Q: What are the packaging challenges facing the medical device industry?

A: The challenges I see facing the industry today are reducing overall costs, increasing process speed and maintaining package integrity. For all these issues, implementation of the right technology throughout the supply chain is the best solution.

Medical product manufacturers are finding they can reduce the amount of materials consumed while increasing productivity and efficiency. Companies are taking more control of the packaging process to eliminate secondary and non-value add processes.

By bringing the packaging process in-house, companies can eliminate the processes of converting materials, reduce material usage and reduce labor through automation. For most of our customers, it’s all about getting to market first, or being able to supply the market more efficiently.

Q: How is Multivac poised to meet these challenges?

A: At Multivac we look to incorporate as much of the filling, packaging, printing, labeling and inspection processes inline to most effectively maximize the horizontal thermoform fill-seal process (TFFS) and provide optimal value.

We’ve developed technology where, instead of using prefabricated medical packaging that is loaded by hand, the process is incorporated right into the supply chain in a liner fashion. This creates efficient and error-free solutions. We work with our partners to automate most packaging systems that need to produce high volume or complex fill to erasure all processes are met quickly and accurately. Specifically, Multivac meets these challenges by providing high-quality medical packaging solutions, employing more than 50 nationwide service technicians and design professionals and maintaining a 24-hour turnaround of customer ordered replacement items. Due to our growth, we’ve also implemented a 24/7 customer assistance service to ensure uptime of our packaging machinery. Because we have built more than 1,100 TFFS machines this year alone, we will continue to invest in the manufacturing facilities and service personnel needed to meet the global demand.

Q: How does medical device packaging equipment differ from food equipment?

A: Mechanically packaging systems are customized to perform differently and the packages have different functional requirements.

On the food side, there are sanitation design requirements and point-of-sale appeal.

Most medical packages, however, must meet complex standards and validation criteria, while providing protection that maintains a sterile barrier.

Medical packaging systems need not only the hardware to form the intricacies of the draw ratios, the depth, the pockets, but the software operating system capable of validating the process. Any sterile barrier that you’re trying to accommodate needs to be validated to maintain seal integrity on a pre-and post-sterile basis.

Sales for Greenway Medical Technology’s Prime Suite, an integrated clinical financial and administrative software solution for medical practices, increased 240 percent within one year as of November 2003. Additionally, the company’s client base increased 198 percent within the same time frame.

Headquartered in Birmingham, Ala., Birmingham Surgical PC (BSPC) is a general surgery group practice with five surgeons who practice at four different surgical locations, representing a weekly volume of 75 cases. These cases were organized by four nurse schedulers, one at each office.

Juggling Routine

BSPC surgical scheduling tasks were, at best, cumbersome and, at worst, a financial drain on the small surgical group. Nurse schedulers were armed with only a primitive desktop scheduling tool that relied on Excel. Each day, they would receive multiple phone calls or would meet with the surgeons to review daily surgical schedules. The nurse schedulers had to manually juggle and analyze a variety of data, with the ultimate goal of identifying each surgeon’s availability to leverage their time and resources.

An audit of nurse schedulers’ time revealed that they were spending, on average, 35 hours a month on non productive scheduling tasks, which led to increased personnel costs. BSPC also wanted to leverage the five surgeons’ time better. It was important to co ordinate surgeons’ schedules to make them available to assist one another, or they would need to hire a surgical assistant at a cost to the surgical group of about $500 per surgery.

Scheduling Central

BSPC adopted WebScheduler Surgical Group Scheduler (SGS-35) from WebScheduler LLC in Lafayette, Calif. The customizable Web and PDA-accessible practice management offering allows BSPC to streamline not just scheduling, but also surgical assists, surgical consults, rounding lists, vacation, conferences and call schedules.

The initial implementation was launched in August 2002, and within a month, BSPC was using the SGS-35 Calendar component exclusively. It was not long before the schedulers became adept at the intuitive procedures to post additions and changes to the BSPC Calendar-so comfortable that several enhancements soon were added, especially in the area of reporting, because nurse schedulers saw additional opportunities to improve the organization’s results.

