News/Issues
Issues & Legislative Committee Report
February 12, 2009
Safety
“Ashes launches practice guidance on environmental cleaning” Healthcare Purchasing News November 2008, pg. 8, www.hpnonline.com
The American Society for Healthcare Environmental Services (ASHES) of the American Hospital Associated has developed two new products. These include the following:
“ Practice Guidance for Healthcare Environmental Cleaning”
“From Top to Bottom: The Environmental Services Series”
The first was prepared by ASHES and reviewed by infection control professionals contains detailed and practical recommendations for cleaning and surface disinfection of clinical and non-clinical areas of healthcare facilities.
The second is a three-part DVD series offering training solutions to Environmental Services and Infection Prevention and Control Managers challenged with employee turn-over, limited training tools, and language barriers when teaching critical skill sets in environmental cleaning. The DVDs are based on the ASHES publication “Practical guidance for Healthcare Environmental Cleaning” and are available in both English and Spanish.
Quality
“HHS announces physical activity guidelines for Americans” Healthcare Purchasing News November 2008, pg. 7, www.hpnonline.com
Adults gain much health benefits from two and a half hours a week of moderate aerobic physical activity, and children benefit from an hour or more of physical activity per day, according to the new Physical Activity Guidelines for Americans. This comprehensive set of recommendations for people of all ages and physical conditions was released by the U.S. Department of Health and Human Services. The guidelines are designed so people can easily fit physical activity into their daily plan and incorporate activities they enjoy.
Ethics / Pharmaceutical / Medical Devices
http://www.nytimes.com/2009/01/24/business/24device.html?_r=2&ref=health
As a result of the scrutiny of the Department of Justice and recent Massachusetts State Legislation, medical device manufacturers are under more pressure than ever to report physician renumeration for their medical device related roles as consultants, lecturers, researchers, or trainers. As quoted from the January 24th, New York Times article, large manufacturers of Hip and Knee prostheses such as Smith and Nephew, Zimmer Holdings, DePuy, and Biomet are “operating under Justice Department oversight as part of a deal to resolve allegations that they gave doctors illegal inducements to use their products”.
The Advanced Medical Technology Association (AdvaMed) has come out in support of the scrutiny, and in turn they have updated their bylaws to include specific language regarding the behavioral expectations of their members. The unfortunate problem is that many believe that the organization created these rules as a reaction to the legal scrutiny, not preemptively to address long standing concerns of unprofessional relationships between Physicians and Device Manufacturers.
The United States Senate has reintroduced legislation as the Physicians’ Payment Sunshine Act. Introduced January 22, 2009, the act is sponsored by Charles Grassley (R-Iowa), Amy Klobuchar (D- Minnesota), and Herb Kohl (D-Wisconsin) and has been assigned to the US Senate Finance Committee for initial review in closed sessions. A parallel process is being generated in the House. If approved, the bill would amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP.
Several large pharmaceutical companies have, in anticipation of the legislation, planned to voluntarily release the names of physicians that they use as consultants. The influence of medical device manufacturers has had a seemingly more pervasive impact on the selection of products used by healthcare.
Many large hospital systems, including Kaiser Permanente, are requiring medical device manufacturers to compete based on their price. They have barred their doctors from taking any money from industry. Many University systems are refusing medical device money, although this has been a long term funding source for them.
While voluntary reporting is great, the real issue lies with the difficulty that many device manufacturers have had trying to understand who and what they have actually paid. They have found that their record keeping has been confusing at best, and with the advent of mandatory reporting with the possibility of legislation, they are scrambling to step up to the plate. Hopefully honesty will prevail, but until many were caught red handed, voluntary reporting felt more like a “wink-wink, nod-nod” travesty than a good faith effort by device manufacturers to come clean. It will be interesting to see where the behavior of business and the legislation leads. Even more interesting will be the response of the Physicians as many of their peers make a call to their professional integrity regarding the influence of device manufacturers, product selection, and Physician renumeration.
AdvaMed’s 2009 Code of Ethics-
- Prohibition of gifts of any type, including all non-educational branded promotional items such as pens, notepads, coffee mugs and raffles at tradeshows, regardless of value.
- Explicit guidelines that allow for companies to enter into royalty arrangements with HCPs in exchange for substantial contributions that improve medical technologies.
- More explicit prohibition on providing entertainment or recreation to HCPs. (Entertainment was previously allowed if modest in value).
- A new section addressing Evaluation and Demonstration of Products, which sets forth appropriate parameters under which companies may provide products intended to educate both doctors and patients about newer or improved medical technologies.
Supply Chain Standards – GS1/HSCSC
GS1 Healthcare workgroups and awareness efforts continue to make progress. Jean Sargent has done three webinars on the standards and each has been filled to capacity. The workgroups will meet March 3-5 in Orlando to work on implementation phases for each individual standard. AHRMM is represented in each of the workgroups: GLN, GTIN, GDSN, and Traceability. SMI announced its support for the standards and their sunrise dates in a press release recently. The standards body GS1 US Healthcare announced sunrise dates for data standards adoption are:
- Adoption of the Global Location Number standard (GLN) for standardized account/location identification and eliminate custom account numbers by December 2010.
- Adoption of the Global Trade Item Number (GTIN®) for standardized product identification by December 2012.





