Writing WorkbookFebruary, 2004

1. Writing Assignment, due March 62. Assignment for computer lab 1, February 73. Assignment for computer lab II, February 84. Assignment for computer lab III, February 215. Assignment for computer lab IV, March 66. Take-home examination, due March 29 (or sooner if you

want your mark more quickly!)

Some recommended short text on grammar:

Northey, M (1983) Making Sense: a student’s guide to writing and style, Oxford: University Press: Toronto Canada

Strunk, W Jr and White, EB (1979) The Elements of Style. 3rd ed. MacMillan, New York

Schertzer, M (1986) The Elements of Grammar. Longman, New York.

** Schwaqger, E. Medical Usage and Abusage. (1990) Oryx Press

**recommended by instructor for grammar section!

These books are available through Amazon at decent prices!

Assignment 1: due March 6

Your employee has handed you this draft of a background piece to be placed in your upcoming regulatory submission. Can you clean it up? Make your revisions with your tracking tool on in Word so that I can see your changes.

A novel inflatable mattress to be used for Pressure Ulcer Prevention

With apologies to Hilton Marc Kaplan & Anne-Caroline Dupont SalterAlfred Mann Institute, University of Southern California

November 2003

Pressure ulcers: scarey and debilitating pathology resulting from very large pressure and shear in the soft tissues of immobilized patients129. There are lots of different words that can be used to describe this really frightening thing (decubitus ulcers, pressure sores, bed sores, ischemic sores, etc.), and a multitude of therapies can be pointed to. The fact that there are so many divergent words is ironically a testament to the relatively poor success of the treatments. There are so many patients that get poor results. There are many reasons for this but let us look at the background.

Etiology

The pathogenesis of pressure ulcers (PUs) derives from a host of compounding etiological factors129:

Pressure over bony prominences are key. A reciprocal relationship between pressure intensity and pressure duration has been clearly recognized since 1930. Just as high pressures over a short time may result in PUs, so did lower pressures over a longer time. Immobility that will come from the inability to shift weight plays an important role. The tissues not experiencing periodic relief from the pressures on them. Friction and shear are important factors too, because they can accesserate the soft tissue damage. Tissue that is damaged, atrophied, scarred or infected gets an increased susceptibility to pressure. The elderly or immune compromised patient and the patient with wound healing or collagen-vascular diseases is at greater risk too. A lack of sensation, being common in many poorly mobile individuals, aggravated the situation further, because the individual may forget to regularly move even to the extent that he or she wants to. Insensate tissues also compromise neurotrophic growth and repair mechanisms. Urinary and/or fecal incontinence may also be present in individuals whose immobility derives from the injury of the spinal cord or brain. The irritation can fuel maceration of the skin and really make worse further susceptibility to the effects of pressure. As blood vessels become occluded or narrowed and as the soft tissues which they supply necrose (break down and die)

because they are starved of nutrients and oxygen, and because they accumulate toxic wastes and metabolites. a

Costs – to the Patient and Society

Age and pathology-matched patient trials have shown that hospital stays increase 3-5 fold in patients suffering from PUs at significant hospital expense101. One of 3.6 immobile patients will develop PU’s114. One group particularly prone to PU’s is the high level poorly functioning spinal cord injured (SCI) Swedish and other European non hospitalized patient group. Over 250,000 individuals have SCI in the US and the US has approximately 10,000 new injuries r each year102: SCI most commonly results in paralysis; as well as repeated and serious associated complications such as PUs, incontinence, sexual dysfunction, etc.! Healing, and rehabilitation, are also impacted by the psychological ramifications: namely depression, resentment, etc.103. The cost of treating PUs in the US has been estimated at over $ 55 Billion annually based on an average increase in hospital stay of 21.6 days at $2,360 per day in almost 1.1 million patients per year101.As socuety asks itself how can we pay for this it must consider the importance of treatment. The President himself has asked why are the costs so high and services so minimal.

Staging of PUs

National PU Advisory Panel Staging112 is a widely accepted method of staging Pus. It has four levels:

Stage I: The non-blanchable erythema of intact skin; the heralding lesion of the skin ulceration.

Stage II: The Partial thickness skin loss involving the epidermis and/or the dermis. Ulcer is superficial and presents clinically as abrasion, blister or shallow crater.

