This month's headlines
 

Joint Commission off the case. The Joint Commission has stopped work on developing recommendations for vendor credentialing, saying that it is not in a position to develop standards on the competence of sales reps. Premier considers vendor credentialing contract. Premier healthcare alliance has issued an RFI to vendor credentialing firms, but is unsure whether it will pursue a contract. Vendor credentialing: Crowded field. Perhaps reflecting a new market opportunity, the number of vendor credentialing companies appears to be growing. IMDA Update contacted them all in an attempt to find out more about each one. Here's what we found out. Vendormate extends pricing program to IMDA members. After igniting industry concerns with its original pricing policy, Vendormate has extended its "Open Access" pricing program, which replaces the per-hospital-per-rep policy, to IMDA members. Beyond price. Materials managers need to expand their focus beyond price, GPO contracts and product standardization in order to achieve big savings in their hospitals or IDNs. But it requires a new way of looking at costs. And suppliers, including IMDA members, need to help out. A right to sue? Should people be allowed to sue medical-device-makers if harmed by a device that received marketing clearance from the Food and Drug Administration? Members of Congress heard both sides of the issue during a public hearing last month.

Watch for coverage of the 2009 IMDA Annual Conference in Charleston, SC, in next month's issue of IMDA Update.

Vendor credentialing Joint Commission off the case

The Joint Commission ceased work on developing proposed recommendations about vendor credentialing. A spokesman said that the Oakbrook Terrace, Ill.-based accreditation organization decided it was not in the business of developing standards of competence for healthcare industry representatives, that is, sales reps. Instead, the Joint Commission is recommending that the industry turn to "professional organizations…recommending general credentialing requirements." The organization specifically cited AdvaMed, which worked with IMDA and others on recommended credentialing requirements. (See the IMDA Website, www.imda.org, for those recommendations.)

The exact date for Joint Commission's decision is unknown. No public announcement was made. But suspicions arose when one IMDA member became aware of a Joint Commission communiqué on the topic, presented as a "Question-and-Answer" on the organization's Website. (To view the entire Q&A, go to http://www.jointcommission.org/AccreditationPrograms/LongTermCare/Standards/09_FAQs/HR/hc_industry_vendor_representatives.htm.)

The Q&A is telling in what it says, and what it does not. In response to the question, "Does the Joint Commission have requirements related to credentialing health care industry/vendor representatives who are involved in care, treatment and services provided by professional staff in accredited health care organizations," the Joint Commission makes the following statements:

• The Joint Commission has no standards that specifically address healthcare industry/vendor reps

• There are no accepted national standards on competence for sales reps.

• There is "no specific licensure, certification, or registration for health care industry/vendor representatives. . ."

• Despite the fact that Joint Commission has no specific credentialing requirements, "some professional organizations are recommending general credentialing requirements for these individuals," such as AdvaMed.

Although Joint Commission begged off on sales reps credentialing requirements, it states in the Q&A that a number of its standards "are relevant to any individual that enters a health care organization who directly impacts the quality and safety of patient care." Among them are:

• Standard EC.02.01.01, which states that in order to protect patient safety, accredited health organizations need to be aware of who is entering their organization and what these individuals are doing in their organization.

• Standard RI.01.01.01, which states that accredited healthcare organizations need to take steps to ensure patient rights are respected.

• Standard IC.02.01.01, which states that accredited healthcare organizations need to take steps to ensure that infection control precautions are followed.

Joint Commission also cites standards relating to the development and implementation of a patient safety program (LC.02.02.05 EPs 1, 3 and 4).

At last year's IMDA Annual Conference in Oak Brook, Ill., Laura Smith, associate project director for the Joint Commission's division of standards and survey methods, told IMDA members that the organization hoped to have suggested recommendations about vendor credentialing -- called a "field review" -- completed and ready for comment by the end of 2008. At that time, Smith said that while Joint Commission was intent on coming up with some general credentialing requirements for sales reps (incorporating, perhaps, such things as knowledge of HIPAA, training on infection control, etc.), it was especially concerned about establishing guidelines on the competence and knowledge of reps who call on patient-care areas, such as the OR. Patient safety is the organization's primary concern, she said, adding that Joint Commission was also investigating whether it should recommend that reps -- particularly those calling on patient-care areas -- demonstrate knowledge of the products they sell.

