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NEWSWIRE


NEWSWIRE from page 6 that expired December 19, that was specific to a newly published list of devices that would need to comply with the regulation within TWO years after the final rule is issued. This list provides clarity to an otherwise


vague section in FDASIA that referenced “devices that are implantable, life-saving, and life sustaining. The FDA announced that it has published a list of devices it believes fall into this category. It’s a wide-ranging and somewhat lengthy list, ranging from sutures and surgical mesh to hyperbaric chambers, and as such warrants a close look by manufacturers that may be impacted and by providers who will hopefully use the UDIs for everything from supply chain processes to recall management. You can review the full list subject to this amendment at the bottom of the proposed rule, www. regulations.gov/#!documentDetail;D=FDA- 2011-N-0090-0001. Just look for reference 12.


MEDICA and COMPAMED 2012 reflect status of medical market The recent staging of MEDICA 2012, Inter- national Trade Fair with Congress – World Forum for Medicine, and the concurrently held COMPAMED 2012, International Trade Fair – High tech solutions for medical technol- ogy, in Düsseldorf, Germany reflected the demand for medical technology and prod- ucts with stable attendance figures: 130,600 visitors from 120 countries took part to get a comprehensive overview of the latest innova- tions in the medical sector. A total of 93% of the visitors had decision-making authority. The 4,554 exhibitors from 64 nations at MEDICA 2012 praised the high quality and international flair of the MEDICA 2012 at- tendees which also included visitor groups from countries such as South America, North Africa and Asia. On the exhibitor side, 74% of the MEDICA exhibitors were from nations other than Germany, including a record 416 companies from the U.S. Other leading foreign exhibitor countries included Italy, Great Britain, France and China. As in the past, Messe Düsseldorf North America organized two successful U.S. Pavilions with 191 companies presenting their latest technologies. “MEDICA is a true reflection of the market.


Due to tight health care system budgets, more and more sales departments and insurance companies intervene in investment deci- sions. Furthermore, the purchasing power in hospital associations and chains centers on fewer and fewer top decision makers,” stated Joachim Schäfer, Managing Director of Messe Düsseldorf. The exhibits at MEDICA 2012 were complemented by a wide ranging ancillary program. The MEDICA Congress attracted


several thousand participants with its broad series of topics ranging from intensive care to homeopathy. At the parallel staged COMPAMED 2012,


the leading international trade fair for sup- pliers to medical device manufacturers, 645 exhibitors from 34 nations presented their latest products and technologies. In two halls, over 16,000 visitors could experience how closely suppliers cooperate with medi- cal device manufacturers in terms of product development. Current supply market trends were also addressed at the two technical forums integrated into COMPAMED, which specifically targeted experts for manufactur- ing processes and product development. In 2013, MEDICA will be held from No- vember 20 - 23 and COMPAMED from No- vember 20 - 22 in Düsseldorf, Germany. For further information visit www.mdna.com.


FDA looks at tainted skin preps Antiseptic skin preparation products can be contaminated by microbes, a problem the FDA will address at an upcoming public hearing. There have been recent reports of microbial contamination of topical antiseptic products that are used before surgery, before an injection, and to reduce the risk of skin infection, and some of the products have been recalled, according to Christina Chang, MD, MPH, and Lesley-Anne Furlong, MD, of the FDA’s Center for Drug Evaluation and Research in Silver Spring, MD. Such contamination, which can occur during manufacturing or during storage, preparation, and use by healthcare profes- sionals, has resulted in outbreaks of infection and even death in some cases, they wrote in the New England Journal of Medicine. “It is important that healthcare providers


be aware that topical antiseptic products, if contaminated, pose a risk of infection and that particular microbes isolated from clinical specimens have been traced to the contamination of such products,” Chang and Furlong wrote. “The isolation of unusual organisms (e.g., Bacillus cereus) after the use of topical antiseptic products should trigger an investigation of possible contamination stemming from an antiseptic product.” In the 1970s, when the FDA was making regulations for drug ingredients that were on the market but had not been approved by the agency, it was thought that antiseptic drug products would not be contaminated by microbes because of their pharmacologic activity. Reports in recent years have dis- puted that notion, however, as infections tied to contaminated antiseptic drug products have resulted in a range of outcomes from localized infections at injection sites to fatal systemic infections.


8 January 2013 • HEALTHCARE PURCHASING NEWS • www.hpnonline.com “The reports implicate all commonly


used antiseptic categories, including alco- hol, iodophors, chlorhexidine gluconate, and quaternary ammonium products,” Chang and Furlong wrote. In August 2009, an FDA advisory com- mittee discussed whether products used on non-intact skin should be required to be produced in sterile conditions. Commit- tee members looked at cost, effects on the active drug ingredients and the product packaging, and uncertainties about the scope of the problem, but did not make a final determination. Chang and Furlong noted that, “although


the scope of nosocomial infections associ- ated with contaminated antiseptic products is difficult to assess, it is most likely broader than has been indicated by postmarketing reports and the medical literature.” “Confirmation of contamination often requires the testing of other units from the same manufacturing lot as the sus- pect product; however, contamination may not occur consistently within a lot, confounding the infection work-up,” the authors wrote. They said other reasons that infections resulting from tainted antiseptic skin products may be under-recognized include variations in the rates of postoperative infection based on the type of procedure and other factors, the potential inability to capture infections treated in ambulatory set- tings, and the fact that reporting nosocomial infections is voluntary. (MedPage Today)


NACHA approves rule supporting electronic healthcare payments via ACH The Electronic Payments Association has adopted a new healthcare payments rule as part of the NACHA Operating Rules. The NACHA Rule, which will become effective on September 20, 2013, supports health plans’ and healthcare providers’ use of the ACH Network for electronic health- care claims payments, and the electronic “reassociation” of these payments with electronic remittance advices (ERAs). Currently, only 33 percent of payments


from health plans to healthcare providers in the U.S. are made electronically, accord- ing to industry estimates. With the adop- tion of standards and rules for healthcare EFTs and ERAs, the industry is poised to save between $3.1 and 4.5 billion over the next 10 years through greater use of electronic transactions. The NACHA rule standardizes the use and the data content of NACHA’s “CCD+” transaction when used for healthcare EFTs, making the payment readily identifiable to providers. HPN


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