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At least 55 records · Page 3Linked to original sources
PubMed1998

[Unintended events in anesthesia due to reuse of disposable equipment].

Two cases concerning reuse of plastic-coated introducers (intended for single-use only) for intubation of children are described. If breaks in the coating occur, the airway can be compromised and removal of the broken piece of the plastic-coating can the treacherous. In this paper, the probable causes of the incidents are discussed and suggestions for avoiding breakage are outlined.

Anesthesia, Inhalation↗
PubMed1996

[Reuse of disposable equipment. Medicolegal viewpoint].

The ethical foundation supporting legislation on medical devices deals with safeguard of both individual and collective rights in health care and protection; there is no ethical reason in protecting individuals from reuse of medical devices, if reuse can be proved safe and efficacious, and if it is a way to ensure provision of services otherwise unextendable to all patients, due to lack of funds. This paper explores legal feasibility of reuse, and provides an interpretation of relevant legislation, with special concern on European Directives on Medical Devices. Whereas it is commonly accepted that controls can be imposed to test whether devices meet legal standards on safety and adherence to label indications, clinical investigations and research may as well illuminate different and wider features of the same items, not considered by the manufacturer and not included in the actual labelling. The present wording of the directives does not provide for an autonomous role of member states in asking for modifications in the provisions of the manufacturer, except when devices do not meet specific requirements stated by the directive. Nevertheless, there is no legal ground to emphasize labelling when contrasting with clinical research findings, thus leading to the conclusion that widening a possible manufacturer's understatement in therapeutic uses of medical devices is legally feasible. In the present situation in which responsibility for casualties from reused medical devices is unduly vested on physicians, Health Authorities in member States bear a moral responsibility in promoting adequate research trials to support safety and efficacy of reuse practices, thereby prompting manufacturers to apply for label modification.

Canada↗
PubMed1999

Evaluation of two new heart valve surgery techniques: partial sternotomy and port-access approaches.

OBJECTIVES: This review attempts to compare the port-access and partial sternotomy approaches of minimally invasive valve surgery. METHODS: Our brief experiences of the two techniques are summarized with an attempt to compare safety, cost-effectiveness of the procedure and post discharge follow-up. One hundred and two patients undergoing the procedures between May 1996 and October 1998 were analyzed. There were 65 patients in the partial sternotomy (MIV) group and 37 patients in the port-access (PAV) group. With the exception of a higher incidence of COPD in the MIV patients, there was no significant difference in pre-operative variables between these two groups. RESULTS: Total operating room time, surgery time and cross-clamp time were significantly increased in the PAV group. The operative mortality of patients with MIV was 3% (n = 2) while the PAV group was 8% (n = 3) (P = ns). More new atrial fibrillation was found in the MIV (26% versus 5%, P = 0.009). Otherwise, there was no significant complications observed in either group. During the 4-6 week follow-up, of those who were employed, 76% of MIV and 69% of PAV patients had returned to work. Of the retired patients more than 95% of the patients in both groups had resumed their daily routine activity. Importantly, the study showed PAV patients returned to work about 4 weeks sooner than MIV patients. CONCLUSIONS: MIV approach is more 'surgeon friendly' and can be carried out without increased intra-operative resource utilization. The PAV approach requires formal training and capital outlay for unique equipment, disposable and ancillary procedures. From a financial perspective, if the PAV technique is to become widely accepted intra-operative efficiencies must be maximized, post-operative fast-tract protocol must be utilized, financial expenditures for disposable equipment must decrease and requirement of ancillary procedures must be reduced.

Aged↗
PubMed1996

The cost-effectiveness of laparoscopic versus abdominal Burch procedures in women with urinary stress incontinence.

STUDY OBJECTIVE: To evaluate the cost-effectiveness of laparoscopic versus abdominal Burch procedures in women with urinary stress incontinence (USI). DESIGN: A historical cohort with a minimum follow-up of 1 year. SETTING: Two tertiary, university-affiliated referral centers. PATIENTS: Women with USI who had either a laparoscopic Burch (31 women) or an abdominal Burch procedure (31). They were matched for the type of procedure as well as any concurrent procedures. MEASUREMENTS AND MAIN RESULTS: The primary outcome was cure, defined as the absence of USI subjectively as described by the patient, and objectively as confirmed by urodynamic and stress tests. Cost data were extracted from hospital charts and office records. To calculate costs we assessed professional fees (physicians, nurses, nursing assistants), investigations (laboratory tests, radiology, urodynamics), drugs, capital equipment, disposable equipment, and length of stay. The cure rates were 97% and 90%, respectively. The mean duration of follow-up was 1.2 years (range 1-2.5 yrs) for a laparoscopic Burch and 2.7 years (range 1-9 yrs) for an abdominal Burch. Preliminary results showed a significant difference in cost effectiveness between the procedures. The average cost for a laparoscopic Burch was $2938.35 and for an abdominal Burch $5692.30. The higher costs for abdominal Burch were due to increased hospital stay. The cost-effectiveness ratios (cost/cure) were $3029.23 and $6324.78, respectively. Sensitivity analysis was performed to assess for robustness. CONCLUSIONS: The preliminary results show that a laparoscopic Burch is more cost-effective than the abdominal Burch in treating women with USI.

