Regulatory Agency Guidelines Research Articles

Environmentally friendly voltammetric determination of melatonin in river water: Development and validation studies

AbstractMelatonin (MEL) is a hormone that can discharge into aquatic bodies and act as an endocrine disruptor; thus, its determination is important. In this study, a boron‐doped diamond electrode was used to develop an electroanalytical method based on square‐wave voltammetry to determine trace concentrations of MEL in river water. The electroanalytical method was developed and optimized in 0.1 mol L−1 sodium phosphate (pH=4.0) with parameters f=10 s−1, a=50 mV, and ΔES=2 mV. The validation study was carried out in the working range of 1.2–10.8 μmol L−1 using the parameters and statistical tools recommended by the validation guidelines of regulatory agencies. The matrix effect was significant; therefore, an analytical curve was directly constructed in the sample matrix by standard addition method. Results of linear regression indicated that the standard addition curve data presented a good adjust to linear model and have therefore a good linearity. Low limits of detection (0.29 μmol L−1) and quantification (0.86 μmol L−1) were observed. The estimates for precision (RSD (%)<15 %) and accuracy (mean recovery>99.5 %) were suitable according to the limits established in the literature; thus, the method was precise and accurate for the adopted working range. The study findings indicate that square‐wave voltammetry combined with a boron‐doped diamond electrode can be used for reliable and consistent determination of trace concentrations of MEL in river water. Furthermore, it presents interesting features such as lower environmental impact, speed, and low cost.

Comparing 1-year and 10-year whole blood metal ion results following Birmingham hip resurfacing for osteoarthritis.

Background:Patients with metal-on-metal hip arthroplasty may develop adverse reactions to metal debris that can lead to clinically concerning symptoms, often needing revision surgery. As such, many regulatory authorities advocate for routine blood metal ion measurement. This study compares whole blood metal ion levels obtained 1 year following Birmingham Hip Resurfacing (BHR) to levels obtained at a minimum 10-year follow-up.Methods:A retrospective chart review was conducted to identify all patients who underwent a BHR for osteoarthritis with a minimum 10-year follow-up. Whole blood metal ion levels were obtained at final follow-up in June 2019. These results were compared with patients’ metal ion levels at 1 year.Results:Of the 211 patients who received a BHR, 71 patients (54 males and 17 females) had long-term metal ion levels assessed (mean follow-up 12.7 ± 1.4 yr). The mean cobalt and chromium levels for patients with unilateral BHRs (43 males and 13 females) were 3.12 ± 6.31 μg/L and 2.62 ± 2.69 μg/L, respectively; for patients with bilateral BHRs (11 males and 4 females) cobalt and chromium levels were 2.78 ± 1.02 μg/L and 1.83 ± 0.65 μg/L, respectively. Thirty-five patients (27 male and 8 female) had metal ion levels tested at 1 year postoperatively. The mean changes in cobalt and chromium levels were 2.29 μg/L (p = 0.0919) and 0.57 μg/L (p = 0.1612), respectively.Conclusion:Our results suggest that regular metal ion testing as per current regulatory agency guidelines may be impractical for asymptomatic patients. Metal ion levels may in fact have little utility in determining the risk of failure and should be paired with radiographic and clinical findings to determine the need for revision.

319 G-Master: A Novel 3D Printed ACL Graft Preparation System That Improves Speed and Autonomy

Abstract Aim One of the most commonly performed procedures in orthopaedics is anterior cruciate ligament reconstruction. Autograft hamstring tendons are mostly used. The preparation of a hamstring autograft varies on patient factors and clinician choices. The use of a bulky, and expensive metal platform is usually involved, or an assistant is tasked to hold the other end of the graft. We aim to produce a 3D-printed sterilisable preparation system (G-Master) that improves autonomy and speed of the surgeon preparing the ACL graft. Method A stereolithography file (.stl) of the device was designed on Blender program and then manufactured on a commercial Fusion Deposition Modelling Ender 5 3-dimensional (3D) printer using a polylactic acid variant. The 3D printed parts include an attachable platform, two pillars whereby the attached pillar is where the endobutton (SN) holding the autograft sits in tension. These were autoclaved at 121°C under 15 psi of steam pressure for 30 minutes before the operation. Approval for device use was subjected to a rigorous process as class I devices as per the UK government Medicines and Healthcare Products Regulatory Agency guidelines and was then successfully used in vivo. Results We found the bespoke device to be beneficial in reducing graft preparation time and overall cost while increasing the autonomy of the surgeon and efficiency of the knee operating theatre list. Conclusions This is, to our knowledge, the first ACL graft preparation system that was produced using rapid prototyping and 3D printing. Other applications of 3D printing in manufacturing orthopaedic surgical instruments should be explored.

