If you’re not part of the solution, you’re part of the problem

In November 1999, the Institute of Medicine (IOM) released a landmark report, To Err is Human, which described the incidence of medical errors and challenged health care professionals to change how they provide care. The lOM’s research noted that more people die in a given year from medical errors than from motor vehicle accidents, breast cancer or AIDS - and that the “national costs… of preventable adverse events … are estimated to be between $17 billion and $29 billion.”

The problems identified in To Err is Human not only occur in hospitals, but also in doctors’ offices and other ambulatory settings. While ambulatory care is generally less technologically complex than inpatient care, it is often more logistically complicated, as an ambulatory episode often involves multiple handoffs and transitions among a number of clinicians, the patient and family.

MGMA study focused on patient safety in ambulatory setting

In 1999, the Medical Group Management Association (MGMA) Center for Research collaborated with the COPIC insurance company of Colorado to evaluate the causes of malpractice claims and assess the patient safety risks associated with ambulatory care. The pie chart below shows how lost test results occurred in 57 percent of the cases studied. Essentially, lost test results are an administrative issue and indicate a breakdown in the practice’s communications systems. Even the second-most-frequent reason for malpractice claims - drug interactions- can be reduced or eliminated if the practice has the right systems.

The study also examined the most common delays in the diagnosis of breast cancer. Underlying reasons were:

* Systems failures such as lost mammogram orders or lost test results;

* Delays by the patient in seeking appropriate health services; or

* Human issues such as failure to screen or delays in test ordering.

The problems associated with managing test results were the focus of a study by Eric Poon, MD, MPH. He and his associates surveyed physicians in internal medicine practices to understand how physicians tracked test results. Poon found that only 52 percent of the physicians in his study kept records of the tests they ordered (graph, below). With almost half of the doctors not having a system in place, it is obvious why test results were lost.

Poon’s research also noted whether the physician had a system to detect if the patient missed a test. The same graph shows only 32 percent of the doctors reporting this safeguard and just over half (59 percent) reporting that they had a staff member review incoming test results.

EHR can help reduce error rate

An electronic health record (EHR) can substantially reduce lost test results, drug interactions and similar problems. Virtually all EHRs can track laboratory and radiology test results and have a module to provide notice of drug interactions (see “Off to a slow start: High costs and lack of physician support , hinder medical groups’ EHR adoption,” MGMA Connexion, October 2005). Properly implemented and universally used, this administrative technology could minimize medical errors attributed to drug interactions and lost test results.

Another means of identifying problems in administrative and human systems that could jeopardize patient care will soon be available. The MGMA Center for Research, the Health Research and Educational Trust and the Institute for Safe Medication Practices are developing a self-assessment to evaluate the state of patient safety in the practice. The three organizations, with funding from the Commonwealth Foundation, will release the survey for use by medical groups and other ambulatory care settings this spring.

The Physician Practice Patient Safety Assessment uses 77 questions to evaluate risk in six domains:

* Medication;

* Handoffs and transitions;

* Surgery/anesthesia and sedation/invasive procedures;

* Personnel/qualifications/competency;

* Practice management/culture; and

* Patient education/communication.

The self-assessment - an anonymous electronic survey - provides immediate feedback comparing the practice’s performance to similar organizations. The medical group uses self-assigned passwords to maintain security and anonymity. The data reported on the assessment cannot be traced to specific respondents.

The practice manager may not directly interact with patients, but the organization’s administrative and clinical systems have a major influence on the quality of patient services. In fact, you may well be the critical factor in the selection and operation of systems that prevent medication errors and lost test results. You may also be the catalyst for assembling a multidisciplinary team of physicians, nurses, technicians and managers to evaluate improvements in patient safety. Thus, that adage from the 1960s is true: If you’re not part of the solution, you’re part of the problem.

We are in the process of moving roughly seven miles from our current location to a former army hospital base east of downtown Denver. The University of Colorado Health Sciences Center is moving its medical school and research facilities, and the University of Colorado Hospital is also moving to the site. The former army base was Fitzsimons. On 160 acres of this site, the Fitzsimons Redevelopment Authority is developing a world-class bioscience park. It will bring together academics, bioscience, and clinical processes to bring new solutions to the healthcare field. It is very exciting.

