The American metalworking industry thrives on complexity. As the designs of modem products and systems become more sophisticated, the value of precision in manufacturing processes and resource management increases substantially. The growing demand for highly complex parts not only narrows the competitive field, but it also places a greater premium on maintaining close contacts between manufacturers, suppliers and customers. Because the human body is much more complex than any of the manufactured mechanisms that support modern civilization, these factors are particularly applicable to the business of medical machining.

Producing medical parts is a demanding business that requires strict control of machining processes and a substantial amount of outsourcing. This heightens the importance of maintaining a network of reliable, specialized suppliers to provide services such as plating, heat treatment, electropolishing, passivation and laser marking. To support their continually evolving processes in the shop, manufacturers of medical components also must forge strong partnerships with machine tool suppliers and distributors.

Omni Components Corporation (Hudson, New Hampshire) is an ISO 9001:2000 organization that manufactures parts for various markets including the medical, optical, instrumentation, communications, electronics and commercial high-technology industries. Founded in 1978, the company originally operated cam-type Swiss screw machines, producing components for Braille typewriters. In 1984, as it expanded to serve other clients in New England, Omni purchased its first CNC Swiss-type lathe. Today, Omni provides a full range of multi-axis machining services. In addition to discrete parts, the company also produces various types of turnkey assemblies.

In the past, the telecommunications industry had provided a larger portion of the firm’s business than it does today. Due to poor economic conditions, this segment of Omni’s business declined significantly during the past 2 years. Responding to this situation, the company has simultaneously boosted the percentage of work that it produces in other markets, particularly its medical work. As a result, medical-related parts now represent more than 20 percent of Omni’s overall business.

The impact of this transition has been quite positive for the company. In 2002, while manufacturers in other industries were scaling back or closing, Omni recorded the most successful year in its history. Pursuant to this strong growth, the firm recently consolidated the operations of two separate facilities by relocating to a 32,000 sq. ft. facility in Hudson.

Turning Process Into Profits

Most of the medical parts that Omni manufactures are surgical instruments and bone screws that are machined from bar stock. Dominated by 25 CNC Swiss-style lathes served by bar loaders, Omni’s new production facility has the appearance of a high-tech screw machine shop. The Swiss lathes include B-, F-, L- and M-Series machines supplied by Marubeni Citizen-Cincom Inc. (Allendale, New Jersey).

Besides some waterjet cutting operations and deburring or cleaning of finished parts, the majority of Omni’s medical components are completely machined on the Swiss-style lathes. Equipped with Citizen-Cincom CAV and IEMCA VIP magazine-type bar loaders, the Swiss lathes can operate unattended for extended periods.

“For medical customers, our typical part runs range from 300 to 1,500 pieces,” says Sean Duclos, Omni’s manufacturing manager of turning operations. “We use the Swiss machines’ macro programming capabilities to make changeovers more efficient within families of parts’ Typically, Omni’s most complex parts are run on the newest Swiss lathes because they provide substantially faster cycle speeds. But the shop’s wide range of machines gives Mr. Duclos considerable flexibility in production scheduling. Despite the lathes’ continuous operations, Omni maintains a very clean shop environment by exhausting contaminants through a Trion Air Boss air cleaning system.

Two key elements in Omni’s machining processes are crucial to the company’s productivity. First, Omni uses targeted, high-pressure coolant to provide better chip evacuation, tool durability and surface finishes. Because the Swiss-style lathes perform multiple functions including stop-spindle operations, the positions of parts and the resulting demands for coolant continually change.

Omni’s machine tool distributor, Brook-dale Associates Inc. (Agawam, Massachusetts), has provided a solution to this challenge by developing a high-pressure coolant delivery system known as the Cool Blaster HD. Omni’s system provides up to eight independent coolant delivery lines for a single machine. Each coolant line is activated as needed via programming codes during machining. Besides improving cycle times and part quality, this system also reduces tool consumption.

Deep-hole drilling and gundrilling are also required for a significant portion of Omni’s work. In some cases, the company’s drilling applications involve depths as great as 25 times the diameter of the hole. In these high-speed drilling applications, high-pressure coolant delivered through the tools is particularly valuable for chip control and accuracy. Instead of producing long, continuous chips that form “bird nests” around the machine spindles, high-pressure coolant causes the chips to break into small pieces that are readily flushed away.