Modeling Pharmacokinetic Natural Product-Drug Interactions for Decision-Making: A NaPDI Center Recommended Approach.

The popularity of botanical and other purported medicinal natural products (NPs) continues to grow, especially among patients with chronic illnesses and patients managed on complex prescription drug regimens. With few exceptions, the risk of a given NP to precipitate a clinically significant pharmacokinetic NP-drug interaction (NPDI) remains understudied or unknown. Application of static or dynamic mathematical models to predict and/or simulate NPDIs can provide critical information about the potential clinical significance of these complex interactions. However, methods used to conduct such predictions or simulations are highly variable. Additionally, published reports using mathematical models to interrogate NPDIs are not always sufficiently detailed to ensure reproducibility. Consequently, guidelines are needed to inform the conduct and reporting of these modeling efforts. This recommended approach from the Center of Excellence for Natural Product Drug Interaction Research describes a systematic method for using mathematical models to interpret the interaction risk of NPs as precipitants of potential clinically significant pharmacokinetic NPDIs. A framework for developing and applying pharmacokinetic NPDI models is presented with the aim of promoting accuracy, reproducibility, and generalizability in the literature. SIGNIFICANCE STATEMENT: Many natural products (NPs) contain phytoconstituents that can increase or decrease systemic or tissue exposure to, and potentially the efficacy of, a pharmaceutical drug; however, no regulatory agency guidelines exist to assist in predicting the risk of these complex interactions. This recommended approach from a multi-institutional consortium designated by National Institutes of Health as the Center of Excellence for Natural Product Drug Interaction Research provides a framework for modeling pharmacokinetic NP-drug interactions.

An innovative method of nonclinical efficacy and toxicological evaluation of recombinant Salmonella typhi Ty21a expressing HPV16 and 18 L1 proteins

Advancement in technology led to development of live attenuated Salmonella typhi Ty21a as enteric vector for expression of foreign proteins. Such vector platform is inevitable for development of vaccine candidate against human papilloma virus (HPV), the etiological agent of cervical cancer with high prevalence in developing nations. The high risk HPVs like type 16 and 18 contributes to 70% of cervical cancer, hence Indian Immunologicals Limited (IIL), Hyderabad, India developed a recombinant HPV vaccine by introducing HPV 16 and 18 L1 protein coding genes into attenuated S. typhi Ty21a vector. Being a genetically engineered enteric vector vaccine, it would be less expensive, with an ease of oral administration, instead of injectable that needs trained personale, is an added advantage for low socioeconomic setup compared to existing HPV vaccines.Establishing the nonclinical efficacy and safety/toxicity as per the national/international regulatory guidelines has become major constrain for such recombinant S. typhi HPV (rSt.HPV) vaccine. Since, the intended clinical mode of rSt.HPV is through oral route, whereas the live attenuated S. typhi Ty21a doesn't colonize in gut of laboratory animals to be used for nonclinical experiments. Hence, an alternate and unconventional method of ‘intranasal drug testing’, was followed for nonclinical efficacy and toxicity evaluations. An array of parameters specified by regulatory agencies were investigated in mice, rat and rabbits administered with rSt.HPV through, intra-peritoneal, intranasal and oral routes, the intended clinical route.•Current unconventional and innovative nonclinical testing procedures helps in exploring the alternate methods by pharmacologist/toxicologist.•Ultimately, such new drugs developed through technology must serve the humankind justifying the guidelines of regulatory agencies.

Study of Harmonic Distortion Propagation from a Wind Park

Wind parks are electrical generation arrangements with non-linear characteristics. In fact, these complexes are potential sources of harmonic current injection upon the electric power systems, since their operation is fundamentally dependent on power electronic-based devices. Given this reality, for the connection of new installations, access studies must be carried out by the proponent according to the regulatory agency guidelines. In Brazil, these guidelines are given by the National Electric-System Operator according to a set of documents and instructions that support the requested studies. In this context, this paper is aimed at evaluating the influences of the PCC transformer representation and also the levels of background imbalance on the harmonic distortion propagation from a wind park. These influences are evaluated in the context of Brazilian regulatory standards by means of a typical national equivalent grid. In summary, the results suggest that the network representation may influence harmonic propagation.