The federal government also recently approved funding to plan for the ultimate move of the VA hospital to this site. All of the hospitals will be separate, but possibly will share some type of infrastructure. We plan to break ground this year, and move in as of 2007. We started to study the possibility of moving about four years ago.

Our current campus on the edge of downtown Denver is landlocked and there is no room for expansion. Many of our current buildings are almost 100 years old and are no longer well suited to today’s clinical processes. We asked ourselves, “What’s best for kids in the long run?” and this move was it.

We interviewed people from the community–community leaders, government officials, other hospitals–to get a sense of whether we had community support for this move. Almost everyone said, “Do the right thing for kids.” That’s practically our motto–we want to make sure we’re doing the right thing for kids through this process.

We need $450 million for this project. We have finalized a bond issue in the past few weeks. We borrowed $275 million, and we will retire $75 million of our current debt. The old debt was defeased with cash, and then we borrowed for the new project. Net, we end up with $200 million of new debt.

We actually did a forward swap. In May, when interest rates were almost at their lowest point, the hospital locked in a fixed interest rate on our bonds so that 70 percent of the total bond issue has a fixed rate of 3.30 percent, while 30 percent will remain in a variable rate mode. We said to ourselves, “Let’s not lose this opportunity.”

We’re working with the rating agencies as a way to improve our access to capital. We want to make sure they know who we are. We have not had a rating in the past, because our bond issues have been small, and we did traditional fixed-rate bonds with insurance, so there was no need to get a rating on our own. Although we will again have insurance on our new bond issue, building that connection with rating agencies and bond insurers has been very important.

We have strong philanthropic support in our community. When we began planning for our new facility, we wanted to make sure our own employees and executive group supported the project by pledging financially themselves. More than 75 percent of the employees have pledged money for the project already.

Our boards of directors for both the hospital and The Children’s Hospital Foundation have committed more than $50 million to building the new facility. The official announcement of a campaign will come later this year, and we will be able to show that our boards and staff are committed to the project.

Like most hospitals, we’re facing challenges with Medicaid. Almost every state, including Colorado, has cut Medicaid over the last couple of years because of state budget tightening. Between 35 to 40 percent of our patients are Medicaid beneficiaries, which is pretty typical of children’s hospitals. When you get no increase on 40 percent of your business, that’s pretty tough. In Colorado, the FY04 budget the governor submitted actually includes a small increase in Medicaid funding, but the number of Medicaid enrollees has been going up, so the dollars may be spread over a greater number of people, and we may see no real increase.

We have made efforts to advocate for kids with state officials to better fund the Medicaid program. Medicaid funding for kids is about 20 percent of the dollars and roughly 60 percent of the enrollees. Typically, nursing homes use the biggest amount of dollars from Medicaid but for a much smaller number of people. So we want the state to continue to put money into the Medicaid program so that there are sufficient dollars for children.

Whenever I talk with local businesspersons about health care, I make sure they understand the dilemma in the system. Fewer state and federal dollars in the system and more uninsured/underinsure force continued increases that exceed inflation for those paying for health care. This cost shifting will continue until more individuals have some form of health coverage and the coverage pays for the cost of care.

I don’t think we’ve seen the worst of the economics of health care. I expect that the number of uninsured will grow, and that the number of people qualifying for Medicaid will grow. These trends will force us to be more creative in our efforts to be as efficient as possible with our operations. Beyond efficiency, we will continually explore medical utilization, best outcomes, and program size.

Source http://findarticles.com/p/articles/mi_m3257/is_2_58/ai_n6077511

A different kind of standardized medical record may soon reach provider offices–and patients’ hands, too. The continuity of care record (CCR) is an XML document standard for a summary of personal health information that patients can carry from one provider to another, eliminating the need for transfer of paper records and repeatedly filling out medical history forms. The CCR is a joint effort of ASTM International, HIMSS and the Massachusetts Medical Society (MMS).