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At press time, Premier healthcare alliance, Charlotte, NC, had issued an RFI to vendor credentialing firms, but had not reviewed them, nor had it made a decision whether to proceed further and pursue an RFP for vendor credentialing services.

"At this point, we don't know if we'll move forward with a contractual relationship with any or many [vendor credentialing companies]," Pam Daigle, director of sourcing, told IMDA Update. "Our members requested we pursue this path. Our intent is to understand the need [for a potential contract] and what the cost structure looks like." Daigle said that some suppliers have "reached out to us, trying to make sure we understand the supplier side of this equation. We are absolutely aware of that, and we want to make sure we fully understand the impact.

GPOs and vendor credentialing Editor's note: IMDA Update asked the major GPOs if they had contracts with any vendor credentialing firms. This is what they told us. Amerinet: Contract with Vendormate. Broadlane: No contract. HealthTrust Purchasing Group: Contract with PreCheck, which offers the VendorCheck program. MedAsset: No contract, no endorsement; but the GPO is working on a new program. Novation: No contract. Premier: RFI has been issued; will consider whether or not to progress in the months ahead.

"I think we need to be clear as we move forward that ultimately, anything that is a cost to the supplier, particularly in the distributor space, will ultimately impact our members," she added.

If Premier members on the contracting committee wish to move ahead, the GPO could have a contract in place by year's end, Daigle said. But it's not at all clear whether they will elect to do that.

Balancing act

Premier Vice President of Supplier Relations and Business Development Dave Edwards described to IMDA Update the balancing act in which Premier must engage as it considers whether to pursue a vendor-credentialing contract. "It is the hospital's right and obligation, from a compliance standpoint and patient safety standpoint, to know who's in their hospital, what they're doing, and whether they have a specific reason to be there," he said. Information technology, particularly the Internet, offers a giant leap forward from the old "Sign in at materials management" approach. With the help of Internet-based tools, hospital administrators can easily see who the reps area, whether they've read vendor policies, and whether (if they're in patient-care areas) they've had appropriate inoculations and adequate training in aseptic technique.

But it is not in hospitals' best interest to use vendor-credentialing to close the door to vendors, Edwards added. "Hospitals recognize that reps bring new technology. They know that the orthopedic rep is central to the delivery of [an orthopedic case], coaching physicians on procedures and services. The same is true with the cath lab, electrophysiology [and other specialties]. Hospitals won't cut off their nose to spite their face."

Premier is trying to consider the issue from the suppliers' perspective, he said. "We know that over time, through cost in service or markups, [vendors] have to recoup their costs, which will come back to our customers [that is, hospitals]. That speaks to our goal, which is to identify solutions that don't add an onerous layer of cost on top of the supplier community, which is already struggling with higher costs."

Edwards said Premier is also concerned about the potentially harmful impact that high vendor-credentialing costs could have on small suppliers. Premier wants to ensure "that the unintended consequence [of vendor credentialing] is not to increase the hospital's ability to keep people out or reduce access for small suppliers.

"We believe that some of the new solutions and best innovations come from small, nimble companies that have their ear to the ground," Edwards said. "That's one of the concerns we have heard about vendor credentialing -- that while it's a solution for hospitals to have appropriate safeguards, on the flip side, it could be expensive, with the implication being that it could hurt small companies more than big ones."

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Editor's Note: Perhaps reflecting a new market opportunity, the number of vendor credentialing companies appears to be growing. Whether there will be a shakeout in the coming months remains to be seen. In the meantime, IMDA Update -- with help from IMDA members -- compiled a list of all the companies we're aware of, then sent each of them a brief questionnaire to fill out about their companies. Of 11 companies contacted, six failed to respond to at least two requests for information. What follows is the information that was provided to IMDA directly from the companies. IMDA members eager to fill in some of the gaps should consult each of the companies' Websites.