Follow-up of Metal-on-Metal Hip Replacements at a Large District Hospital and the Implementation of Medicines and Healthcare Products Regulatory Agency Guidelines: A Review of 297 Patients.

BackgroundMedicines and Healthcare products Regulatory Agency (MHRA) guidance for patients with metal-on-metal (MoM) hip replacements was provided in 2012 and updated in 2017 to assist in the early detection of soft-tissue reactions due to metal wear debris. A large number of MoM hip replacements were undertaken at our hospital trust. A program of recall for all patients with MoM hip replacements was undertaken and MHRA guidelines were implemented. In this study, we aimed to investigate the effectiveness of the revised MHRA guidelines in the detection of early adverse reactions to metal debris and to re-evaluate the indications for metal artifact reduction sequence magnetic resonance imaging (MARS-MRI) and revision surgery.MethodsIdentification and recall of all patients with MoM hip replacements from 2001 were conducted by using theatre logs, patient records, clinical coding information, and consultant logbooks. Two senior arthroplasty consultants reviewed X-rays and patient records. Postal questionnaires were forwarded to patients, together with requests for general practitioners to complete cobalt and chromium blood tests. The two consultant-led review of MOM replacements was undertaken with further radiological investigations (X-rays, MARS-MRI) performed according to the 2017 guidance with support of consultant radiologists.ResultsOf 674 identified patients, 297 were available for review: 26 patients did not have MoM implants, 36 were untraceable, 59 refused follow-up, 87 moved out of area, 147 had died, and 22 already had revision. Of 297 patients, 126 were women and 171 were men; age range was 39 to 95 years (mean age, 69 years); 126 had resurfacing and 171 had MoM replacements. Twenty-six patients had elevated metal ions. Thirty-three patients underwent MARS-MRI: MARS-MRI results were positive in 17 and negative in 16. Of 17 patients with positive MARS-MRI, 10 patients were asymptomatic and seven were waiting revision.ConclusionsPositive MARS-MRI can often occur in the absence of elevated metal ion levels; elevated blood metal ion levels do not mean MARS-MRI will be positive. All patients with MoM replacements were at risk. It is imperative to assess patients regularly for symptoms that may raise clinical suspicion and maintain a low threshold to performing MARS-MRI.

A Rapid Two-Step Iduronate-2-Sulfatatse Enzymatic Activity Assay for MPSII Pharmacokinetic Assessment.

Clinical studies involving enzyme replacement therapies (ERTs) have increasingly utilized enzymatic activity assays to monitor efficacy and biofunction of the drug; as a result, these assays have become an important part of pharmacokinetic (PK) and pharmacodynamic assessments in ERT trials. This paper presents a two-step enzymatic activity assay for iduronate-2-sulfatase (I2S) (EC 3.1.6.13) which we have optimized to fit in 1 day and to complete in less than 6h. The rapid assay presented here is a significant improvement over the original two-step method with run time of 24h which spanned 2 days. The resulting 1 day assay is efficient, robust, reproducible, and better suited for use in pharmacokinetic studies. The method was fully validated in accordance with regulatory agency guidelines so that it could be implemented in PK studies. Validation of the method required additional modifications to circumvent limitations surrounding the calculation of accuracy. This challenge was overcome by developing strategies to determine both the expected and the measured values of validation samples in activity units. Subsequently, the method was validated in accordance with the FDA guidance for the validation of quantitative ligand binding assays (LBAs). Results of method development and optimization with focus on evaluations aimed at reducing the total assay run time as well as a summary of method validation performance are presented in this publication.

Primary Ciliary Dyskinesia: First Health-related Quality-of-Life Measures for Pediatric Patients.