ASTM International was expected to approve a final draft of the CCR in January, said MMS President Thomas Sullivan, M.D. Microsoft and MMS will also offer a demonstration of the CCR at this year’s HIMSS conference.

Information can be stored on a memory stick or a disk, as either a PDF file or a Microsoft Word document. The CCR would be an ongoing record of care, created or updated at the end of every healthcare encounter and available for review by the next provider, no matter what and where the healthcare setting might be. The result, the associations say, would be documents that will better guide providers in the care process, based on timely patient information. Patients also may request a CCR printout to provide current information for other healthcare providers. An authorized physician could open the document through any standard Internet browser.

Sullivan hopes the CCR will bridge the gaps between often-incompatible systems among healthcare organizations. The initial record offers a minimum data set, but extensions to the CCR will offer specialty-oriented information fields for individual types of physicians, Sullivan said. For instance, a pathologist might want a way to include tumor reports in the CCR, or a pediatrician might need a way to record a child’s head circumference.

Once the CCR gains ASTM’s approval, it will post a version of the CCR on its Web site and allow users to demo and test the product. Sullivan expects major vendors like Microsoft and Siemens to join the trade associations in promoting the CCR.

Source http://findarticles.com/p/articles/mi_m0DUD/is_2_25/ai_n6014957

With financial ties to nearly two dozen drug and biotech companies, Dr. Charles B. Nemeroff may hold some sort of record among academic clinicians for the most conflicts of interest. A psychiatrist, a prominent researcher, and chairman of the department of psychiatry and behavioral science at Emory University in Atlanta, Nemeroff receives funding for his academic research from Eli Lilly, AstraZeneca, Pfizer, Wyeth-Ayerst–indeed from virtually every pharmaceutical house that manufactures a drug to treat mental illness. He also serves as a consultant to drug and biotech companies, owns their stocks, and is a member of several speakers’ bureaus, delivering talks–for a fee–to other physicians on behalf of the companies’ products.

But it was just three of Nemeroff’s many financial entanglements that caught the eye of Dr. Bernard J. Carroll last spring while reading a paper by the Emory doctor in the prominent scientific journal, Nature Neuroscience. In that article, Nemeroff and a co-author reviewed roughly two dozen experimental treatments for psychiatric disorders, opining that some of the new treatments were disappointing, while others showed great promise in relieving symptoms. What struck Carroll, a psychiatrist in Carmel, Calif., was that three of the experimental treatments praised in the article were ones that Nemeroff stood to profit from–including a transdermal patch for the drug lithium, for which Nemeroff holds the patent.

Carroll and a colleague, Dr. Robert T. Rubin, wrote to the editor of Nature Neuroscience, which is just one of a family of journals owned by the British firm, Nature Publishing Group, pointing out the journal’s failure to disclose Nemeroff’s interests in the products he praised. They asked the editor to publish their letter, so that readers could decide for themselves whether or not the author’s financial relationships might have tainted his opinion. After waiting five months for their letter to appear, the doctors went to The New York Times with their story–a move that sparked a furor in academic circles, and offered the public yet another glimpse into conflict of interest, one of the most contentious and bitter debates in medicine.

In his defense, Nemeroff told the Times he would have been happy to list his (many) relationships with private industry–if only the journal had asked. “If there is a fault here,” he said, “it is with the journal’s policy,” which did not require authors of review articles to disclose their conflicts of interest.

And that is pretty much where the debate over conflict of interest in medical journals stands: Should research scientists who have financial stakes in the products they are writing about be forced to disclose those ties? To which the average person might reasonably respond, of course they should. But the more pertinent question is why scientists with financial stakes in the outcome of scientific studies are allowed anywhere near those studies, much less reviewing them in elite journals.