Cost criterion was met with a minimum upfront, first-year investment: an initial $300 licensing fee and a quarterly $750 fee for a total first-year investment of $3,300. (The normal licensing fee, depending on the size of the practice, ranges from $500 to $1,500, but was reduced for BSPC since it was the first to use the WebScheduler technology in the Surgical Group Scheduler configuration.)

With all scheduling tasks centralized now, nurse schedulers’ time has been reduced, and there is no longer the need to drive from location to location to keep the schedules current. Based on original projections, BSPC reduced nurse schedulers’ unproductive time by 35 hours a month-in effect, eliminating all of the unproductive hours first noted in its audit. At $18 an hour, this represents an annual savings of $7,560 for a nurse scheduler’s time.

BSPC dramatically exceeded its own objectives in better leveraging surgeons’ time and schedules so they can assist each other in surgery, rather than incurring costs for surgical assistants. Instead of the 10 percent reduction in using surgical assistants originally targeted, BSPC achieved almost a 30 percent reduction. This means that BSPC was able to arrange its surgeons’ schedules so they can assist one another an average of 25 surgeries out of 75 surgeries per month. At a $500-per-case surgical assist fee, this represents $12,500 per month in savings, or $150,000 in savings annually. In just the first year, with a total investment of $3,300, BSPC added an extra $150,000 in gross charges, or a gross ROI of 45 times its investment.

Three options for physicians to lay an EMR foundation without implementing a complete system until they are ready.

Electronic medical records (EMRs) will soon be the primary means of clinical documentation for ambulatory medical practices. That’s evident because EMRs are one of the few tools available to physicians and healthcare enterprises that can positively impact both the clinical and administrative efficiency of the practice.

However, not all organizations are prepared for the scope and scale of a full EMR project. Is there a way to begin establishing a foundation for electronic medical records that will allow an individual practice or enterprise to begin the transition on an incremental basis?

Yes, there is. The incremental approach to an EMR allows practices to lay a foundation for an EMR without implementing a complete EMR system. Using a scalable system, practices can begin to create and store their data in a way that is compatible with EMRs, while minimizing physician workflow changes and capital investment requirements. By taking steps such as saving transcribed notes in an EMR-friendly way to implementing an electronic repository of data for viewing, an incremental approach allows sites to tailor a system to meet their current needs. At the same time, they are preparing for the inevitability of an EMR system.

When the decision is made to implement a full EMR in the future, the practice can build on the foundation established by the following incremental steps, helping ensure a successful transition to an electronic record.

Variety of Configurations

The incremental approach to an EMR allows for a variety of configurations, depending on the practice’s particular needs, and may follow one of these three options:

* Transcription

* Medication Management

* Repository

Option 1: Transcription

For sites that currently use transcription for clinical documentation, we recommend specific, easy-to-use formatting of transcribed notes so they can be downloaded into the EMR when the practice is ready to make that move. There are two levels to this strategy that should be addressed by your foundation system.

Level 1 is simple formatting that allows for the basic identification of the patient and provider. The formatting involves placing markers (dot codes) within the transcription that allow the program to identify the patient and download the progress note into the appropriate chart when the EMR is implemented. For practices that already store their transcription electronically in a well-defined format, it is possible to write utilities that allow for the insertion of these markers retroactively. The limitation of this level is that information contained within the progress note does not update the entire chart.

Level 2 allows for more information to enter a patient’s chart. It involves the insertion of additional dot codes within the body of the transcribed text that allow the application to parse out specific information such as medications, allergies, problems, diagnoses and labs, and place them into the appropriate sections of the chart. The practice gets the benefit of a complete progress note and a complete chart. The Level 2 strategy requires some modification in behavior for both providers (in terms of their methodology of dictating) and the transcriptionists. We typically recommend a coordinated training and project plan to ensure that all parties are prepared to successfully carry out this strategy.

Storing transcription in an EMR-friendly way allows a clinic to establish the basis of a complete electronic medical record with only a minor modification of its daily activities. When the EMR project is ready to go live, the stored information can be downloaded, and the practice will be up and running with a significant amount of clinical data already in place. This strategy involves the least expenditure of capital as a site begins building its EMR.