While the proprietary nature of the actual metalworking processes used for making “body parts” tends to be more mystique than technique, there are some things to think about for shops that are looking to do this kind of work.

It’s no secret that one of the very few bright spots in the metalworking business has been the machining of medical components. It only makes sense if one considers the demographic glut of the aging baby boomer generation.

More bodies are reaching a point where replacement parts are needed. Demand creates supply with so many of us among that aging human fleet.

Like much of the high tech label that surrounds medicine and its practice, some shops are hesitant to consider medical machining applications because they believe the special demands may be beyond their capability. There are exceptions, but in general the metalworking process knowledge to make medical components is generic. Cutting metal is cutting metal, and although some of the materials specified for medical components might be considered “exotic” they are certainly not exclusive to medical applications.

One area of medical machining where a shop looking to create a successful process might need to understand a few things is the application of metalworking fluids. In general, traditional machining guidelines for fluid use are in effect for most medical machining applications, but there are some considerations in applying them that can help make the job easier.

We spoke to Tom McClure, manager of the fluids business at TechSolve (Cincinnati, Ohio), and Greg Foltz, engineering and development manager for Cimcool at Milacron Inc. (Cincinnati, Ohio), to learn more about the role of metalworking fluids in machining of medical components.

Medical Parts

There are two main categories of machined parts for medical applications. They are components that are implanted in the body on a permanent or semi-permanent basis and those that are used in the body for short durations, such as during surgery. Most of the specialized cutting fluid considerations are targeted at the transplanted parts.

Implanted components such as hip joints, knee joints, bone screws, spinal fusion plates and other hardware must be designed to withstand a relatively tough environment within the human body. Many of these components are specified to be made from tough materials such as titanium and nickel alloys to withstand a hopefully long service life within the acidic environment that exists in our bodies, which have a general pH of around 5.4.

Greatly simplified, on skeletal replacement or reinforcement parts, the hope is that once the component is in place, the surrounding tissue will adhere to the surface of the metal–literally grow on it to form a strong connection–like a weld. This critical union between body and part is where what the shop did upstream through its application of metalworking fluid and the subsequent cleaning of the parts can be a determining factor in the transplant’s success.

Oil Is OK, But Be Careful

According to Mr. McClure, most of the medical machining shops that TechSolve has worked with use water-based coolants in their medical parts manufacturing. “That’s not to say oils cannot be used,” he says, “but the cleaning of those components must be especially thorough.”

It seems there was a lawsuit filed against a medical parts supplier after a batch of implanted parts failed to knit with the surrounding tissue. These had to be removed and replaced. No doubt the malpractice lawyers had a field day.

Analysis showed that microscopic amounts of the cutting oil were present in the microstructure of the implanted part. This residue was sufficient to prevent the tissue from bonding to the component. This is a patient’s horror story for sure, and a cautionary tale to parts suppliers.

Obviously if cutting oil is the right fluid for the job, the shop should use it. But it is important to make sure the subsequent cleaning process can get the oil off the parts.

Coolant Considerations

For medical component applications, coolant selection is a twofold exercise. First, of course, are the performance characteristics created by the interaction among the coolant, cutting tool material and the workpiece material. These are generic concerns applicable to any metalworking process.

Looking then at synthetic and semi-synthetic coolants, what should the shop think about? Matching the right coolant to the job is, of course, key. It is also important to reduce any incidences for bacterial growth in the coolant. According to Mr. McClure, most shops doing medical machining make coolant cleanliness a higher priority than is generally seen in traditional shops.

Coolant tanks are covered, and nothing foreign is allowed into the system. Way oil is monitored and removed regularly. Many shops use individual coolant tanks, one for each machine. In the case of an outbreak of bacteria or other contamination, dumping a single tank is less disruptive to production than dumping a central system, and it isolates any problems to a single machine instead of the entire shop.

According to research in the December issue of Academic Medicine, rules implemented in 2003 restricting the number of hours medical residents can work have had an impact on family medicine residency programs. Residency program directors reported an increase in faculty patient care duties, a decrease in formal resident educational activities, a decrease in specialty clinic rotations for residents, and a decrease in residents caring for their patients in continuity clinics.