Stage III: The full thickness skin loss involving the damage or the necrosis of subcutaneous tissue which may extend down to, but not through, underlying fascia. Ulcer presents clinically as deep crater with or without undermining of adjacent tissue.

Stage IV: The full thickness skin loss with extensive destruction, tissue necrosis or damage to the muscles, the bone or the supporting structures (e.g. tendon, joint, capsule, etc.).

Current Treatments

Current treatments usually involve months of care and hospitalization, including:

Tissue Load Reduction:Specialized pressure support surfaces like air fluidized low airloss alternating air static flotation air or water foam standard or Roho dry floatation mattress126 are used to reduce the continuous pressure on tissues.

Nursing Care and Allied Therapists:

Patients are usually supplied with mediocre nursing care and helpful assistance for most of their regular activities of daily living. Typically, they must be regularly turned over or often moved up at least every 2 hours (which usually involves at least 2 staff members). Physiotherapists, occupational therapists, nutritionists, and social workers and psychologists are all definitely integral to very successful treatment and rehabilitation as well.

More detailed guidelines on preventive care given by the National PU Advisory Panel124

Control Skin Moisture:Careful management of skin moisture is essential to prevent maceration and minimize friction. Patients should be bathed only when needed for comfort or cleanliness; skin should be cleaned as soon as soiled with urine or stool; assess and treat urine leaks; skin should be protected with cream or ointment; and absorbent pads and/or briefs with quick-drying surfaces should be used.

To Prevent Over-Drying of the Skin. Friction should be reduced:

Lifting, rather than dragging, when repositioning; cornstarch on skin would be helpful. Change Position / Turning:

At least every 2 hours if bed-ridden; at least every hour if confined to a chair; and every 15 minutes if the bedridden subject is able and willing to shift his or her own weight around on the hospital bed or the sheelchair.

Pressure Distribution:Keeping the patient as flat as possible if bed-ridden (raising the head of the bed as little and for as short a time as possible); use foam, gel, or air cushions to relieve pressure; and pillows or wedges to keep knees or ankles from touching each other.

Nutritional Support:Ensure adequate caloric intake of a balanced diet and food supplements as required.

Treatment of Complications and Supportive Treatment

Where indicated:

An antibiotic cover (systemic and topical), swab cultures.The nutritional supplementation (enteral and parenteral).A blood transfusions, iron and folate supplementation.

The management of pain Minimization of muscle spasticity (to optimize healing by secondary intention)125.

Wound Care and Surgical Interventions 127 :Dressings: if wound is shallow and clean – hydrocolloid wafers, semipermeable foam, or polyurethane film. if wound is deep and clean – fill dead space with wet gauze; If there is necrotic debris – wet-to-dry dressings excessive exudate – absorptive dressings.

Surgical repair: once wounds are clean (< 100,000 organisms/cm2) and the patient is medically stable, a variety of reconstructive techniques may be utilized including; direct closure, skin grafts, skin flaps, musculocutaneous flaps, and free flaps.

The Gluteal Rotation Flap:While a variety of musculocutaneous flaps are useful in treating PUs, the gluteal rotation flap is of particular relevance to this study. The gluteal rotation flap is an axial flap based on the inferior (and/or superior) gluteal artery, located between the greater trochanter and the ischial tuberosity125 (Fig.s 1 & 2). After excising the PU wound, the muscle flap is elevated, together with an overlying skin paddle which is supplied by musculocutaneous perforators, and may then be rotated superomedially to cover sacral PU wounds, or inferomedially to cover ischial PUs (Fig.s 3 & 4) thus healthy muscle and skin are brought in to repair the deficient area, and provide healthy tissue over bony prominences, while scars are designed to lie away from these areas.

Fig.1: Gluteus Maximus131

ischial tuberosity

hypogastric artery

Superior gluteal artery

The inferior gluteal artery& nerve

Fig.2: Neurovascular pedicles

greater trochanter

Adjuvant Therapy:

The adjuvant therapies include: the electrical stimulation, the hyperbaric oxygen, the infrared or ultraviolet light, the low-energy laser irradiation, the ultrasound therapy, and the topical applications of the agents as varied as the growth factors and the maggot therapy.