The answer to that question is at once both predictable and shocking: For the past two decades, medical research has been quietly corrupted by cash from private industry. Most doctors and academic researchers aren’t corrupt in the sense of intending to defraud the public or harm patients, but rather, more insidiously, guilty of allowing the pharmaceutical and biotech industries to manipulate medical science through financial relationships, in effect tainting the system that is supposed to further the understanding of disease and protect patients from ineffective or dangerous drugs. More than 60 percent of clinical studies–those involving human subjects–are now funded not by the federal government, but by the pharmaceutical and biotech industries. That means that the studies published in scientific journals like Nature and The New England Journal of Medicine–those critical reference points for thousands of clinicians deciding what drugs to prescribe patients, as well as for individuals trying to educate themselves about conditions and science reporters from the popular media who will publicize the findings–are increasingly likely to be designed, controlled, and sometimes even ghost-written by marketing departments, rather than academic scientists. Companies routinely delay or prevent the publication of data that show their drugs are ineffective. The majority of studies that found such popular antidepressants as Prozac and Zoloft to be no better than placebos, for instance, never saw print in medical journals, a fact that is coming to light only now that the Food and Drug Administration has launched a reexamination of those drugs.

Today, private industry has unprecedented leverage to dictate what doctors and patients know–and don’t know–about the $160 billion worth of pharmaceuticals Americans consume each year. This is an unsettling charge that many (if not a majority) of doctors and academic researchers don’t want to acknowledge. Once grasped, however, the full scope and consequences of medical conflict of interest beget grave doubts about the veracity of wide swaths of medical science. As Dr. Drummond Rennie, deputy editor of The Journal of the American Medical Association (JAMA), puts it, “This is all about bypassing science. Medicine is becoming a sort of Cloud Cuckoo Land, where doctors don’t know what papers they can trust in the journals, and the public doesn’t know what to believe.”

Source http://findarticles.com/p/articles/mi_m1316/is_4_36/ai_n6006942

The journey to evidence-based health care requires information age skills and a shift from knowing a static body of information to knowing how to access an evolving knowledge base to support the needs of patients (Haase-Herrick, 2004). This is important because according to the Institute of Medicine (IOM) studies, nearly 100 people die each day because currently, a paper-based health care system introduces errors, delays in treatments, and by its nature, limits what health care professionals know because current evidence is not available. Yet today, with the increased use of computers in health care, many opportunities exist. Consumers will be empowered to help manage their own health with the availability of personal health records that include medication histories and links to information about diseases. Health may be improved because providers and hospitals will be enabled to deliver safe and timely therapy and keep up with medical advances and innovations (such as electronic health records, E-prescribing, quality monitoring and reporting, chronic disease management, childhood immunization records, and employee empowerment tools). Another area of opportunity is in public health protection, with the availability of information that allows for monitoring and management of public health threats that result from episodic or unexpected events that affect whole populations (such as emergency information networks, bio-surveillance, and pandemic surveillance [syndromic surveillance]). Systems for adverse drug reporting and notification have the potential to further enhance safety.

The challenge for ambulatory care nursing with the emerging electronic health records is to be able to integrate evidence-based content that affects nursing practice decisions at the point of care. Current, relevant, systematically synthesized, rigorous evidence can inform and strengthen decision making and will allow for evidence-based practice. The term best practice, while frequently used, is not considered equal to evidence-based practice because often, best practices tend to be what has always been done. Yet, evidence alone is rarely enough. Clinician skill and expertise, as well as patient values and preferences, need to be incorporated in clinical decision making.

For clinical knowledge to be considered good, it must be clinically accurate, current, and come from the highest levels of evidence available. It also must be “delivered” to the nurse in the appropriate form. This requires a data model that allows concepts of interest in the content (such as nursing problems, expected outcomes, orders, and activities to be incorporated). A terminology is then selected to provide the values for all the data elements in the model. In an electronic health record, it is important to use standardized and logically interrelated terminology.

Automated systems require clinical data that is recorded at the appropriate level of detail (neither too general nor too specific), remains consistent over time and across settings, can be transmitted without loss of meaning, can be aggregated at more general levels and from multiple perspectives, and can be interpreted by automated systems. Standardized terminologies are necessary for clear, accurate, unambiguous data about patients; to allow for coded data for analysis and storage; and to promote interoperability within information systems.

Standardized terminologies also help to summarize medical information and allow manipulation of data for aggregation and analysis (for example, “How many new cases of diabetes have we seen this month?” “Is this person’s blood sugar improving?”). Standardized terminologies also allow automated reasoning to support evidence-based practice and decision making. In other words, the content in electronic systems must be useable to the provider.