Many practicing physicians, national organizations of health care professionals, medical educators, government agencies and the public support the belief that preventive care services should be delivered by physicians. Unfortunately, most studies indicate that compliance wih recommended preventive care guidelines is low. In most intervention studies designed to increase implementation of health maintenance, the performance of screening tests, counseling and immunizations rises to only about 50 percent in eligible patients. Hahn and Berger evaluated the use of a systematic health maintenance protocol in over 1,400 patients seen in a family practice setting over an 18-month period. The results obtained with the protocol were compared with the results of “usual care.”

At the end of each patient visit, an adult health maintenance flow sheet was reviewed with the patient to determine if indicated procedures had been performed and, if so, whether the results were normal. The physician recommended procedures that had not been performed and provided a brief explanation of each. The flow sheet consisted of ten to 15 health maintenance items, including a Papanicolaou test, blood pressure reading and tetanus booster. The protocol took between two and four minutes to complete.

After 18 months, a random audit of medical records showed that physician compliance with the protocol was 97 percent in eligible patients. Patient acceptance of recommended preventive services varied from 77 percent (sigmoidoscopy) to 97 percent (cholesterol screening). The patients in the usual care group received significantly fewer preventive services.

The following guidelines have been developed and endorsed by the American Academy of Family Physicians.

Approved by the AAFP Board of Directors in November 1993, these guidelines represent the “core” educational objectives for training family practice residents in the field of risk management and medical liability. Family physicians in practice may wish to review the guidelines in preparing for their board examinations. Other specialists may refer to the guidelines in developing continuing education courses for family physicians or in preparing articles for American Family Physician.

Risk management refers to strategies that reduce the possibility of a specific loss. The systematic gathering and utilization of data are essential to this concept. The risk management process comprises:

* Identification of risk or potential

risk (diagnosis)

* Calculation of the probability

of adverse effect from the risk

situation (assessment)

* Estimation of the impact of the

adverse effect (prognosis)

* Control of the risk (management)

Good risk management techniques improve the quality of patient care and reduce the probability of an adverse medical malpractice claim.

This core curriculum outlines the attitudes, knowledge and skills currently recommended for residents in the area of risk management.

Attitudes

The resident should develop attitudes based on:

A. An awareness of potential risk

and professional liability.

B. An appreciation of the importance

of good communication.

C. An appreciation of the importance

of good medical records.

D. A sensitivity to the roles of federal,

state, commercial and

other agencies involved in risk

management and medical

liability issues.

E. An awareness of the inherent

conflict between defensive

medicine and cost

effectiveness, between individual

good and social good.

Knowledge

A. Physician-patient relationship

1. Definition

2. Termination

a. Mutual consent of parties
b. Physician services no
longer needed
c. Withdrawal of physician
from case after
reasonable notice to
patient and completion of
current treatment

3. Abandonment

B. Informed consent

1. Components

a. Diagnosis
b. Nature and purpose of
proposed treatment
c. Possible complications
d. Available probability of
success
e. Alternatives
f. Documentation of
conversations
g. Written form completed

2. Special patient situations

a. Minors
b. Mental incompetence
c. Emergencies
d. Therapeutic privilege

C. Communication

1. Doctor/patient

a. Time spent with patients
b. Use of clear, understandable
language
c. Careful and attentive listening
d. Sensitivity to needs of
patients
e. Flexibility in responses
to the spectrum of
patients
f. Mechanism for
addressing patient
complaints

2. Staff communication with

patients

3. Doctor/legal system

a. Response to request for
records
b. Subpoenas
c. Depositions
d. Attorney selection
e. Malpractice panels
f. Court appearances