For wound-healing effects, only electrical stimulation of skin has been recommended by AHCPR (US Dept of Health and Human Services, Agency for Health Care Policy and Research) as adjunct to conventional therapy for nonhealing ulcer128. Abstracts reviewed did not include electrical stimulation of underlying muscle to relieve pressure or reverse atrophy of muscle.

Electrical Stimulation for PU Prevention

Fig.3: Rotation for Sacral PU Repair Fig.4: Rotation for Ischial PU Repair

Since transcutaneous electrical stimulation (ES) of muscle for its pressure-relieving effects has been researched for well over 2 decades now, with multiple papers indicating the positive benefits of this therapy100,104,105,106.

As a patent on using ES for PU inhibition was filed with the USPTO in 1985, it issued in 1988. Assigned to The University of Michigan, it is based on transcutaneous ES over potential PU sites and claims benefits since there will be the resultant shifting of weight, muscle ‘blood pump’ effect, muscle hypertrophy (padding) and the ‘conditioning’ of atrophic muscles100.

Further benefits of ES and wound healing are also widely reviewed104,107, although of less direct significance when stimulation is in limited areas to achieve particularly muscle movement and reconditioning.

Current Drawbacks

The many and important limitations of current invasive and noninvasive patient and cargiver treatments are of great concern. Despite the wide variety of past and current preventive measures, PUs remain a significant medical and clinical pathology (as attested to by the high incidence of Pus of different levels of severity (60%?) and the extremely high and hard to prevent recurrence rates (20%?). ES – a therapy that has demonstrated significant potential benefits in the medical and clinical literature available in most university libraries – remains unharnessed because of all of the special limitations imposed by the prerequisite “wiring” of patients.

References

100. Levine SP, “Functional Electrical Stimulation for Pressure Sore Inhibition”, USPTO Patent 4,727,878, 1988 March 1 (filed 1985 Sept 26; Assignee: The University of Michigan, Ann Arbor, Mich.).

101. National Decubitus Foundation, “Cost Savings Through Bedsore Avoidance”, National Decubitus Foundation, 4255 S. Buckley Rd., Suite 228, Aurora, CO 80013 (www.decubitus.org/cost/cost.html).

102. Wells C & Hooker S, “The Spinal Injured Athlete”, Adapted Physical Activity Quarterly, 7:265-285, 1990.

103. Rimmer J, “Fitness and Rehabilitation Programs for Special Populations”, p.238, Brown and Benchmark, Madison, WI, 1994.

104. Bogie KM et al, “Electrical Stimulation for Pressure Sore Prevention and Wound Healing”, Asst Technol 12:50-66, 2000.

105. Bogie KM et al, “Improving the Health of Paralyzed Tissue using Electrical Stimulation”, U.S. Department of Veterans Affairs, Rehabilitation Research & Development Service, 3 rd National Rehabilitation R&D Meeting, www.vard.org/va/02/htm/rrds_feb_2002_confbogie1.htm, Feb 2002.

107. HK DCES IEEE Paper.108. Fourth National PU Prevalence Survey.109. Grays.110. HK dissection.

111. Fuhrer, Garber et al '93.112. National Pressure Ulcer Advisory Panel, “Pressure Ulcers: Incidence, economics, Risk Assessment”,

Consensus Development Conference Statement, West Dundee, Illinois, S-N Publications Inc., 1989.

113. Stacy RW, "Health & Economic Benefits of FES Induced Active Physical Therapy", 1986.114. 1 in every 3.6 immobile person develop pressure ulcers (Nick).124 National Pressure Ulcer Advisory Panel, “Clinical Practice Guideline on Pressure Ulcers in Adults:

Prediction and Prevention”, www.npuap.org.125. Wilhelmi BJ & Neumeister M, "Pressure Ulcers, Surgical Treatment and Principles", eMedicine,

www.emedicine.com/plastic/topic462.htm, Feb 14 2002.126. U.S. Department of Health and Human Services, "PU Treatment - Quick Reference Guide for

Clinicians", AHCPR Publication No. 95-0653, Rockville, MD, Dec 1994.127. Dharmarajan TS & Ahmed S, “The Growing Problem of Pressure Ulcers – Evaluation &

Management for an Aging Population”, Postgraduate Medicine, Vol. 113,5, May 2003.