IMDA Announcement Door Opener If your reps call on the OR, you know the drill: They have to demonstrate their knowledge of OR protocol, HIPAA, bloodborne-pathogen regulations and more. Today, with vendor credentialing in the mix, the barriers to entry into the OR are higher than ever. Help your reps pass through those barriers by enrolling them in online OR training courses from HealthStream. As an IMDA member, you'll receive a discount. Upon completing them, your reps will receive a wallet-sized card provided by AORN and HealthStream. That card is a door-opener. To learn more about the program, visit this URL today: www.healthstream.com/products/sts.htm. To take advantage of the special IMDA discount, go to the "Members Only" portion of the IMDA Website (www.imda.org) and scroll to the box on "Surgical Environment Training."

1. Compliance Depot
www.compliancedepot.net
(214) 291-8900
Editor's Note: Did not respond to IMDA Update's inquiries.

2. Medical Vendor Watch
Syracuse, NY
(888) 532-3930
www.medicalvendorwatch.com
Editor's Note: Did not respond to IMDA Update's inquiries.

3. ProTech Compliance
Pittsburgh, PA
(Editor's Note: Appears to be owned by the University of Pittsburgh Medical Center)
(412) 586-0730
www.protechcompliance.com
Editor's Note: Did not respond to IMDA Update's inquiries.

4. REPtrax
Lewisville, TX
www.reptrax.com
Vendor contact: Peter Sheehan, (312) 388-8729, psheehan@deviewelectronics.com
(Editor's Note: IMDA Update spoke with Sheehan but was unable to get responses in time for publication.)

5. Status Blue
Marietta, GA
www.status-blue.com 

• Supplier contact: John Wills, founder, (678) 324-4487, jwills@status-blue.com

• Month in which vendor-credentialing service established: October 2005.

• Number of hospital or multihospital system clients: N/A.

• Number of hospital locations/sites: Over 250.

• Number of non-hospital clients: A few nursing homes, less than two dozen ambulatory surgery centers.

• Credentialing fee for supplier: No more than $85 per rep per year (not per hospital).

• Contract or endorsement from a GPO? At this point, no. We have some regional relationships, whether statewide or separate co-ops. We pay no administrative fees. More of an endorsement.

6. Vendor Credentialing Service
Spring, TX
www.vcsdatabase.com

• Supplier contact: Troy Kyle, president, (281) 863-9500, troykyle@vcsdatabase.com

• Month in which vendor-credentialing service established: November 2006.

• Number of hospital or multihospital system clients: 300+.

• Number of hospital locations/sites: 800+.

• Number of non-hospital clients: 100+ (medical offices)

• Credentialing fee for supplier: Between $29 and $149 annually per representative. (The fee for a clinical rep and non-clinical rep are different: $149 and $29-$99, respectively.) When the representative registers, we also credential the representative's company (supplier) at no additional cost. Once the annual fee is paid, the representative's and supplier's details can be shared with any hospital/medical office in the VCS system.

• Contract or endorsement from a GPO? Contracts with VHA Texas, VHA Montana, Greater New York Hospital Association, First Choice Co-Op, Ascension and others.

• Please summarize your company's key benefits for vendors: Vendor Credentialing Service offers more benefits to the vendor community than any other credentialing provider. Due to these benefits, and differences, VCS has partnered with vendors of all sizes. The VCS solution can be utilized by your company at a net zero cost. Additionally, VCS offers many tools, at no additional cost, that will save you time, effort and money.

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7. VendorCheck (offered by PreCheck)
Houston, TX
(713) 590-1139
www.vendor-check.com
Editor's Note: Did not respond to IMDA Update's inquiries.

8. VendorClear
Eden Prairie, MN
(888) 850-7484
www.vendorclear.com
Editor's Note: Responded to IMDA Update's e-mail, but did not give information.

