to better level the playing field between non-laundered industrial wipes and laundered shop towels. INDA and other stakeholders had hoped the long-awaited rule, which was initiated when this author was ten years old, would be published this past summer after the EPA forwarded its draft final rule to the White House Office and Management and Budget’s (OMB) for its final regulatory review last April. Typically, OMB reviews only take 60-90 days.

Unfortunately, the OMB review process, not to mention most other regulatory and legislative action in Washington, ground to a halt in the months leading up to the November elections due to concerns about advancing a measure that could register controversial at the polls. Now OMB staff faces a significant backlog of  regulatory reviews and it appears the wiper rule has, once again, drawn the short straw.

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