Primary ciliary dyskinesia (PCD) is a rare disease. There are no available data on disease-specific pediatric patient-reported outcomes. Our objective was to create developmentally appropriate, health-related quality-of-life questionnaires (QOL-PCD) for children (6-12 yr) and adolescents (13-17 yr) with PCD and a parent proxy measure. The QOL-PCD was developed using a cross-cultural protocol-driven approach satisfying both North American and European drug regulatory agency guidelines. A conceptual framework was generated by literature review, focus groups (expert clinicians and patients/parents), and open-ended interviews with children, adolescents, and parents of patients with PCD. We recruited participants from international research consortiums, PCD clinics, and patient advocacy groups, aiming for representation of a wide spectrum of disease severity, sociodemographic status, and ethnicity. Qualitative interviews were conducted by trained and experienced research assistants and psychologists. Transcripts were content-analyzed with Atlas.ti/NVivo to assess saturation of content. A self-completed item relevance survey was administered to E.U. Qualitative and quantitative data were used to construct draft instruments. Questionnaires were further refined after cognitive interviews. Focus groups (n = 62 experts; n = 20 patients/parents) and open-ended interviews with patients/parents (n = 69; 34 males; age at diagnosis, 0-15 yr; FEV1, 58-118% predicted) revealed a wide spectrum of issues unique to this population. Content analysis of transcripts identified the following domains, depending on age: Respiratory Symptoms, Physical Functioning, Emotional Functioning, Treatment Burden, Ears and Hearing, Sinus Symptoms, Social Functioning, Role Functioning, Vitality, Health Perceptions, School Functioning, and Eating and Weight. Various items were retained in questionnaires, based on age and role of respondent: 37, 43, and 41 items for children, adolescents, and parent proxy, respectively. The item relevance survey (n = 57) yielded results similar to those of open-ended interviews. Cognitive testing (n = 47; 20 males; age at diagnosis, 0-11 yr; FEV1, 49-124% predicted) confirmed that items and response choices were clear and understood by respondents, and that all relevant items were included. The QOL-PCD measures, developed using rigorous, protocol-driven methods and international collaborations, have demonstrated content validity and cross-cultural equivalence for implementation in English-speaking populations. Psychometric testing is underway to determine their measurement properties for evaluating clinical interventions and informing quality of care.

Purification of supercoiled G-quadruplex pDNA for in vitro transcription

Abstract The formation of G-quadruplex in G-rich regions of DNA can be induced by transcription and is formed within plasmid transcribed in Escherichia coli. The G-loops are more evidenced on supercoiled (sc) topology than on relaxed (oc) or linearized (ln) plasmid isoforms. Thus, the present work reports different purification strategies to efficiently purify the pPH600 sc isoform from other plasmid topologies and host contaminants present in a clarified E. coli lysate. To accomplish this purpose, two affinity supports, l -tyrosine-Sepharose and l -tryptophan-Sepharose were prepared by linking l -tyrosine and l -tryptophan onto epoxy-activated Sepharose CL-6B and were further characterized. The commercial support l -arginine Sepharose was also used to purify sc pPH600 since it has already been efficiently applied to separate sc isoforms of other plasmids using mild binding and elution conditions. A first screen was performed to select the best support that allows to obtain highly pure sc pPH600 from a native sample (sc + oc). By comparing the binding/elution conditions of the three supports, l -tyrosine support showed the preeminent result in separation of two isoforms, allowing the total recovery of sc pPH600, using a decreasing (NH4)2SO4 gradient in HEPES 100 mM at 10 °C. The purification of sc pPH600 directly from clarified E. coli lysate was achieved with the support l -tyrosine-Sepharose and the quality control analysis revealed that the level of E. coli impurities (other pDNA topologies, proteins, endotoxins, gDNA and RNA) present in the final sc pPH600 sample was in accordance with the guidelines of regulatory agencies. In vitro transcription was performed using the purified sc pDNA to induce G-quadruplex formation and it was confirmed by circular dichroism (CD) that the transcript adopted parallel G-quadruplex topology. Overall, this work showed that sc pPH600 can be purified using l -tyrosine support and the transcript adopted parallel G-quadruplex topology.

Product warnings and the involuntary capture of attention

In both published papers and in guidelines of regulatory agencies and voluntary standards, examples can be found where the assumption is made that what will capture attention is that which is salient or conspicuous, and that these qualities are both necessary and sufficient to capture attention. A review of the published, peer-reviewed literature on attention capture, however, invites the conclusion that there are very few features of an object that will draw attention to themselves without or against the observer’s intentions. The ability of warnings to draw attention to themselves involuntarily is discussed within the context of the extant attention capture literature.

Adverse reaction to metal debris is more common in patients following MoM total hip replacement with a 36 mm femoral head than previously thought: results from a modern MoM follow-up programme.