128. Bergstrom N et al, "Treatment of Pressure Ulcers. Clinical Practice Guideline No. 15", US Dept of Health and Human Services, Agency for Health Care Policy and Research, Rockville, MD, AHCPR Publication 95-0652, www1.neweb.ne.jp/wb/decubitus/Clinical_Practice_Guideline.htm, 1994.

129. Yarkony GM, “Pressure Ulcers: A Review”, Arch Phys Med Rehabil, 75:908-917, Aug 1994.130. McGraw JB & Arnold PG, “McGraw & Arnold’s Atlas of Muscle and Musculocutaneous Flaps”,

Hampton Press Publishing Company, Inc., Norfolk, VA, 1986.131. Mathes SJ & Nahai F, “Clinical Atlas of Muscle and Musculocutaneous Flaps”, CV Mosby

Company, St Louis, MO, 1979.

Assignment for computer lab II

1. The above text (Assignment 1) needs to be formatted into a numbered heading structure. Complete this task as shown in the example on the next page.

2. Set up a heading structure in outline mode to base a clinical protocol that will mirror the clinical protocol TOC on the attached page.

Computer lab I: See appended files

3. INVESTIGATIONAL PLAN Error: Reference source not found

3.1. Purpose ........................................ Error: Reference source not found

3.2. Summary of Study Design ............ Error: Reference source not found

3.3. Protocol ......................................... Error: Reference source not found 3.3.1. Inclusion and Exclusion Criteria Error: Reference source not found

3.3.1.1. Rationale for Inclusion Criteria . Error: Reference source not found3.3.1.2. Rationale for Exclusion Criteria Error: Reference source not found

3.3.2. Subject Selection Procedures Error: Reference source not found 3.3.2.1. Initial Screening Stage: ..... Error: Reference source not found

3.3.2.2.1. Permission from Treating Physician Error: Reference source not found

3.3.3. Informed Consent ................... Error: Reference source not found

3.4. Conduct of Study ........................... Error: Reference source not found 3.4.1. Baseline Measures ................. Error: Reference source not found 3.4.2. Device Implantation ................ Error: Reference source not found 3.4.3. Stimulation Protocol ............... Error: Reference source not found 3.4.4. Testing Strategy ..................... Error: Reference source not found 3.4.5. Follow-up ................................ Error: Reference source not found

3.5. Measurements of Outcome Parameters Error: Reference source not found

3.5.1. Shoulder Subluxation ............. Error: Reference source not found 3.5.2. Muscle Thickness ................... Error: Reference source not found 3.5.3. Voluntary Muscle Strength and Range of Motion Error: Reference source not found3.5.4. Pain ........................................ Error: Reference source not found 3.5.5. Functional Activity .................. Error: Reference source not found 3.5.6. Inflammation ........................... Error: Reference source not found 3.5.7. Assessment of Device Movement Error: Reference source not found 3.5.8. Tone ....................................... Error: Reference source not found

3.6. Statistical Plan .............................. Error: Reference source not found 3.6.1. Sample Size Considerations . . Error: Reference source not found 3.6.2. Hypotheses Related to Efficacy Error: Reference source not found 3.6.3. Hypotheses related to safety: . Error: Reference source not found

3.7. Risk Analysis ................................ Error: Reference source not found 3.7.1. Hazard Assessment ............... Error: Reference source not found

3.7.1.1. Hazard Category I: Patient Injury Error: Reference source not found

3.7.1.1.1. Direct Tissue Damage Error: Reference source not found 3.7.1.1.2. Functional Damage ..... Error: Reference source not found

Computer lab III and IV: Electronic Submissions: to be provided

Assignment 6: Take Home Examination

MPTX 518- Spring 2004Class Project

Hilton Kaplan could use some help! He has to prepare for a clinical trial of an implantable device. I suggested that you help him with his writing challenges. Hilton will explain his trial to you, and then your work begins….

1 Group I: Hilton needs an IRB submission. Your group is responsible for writing the main body of the IRB submission for the Primary IRB. You will need to find the format for such a submission, and you will need to consult with Hilton to be sure that you are representing his case well.

2. Group II: Hilton needs an informed consent form. You will be responsible for creating this informed consent form in a format that should satisfy all of the IRBs.