D. Legal definitions

1. Sources of the law

a. Supreme law
b. Statutory law
c. Decisional law
d. Quasi-judicial law

2. General legal liability

a. Contract
b. Torts, intentional
negligence

3. Duty to exercise care

4. Applicable standard of care

5. Breach of standard of care

6. Causal relationship between

breach of duty and injury

7. Statute of limitations

8. Statutory immunity

E. Documentation

1. Physician record

a. Accurate
b. Complete
(1) Patient
examination
(a) Baseline history
and physical
examination
(b) Updated lists of
known allergies,
prior illnesses,
immunization
status
(c) Specific notes on
symptoms, patient
noncompliance,
patient responses
(2) Patient disposition
(a) Differential diagnosis,
current
diagnosis, therapy,
plan of action
(b) Specific time of
return visit
(c) Referral to other
physicians
including reasons
and date of
appointment
(d) Follow-up system
(3) Telephone calls
(a) Substance of telephone
conversation,
both during
and after office
hours
(b) Conversations
with patient, family
members and
other physicians
(4) Reports of tests
(a) Physician
acknowledgment
of results
(b) Inclusion in chart
(c) Follow-up plan for
abnormal results
(5) Technical matters of
form
(a) Preprinted forms
with fill-in-the-blank
style
(b) Little empty paper
(white space)
(c) All entries signed
and dated
(d) Pages securely
bound
(e) Complete entry
at time of
examination
(f) Missed or canceled
appointments noted
(g) Problem list
c. Legibility and readability
d. Proper corrections and
modifications
e. Timely completion of
medical records
f. Confidentiality
(1) Legal breach of
confidentiality
(a) Physical or sexual
abuse of children
(b) Patient presents
clear danger to self
or others
(c) Patient to be
involuntarily committed
to mental
health facility
(d) Certain health
conditions, i.e.,
human immunodeficiency
virus
(e) Reportable
communicable
diseases, i.e.,
tuberculosis, sexually
transmitted
diseases

The new Institute of Medicine definition of primary care is not vet operational since it is unknown whether its description fits reality. Different primary care clinicians, ie, family physicians, pediatricians, general internists, and nurse practitioners, have different frames of reference, training programs, and views on their involvement in the delivery, of care.Rapid changes in the United States health care system complicate the operationalization of the definition considerably, especially with regard to the central issue of the large majority of personal health care needs.

The episode of care is designated as the unit of assessment for deciding whether a clinician indeed provides care for the large majority of health care needs of persons who consider him or her their usual provider. The term episode of care refers to a health problem from its first encounter with a health care provider through the completion of the last encounter related to that problem.  An episode of care, therefore, differs from an episode of disease, which is a health problem from its onset through its resolution or until the patient’s death, and an episode of illness, which is the period during which a person suffers from symptoms or complaints experienced as an illness. Not every disease and certainly not every illness results in an episode of care. Most episodes of care, however, are part of an episode of disease and, less often, of illness. Health maintenance episodes can be considered a special form of episodes of care.

The prevalence of an episode of care consequently is lower than the prevalence of a given disease in the population. For some diseases, the prevalences will be similar, as with fractures, strokes, metastatic malignancy, and blindness. More often, however, there will be considerable discrepancies between the actual demand for care and the potential need as expressed by data from population studies (disease), from health interviews (illness + disease), and from utilization studies (care). In the United States, the National Ambulatory Medical Care Survey,[10] National Health Interview Survey, and National Medical Expenditure Survey are major sources for such data.

A Core Concept for Family Practice

The episode of care is central to the use of the International Classification of Primary Care (ICPC), developed by the World Organization of Family Doctors. This system is designed to characterize the three essential elements of primary care episodes: the patient’s reason for the encounter, the diagnostic label, and the diagnostic and therapeutic intervention.

The content of primary care has been described in several epidemiologic studies. From these studies, the family doctor emerges as the prime candidate to meet the requirement of dealing with the large majority of personal health care needs. Everyone for whom a family physician is the usual provider of care can present to him or her with any health problem at any stage of development. These problems as distributed represent the large majority of personal health care needs for different sex and age groups and are globally known, in both the United States and elsewhere.

In addition to providing personal continuity of care, family physicians also provide factual continuity of care when they structure and update the medical life histories of their patients over time, taking into account the changes in medicine, in society and in their patients’ lives.

The main goal of this article is to illustrate how the content of family practice can be characterized in an episode-oriented epidemiologic model,

Methods

In the Netherlands, patients cannot seek specialist care without a referral by the family physician. This circumstance allows a rather close approximation of the large majority of personal health care needs. The Dutch health care system, in which family physicians are designated as primary care physicians, differs from that in the United States, where not only family physicians but also general internists, pediatricians, and gynecologists serve as primary care clinicians.

