Med Device Technol 2001 Jan-Feb;12(1):13-6 (ISSN: 1048-6690)

Williams D Department of Clinical Engineering, University of Liverpool. Are medical products killer devices or life-improving instruments?

This issue is being fought out in the general media today. The first article in a new series of the Material Matters column discusses this unwelcome phenomenon and examines the arguments.

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Clinical governance, litigation and human rights. J Manag Med 2001;15(3):227-41

(ISSN: 0268-9235) Harpwood V Cardiff University, Cardiff, UK.

Explores the relationship between doctors, lawyers and the government in the context of the explosion in clinical negligence litigation, clinical governance and the introduction of the Human Rights Act 1998. Examines these issues from a legal perspective. Concludes that successful risk management, careful monitoring and the implementation of authoritative guidelines hold the key to legal change.

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Sales and science: changing patterns of pharmaceutical and medical device advertising in peer reviewed urology publications, 1975-2000 J Urol 2001 Dec;166(6):2317-20 (ISSN: 0022-5347) Nelson CP; Bloom DA

Department of Urology, University of Michigan, Ann Arbor, Michigan.

PURPOSE: The effects of advertising on urological practice are controversial. We studied patterns of pharmaceutical and medical device marketing in peer reviewed urological journals in 1975 and 2000. MATERIALS AND METHODS: Pharmaceutical and medical device advertising in 1 European and 2 American peer reviewed urological journals were evaluated in 4 randomly selected issues of each journal published in 1975 and 2000, respectively. Advertising quantity and the qualitative characteristics of each advertisement were analyzed. RESULTS: We analyzed 574 advertisements in 24 issues.

Advertising decreased between 1975 and 2000 based on the number of pages per issue (55.3 to 31.9, p = 0.04), number of advertisements per issue (30.4 to 17.4, p = 0.0098) and the ratio of advertising-to-scientific pages (0.399 to 0.151, p= 0.0016). Mean advertisement length was stable at 1.8 pages. The top 3 advertisers in 1975 were Eaton, Roche and Warner compared with Pfizer, AstraZeneca and Merck in 2000. Advertising for antibiotics comprised 70.3% of all pharmaceutical advertisements in 1975 but only 15.2% in 2000 (p = 0.0001), while advertising for benign prostatic hyperplasia, erectile dysfunction and hormonal therapy increased sharply. Nutritional supplement marketing increased from 0.5% of all advertisements in 1975 to 4.3% in 2000 (p = 0.0026). The incidence of advertisements citing peer reviewed literature increased from 16.7% to 33% (p = 0.0001) with a greater increase in the European than in the American journals.

CONCLUSIONS: Advertising in peer reviewed urological journals has decreased since 1975 and fewer companies now market more products. Few advertisements cite the scientific literature. Better understanding of pharmaceutical marketing patterns may improve awareness of these efforts to influence physician practice.

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Associated infections: a macroproblem that starts with microadherence Clin Infect Dis 2001 Nov 1;33(9):1567-72 (ISSN: 1058-4838) Darouiche RO Infectious Disease Section and Center for Prostheses Infection, Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX, USA.

Medical devices are responsible for a large portion of nosocomial infections, particularly in critically ill patients. Device-associated infections can cause major medical and conomic sequelae. Bacterial colonization of the indwelling device can be a prelude to both infection and malfunction of the device. The pathogenesis of device-associated infection centers around the multifaceted interaction among the bacteria, the device, and the host. Bacterial factors are probably the most important in pathogenesis of infection, whereas device factors are the most amenable to modification with the objective of preventing infection. Some, but not all, of the studied bacterial receptors satisfy the proposed "adherence/infection" version of Koch's postulates. Traditional surface-modifying preventive approaches have largely focused on antimicrobial coating of devices and resulted in variable clinical success in preventing device-associated infections. The potential protective role of newer innovative approaches, such as biofilm modification and bacterial interference, ought to be further investigated.

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Biomed Instrum Technol 2001 Sep-Oct;35(5):331-7 (ISSN: 0899-8205) Levin M

Medical devices that met standards have been recalled. Quality systems that were said by internal audits to be in compliance with FDA regulations or ISO quality standards received serious questions after external auditing. Devices meeting standards or produced by quality systems felt to be in compliance have put patients at risk by failing at critical moments. Something more than just meeting standards and regulations is needed to provide safe and effective medical devices.

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Synergistic induction of cyclooxygenase-II by bacterial lipopolysaccharide in combination with particles of medical device materials in a murine macrophage cell line J774A.1. J Biomed Mater Res 2001 Jun 15;55(4):547-53 (ISSN: 0021-9304) Lee DH; Park JC; Suh H Department of Medical Engineering, College of Medicine, Yonsei University, 134, Shinchon-dong, Seodaemun-ku, Seoul 120-752, Korea.