Option 2: Medication Management

Another incremental strategy is a partial implementation of the EMR, focusing on a specific activity that is commonly performed within a practice. The obvious choice for this is prescription writing and medication management. The benefits of electronic prescription writing within the context of an electronic medical record are well established:

* Legibility (since scripts are either printed or sent electronically to a pharmacy).

* Drug-to-drug and drug-allergy checking prior to the writing of the script.

* Automatic updating of the medication lists, which is performed as the prescription is written and includes current, historical and ineffective lists.

* One-step renewal: Drugs can be automatically renewed from the medication list with a push of a button.

* Formulary checking: As scripts are written, they can be compared against a patient’s formulary to ensure compliance.

* Template driven: Routine information, including correct spelling, instructions, dosage and administration route are all accurately recorded on the prescription.

 The U.S. Department of Health and Human Services (HHS) has initiated two new steps in building an electronic health care system that will allow patients and their physicians to access their complete medical records as needed, leading to reduced medical errors, improved patient care, and reduced health care costs.

HHS Secretary Tommy Thompson said HHS has signed an agreement with the College of American Pathologists (CAP) to license the college’s standardized medical vocabulary system and make it available without charge throughout the country.

He said this action opens the door to establishing a common medical language as a key element in building a unified electronic medical records system.

HHS also has commissioned the Institute of Medicine to design a standardized model of an electronic health record. The health care standards development organization, known as HL7, has been asked to evaluate the model once it has been designed.

HHS will share the standardized model record at no cost with all components of the U.S. health care system and expects to have a model record ready in 2004. It estimates that the free system will reduce medical errors and reduce health care costs by about $100 billion per year. However, many health care institutions will need to invest in computers and train staff.

With terms for more than 340,000 medical concepts, CAP’s standardized system has been recognized as the world’s most comprehensive clinical terminology database available, the agency said.

The licensing agreement with CAP will make it possible for health care providers, hospitals, insurance companies, public health departments, medical research facilities, and others to incorporate this uniform terminology system into their information systems.

The National Library of Medicine (NLM) at the National Institutes of Health will administer the CAP agreement under a five-year, $32.4 million contract to the organization for a permanent license for their terminology, known as SNOMED (Systematized Nomenclature of Medicine) Clinical Terms.

The contract includes a one-time payment shared by the Departments of Veterans Affairs, Defense, and several HHS agencies–with annual update fees paid by the NLM.

To obtain CME credits, complete the test below, following these guidelines:

1. Read each article carefully.

2. Choose the most appropriate response to each of the following questions and record these on the registration form. Unanswered questions are considered incorrect.

3. Send the completed registration form and your payment (check, money order, VISA, MasterCard, American Express) to the Center for Continuing Education, University of Nebraska Medical Center (UNMC).

4. After your test has been graded, you will receive a receipt, a copy of the correct answers, and a credit statement certifying completion from the UNMC. Questions about the test should be addressed to UNMC Center for Continuing Education (402-559-4152).

Credit: The University of Nebraska Medical Center, Center for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The University of Nebraska Medical Center, Center for Continuing Education designates this educational activity for a maximum of 3 hours in category 1 credit towards the AMA Physician’s Recognition Award. Each physician should claim only those hours of credit that he/she actually spent in the educational activity.

This CME activity was planned and produced in accordance with the ACCME Essentials.

1. Schweinfurth, in this month’s Laryngoscopic Clinic, cites a source that reports as much as what percentage of patients in whom stenosis occurs after they have been subjected to more than 10 days of endotracheal intubation?

a. 1.4%

b. 4.1%

c. 14%

d. 41%

2. What should be monitored in patients who are on long-term minocycline therapy, according to Pantanowitz and Tahan’s recommendation in this month’s Pathology Clinic?

a. thyroid function

b. liver function

c. kidney function

d. blood pressure

3. According to Ruenes and Palacios in this month’s Imaging Clinic, approximately 20% of extramedullary plasmacytomas occur in the head and neck.

True or False?