9. Vendor Credentials LLC
Philadelphia, PA
www.vendorcredentials.com

• Supplier contact: Ed Hilem, president, (800) 971-5006, ehilem@vendorcredentials.com

• Month in which vendor-credentialing service established: August 2007

• Number of hospital or multihospital system clients: Due to the fact that this entire industry is no more than a few years old, we anticipate a lot to change in the coming year or two. We have spent a lot of time perfecting our software in anticipation of these changes. At this time, our actual number is not reflective of the time and effort that has gone into our product. However, we are in the middle of negotiations with a number of hospital and multi-hospital systems.

• Credentialing fee for supplier: $59 per vendor. This includes nationwide access and doesn't differentiate on access privileges (clinical vs. non-clinical).

• Contract or endorsement from a GPO? Pending.

• Please summarize your company's key benefits for vendors: Our company was founded by two vendors who have between them over 50 years experience in healthcare sales. We saw a growing industry set to exploit the vendors from the outset, and wanted to prove that this service could be done fairly and sensibly while still maintaining the necessary security and features that facilities have grown to expect. We aim to be the most people-friendly service: simple signup procedure; verification is done with a driver's license, so you don't have to remember a badge; and our tech support line routes to the same people who helped design the system, and it is the reason we pride ourselves on solving problems as quickly as we have. As outlined above, we have no hidden fees or complicated pay structures, and we do not believe in rating vendors. We offer a discount to vets and are the least expensive service in the industry.

10. Vendormate
Atlanta, GA
www.vendormate.com

• Supplier contact: Kristine Hayes, director of vendor services, (404) 920-3138, Kristine.hayes@vendormate.com.

• Month in which vendor-credentialing service established: March 2005.

• Number of hospital or multihospital system clients: 600+.

• Number of hospital locations/sites: 600+.

• Number of non-hospital clients: We currently serve customers in a variety of other industries, especially financial services.

• Credentialing fee for supplier: Various pricing options exist. Vendor companies that work with several Vendormate healthcare customers may opt for Vendormate Open Access, a single annual fee that allows the vendor company to register with all Vendormate customers. Other companies opt for a pay-as-you-register structure. Still others outsource their entire healthcare credentialing program for Vendormate to manage. In all three programs, the company, the principals, all registering reps and other registering staff (both current and on-boarded during the registration period) are included. Credentialing requirements are typically driven by the risk and requirements of the business relationship. Vendors essential to service delivery (high dollar contracts) or vendors with access to clinical areas or patient data are the highest risk to the healthcare system's ability to serve its market; therefore, the credential requirements are commensurately greater.

• Contract or endorsement from a GPO? Yes. Amerinet.

• Please summarize your company's key benefits for vendors: Healthcare credentialing compliance means documenting your company's standing as well as every representative that enters your customers' facilities. Hospitals select Vendormate as their credential and compliance solution because we understand their requirements and the vendor's realities. At the vendor company level, [Vendormate offers] flexibility (ala carte pricing to fully outsourced credential management) and insight (management reports that let vendors know which reps are registered and are fully compliant at which healthcare systems.) At the representative level, [Vendormate offers] 24/7 access to each healthcare system's unique requirements, ability to manage your documents securely online, e-mail alerts of compliance status, privacy (no social security numbers, no driver's licenses, no "community" commentary), and live phone and e-mail support.

11. VeriRep
Williamsville, NY
www.verirep.com 
(Editor's Note: From the Website, it appears the company may be at least partly owned by Kaleida Health in western New York.)
Company did not respond to IMDA Update's inquiries.

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Vendormate Inc., Atlanta, GA, has extended its "Open Access" pricing program to IMDA members. The program allows suppliers to gain access to all Vendormate accounts for one year with one annual fee. IMDA members with one rep pay $450 annually; those with two reps pay $900; three reps, $1,350; four reps, $1,620; and five reps, $1,800. Those with more than six reps are asked to contact Vendormate. "Vendormate respects your privacy and never asks for SSNs or driver's licenses," the company said in its announcement. "You'll enjoy 24/7 access to your profile, courtesy alerts as new hospitals select Vendormate, and toll-free and email account support."