Ambulatory care nurses spend a majority of their time managing information. When they have access to available evidence-based content, they can make better decisions. Having poorly organized or too much information is no better than having insufficient information. Consequently, content must be efficient to access and use. Content needs to provide linkages between problems, interventions, and outcomes, and support clinical workflow and decision making. Figures 1 and 2 depict the role of knowledge and care process in information systems.

Figure 1 demonstrates an information system without clinical content. A system without clinical content provides limited support to the provider. In Figure 2, where clinical content is actually incorporated into the system, the impact is powerful. The nurse has clinical content/knowledge available to assist in decision making during his or her encounters with patients. In addition, the documentation that occurs as a result of each individual patient encounter can then be incorporated into the data base, aggregated with the data from other similar encounters, and used to generate nursing knowledge and to support future encounters. Important clinical content can be available to the provider in the form of referential knowledge available to the nurse at the point of care and can also be “pushed” to the nurse in the form of alerts for optimal impact on patient care.

Source http://findarticles.com/p/articles/mi_qa4022/is_200609/ai_n17191971

Three days after HHS released its 80-page report summarizing 500-plus responses on what’s required to build a nationwide network of interoperable health data exchange, HHS Secretary Mike Leavett announced on June 6 a multipoint plan for the private sector to join the reds in transforming “health care as we know it.”

Leavett announced the formation of the American Health Information Community (AHIC), a public-private collaboration of up to 17 members that will advise HHS on “how to make health records digital and interoperable, and assure that the privacy and security of those records are protected.” At the same time, Leavett firmly pushed the reds into a leadership post, saying that more than one-third of all U.S. healthcare is paid by the federal government, and that it should demonstrate leadership in the areas of architecture, standards and certification for future interoperability.
AHIC was designed for an initial two-year life span, with an option to extend up to five years. After that, AHIC will be sunsetted and HHS expects that a private-sector healthcare IT initiative will take over the AHIC role, adopt “additional needed standards, certify new health information technology and provide long-term governance for health care transformation.” Leavett summarized the government’s leadership role by saying that “once the market has structure,” efficiencies, healthcare innovations and improvement in care delivery would be the purview of patients, providers, medical professionals and vendors.
Beyond formation of AHIC, Leavett also promised that HHS soon will issue four RFPs around creating processes for setting standards, IT certification, architecture for an Internet-based nationwide exchange of health information and privacy/securities policies. He anticipates a federal spending of $200 million in two years, including HHS’s dedication of $86.5 million in fiscal 2005 and the $125 million requested by President Bush for fiscal 2006.

Drawing rare and rapid support from both sides of the Congressional aisle and wide agreement from healthcare organizations, a bill introduced in mid-May looked by early June to be headed for quick passage in the 109th Congress. The 21st Century Health Care Information Act, introduced by Rep. Tim Murphy (R-Penn.), and cosponsored by Rep. Patrick Kennedy (D-R.I.), promotes creating more regional healthcare information networks that showcase interoperability of medical record software. Also, Sen. Hillary Clinton (D-N.Y.) said she was working with former speaker Newt Gingrich (R-Ga.) on a companion to the House bill that would “spur the adoption of electronic record-keeping applications.”
When introducing his bill, Murphy underscored the need for action by reporting several findings: Lab and radiology results and medical histories were missing during 13.6 percent of patient visits in a recent JAMA study; improper medications are prescribed in about one of every 12 physician visits, per a CDC report; and patients receive recommended care only about 55 percent of the time, according to a Rand Corporation investigation. Murphy also pointed out the need for a more coordinated national effort, citing that 32 states and the District of Columbia have funded healthcare IT initiatives and that 23 federal agencies have adopted standards for electronic exchange without coordination with private industry or individual states.
Murphy’s House legislation (H.R. 2234) would give the Department of Health and Human Services (HHS) Secretary the authority to award up to $50 million total in 20 grants in fiscal 2006 to help establish interoperable regional health information networks and promote the adoption of IT products. It also authorizes similar spending on regional health information organizations (RHIOs) grants in each fiscal year from 2007 through 2010. The law would require RHIOs that receive federal grants to utilize federally-certified healthcare IT products. The overseeing federal agencies will have approval rights if an IT certification process is not yet in place by the time the projects are implemented, in 2006 or 2007.

