Issues & Legislative Committee Report
March 8, 2005
The OIG has recently rendered five advisory opinions related to Gainsharing between a hospital and cardiac surgeons and/or cardiologists. From the Opinions it appears that the work behind creating the Gainsharing process was extensive and carefully planned. The Opinion numbers are 05-01 through 05-05. I will be putting together an article based on information in the Opinions as well as articles published about the Opinions. It should be noted that these Opinions are specific to the requestors. For those organizations interested in similar arrangements, their own OIG Opinion should be sought. View OIG Advisory Opinion No. 05-01
JCAHO: Joint Commission Seeks Input On Potential National Patient
The Joint Commission is requesting assistance in the review of potential new National Patient Safety Goals and/or Requirements for 2006. The Board may maintain some of the current goals and requirements, shift some existing requirements into the standards, and/or adopt a subset of the proposed goals and their associated requirements in their present or modified forms. The latter action will be based in substantial measure on the results of this field review.
Single-Use Device Reprocessing Still Controversial
Reprocessing of single use devices falls under the “Medical Device User Fee and Modernization Act of 1992” (MDUFMA). Controversy revolves around sterilization, packaging, and labeling issues. The law (MDUFMA) required that the FDA publish a list of those items which are no longer exempt from submitting 510k applications or validation data. In late 2004, the FDA reviewed the applications (1800 model of devices were covered and reviewed) and results of the audit were as follows:
- 52% of devices covered in the applications were found to be substantially equivalent to the original device. These remain on the market.
- 33% were found to be not substantially equivalent.
- 15% were withdrawn by the reprocessors
A major source of the controversy is the MDUFMA provision that the reprocessor’s name be labeled on an SUD. Device manufacturers maintain that the OEM is called upon to address the failure of a reprocessed SUD despite never intending for the device to be used more than once. Those in the industry maintain that the reprocessor’s name on the label hasn’t solved the confusion. The package label still often refers to the OEM but the device inside by FDA rules is a “new device.”
For sterilization validation the FDA has recommended that the reprocessors follow ISO 11134 for industrial moist heat or ISO 11135 for ethylene oxide. There were no previous standards on cleaning validation. The FDA’s definition of “clean” means that the “device could subsequently be sterilized successfully, and that residual soil would not accumulate after multiple cycles of reuse and resterilization.”
Packaging validation by reprocessors remains a sizeable challenge to date. The FDA’s Larry Spears of the Office of Compliance has been quoted as saying that: “We are looking at supplemental validation submissions to help us identify issues in the field.” “In many cases there is a question as to whether the packaging validation is adequate.”
Source: “Single-Use Device Reprocessing Still Controversial”, January 2005. www.devicelink.com
eCommerce and Bar Coding
There have not been many changes other than the mandate from the FDA that bar codes must appear on all newly approved drugs and biologicals within 2 years. HIMSS advocates barcoding, but there are no new developments. HIMSS states benefits could be derived from patient registration, admissions processes, patient safety, and all product and supply logistics, patient accounting, and billing.
Radio Frequency Identification (RFID)
The RFID Journal website has a “White Papers” section specific to healthcare. For those interested, this may be a valuable source of information to see where RFID being applied to our commodity. Site registration is required, and the reports should be free. http://www.rfidjournal.com/whitepapers/
Federal RFID Spending to Rise
RFID is becoming very big business in the federal sector. The two agencies investing the most into this technology are Department of Defense and Department of Homeland Security. It is estimated that spending will grow from $51 million in Fiscal Year (FY) ’04 to $112 million in FY ’09. This represents a 120% increase. DoD will represent 78% of the total RFID spending, which is not surprising given the mandate that contractors be able to track to the pallet level beginning this fiscal year.
RFID Aided Marines in Iraq
The Marines used RFID to track supplies and equipment being sent into the recent battle for Fallujah in Iraq. They used both active and passive tags to track high priority shipments. RFID readers were set up at a distribution center in Kuwait, at the Iraq-Kuwait border, and then at checkpoints along the route. Col Mark Nixon of the Marine Corps Logistics Vision and Strategy Center said, “(RFID) allows commanders to reduce how many parts they order because they are no longer afraid that they’re not going to get what they need.”
MasterCard PayPass at NFL Stadiums
For those familiar with PayPass which is used extensively at gas stations and toll roads across the country, a new application of that technology has been developed. The Baltimore Ravens and Seattle Seahawks will be issuing an RFID enabled MasterCard that can speed you through paying for items at busy stadium venues. No more waiting in line at the snack bar…just waive our master card in front of the reader and you are on your way. Exxon customers, who use the key chain “speedpass”, will be very familiar with this technology. When fueling at an Exxon station you only need to dangle your “speedpass” in front of the reader on the pump, and you are ready to go. While the speed is significant, a PayPass transaction takes 12 – 18 seconds less than other payment methods, customers who use PayPass spent 25% more than customers using cash.
HIMSS Survey Results
Survey conducted by Health Information Management & Systems Society (HIMSS) indicates that “57% of IT leaders at 253 hospitals identified patient safety as their #1 business issue.”
Source: Modern Healthcare, 2/14/2005.
Consumer-Driven Healthcare: Insurance Impact on Materials Management Purchases
A recent Modern Healthcare article discussed consumer requirements for accurate infection control rates. M/M plays a key role in insuring product sterility for those produced in house as well as prepackaged from the manufacturer. Consumers are also requiring that prices for certain services be posted. South Dakota has enacted such recently.
Most Wired Hospitals
The 2005 Most Wired Survey and Benchmarking Study conducted by Hospitals & Health Networks, a publication of hospital industry organization American Hospital Association, measured the nation's hospitals on their use of Internet technologies for quality, customer service, public health and safety, business processes, and workforce issues. The 100 most wired hospitals were chosen from 1,298 hospitals that voluntarily participated in the sixth annual survey. The study indicates that 90% of the most-wired hospitals provide access to current patient medical records online, 87% provide online access to medical history, 88% provide online access to patient demographics, and 69% provide online access to nurses' notes.
To see the list of the U.S. News & World Report’s “Most Wired Hospitals” for this year, visit http://www.usnews.com/usnews/health/mostwired/mw_wired.htm