Data on patients enrolled (listed) with a family physician are presented in the form of standard presentations with a 1-year time window (Transition project of the Department of Family Practice, University of Amsterdam). In the period 1985 to 1994, complete data on 236,023 episodes of care during 93,297 patient years were routinely registered and coded by 43 family physicians. Data on episodes of care in women 2 5 to 44 years of age have been selected for use in this paper to provide an indication of the potential involvement of different primary care providers, ic, family physicians, general internists, and gynecologists, in the large majority of the health care needs in this group.

Few of us today realize that only a quarter of a century ago, the family physician seemed about to fade out of the American medical scene. The earlier quarters of the 20th century had seen a burgeoning of scientific medicine, a proliferation of specialties and rapid refinement of medical technologies. These developments were accompanied by a notable decline of the family physician’s function. In the mid-1960s, a growing popular disenchantment with the profession’s response to the people’s need for continuing medical care was reflected by articles then appearing in such publications as Time, Life, the Saturday Review, The Wall Street Journal, Science, The New York Times Magazine, the New Republic and Harpers Monthly. The articles noted, with varying degrees of regret, resignation or approval, the approaching demise of the general practitioner.

Between April 1965 and February 1967, the Family Health Foundation of America (FHFA)–a study and development arm of AAFP’s antecedent organization, the American Academy of General Practice–sponsored with the Association of American Medical Colleges a series of conferences devoted to family practice. The conferences focused on defining family practice, developing its core curriculum and formulating plans to stimulate the establishment of family practice departments, residencies and, ultimately, a certification procedure in the specialty of family practice.

Simultaneously, three other major studies were under way: one by a national commission chaired by the late Marion Folsom, former Secretary of the then department of Health Education and Welfare; another by a citizens’ commission led by the late Dr. John Millis, president of Western Reserve, and the third by the American Medical Association’s Council on Medical Education. The reports of these three bodies converged upon the theme that individuals should have personal physicians who are the central point for integration and continuity of all medical and medically related services to their patients; recognition and status equivalent to other medical specialties should be given to family practice, and there should be a specialty board, certification examinations and diplomate status for physicians highly qualified in comprehensive care.

All these studies, and the conferences sponsored concurrently by the FHFA, were based on the recognition that in the pride of its scientific accomplishments, American medicine seemed to have lost sight of its essential objective: to provide continuing comprehensive care to the whole patient. Indeed, the Millis commission pointed out that precisely because “the science and art of medicine devoted to understanding and treating individual organs and systems have outrun the science and art of understanding and treating the whole man, specialty practice has become more necessary and more attractive.” But Sir Theodore Fox, writing in The Medical Post in 1965, suggested that the very growth of scientific medicine makes it all the more imperative that the investigator and specialist “be balanced by someone who is concerned with people rather than things.”

In a specialty commissioned report on the situation confronting family practice in the mid-1960s, I wrote: “What confronts us in medicine today is a societal monstrosity, a profession standing on its head. Its management function–its coordinator–lies at the bottom of the heap and is rapidly being ground out of existence by the pure weight and commotion of the proliferating mass of uncoordinated specialists milling about above it.”

The pyramid still stands precariously on its apex. But the specialty of family practice is gaining daily in numbers, in prestige, in popular acceptance and appreciation. Many other primary care physicians, especially general internists, are practicing what is essentially family medicine.

Bringing these revelations to present-day significance, the resource-based relative-value scale (RBRVS) study, produced under congressional mandate by William C. Hsiao, Ph.D., and colleagues at the Harvard School of Public Health, recently became the hottest topic in medical economics, stimulating a profession-wide debate.

In the midst of this debate, American Medical News reports that “the positions of the contending medical groups largely coincide with [their] financial interests.” The same source reports that each of the score or more specialists groups has retained a consultant to help it present its case.

The RBRVS formula will inevitably be revised, and special concerns, where reasonable and clear, will be accommodated. But some of the reported reactions raise the specter of a confusion of counsel or Babel of tongues such as might lead highly stressed politicians to look for a more simplistic plan for Medicare reimbursements.