It was Vendormate's original pricing strategy -- calling for suppliers to pay as much as $250 per company per hospital (or IDN) -- that ignited the concerns of IMDA members and other suppliers and manufacturers over the past two years.

To take advantage of the "Open Access" program, IMDA members with up to five reps should contact Freddie Snell at Freddie.snell@vendormate.com. Those with six or more reps should contact Flo Gentry at flo.gentry@vendormate.com.

Materials managers need to expand their focus beyond price, GPO contracts and product standardization in order to achieve big savings in their hospitals or IDNs. But it requires a new way of looking at costs. And suppliers, including IMDA members, need to help out. That's the opinion of Robert Yokl, chief value strategist for Strategic Value Analysis In Healthcare®, Skippack, PA.(www.strategicva.com). 

"Taking the time, effort and expense to prove your value to your customers is what being a value analysis advisor is all about," says Yokl, who spoke about the topic recently with IMDA Update. True, not all materials managers or suppliers want to devote the time to do that. But in today's environment, it's simply something that must be done, particularly as more materials managers adopt a broader, more sophisticated view toward cost.

Prior to founding his company in 1987, Yokl spent many years in materials himself, first in a number of stand-alone facilities, then in a 926-bed multihospital system. He also served as vice president of support services for a nursing home chain and vice president of operations for a small med/surg distributor.

He created Strategic Value Analysis in Healthcare® to provide healthcare organizations with software, training and consulting services to give them better information and better focus, so they could make better decisions and exert more control over their supply chains.

For some time, hospitals and IDNs have used so-called "value analysis teams" to help them decide whether to bring in new products and equipment. But those teams have lost much of their power, says Yokl. "They're focused solely on price, GPO contracts and standardization," or what Yokl calls "traditional value analysis." What's more, committee members too often are selected on the basis of their titles -- e.g., director of nursing, infection control practitioner, etc. -- rather than on the basis of their abilities or enthusiasm for the process. Consequently, hospitals are missing the boat on somewhere between 7 percent to 15 percent of new savings opportunities.

Perhaps the biggest missed opportunity -- and the one that IMDA members must help providers address -- is what Yokl refers to "utilization misalignment," which he defines as "wasteful, inefficient consumption, misuse, misapplication and value mismatches in products, services and technologies." Example: Prior to a surgical procedure, the surgeon routinely orders three cartridges of staples, and ends up using one and throwing out the other two. Or the surgeon routinely orders a specialized electromechanical in his or her custom pack, but uses it only in only a fraction of the cases.

IMDA Announcement Refer a member and get $50 Every time IMDA gains a member, our collective voice grows louder, our collective wisdom becomes greater, and our collective influence in the market grows. It's good for everyone. And there's no better source for new members than current ones. After all, you know the market, you know the people. That's why IMDA is offering members $50 for every new member who joins as a result of your referral. So when you're walking the floor at your next trade show, or taking a break at your next sales meeting, keep an eye out for companies that might benefit by joining IMDA. Collect business cards and send them to headquarters. Fifty bucks is nice. But the added wisdom, knowledge and camaraderie that a new member brings are even greater payoffs.

Rather than sit around a table over coffee and discuss how much an item costs, then, the hospital's value analysis members need to venture out into treatment areas and see firsthand how -- and in some cases, whether --devices are being used appropriately. Just as important, the team members need to measure how the hospital's or IDN's usage compares with others of similar size, demographics, etc. Are the surgeons using more devices than others? Are their total costs per procedure higher? Although data like this provides important clues for value analysis team members, it is almost impossible to collect manually, that is, without the help of automated systems and a database that spans several hundred hospitals, says Yokl.

In one case, using his company's automated information system and database, Yokl's team found that a hospital client was using many more point-of-service diabetes tests than others. Upon investigation, they found that the test itself was defective, necessitating the use of multiple strips for each test. They also found that the nurses, out of generosity and goodwill, were giving their diabetic patients some tests to take home upon discharge.