4. With which of the following statements regarding juvenile xanthogranuloma would Sahhar and colleagues disagree?

a. It is benign.

b. It is the least common form of non-Langerhans’ cell histiocytosis.

c. It usually appears as a localized cutaneous lesion.

d. When lesions occur cutaneously, they can be either solitary or multiple.

5. Of the following, which is the most common extracutaneous site of juvenile xanthogranulorna, according to Sahhar et al?

a. larynx

b. spleen

c. kidney

d. eye

6. According to Cinar et al, which of the following terms is/are synonymous with oncocytic carcinoma?

a. oncocytic adenocarcinoma

b. malignant oncocytoma

c. malignant oxyphilic adenoma

d. all of the above

7. Cinar et al state that radiation does not appear to favorably alter the biologic behavior of oncocytic carcinoma.

True or False?

8. According to a source cited by Purcell and her colleagues, prominent ears occur in approximately what percentage of the population?

a. 3%

b. 5%

c. 7%

d. 9%

9. According to the article by Church et al, which of the following statements regarding pigmented villonodular synovitis is false?

a. It is a malignant disease.

b. It usually involves a major joint.

c. It arises from the synovial membranes of the joints, bursae, and tendon sheaths.

d. It is usually monarthric.

10. At which of the following sites does pigmented villonodular synovitis occur most frequently?

a. hip

b. ankle

c. knee

d. shoulder

As we move forward in the 21st century, healthcare issues dominate. We are seeing medical advances that were unheard of in the early 1900s. Organ transplants, for one, have become almost commonplace. Meanwhile, Financing health care has become a political hot potato. Federal and state governments are struggling to provide health care in the face of budget shortfalls and rising costs. With dwindling resources, the question becomes how can those resources be best used to serve the greatest numbers of American people? Who is entitled to what?

One of the greatest opportunities for American public policy to improve the nation’s health is to differentiate between the macroallocation and the microallocation of resources. Those who distribute commonly collected resources, such as tax monies and health premiums, among a group of people macroallocate. Healthcare providers microallocate when their decisions focus on specific patients. We must better think through these two roles.

The individual focus of biomedical ethics is too Narrow to be useful in the macroallocation by payers. Macroallocation involves trade-offs and setting priorities. Distributing commonly collected resources among a group of patients involves very different dynamics than a provider caring for individual patients. Those distributing commonly collected funds do not have the luxury of individualized care. Government must provide multiple services to its citizens, and health insurers must provide service to multiple beneficiaries. Both have comprehensive duties to a wide group of beneficiaries. The scope of the differences between macroallocation and microallocation is considerable.

No nation, state, or health plan in the macroallocation of its funds can assume that its healthcare distributions can meet the cumulative medical need of all its individual members. This is clearer in other nations where the government more directly funds health care.

We must better reconcile individual need with the common resources that fund most of that individual need. Providers theoretically can meet all the medical needs of their patients; states can never meet all the health needs of their citizens. Providers can focus on an individual, but a government must meet many needs of all its citizens in a world of trade-offs and priorities. Providers ration when they fail to provide a medical service to a patient. A state or nation, however, rations both when it denies a needed medical benefit and when it fails to provide universal coverage. All governments ration medicine.

Once we slop avoiding the responsibility of rationing health care, we will recognize the occasional conflict between the goals and ethics of paying for (macroallocating) health care with commonly collected funds and the goals and ethics of delivering (microallocating) health care. To recognize and admit this conflict exists will be politically difficult but socially inevitable. Doing so will require a change in the cultural values of citizens and healthcare providers, but the rewards are gargantuan. America can deliver more health to its citizens for less money once it adopts a broader moral vision of health care.

Medical practice and ethics have been developed without consideration of trade-offs with other public goods, even though taxpayers pay almost half of the healthcare dollar. Government now funds about 45 percent of U.S. health care, and employers fund another 33 percent, bringing the total government and employer share of healthcare funding to almost 80 percent. (a) We lack a means of setting priorities in the macroallocation of health care and the tools for comparing health needs with other needed social goods. We have just begun to analyze the moral framework applicable to the macroallocation of resources.