The RBRVS proposal essentially offers these advantages or attractions to a free American medical profession: (1) It would seek to relate compensation to relevant factors in the costs of providing medical services. (2) It would appropriately adjust compensation for the elemental professional skills of patient care. (3) It would greatly strengthen the profession’s hand in resisting growing public pressures for federalized medicine. (4) It would render the economic practices of the profession more reasonable and logical to the people.

The identification of strategies for the prevention, diagnosis, and treatment of cancer is a high priority for the nation. It is estimated that $10 billion is spent each year for hospital and physician services, $25 billion represents lost income, and over two million work-years are lost because of cancer.[1] With 1990 figures from the American Cancer Society (ACS) showing approximately 37,900 new cases in Michigan alone,[2] interventions aimed at early detection and treatment of cancer are actively being sought and implemented. The primary care physician, by virtue of practice location and accessibility to a large percentage of the population, has been identified as an important link in delivering the necessary education and early diagnostic procedures

Much of the literature on prevention of death and disability from cancer, including the ACS report on the cancer-related checkup,[4] assumes that the search for early cancer in asymptomatic individuals will afford the greatest medical benefit in a safe and practical way. Studies in various settings, however, have demonstrated that screening protocols are seldom implemented.[5-9] Patient, physician, test, and health care delivery system factors have all been cited as responsible for the failure to complete cancer screening.

Reports of cancer detection in practice settings are few. A retrospective study of cancer diagnoses from a single family practice over a 10-year period demonstrated that 69 cancers, or approximately one new cancer diagnosis every 2 months, were identified.[12] In the study, the majority of cancers were diagnosed among patients who were participating in cancer screening; however, only 2 of 11 patients with a diagnosis of colon cancer and 2 of 11 women with a diagnosis of breast cancer were asymptomatic. To improve the frequency and effectiveness of cancer screening by primary care physicians, more information is needed on how cancer is currently identified among their patients .

The purpose of the present study was to describe practitioner beliefs about cancer screening, early detection, and actual cancer detection rates (by both screening and case finding) in a population of patients cared for by a group of family practice physicians. It was hypothesized that the majority of cancer cases detected by these physicians would be among patients presenting with symptoms. In addition, it was hypothesized that those reporting a belief in more aggressive screening strategies would detect more asymptomatic cases and more cancers at an early stage of illness.

Methods

Subjects

Physicians who participated in this study were members of the Michigan Research Network (MIRNET), a voluntary network of Michigan practitioners interested in collaborating on primary care research projects. Twenty-nine family physicians and six physician assistants (PAs), representing 10 of the 18 MIRNET practices, participated in the study. These practices included 4 solo physician practices, 2 community-based family practice (FP) teaching faculty practices (7 physicians and 2 PAs), 1 academic FP faculty practice (four physicians), and 3 FP group practices (14 physicians and 4 PAs). Five practices were in rural locations (3 solo, 2 group practices). The 4 PAs in the group physician practices reported cases through the supervising physician rather than independently contributing information; therefore, the total number of practitioners participating in the study was 31.

Measures

A previously validated self-administered questionnaire on cancer screening practices was used with permission from Woo et al.[8] This questionnaire requested information on how often asymptomatic patients of varying ages should receive general (physical or pelvic examination) and specific (breast and/or rectal examination, fecal occult blood, sigmoidoscopy, Papanicolaou [Pap] smear, and mammography) cancer screening. Screening frequencies were reported as never, once in a lifetime, once every 10 years, every 4 to 5 years, every 2 to 3 years, or once annually. Subjects were also asked to rate themselves in general terms regarding the use of screening procedures (more, same, or less than recommended) and to list in rank order the reasons for following this approach. Information was requested on personal and family history of cancer.

A patient information card was used to identify each patient with a new diagnosis of cancer. This card was used to report the patient’s name and identification number, age, sex, diagnosis, screening and diagnostic tests used to identity the cancer, and whether the patient presented with symptoms attributable to the cancer. A test or examination w as considered part of screening if the patient was asymptomatic at the time of testing and the performance of the test was not prompted by the patient. A test or examination was considered diagnostic if the test was performed in response to either patient symptoms or a positive screening test. Cancers considered detectable by routine screening included breast cancer (clinical breast examination and mammography), cervical cancer (Pap smear), colorectal cancer (digital rectal examination, fecal occult blood, and sigmoidoscopy), prostate cancer (digital rectal examination with or without prostate specific antigen [PSA] test), and skin cancer (skin inspection during physical examination). The designation of these cancers as detectable was based on recommendations offered by the ACS.