What IMDA members can do

The question for IMDA members is, "What does this have to do with me?" Plenty, says Yokl. More and more materials executives and clinicians are recognizing that the potential savings through correction of "utilization misalignment" is greater than that through price-shopping. That means they are going to be more demanding of their suppliers to prove not only the clinical efficacy of their products, but their cost-effectiveness as well. "You have to validate your claims," he says.

"I get calls several times a month from manufacturers who are scrambling for ideas" on how to sell their products, he says. "I tell them, ‘You can't use studies you've done somewhere else,' though that's a nice place to start a conversation. ‘You have to do a study at the hospital.'" The goal is to demonstrate in the hospital that the total cost (not the purchase price) of your device is lower than that of your competitors or of existing technologies, he says.

The supplier must first develop the metrics, or "measuring sticks," which it will use to prove its case; then observe the new device in use; then compare the cost of the new device or procedure with that of the customer's existing technology or procedure. "It has to be with data in order to be credible," he says. And it has to be quantifiable. In other words, the supplier must assign a dollar amount to every benefit -- even the soft ones -- which its device brings the hospital or IDN.

"This isn't theory," says Yokl. "We do it." And so must suppliers, including IMDA members.

"Cost management is everybody's business," he says. "It's something that has to be done, like putting gas in your car or brushing your teeth in the morning." That's true for both the customer and the supplier. "The alternative is that millions of dollars are left on the table."

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At issue: Should medical device makers be subject to lawsuits? Congress gets an earful

Should people be allowed to sue medical-device-makers if harmed by a device that received marketing clearance from the Food and Drug Administration? Members of Congress heard both sides of the issue during a public hearing last month.

At issue is the Medical Device Safety Act of 2009, introduced in March by U.S. Representatives Frank Pallone Jr. (D-N.J.) and Henry Waxman (D-Calif.). A companion bill was introduced into the U.S. Senate by Senators Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.).

IMDA members may recall that in February 2008, in Riegel v. Medtronic Inc., the Court ruled that once a medical device receives premarket approval by the FDA, federal law bars most claims challenging its safety or effectiveness, design or label. (See May 2008 IMDA Update.) In the Riegel case, claims brought about by Charles Riegel, who suffered permanent injury when a Medtronic balloon catheter burst during an angioplasty, were thrown out on the basis that they were "preempted" by the FDA's approval of the device.

Earlier this year, in March, the Court found no such pre-emptive language in the statutes governing drug regulation. As a result, the Court upheld Vermont state rulings that awarded damages to a woman who developed gangrene and had part of her arm amputated after being treated with an anti-nausea drug.

The Medical Device Safety Act would in essence overrule Riegel v. Medtronic and allow people to sue medical-device makers.

"[Riegel v. Medtronic] left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings," according to the U.S. House of Representatives Committee on Energy and Commerce, which is chaired by Waxman. "It also removed one of the industry's most important incentives to maintain product safety after approval and disclose newly discovered risks to patients and physicians. The Medical Device Safety Act of 2009 protects patients from dangerous and defective devices by correcting the Court's flawed interpretation of the [Medical Device Amendments]. The legislation explicitly clarifies that state product liability lawsuits are preserved.

The two sides

IMDA Announcement Looking for lines? View a list of all medical devices receiving FDA marketing clearance in May by visiting the FDA Website. You might find a company in need of your expertise.

There are two sides to just about every argument. Such is the case with the Medical Device Safety Act, as proven by the recent one-day hearing by the health subcommittee of the Energy and Commerce Committee.

Opponents of the bill argue it would stifle innovation by subjecting device-makers to scores of lawsuits across the country. One of them, Michael Kinsley, a Washington Post columnist who suffers from Parkinson's disease, voiced his dissent at the hearing. Kinsey uses a brain stimulator made by Medtronic to help manage the disease.

"So here's the problem," said Kinsey, who called himself a "grateful customer" of the pharmaceutical and medical device industries. "We all want the government to protect us from dangerous drugs and devices. But we don't want the government to prevent us from getting helpful or even life-saving drugs and devices. Yet the most important drugs and devices are both. They save lives, and they can cost lives. The government's job is to weigh the risks against the benefits." In Kinsley's opinion, that job should be left to the FDA, not state courts.