Corrosion and wear of implanted medical devices may produce particulate debris, leading to acute and chronic inflammatory responses in the host. In the presence of biomaterial wear particles, host monocytes/macrophages are activated to synthesize or secrete mediators of inflammation. In order to understand the mechanisms underlying the host response to particulates and device-associated infections, we have focused on the effects of medical device particles on macrophage function, because these cells play a pivotal role in the body's response to foreign bodies and their interaction with other cellular components of the immune system. In order to evaluate the effects of particles of medical device materials on functional activities of macrophages, we developed a cyclooxygenase-II (COX-II) assay system using J774A.1 macrophages.

Constitutive cyclooxygenase (COX-I) is present in cells under physiological conditions, whereas inducible COX-II is induced by some cytokines, mitogens, and endotoxin, presumably in pathological conditions such as inflammation. We have evaluated the inductive effects of implant materials, i.e., particles of polymethylmethacrylate (PMMA), hydroxyapatite (HA), titanium oxide, and silica, on the activity of COX-II using thin layer chromatography of prostaglandin D(2) (PGD(2)) formed from [1-(14)C]-labeled arachidonic acid (AA). Also, we have assessed the synergistic effects of these particles on lipopolysaccharide (LPS)-mediated macrophage activation. Addition of LPS to these particles increased PGD(2) production several-fold greater than the addition of any inducer alone. Our results indicated that device-associated infections could enhance inflammatory responses to the wear particles in subjects with medical implants or in whom particulate biomaterials are used for clinical purposes. The use of this model COX-II assay system may lead to the identification of inflammatory potentials for implant materials more specifically than present in vivo assays.

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Reasons for patients' discontent and litigation. J Craniomaxillofac Surg 2001 Jun;29(3):181-3 (ISSN: 1010-5182) Krause HR; Bremerich A; Rustemeyer J Klinik fur Mund-, Kiefer- und Gesichtschirurgie Zentralkrankenhaus Bremen, Germany.

INTRODUCTION: Discontent and litigation among patients is a problem which increasingly preoccupies the medical profession. AIM: We aim to analyse the origin of discontent and litigation and to help avoiding these claims.

MATERIAL: One hundred and seventy-eight medical expert opinions were evaluated, all made following examination of the complainant. METHODS: Depending on the results of the clinical examination and the study of the files it was determined whether there was either a case of malpractice or insufficient informed consent, or no fault at all in a legal sense. In addition the patient and the surgeon were questioned as to their point of view regarding the procedure and their communication and relationship before and after treatment.

RESULTS: Frequent complaints were pain (either during treatment or afterwards), major swelling or bleeding, disturbances of trigeminal or facial nerve function, poor scar formation, loss of teeth or fixtures, faulty occlusion and discrepancies between the expected and the actual result of treatment. In 26 cases actual faults made during medical treatment were discovered. In 49 further cases, poor explanation of the proposed procedure was the reason for complaint. In the majority of remaining cases, neither faulty treatment nor insufficient information given to the patient lead to the complaint but the patient's expectations were unrealistically high.

CONCLUSION: A considerable proportion of lawsuits originate from misunderstandings, and not treatment errors: The surgeons often concentrate on the legal requirements of informed consent and neglect to explain the practical consequences of the operation; the patients in turn tend not to ask about possible complications.

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Classifying medical devices according to their maintenance sensitivity: a practical, risk-based approach to PM program management. Biomed Instrum Technol 2001 May-Jun;35(3):167-76 (ISSN: 0899-8205) Ridgway M Masterplan, Inc, 21540 Plummer St, Chatsworth, CA 91311-4103, USA.

Many medical equipment items need periodic attention to ensure that they continue to operate properly and safely; and most inspecting agencies require healthcare facilities to have a competent equipment maintenance program that is focused on the most critical of those devices.

There is however a long-standing lack of consensus on how best to determine which devices should be included in this critical device category, and which can reasonably be excluded. A new methodology is proposed for establishing a logical, fact-based framework for determining which devices should be included. It is based in part on a new FDA-sanctioned definition of what an appropriate regimen of planned maintenance activities for a medical device should include. This new definition addresses the medical device users' concerns about periodic performance verification and safety testing as well as detecting and correcting the wear or progressive deterioration of any non-durable parts, which is the primary focus of the conventional preventive maintenance programs found in less critical industries. The analytical approach proposed utilizes technical information that is either already available or which can be easily developed. It characterizes each different device by means of a 3-letter maintenance sensitivity profile that can be used to analyze the effectiveness of the maintenance procedures as well as quantify the device's sensitivity to planned maintenance. A collaborative effort to assemble and organize this data would provide the industry with a sound, logical platform for narrowing the scope of most PM programs and allow us to redirect a significant amount of scarce technical manpower into more productive activities such as device user training.