Medical abortion has been available in the United States for some time but, until recently, was viewed mainly as an experimental procedure or new technology.[1] Publication of the article by Gold, Luks and Anderson[2] shows how medical abortion could enter into the mainstream of family practice and highlights the controversy surrounding this subject.

The accessibility of medical abortion brings family physicians to yet another crossroads. The procedure itself is effective, low-cost, easily learned, noninvasive, well-tolerated and potentially accessible to nearly all patients. Yet medical abortion, with its moral implications, may only complicate the practices of many family physicians.

Family physicians are still divided on their attitudes toward abortion.[3] One survey, taken at a time when only surgical abortion was available, reported that although approximately 50 percent of family physicians supported a woman’s right to choose an abortion, only 3 percent were performing abortions.[4] Perhaps the technical aspects of a surgical abortion were too daunting for most family physicians, or the public nature of the procedure deterred physicians from performing surgical abortions. Equally plausibly, the gap between believing that a woman has the right to choose an abortion and actually performing an abortion presented too great a moral leap for most practitioners to take. Medical abortion eliminates the first two potential obstacles, leaving family physicians to wrestle with the moral implications of the procedure.

Paradoxically, the simplicity and convenience of medical abortion may also be a drawback. A patient can now simply go to her physician for a “routine” visit to discuss her pregnancy options and terminate her pregnancy if she chooses. No special location is required. No special time to schedule a procedure is necessary. Medical abortion thus offers a woman and her physician more control over her decision and moves discourse about the procedure more out of public view. The patient’s support network can easily be excluded if she wishes. The physician will more often be left managing a “family secret” in addition to an undesired pregnancy. Managing such secrets will further complicate primary care practice.[5]

Nevertheless, the distinct advantages of medical abortion over surgical abortion as a primary care procedure will lead most family physicians to consider whether to offer this procedure. Many family physicians who have been daunted by barriers imposed by surgical abortion will make the decision to offer medical abortion to patients, undoubtedly after significant soul searching. Others will decide to not provide medical abortion in their practice. Family physicians will also decide whether to assist patients who are suffering the adverse effects (both physical and psychological) of medical abortion, although most family physicians presumably have already faced this issue with respect to surgical abortion and will extend the medical care provided in their practice into this new realm.

The question of how to interact with colleagues who are making a different choice is important. Family physicians absolutely opposed to abortion view abortion of any type as the taking of human life. How then does a family physician absolutely opposed to abortion interact with a colleague who decides to offer medical abortion?

Because few family physicians have performed abortions, different views toward abortion within the same practice have been manifested by the nature of counsel offered around the issue of abortion and in referral patterns for patients considering abortion. A patient made her choice and, if she chose termination, terminated her pregnancy outside the immediate realm of her family physician’s office. A family physician’s support for abortion was ultimately manifested by events that occurred outside the physician’s office. Family physicians opposed to abortion might continue to practice with colleagues supportive of abortion based on one or several of the following rationales: (1) The colleague is only recommending or facilitating abortion, not performing it. The patient still is able to choose on leaving the office. (2) Patients who would otherwise pursue abortion without first considering alternatives may hear those alternatives, because the practice includes physicians who oppose abortions as well as those who do not. (3) Colleagues may be persuaded to become less supportive of abortion. Now, on the other hand, abortion or the definitive event leading to it can occur routinely in the physician’s office. This is an untenable position for a family physician absolutely opposed to abortion, who may have been able to coexist with different opinions but cannot coexist with different practices. Having a dialogue about taking human life may be upsetting, but being potentially present when human life is being taken is a call for definitive action for some practitioners.