Adult↗
PubMed1999

Sharps disposal in the ED: simple techniques and equipment.

Disposal of sharp instruments and needles ("sharps") is an ongoing problem in the emergency department (ED). Cleanup and disposal of needles and other sharps after a procedure is the responsibility of all ED personnel, including physicians. Simple cleanup techniques are explained and illustrated. All techniques are designed to be done (1) without exposing physician to a needle stick, (2) with equipment readily available in the ED, and (3) with containers readily seen by those disposing of the sharps and other materials. Adherence to these cleanup procedures should help lessen the problem of sharps and disease exposure in the ED.

Accidents, Occupational↗
PubMed1997

Therapeutic ERCP: a cost-prohibitive procedure?

BACKGROUND: ERCP is increasingly being performed for therapeutic purposes and engenders a proliferation of disposable equipment without a clear indication of cost-effectiveness. METHODS: We analyzed the financial impact of ERCP by prospectively analyzing ERCPs performed in our institution from June 1, 1994, to September 30, 1994, by calculating charges related to indirect costs, disposable equipment costs, and overall reimbursement. The data were analyzed according to insurance payor as well. RESULTS: Disposable equipment costs a mean of $149 per diagnostic ERCP and $532 per therapeutic ERCP. For diagnostic ERCP, disposable equipment accounted for 27% of reimbursement; for therapeutic ERCP, disposable equipment accounted for 68% of reimbursement. Although overall reimbursement was higher for therapeutic ERCP, the very high direct costs related to disposable equipment limited the ability of reimbursement to cover indirect costs. CONCLUSIONS: Depending on the complexity of cases, quantity of disposable equipment used, and patient-insurance mix, therapeutic ERCP may be cost prohibitive for a given endoscopy unit. Indirect costs should be more carefully and quantitatively analyzed. Disposable equipment should be evaluated in terms of cost, safety, and patient outcome.

Cholangiopancreatography, Endoscopic Retrograde↗
PubMed2003

Cost-effectiveness of intracoronary ultrasound for percutaneous coronary interventions.

The Strategy for Intravascular Ultrasound (IVUS) guided PTCA and Stenting trial included a prospectively designed economic analysis to investigate whether routine IVUS guidance intervention is cost-effective. Consecutive patients (n = 269) with 356 lesions were randomly assigned to receive provisional stenting with angiographic guidance only (ANGIO) or with IVUS guidance. The 2-year major adverse cardiac event-free survival (effectiveness) was significantly higher in the IVUS-guided group (80% vs 69%, p <0.04). In-hospital costs for procedural personnel, capital equipment, and disposable equipment were higher in the IVUS group. This was offset by lower costs for inpatient care and urgent target vessel revascularization in the IVUS group. Therefore, the total in-hospital cost was only slightly higher with IVUS (5,245 +/- $2,256 [IVUS] vs 4,776 +/- $2,961 [ANGIO], $/patient, p = 0.15). During a 2-year follow-up, costs for cardiac hospitalizations were slightly lower in the IVUS group, whereas costs for medication and indirect costs were similar. This resulted in identical total costs over the 2-year period (15,947 +/- $8,545 [IVUS] vs 16,103 +/- $9,954 [ANGIO], $/patient, p = 0.89). The incremental cost-effectiveness ratio for IVUS guidance calculated to -$1,417/major adverse cardiac event-free survival gained. In 55.3% of bootstrapping replications, IVUS was less expensive and more effective. In conclusion, when used in a provisional stenting strategy, routine IVUS imaging is cost-saving half the time.

Angioplasty, Balloon, Coronary↗
PubMed1975

[Determination of radiation dosage for radiosterilization of disposable medical equipment].

The study on radiation resistance of 17169 microbial clones was performed including 15376 clones of bacteria isolated from the factory rooms in which injection needles were manufactured and those adjacent to strong sources of ionizing radiation. Out of this number of examined clones, there were selected 955 clones which survived the radiation doses of 2-4 Mrad. Basing on analysis of resistant bacteria according to radiation, the dosages for sterilization of disposable medical equipment are proposed.

Bacteria↗