RHIOs have been taking root across the U.S. since late 2004, when federal seed money helped establish five programs (in Colorado, Indiana, Rhode Island, Tennessee and Utah) to demonstrate exchange of health data among systems with varying software products. Many RHIOs, including new ones in California and Massachusetts, have sprung up without help of federal funds.

In May, Massachusetts formally launched three large-scale regional health IT pilots in Brockton, Newburyport and northern Berkshire. Led by not-for-profit Massachusetts eHealth Collaborative, it is also funded in part by $50 million from Blue Cross Blue Shield of Massachusetts. Also in May, CalRHIO, a statewide network managed by the non-profit Health Technology Center, announced it would electronically link state emergency departments and ultimately permit transfer of patient data between labs, pharmacies, hospitals and physician offices.

Murphy’s bill earned favor from many physician organizations including the American Academy of Family Physicians, the American College of Physicians and the American Health Care Association. The bill directs AHRQ (Agency for Healthcare Research and Quality) to create a National Technical Assistance Center to assist physicians, financially and technically, and to give priority to small practice.

Clinical Quiz questions are based on selected articles in this issue. Answers appear in this issue.

American Family Physician has been approved by the American Academy of Family Physicians as having educational content acceptable for Prescribed credit hours. Term of approval covers issues published within one year from the beginning distribution date of January 2002. This issue has been reviewed and is acceptable for up to 4 Prescribed credit hours. One half hour of these credit hours conforms to AAFP criteria for evidence-based CME clinical content. Credit may be claimed for one year from the date of this issue. When reporting CME credit hours, AAFP members should report total Prescribed credit hours earned for this activity. It is not necessary for members to label credit hours as evidence-based or Prescribed for CME reporting purposes.
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The AAFP designates this educational activity for a maximum of 4 hours in Category 1 credit toward the American Medical Association Physician’s Recognition Award. Each physician should claim only those hours of credit that he or she actually spent in the educational activity.

AAFP Credit

Each copy of AFP contains a Clinical Quiz answer card. AAFP members may use this card to obtain the designated number of Prescribed credit hours for the year in which the card is postmarked.
AMA/PRA Category 1 Credit

AAFP members who satisfy the Academy’s continuing medical education requirements are automatically eligible for the AMA/PRA.

Physicians who are not members of the AAFP are eligible to receive the designated number of credit hours in Category 1 of the AMA/PRA on completion and return of the Clinical Quiz answer card. AFP keeps a record of AMA/PRA Category 1 credit hours for nonmember physicians. This record will be provided on request; however, nonmembers are responsible for reporting their own Category 1 CME credits when applying for the AMA/PRA or other certificates or credentials.

For health care professionals who are not physicians and are AFP subscribers, a record of CME credit is kept by AAFP and will be provided to you on written request. You are responsible for reporting CME hours to your professional organization.

NOTE: The full text of AFP is available online (www.aafp.org/afp), including each issue’s Clinical Quiz. The table of contents for each online issue will link you to the Clinical Quiz. Just follow the online directions to take the quiz and, if you’re an AAFP member, you can submit your answers for CME credit.

INSTRUCTIONS

(1) Read each article, answer all questions on the quiz pages, and transfer your answers to the Clinical Quiz answer card (bound into your copy of AFP).
(2) A Mail the Clinical Quiz answer card within one year (by September 30, 2003). The bar code on the answer card contains your identification for CME credit hours.

THE STATE OF REPROCESSING

Reprocessing offers health care providers a patient-safe, economic alternative with a proven safety record. (1) Medical devices represent the highest recurring expense to hospitals after staffing. Reusing rather than disposing of these expensive devices translates into cost savings that can be reinvested in resources (eg, more nurses, new technology) health care providers may need to better serve patients.