3. Group III: Hilton needs a patient brochure so that patients can have a reference for their questions and concerns. You will be responsible for putting together this brochure.

4. Group IV: Hilton needs a clinical plan for the IDE submission that will be more detailed than that for the IRBs. You will be responsible for working on the clinical plan using the material that has been developed to date.

5. Group V: Hilton will need an investigator binder. Your job is to identify the materials that should be in the binder and assemble the binder with the materials that are currently available

6. Group VI: Hilton will need a plan to integrate all of these activities…and more! Your task is to write a project plan that will identify what needs to be done to have a successful trial and to put together a first draft of a clinical trial plan that includes tasks, timelines and budget.

How to Comply with Management Controls under Quality System Regulation?As a device company, we are required to have good manufacturing practice inspections

conducted by FDA on class II or III medical devices except those that have been exempted from the Quality System regulation (QSR). Traditionally, FDA investigators began an inspection by examining some typical quality problems from complaints and on the base of that review, they conducted a “for-cause” inspection to determine whether deviations from QSR existed. However, this ‘bottom up’ approach is not efficient enough. So FDA worked together with industry and developed a new method for conducting inspections under QSR in attempt to decrease the time spent and increase the focus of FDA medical device, called the Quality System Inspection Technique (QSIT), a ‘top down’ approach to inspections. Inspectors start inspections by examining whether procedures that address the requirements of QSR have been defined and documented, then they sample records to check if the procedures are being followed.This new approach has been rolled out on a nationwide basis in late fall of 1999. All manufacturers of medical devices will be subjected to inspections using this new technique. Under QSIT, FDA inspectors are directed to approach the inspection process by focusing on four “subsystems”: Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), and Production and Process Control. But management controls are seen as encompassing all subsystems.

Responding to the new changes, here we are going to establish proper and correct strategies to demonstrate compliance with management controls under QSIT.Usually, inspections on management controls will cover quality policy, management review, quality audit procedures, quality plan, quality system procedures and instructions, and overall organizational structure.Senior employees of a manufacturer have the authority to establish or make changes to the manufacturer’s quality policy and quality system. We should oversight their authority to avoid abusing. After quality policy and quality system are established, a management representative should ensure that the quality policy is understood, implemented and maintained at all level of the organization. He or she could delegate another individual the authority and responsibility for ensuring that the quality system requirements are effectively established and maintained.Each company is unique owing to its product, targeted patients and customers, employees, and location. So a company set up its quality policy according to it s own needs and values. Generally, we might include some or all of the following statements in our quality policy and objectives:

A statement that the company is committed to providing high quality products that are safe and effective for their intended purposes.

A statement that the company is committed to complying with all applicable laws and regulations.

A statement that the company is committed to providing training on its quality policy and procedures.

And we could prepare some evidence to demonstrate the dissemination of quality policy to FDA investigators, including:

Notations in employee training records Leaflets distributed to employees (permanent, contract, and temporary) Signage located around the company

Articles in company newsletters Notices on the company’s Intranet

Management review refers to the procedures for reviewing the implementation of quality system and quality policy in a company, such as

The procedure or requirement for reviewing such items as supplier audits, internal audit reports, quality problems, and quality data.

The procedure or requirement for initiating, documenting and following-up on corrective and preventive actions, including those from previous management reviews.

The procedure or requirement for reviewing/evaluating product and process variations and nonconforming products.

The procedure or requirement to ensure that minutes from management reviews are accurate and contain appropriate language.

The procedure or requirement that minutes from management reviews are to be stamped confidential and should not be disclosed during a routine inspection.

We may consider setting up management reviewing procedures that outline: The frequency of the management reviews The content of the material to be discussed at those management reviews The level of those in attendance

And minutes from management reviews should be maintained in accordance with the company’s document retention procedures. During the inspections, we could provide evidence that management reviews are being conducted. Those evidence might include:

Procedures for management reviews that contain standard agendas with headings that discuss review of: supplier audits, internal audits, quality problems, corrective and preventive action, and follow-up.

Agendas relating to the review of the quality system, and dates and attendance lists for management reviews that have taken place.

Corrective actions that resulted from the management reviews (sometimes FDA investigators may want to know how nonconformity was detected).