Although the right to conscientious refusal to assist with abortion has been discussed,(6) there has yet been no dialogue among physicians about how to deal with the refusal to “coexist” with abortion. How each physician, either alone or in a group practice, answers this question has profound implications for the practice of family medicine. (Other staff working in outpatient family practices will face similar questions.) Practices may eventually sort into “medical abortion” and “no medical abortion” groups. The introduction of a very private procedure into family practice may paradoxically force physicians to publically declare their support or disdain for it. Thus, while the patient will have less motivation than before to discuss her choice with her family, counselors and friends, physicians may be compelled to enter into a potentially divisive dialogue that might undermine their collegial relationships.

The development of practice policies or clinical guidelines has recently met with great popularity in many countries.(1)(2)(3)(4) National consensus development, modeled after the original National Institutes of Health procedure, can be seen in Canada, Scandinavian countries, France, the United Kingdom, the Netherlands, and elsewhere. A more recent initiative is the clinical guideline development by the Agency for Health Care Policy and Research (AHCPR) in the United States.(5) Guidelines are also developed on a large scale by professional bodies and by regional or local groups of care providers and other organizations.(2) Guideline setting is now considered by most policymakers and professional organizations of care providers to be a priority, and essential for the improvement of the quality and efficiency in health care.

A crucial question in this development is: how effective are all these different approaches for setting guidelines? This paper outlines a method for national guideline development for family practice in the Netherlands and provides a comparison of this method with that of the AHCPR in the United States.(6)(7)(8)(9) In the Netherlands, national guidelines for family practice care have been developed and disseminated in a rigorous, structured manner since 1987.(10)(11)(12) More than 45 of these guidelines covering a wide range of topics have been disseminated among more than 80% of all Dutch family physicians. Using a systematic updating program, which was started in 1991, eight to ten new topics are addressed each year. The guidelines are developed by the Dutch College of General Practitioners (NHG), the scientific organization of family physicians, while the National Association of Family Physicians (LHV, the “union”) is responsible for their implementation. A large majority of the almost 7000 practicing family physicians are members of these professional bodies.

This guideline initiative has been quite successful because it is initiated and “owned” by the family physicians themselves. It is also linked to the specific role of the family physician in the Dutch health care system: being the gatekeeper for specialist care, providing long-term, continuous care to patients, and treating patients for minor as well as chronic problems. In addition, guideline development is being adapted to the morbidity in primary care. Watchful waiting and the prevention of unnecessary or potentially harmful care, therefore, are important basic values for the guidelines. The emphasis in the model for Dutch guideline setting differs considerably from that of the AHCPR (Table), which has focused on expensive procedures, such as cataract surgery.

Table. Differences in Aims and Emphasis Between Guideline-Setting

Procedures of the Agency for Health Care Policy and Research (AHCPR) and the Dutch College of General Practitioners

AHCRP                                Dutch College
* Governmental initiative        * Initiative of professional
organization of family
physicians
* Mainly experts developing      * Experts and practitioners
guidelines                      developing guidelines
* Multidisciplinary, including   * Only family physicians
consumers
* Strong emphasis on evidence-   * Emphasis on mixture of
based, scientifically
justified                       scientific evidence and
guidelines                      feasibility in practice
* Development and
implementation                 * Implementation is part of
are separate processes          developmental process
* Patient/consumer preferences
on                             * Patient preferences not
outcomes taken into account     included
* Small range of topics           * Broad range of topics
* Development carried out by     * Development by and owned
independent scientific
institutions                    by family physicians
(contractors)
* Central aim: elimination of    * Central aim: supporting family
inappropriate, unnecessary,
and                             physicians in daily work and
inefficient care                strengthening family medicine
as an independent specialism

Guideline-Setting Procedures of the Dutch College of General

Practitioners

The 45 guidelines as developed by the Dutch College cover a wide range of problems and conditions seen in family practice, such as type II diabetes, sprained ankle, otitis media, dementia, and sleeping disorders. A guideline incorporates statements on adequate care, sometimes in the form of an algorithm, and supporting background materials. It is structured according to the steps involved in patient contacts (history, examinations, tests, evaluation, patient education, treatment, follow-up, referral), preceded by a clarification of terms and concepts. The aim of guideline development is to provide family physicians with a point of reference for their daily work and to provide a basis for continuing medical education and postgraduate training for family physicians.