Reprocessing is not a secret. Hospitals have reprocessed devices safely for two decades, and third-party reprocessing has become a $40 million-a-year industry. (2) Even before the FDA’s updated guidance was issued, third-party reprocessing was regulated by the FDA. Regulations governing reprocessing have existed for as long as there have been regulations for medical devices. The Federal Food, Drug, and Cosmetic Act, established in 1938 and amended in 1976 to include medical devices, regulates the sale of devices intended for use on humans in the United States. Reprocessed SUDs are not excluded from these regulations. In fact, the FDA/ORA Compliance Policy Guides Manuals, issued in 1987, assigns responsibility for the safety and effectiveness of a reprocessed SUD to the party performing the reprocessing. (3)

Third-party reprocessors must comply with a host of regulatory requirements, the most significant of which is the Quality System Regulation (QSR), which includes extensive controls over all manufacturing operations (eg, cleaning, disinfecting, packaging, labeling, sterilizing, distributing). The FDA’s QSR requirements apply to both third-party reprocessors and OEMs, as do the premarket submission requirements in the FDA’s guidance. Reprocessors take exhaustive measures to ensure the quality and effectiveness of reprocessed SUDs for physicians, hospitals, and patients.

When the FDA was formulating its guidance for reprocessing SUDs, one major issue was whether hospitals that reprocess their own SUDs would be considered manufacturers. If they were, the FDA would have regulatory oversight of their reprocessing activities. A secondary issue was whether third-party reprocessors and hospitals would have to submit premarket notifications for reprocessed SUDs, either through the 510(k) premarket notification process or the premarket approval (PMA) process. This point was debated because reprocessors essentially would be submitting a device for premarket clearance that already had received premarket clearance when first introduced by the OEM. Ultimately, the FDA decided that hospitals and third-party reprocessors would be regulated in the same way as manufacturers. There was never a question as to the regulatory status of third-party reprocessors, however, because the FDA always has regulated them.

THE LABELING QUESTION

A three-tiered classification system for devices listed in the Code of Federal Regulations (CFR) forms the basis for determining what type of premarket clearance is required of any new medical device. This system applies to all devices, not just reprocessed SUDs. For a time, the FDA looked at a special classification scheme for reprocessed SUDs, but it ultimately decided to use the existing system. In August 2000, the FDA issued a guidance document titled “Enforcement priorities for single-use devices reprocessed by third parties and hospitals.”

Healthcare personnel have a duty to protect the physical and mental health of such individuals and to provide appropriate treatment for disease and injury, according to a policy memorandum released by Dr. William Winkenwerder, Jr., the Assistant secretary of Defense for Health Affairs.

Our policy is meant to make clear for our medical care providers that if a detainee provides information that directly bears upon a national security issue-for example, plans to commit a terrorist act that kills or harms Americans-the medical provider should, with proper documentation and approval, pass along the information to responsible security and intelligence authorities,” Winkenwerder said.

Specific guidance in the overall policy includes: direction to accurately and completely create and maintain medical records on all detainees; to ensure clear separation of duties between personnel providing healthcare to detainees and behavioral science personnel consulting with interrogators; to carefully record disclosure of all patient-specific information for lawful purposes other than treatment; to report possible violations of applicable standards for the protection of detainees; and to ensure healthcare personnel have appropriate training regarding the care and treatment of detainees.

Although detainees do not have an absolute right of confidentiality with respect to information they share with medical care providers, the general guidance is to maintain such information confidentially, except for approved and documented specific reasons. This is the same standard that would apply in U.S. federal prisons.

“Any detainee related information provided by healthcare personnel for reasons other than treatment must be for a specific purpose, documented and approved by a medical commander before it is released,” Winkenwerder said. “This process creates a strict set of guidelines to ensure the information is used

“To the best of my knowledge we have no credible evidence that a military physician participated in detainee abuse,” said Winkenwerder. “The department investigates credible allegations and if substantiated, holds accountable those who are responsible. We expect military medical personnel, and all other service members, to abide by policies that require detainees be treated humanely and to report any suspected detainee mistreatment.”