We conducted a retrospective study to assess the prevalence of adverse reactions to metal debris (ARMD) in patients operated on at our institution with metal-on-metal (MoM) total hip replacements with 36 mm heads using a Pinnacle acetabular shell. A total of 326 patients (150 males, 175 hips; 176 females, 203 hips) with a mean age of 62.7 years (28 to 85) and mean follow-up of 7.5 years (0.1 to 10.8) participating in our in-depth modern MoM follow-up programme were included in the study, which involved recording whole blood cobalt and chromium ion measurements, Oxford hip scores (OHS) and plain radiographs of the hip and targeted cross-sectional imaging. Elevated blood metal ion levels (> 5 parts per billion) were seen in 32 (16.1%) of the 199 patients who underwent unilateral replacement. At 23 months after the start of our modern MoM follow-up programme, 29 new cases of ARMD had been revealed. Hence, the nine-year survival of this cohort declined from 96% (95% CI 95 to 98) with the old surveillance routine to 86% (95% CI 82 to 90) following the new protocol. Although ARMD may not be as common in 36 mm MoM THRs as in those with larger heads, these results support the Medicines and Healthcare Products Regulatory Agency guidelines on regular reviews and further investigations, and emphasise the need for specific a follow-up programme for patients with MoM THRs.

Completing a Yellow Card report following an adverse reaction to a medicine

Aesthetic nurses are more than aware that medicines have the potential for unwanted effects. Whereas some adverse effects are predictable and dose-related, others are less predictable and may bear little relationship to the dose in question. Any suspected adverse reactions to a therapeutic agent, including complementary and herbal products, should be reported as an incident and the online or paper Yellow Card sets out the information required. In this article, the author summarises the Medicines and Healthcare Products Regulatory Agency's guidelines on completing a Yellow Card report.

Treatment of demodicosis in dogs: 2011 clinical practice guidelines

These guidelines were written by an international group of specialists with the aim to provide veterinarians with current recommendations for the diagnosis and treatment of canine demodicosis. Published studies of the various treatment options were reviewed and summarized. Where evidence in form of published studies was not available, expert consensus formed the base of the recommendations. Demodicosis can usually be diagnosed by deep skin scrapings or trichograms; in rare cases a skin biopsy may be needed for diagnosis. Immune suppression due to endoparasitism or malnutrition in young dogs and endocrine diseases, neoplasia and chemotherapy in older dogs are considered predisposing factors and should be diagnosed and treated to optimize the therapeutic outcome. Dogs with disease severity requiring parasiticidal therapy should not be bred. Secondary bacterial skin infections frequently complicate the disease and require topical and/or systemic antimicrobial therapy. There is good evidence for the efficacy of weekly amitraz rinses and daily oral macrocyclic lactones such as milbemycin oxime, ivermectin and moxidectin for the treatment of canine demodicosis. Weekly application of topical moxidectin can be useful in dogs with milder forms of the disease. There is some evidence for the efficacy of weekly or twice weekly subcutaneous or oral doramectin. Systemic macrocyclic lactones may cause neurological adverse effects in sensitive dogs, thus a gradual increase to the final therapeutic dose may be prudent (particularly in herding breeds). Treatment should be monitored with monthly skin scrapings and extended beyond clinical and microscopic cure to minimize recurrences.

The Laws, Regulations, Guidelines, and Industry Practices that Protect Consumers Who Use Gift Cards

This paper discusses consumer protections available to gift-card users. Specifically, it examines the ways in which value loaded at the time of purchase is protected for future card use or returned to consumers when the card is not used or has expired. The consumer protection information included in this paper is derived from a number of sources, including several types of state statutes, Federal Trade Commission decisions, financial industry regulatory agency guidelines, and previous interviews with payments industry experts regarding practices concerning network-branded gift cards. This paper expands research begun by the Payment Cards Center in 2004 into prepaid cards generally and the protections available to consumers who use gift cards specifically.