The other side of the debate was represented at the hearing by Bridget Robb, Gwynedd, Pa., a 35-year-old mother with cardiomyopathy and congestive heart failure. "On December 31, 2007, I was awoken from my sleep by a series of shocks to my heart that felt as if a cannon was being repeatedly shot at my chest at close range," she testified. Throughout the night, she received a total of 31 shocks from her implantable cardiac defibrillator. "It was excruciating pain," she said. "Ever since that day, I have been unable to sleep in my own bed due to the trauma I experienced." (Subsequently, the Medtronic Spring Fidelis lead was recalled due to its potential to fracture.) "I find it discouraging and demoralizing that I have no recourse for my injuries, and that a company that manufactured a defective product that has harmed me and thousands of other individuals has no accountability."

Medical industry weighs in

Not surprisingly, the medical device industry opposes the Medical Device Safety Act. In March, when it was introduced, AdvaMed President and CEO Stephen J. Ubl issued a statement. "If enacted, this legislation would effectively allow state courts to review medical devices and ultimately lead to a patchwork of inconsistent and confusing guidance on the use of medical treatments for patients and physicians, or limit their availability altogether," he said. "America needs a central expert authority to regulate medical devices based on a scientific risk-based approach to public health and safety for all Americans, not ad hoc regulation through state court verdicts."

On the other side, the New England Journal of Medicine published an opinion piece in April by two medical doctors and a Ph.D. in strong support of the bill. "Every medical intervention has benefits and risks," wrote the authors. "Patient safety can be ensured only when the makers of drugs and devices fully and openly disclose both the benefits and the potential adverse effects associated with an intervention. . . .Unfortunately, one major stakeholder, the medical-device industry, has been shielded from the potential consequences to adequately disclose risks.

"Since the Supreme Court ruling in Riegel, thousands of lawsuits against medical-device manufacturers have been tossed out of court by judges following the Court's lead in deeming such lawsuits to be preempted. We believe that preemption will result in medical devices that are less safe for the American people."

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IMDA Update Published by IMDA 5204 Fairmount Ave., Downers Grove, IL 60515 Phone:  (630) 655-9280 (866) IMDA-YES (866-463-2937) Fax: (630) 493-0798 Website:  www.imda.org E-mail:  imda@imda.org   Staff Katie Swartz: Executive Director Judy Keel: Executive Vice President Patti Perillo:  Senior Administrator Mary Moran:  Chief Financial Officer Mark Thill, Editor & Communications Director (847) 255-0716 Mitchell Kramer, Legal Counsel (800) 451-7466 Barbara Kramer, Legal Counsel (734) 930-5452 George Ayd, Jr., Insurance Administrator (703) 652-1309         2009-2010 Directors President Kevin Trout, Grandview Medical Resources, Inc. (412) 914-0950 President-Elect Anthony Marmo, Martab Medical (201) 512-1100 Secretary/Treasurer Hal Freehling, Jr., O.E. Meyer Company (419) 609-1633 Chairman of the Board Dave Campbell, PhD, Vital/Med Systems Corporation (303) 660-0888 Directors-at-Large Tom Birmingham, Bay State Anesthesia, Inc. (978) 682-6321 George Howe, Mercury Medical (727) 573-0088 Philip M. Reilly, KOL Bio-Medical Instruments, Inc. (703) 378-8600 Don Reiter, Specialty Respiratory Care, Inc. (818) 717-8807 x19 Bill Schultz, IPV Medical, LLC (760) 212-2769 Past-President Shawn Walker, Bay State Anesthesia, Inc. (978) 682-6321 Manufacturer Representative to Board Tim Beevers, Beevers Manufacturing & Supply (503) 472-9055 The ideas presented in this newsletter may or may not be applicable to your particular situation.  Always consult your tax advisor, attorney or CPA before putting them into effect.