Schedules of management reviews (past and present)And we should develop an internal policy and /or procedure on how to handle the requests for information relating to internal management reviews.

Quality audits are composed of quality system audits, process audits, product audits (new and released), and supplier audits. For this part, we could include but not limit to following elements:

The systematic audit of all activities to ensure adequacy and compliance with all elements and subsystems of the QSR on a regular or special basis.

Comprehensive follow-up from previous audits and documentation of the follow-up action.

Position descriptions of the auditors and a statement that they are qualified by training and experience, independent of the areas being audited, and able to be objective in their assessment.

The requirement to document the dates when audits occur.

The requirement to ensure that audit reports are accurate and contain appropriate language.

The procedure for the distribution of audit reports, limited to specific individuals.

The procedure or requirement that the results from audits are to be stamped confidential and should not be disclosed during a routine FDA inspection.

And audit reports should be maintained according to the company’s document retention program.Evidence we could show to an inspector that audits have been conducted might consist of:

Audit procedures A list of the audits conducted, the dates they were conducted, and their scope. List of audit team members Corrective actions that resulted from quality audits Schedule of upcoming audits

Besides, we should develop an internal audit policy or procedure to handle with requests related.Quality plan may be general to address all aspects of the quality system or specific only relating to one product or process. We need to include device master record, design and development plan, production procedures and process flow diagram, and results of management reviews and internal audits in our quality plan. We also need set up some procedures such as sampling, testing, and acceptance criteria for receiving, in-process, and finished device inspection to help with the compliance to our quality plan.To demonstrate that quality system procedures and instructions have been established, we could prepare the following evidence:

Quality system record as defined in 21 CFR 820.186, “… which include[s],or refer[s] to the location of , procedures and the documentation of activities… that are not specified to a particular type of device(s)…”

A document control systems that contains an outline of the structure of the documentation used in the quality system.

Procedures showing how documents are controlled, maintained, and are accessible.

Procedures relating to all aspects of the process and quality assurance functions from the design to testing and release and servicing of finished devices that are in compliance with the quality system requirements.

The organizational structure would contain provisions for responsibilities, authorities, independence, and necessary resources for implementing the quality system, possibly including:

Designation of “management representatives” Individuals’ authorities to deploy resources Procedures through which key officials are able to control the release of

products or to authorize appropriate corrective and preventive action to be taken to prevent or eliminate non-conformities

In order to inform our employees the organizational structure, we could take methods like talking with management, obtaining the advice of company counsel, contacting the

human resources department, calling the company hotline, using company suggestions box, and talking to the management representatives or individuals in the quality department.So we can show the pertinent pages of the quality manual, parts of the organization chart, position descriptions, and authorization procedures as evidence to demonstrate our organization structure to an FDA inspector.Another important point, to help FDA officers improve the efficiency and establish a cooperative atmosphere, we should seriously prepare documents regarding overall or top level quality system policies and procedures such as management review procedures, quality policy, and quality plan. As appropriate, such documents should be clearly marked “Confidential” and company officials should ensure that these documents are returned before the end of close-out meeting. During the inspection, an FDA officer has access to and is entitled to make copies of individual document. Providing these documents in advance can help reduce in-plant time.

The above discuss is only for management controls subsystem under new QSIT. Since management is the core for compliance with QSR in a company, it is worthy for us spending a lot of time in setting up a good management controls system and making it being properly implemented in the following year.

Microbiological Hazards in Foods

Microbiological Hazard in food may cause seveer poisoning to us. One of the best-known mass food poisoning cases involved beef contamination in the fast food chain, Jack in the box. In January 1993, food poisonings were reported in the states of Washington, California, Nevada and Utah. Escherichia coli O157:H7 infected more than seven hundred people. Of those, 171 were hospitalized, 30 were diagnosed with hemolytic uremic syndrome and 4 died.

E.coli O157:H7 poisoning has then become a major concern.

E. coli is a species of intestinal bacilli named after German physician Theodor Escherich E.coli might serve in vitamin synthesis. Most strains of the E coli are not pathogenic. There are six categories of E.coli bacteria: Eneteropathogenic E.coli (EPEC), enterotoxigenic E.coli, enteroinvasive E.cole, diffuse-adhering E.coli (DAEC), enteroaggregative e.coli (EaggEC), and Shiga toxin-producing E.coli (STEC). E.coli O157:H7 is in the STEC group and is able to produce a toxin that is not typical in E. coli but produced by shigella, the same agent that causes dysentery.