A review of in vitro methods to assess the biological activity of tobacco smoke with the aim of reducing the toxicity of smoke

In the last few years tobacco companies have been developing several research strategies in order to reduce the risks associated with smoking. These strategies include, for example, the refining of alternative cigarette designs that reduce the amount of hazardous chemicals in the mainstream smoke by introducing modified filters, and/or reducing the amount of biologically significant ingredients in tobacco-burning cigarettes. In the last few decades numerous studies have been published to assess the biological activity of tobacco smoke using in vivo and in vitro test systems. In this scenario a general scientific consensus on how to measure and characterize the risk associated with cigarette smoke is still lacking. Short-term in vitro assays, which are widely accepted by regulatory agencies around the world, are useful tools to evaluate both the biological activity and the progress towards a reduction of tobacco smoke toxicity. These assays could be mainly applied to evaluate cytotoxicity and genotoxicity properties on whole cigarette smoke as well as condensates or fractions of whole smoke. Cytotoxicity induction can be measured as cellular viability and growth rates using different end-points. Otherwise, the target of genotoxicity studies is the DNA molecule. For genotoxicity evaluation, the end-points and cell systems should be chosen from those that are relevant and appropriate as clinical surrogate markers. In this respect, the occurrence of early biological effect markers, such as mutational or clastogenic events (point mutations, frameshifts, micronuclei, SCE, DNA adducts) in bacterial and mammalian cells should be studied in a tiered approach following the guidelines of regulatory agencies. The choice of criteria shall be matter of discussion.

Prospective assessment of an intervention to rationalize prescribing of nonsteroidal anti-inflammatory drugs.

Guidelines for the prescription of nonsteroidal anti-inflammatory drugs (NSAIDs), drawn in the Health Ministry and published by the Drug Regulatory Agency, were introduced in the emergency department of a university hospital. The main objective was to determine, in this prospective, before-and-after study, whether a teaching program could help doctors improve their NSAID prescribing practices. Correct prescribing included limiting NSAIDs to their most admitted indications, avoiding their prescription to accident-prone patients, and reducing treatment duration and daily dosage. An overall reduction of NSAID prescriptions was also expected. Prescribing errors were divided into violations (prescribing when unwarranted or against a contraindication) and inadequacies (if the compound or treatment schedule was not suited to the condition addressed). We measured the effect of the intervention 45 days after its initiation. Twenty-seven doctors participated in the two study phases (595 and 520 patients) and wrote 50 NSAID prescriptions in each (8.4% and 9. 6% of patients, respectively; P = 0.44). Prescribing errors decreased from 20% to 14% of cases (P = 0.60). There was a trend toward more prescriptions conforming to the Drug Regulatory Agency guidelines (P = 0.08). Treatment duration decreased from 10.4 +/- 5. 4 to 9.0 +/- 4.0 days (P = 0.03). The teaching of guidelines has helped physicians to improve their NSAID prescribing practices; however, it did not succeed in curbing the overall prescription rate. Unrestricted lists that include soft indications may influence younger doctors into prescribing more NSAIDs.

Testing Guidelines for Evaluation of Foodadditives Effects on Male Reproduction

The revised FDA Redbook guide lines presented in this article reflect current thinking concerning male reproductive toxicology. A number of different end-points to assess m ale repro ductive function have been included in the present draft of the FDA Redbook II guidelines to better assess potential effects of direct food additives and color additives on male reproductive function. The guidelines reflect a harmony with the development of the guidelines of regulatory agencies in this country and around the world.

A New Approach to the Safety Assessment of Pharmaceutical Excipients: The Safety Committee of the International Pharmaceutical Excipients Council

This article presents a set of proposed guidelines for the safety assessment of new pharmaceutical excipients. These guidelines were developed by the Safety Committee of the International Pharmaceutical Excipients Council and represent a new, scientifically based approach to establishing conditions for the safe use of proposed pharmaceutical excipients utilizing various routes of human exposure. They are based upon the best currently available toxicological science and have taken the deliberations of the International Conference on Harmonization into consideration. These guidelines were developed because there are no regulatory agency guidelines currently available which specifically address the toxicological testing of a material intended for use as an excipient in pharmaceutical preparations. Only materials which have been previously permitted for use in a pharmaceutical preparation or which have been permitted for use in foods may be considered safe under current practices. If implemented, these guidelines should expedite the review of a proposed new excipient by regulatory agencies.

Dissolving the problem of infectious medical waste.

Decisions in purchasing healthcare products are based on fiscal responsibility, employee safety, regulatory agency guidelines, and environmental conservation. One of today's major dilemmas in health care is that of disposing of medical waste. The Isolyser Company of Norcross, Georgia, is one of the first to develop a biocycle system to reduce the problem of contaminated waste. A description of the system is provided, along with its advantages and disadvantages.