Public policy has allowed providers to be the definers of the nation’s health and the chief architects of the nation’s healthcare system. We have been assuming, inappropriately, that a nation’s best route to health was to fund medical care one patient at a time, thereby allowing healthcare providers to impose their doctor-patient relationship on taxpayer monies without accountability or oversight. The total need of the group was the sum total of individual need. Public policy has not adequately asked the larger question, “How do you keep a society healthy?” How do we reconcile macroallocation with microallocation? Those who fund health care from collective funds must look beyond the individual to the entire group. When pooling money, we have to ask, “What maximizes the health of those who make up the pool?”

PROBLEM. Adverse childhood experiences have been found to be a strong predictor of emotional and physical problems in adulthood. However, the long-term sequelae for children who have suffered critical illness and exposure to invasive medical procedures are less well documented.

METHODS. This is a case study of an adult client who sought treatment for depression and attention deficit disorder. The psychotherapy treatment is discussed and the use of eye movement desensitization and reprocessing (EMDR) is described targeting a memory of a medical trauma resulting from a tonsillectomy when the client was 8 years old.

CONCLUSIONS. Significant healing outcomes were attained as a result of the therapy, i.e., decreased depression, less hypervigilance, and increased ability to concentrate, which resulted in the discontinuation of medication for depression and ADHD as well as significant improvement in overall functioning.

Search terms: Childhood trauma, EMDR, psychodynamic psychotherapy

Adverse childhood experiences have been found to be a strong predictor of emotional and physical problems in adulthood (Felitti et al., 1998). In a study of almost 10,000 participants in a medical setting, those with histories of being abused as a child were found to be at 1.6-2.9 times greater risk for cancer, chronic lung disease, skeletal fractures, hepatitis, diabetes, stroke, liver disease, and ischemie cardiac disease. In addition to these findings, the incidence of alcoholism, depression, drug abuse, and suicide was 4-12 times greater than for those without a history of abuse. Risk factors such as smoking, obesity, and promiscuity also increased significantly for adults who have suffered trauma as children.
Perry (2002) says that long-term consequences of childhood trauma include: attachment problems, eating disorders, depression, suicidal behavior, anxiety, alcoholism, violent behavior, mood disorders, and posttraumatic stress disorder. When left untreated, childhood trauma contributes to a multitude of physical and mental health problems throughout the life span. Researchers have found that trauma causes lasting neuronal and hormonal changes which shape brain structures and functioning, which then can have profound effects on all dimensions of development, social, cognitive, biological, and emotional (van der KoIk, 2003).

However, the long-term sequelae for children who have suffered critical illness and exposure to invasive medical procedures are less well documented. Shortterm behavioral responses have been documented during hospitalization. It is thought that the severity of the illness and the developmental level of the child most likely influence the subsequent responses to such events. The younger the child, the more seriously ill and invasive the procedures, the more likely the child is to have ongoing adverse affects and posttraumatic stress disorder (Rennick, Johnston, Dougherty, Platt, & Ritchie, 2002). One study of 43 children from ages 5-12 found that children undergoing cardiac surgery are at risk for developing PTSD, especially if the ICU stay is prolonged (Connolly, McClowry, Hayman, Mahony, & Artman, 2004). Postoperatively, PTSD symptoms increased in 23% of the children, with 12% meeting the criteria for a diagnosis of PTSD. No child had PTSD preoperatively. Wintgrens, Boileau, and Robacy (1997) believe that emergency interventions after accidents and painful, repeated medical procedures are traumas that could lead to posttraumatic stress reactions, but this has not been tested.

In addition to the effects of the trauma on the child, the parents are also affected, which in turn affects the child. Parental uncertainty related to survival of their child has been found to have a profound impact upon the child after a life-threatening childhood illness (Santacroce, 2003). A parent, who has had to face the loss of a child, suffers from an emotional trauma that may interfere with the ability to connect and nurture and the parent may unknowingly distance, which affects caretaking ability. This paper presents a case study of a client who suffered a significant medical trauma when he was 8 years old and his treatment as an adult in psychoanalytic psychotherapy using eye movement desensitization and reprocessing (EMDR) to target that trauma.

This year’s rally in the dollar is having an adverse impact on locally based medical device makers because they are becoming more expensive for overseas buyers.