Ground beef was contaminated by feces during processing. When the cattle was cut into pieces, the internal organs and feces were exposed to the surface of the meat. During the grinding process, bacteria got mixed into the beef.

One of the possible reasons that caused E.coli O157:H7 to grow in the cattle was because of grain feeding. A microbiologist in the U.S. Department of Agriculture, James Russell, found that the reversal from grain feeding to the traditional hay diet causes the amount of acid-resistant E.coli in cattle manure to drop dramatically.

Both the burger chain store and the beef industry were seriously impacted by this incident. Jack in the box was sued by food poisoning victims. In turns,

Jack in the Box sued its suppliers. The suppliers sued their suppliers. One of the few companies not to sue anyone was a cow boning plant, one of the chain's smallest suppliers.

According to American Meat Institute, significant strides have been made by the industry to reduce and eliminate E.coli O157:H7 from beef products. The slaughter process has been improved.

Starting from 1997, Hazard Analysis Critical Control Point (HACCP) is mandated for all federal inspected plants. HACCP is a risk management system originally developed by NASA. It brings in some sterilizing treatments such as carcass washes, citric acid treatments and air exchange systems.

After the incident, the general public becomes more aware of the hygiene of meat they eat. The consumers realized that not only bacteria could be found in our foods, but also animals’ fecal matter. They were shocked to realize that 1,200 veterinarians in the Food

Safety and Inspection Service (FSIS) but not a single human health professional. They demanded the Government implement policies that would prevent future occurrence of such an incident.

Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) inspect all the meat that goes into the market. In 1994, FSIS declared E.coli O157:H7 an adulterant in raw ground beef and initiated a microbiological testing program. In 1996, new regulations that modernized the nation's meat and poultry inspection system were announced for the first time in 90 years. Analysis and Critical Control Point (HACCP) plan was required to address and prevent all identified hazards in the process. In 1997, a generic E.coli testing for all meat and poultry slaughter plants and Sanitation Standard Operating Procedures were required. Now, all U.S. meat processors either contract routine services of a lab or have an in-house microbiologist.

However, since the HACCP system focuses only on processes from slaughtering to packaging and currently, it relies on “decontamination” of the contaminated meat while allowing the contaminations to occur. Consumers are at risk of exposure to ineffectively decontaminated beef. HACCP should monitor feeding and waste disposal processes as well. Also, there is no rigid regulation defined by USDA. Critical points are defined by the industry. For example, it is acceptable to find Samonella in one out of two turkey.

USDA should define a rigid and objective standard for classifying food contamination. Relying on cooking to ensure food safety is simply not a solution, although, according to Food Safety.gov, cooking with 70°C heat can kill E.coli O157:H7.

Resources:

United States Department Of Agriculture Food Safety And Inspection Service:http://www.fsis.usda.gov/

Government Food Safety Information:http://www.foodsafety.gov/foodsafe.html

CDC- Food Safety Office:http://www.cdc.gov/foodsafety/

Food Safety Network:http://www.foodsafetynetwork.ca

Reference:

“The Final Rule on Pathogen Reduction and Hazard Analysis and Critical Control Point (HACCP) Systems”, USDA, http://www.fsis.usda.gov/OA/background/finalrul.htm

“CDC, Division of bacterial and Mycotic Disease, Disease Information, Escherichia coli O157:H7”, CDC, http://www.cdc.gov/ncidod/dbmd/diseaseinfo/escherichiacoli_g.htm

“The 1996 Pathogen Reduction/Hazard Analysis and Critical Control Point (PR/HACCP) Final Rules”, FSIS, http://www.fsis.usda.gov/OA/background/ec0902.htm

“Draft Risk Assessment f the Public Health Impact of Escherichia coli O157:H7 in ground Beef”, American Meat Institute, http://www.meatami.com/Template.cfm?Section=_i_E_coli__i_&NavMenuID=129&template=TaggedContentFile.cfm&NewsID=467

Emily Green, “The Bug That Ate the Burger”, Times, June 6, 2001, http://www.stats.org/statswork/latimes-ecoli.htm