The recent gains come after a sharp downturn in the dollar over the past two years. The dollar fell 50 percent from 2002 through 2004 as the trade deficit widened and foreign debt piled up. But with the U.S. dollar strengthening against other foreign currencies, products made here and sold elsewhere become less appealing to those foreign buyers.

“While foreign exchange has benefited many (medical technology companies) over the last several years, it is poised to do a U-turn, dampening revenue growth and–depending on the company’s hedging program–potentially dulling earnings per share growth,” said Joanne Wuensch, a medical device analyst with New York investment bank Harris Nesbitt & Co.

The dollar’s 2005 rise led Wuensch to reduce quarterly revenue estimates for several device companies she covers, including Bausch & Lomb, a rival to Santa Ana-based Advanced Medical Optics Inc. and Lake Forest-based Cooper Cos.; Biomet Inc., which purchased Interpore Cross International, a bone device maker that was based in Irvine; and Boston Scientific Corp., which has invested in several Southern California startups.

Wuensch didn’t change her revenue or earnings estimates for either Advanced Medical or Cooper. That’s because both companies earlier lowered their earnings guidance based on the strengthening dollar.

The dollar fluctuations are becoming an important issue for companies like Advanced Medical, a maker of eye surgery devices.

“With the recent softness in the euro, there is a concern that all of the benefit that corporate America has been receiving in terms of revenue growth and increased demand could create somewhat slowing revenue growth,” said Randy Meier, chief financial officer of Advanced Medical, which does about 70 percent of its business overseas.

In early June, Advanced Medical said it expects to post 2005 sales of $920 million to $930 million, down from an earlier forecast of $955 million.

That guidance “did incorporate some of our thinking about where currencies were going. But we also said that we did not expect that currencies would have a major impact in the second half of this year,” Meier said.

Hedging factor

Meier said Advanced Medical has benefited from several acquisitions that gave it manufacturing operations in foreign countries. The benefit: so-called “natural hedging” versus a dollar gain.

In the past few years, Advanced Medical has bought a cataract surgery device unit of Pfizer Inc., laser device maker Visx Inc. and a plant in Spain. The buys allow the company to make devices in Europe for sale there or export to other countries.

“A global company with operations and expenses that are in that local currency, whether it’s the euro or the yen, are somewhat naturally hedged against the fluctuations of currency,” Meier said.

Companies also use currency hedging to offset risk. They can buy contracts to convert a certain amount of foreign currency at a set U.S. dollar rate in the future. The downside is that the contracts can be expensive. The upside is that the effects of currency moves are limited.

Since Advanced Medical hedges its pretax income, a certain amount of its cash flow is converted to U.S. dollars, depending on currency trends.

Edwards Lifesciences Corp., the Irvine-based cardiovascular device maker, counts a majority of its sales from overseas buyers.

Edwards reported U.S. sales of $119 million and international sales of $139 million in the second quarter. About 47 percent of its international sales came from Europe with 34 percent from Japan.

Edwards took foreign currency issues into account when it issued its 2005 sales and earnings forecasts, said Corinne Lyle, its chief financial officer.

Lyle said the heart device maker’s sales are two-thirds hedged with foreign currency contracts, and that it’s also protected against foreign exchange issues because it makes products outside the U.S. in local currencies.

LIMITED HEALTH-CARE RESOURCES obligate physicians, employers, and third-party payors to periodically evaluate the cost-effectiveness of any medical assessment process. Evaluation is especially necessary when the process has become routine, as is the case with preemployment medical assessments. White-collar employees experience low risk at work. Office workers may perform multiple tasks, including answering the telephone, interacting with the public, handling money, receiving and delivering mail, typing and transcribing, operating office machinery, filing, and lifting supplies or parcels. Individuals may also perform professional duties (e.g., writing, editing, accounting, research, interviewing). Examples of white-collar occupations are government employees, telephone operators, clerks, and office equipment operators (e.g., computer programmers/technicians, financial workers). (1) All of these occupations are nonhazardous positions, and there is a lack of guidelines for preemployment health assessment of such workers.