Biomedical subjects

R E Dister

Publications and source records attributed to R E Dister.

5 recordsLinked to original sources

PubMed1991

Informed consent for extended-wear patients.

Because of the risk of complication posed by extended-wear lenses, contact lens practitioners must comply with the requirements of informed consent, which obligate the optometrist to communicate these risks to patients. Documentation of informed consent can be obtained by using printed agreements that describe the risks of wear, instructions for lens care, wearing schedules, and required follow-up evaluations. In determining wearing schedules for patients, optometrists should not recommend more than 7 days (ie, 6 nights) of continuous wear without demonstrable benefit to the patient, and informed consent requirements should be complied with and adequate documentation retained whenever extended periods of wear are contemplated. For wearers of disposable lenses, informed consent is necessary because practitioners are not able to inspect lenses prior to wear. Patients must be advised to remove lenses if pain, redness, reduced acuity, discharge, or photophobia result and to return for examination when these symptoms occur. Documentation of this warning and of other aspects of disposable lens wear may be provided by a printed agreement.

Consumer Product Safety↗

PubMed1990

Professional liability and the Federal Tort Claims Act.

Professional liability claims against military optometrists must be brought in federal court under the Federal Tort Claims Act, which establishes rules of procedure that are somewhat different from those found in malpractice claims against private sector optometrists. Despite these differences, cases litigated against military optometrists may potentially be used as precedents to be applied to cases involving private practitioners. Recent decisions of the federal courts have in fact set such precedents, in cases alleging misdiagnosis of ocular disease, failure to refer for medical treatment, and failure to warn of the significance of symptoms.

Diagnostic Errors↗

PubMed1990

Legal consequences of the FDA's 7-day extended wear letter.

The U.S. Food and Drug Administration (FDA) recently sent contact lens practitioners a letter advising them that the FDA had asked manufacturers to indicate a maximum recommended wearing time of 7 days for cosmetic extended wear soft contact lenses. This paper discusses the authority of the FDA and the legal consequences of the FDA's "7-day Letter." Congress has authorized the FDA to enact rules, guidelines and recommendations. The 7-day letter does not appear to be any of the above. However, it does have a significant effect on contact lens practitioners' professional responsibilities and legal obligations because the letter has led to changes in product labeling and the standard of care for extended wear patients. Practitioners would be wise to give careful consideration to any deviation from the FDA's recommendation and the provisions of the product labeling. As any deviation will likely impose greater legal responsibility on the practitioner, the special circumstances that justify the deviation should be thoroughly documented in an informed consent agreement.

Contact Lenses, Extended-Wear↗

PubMed1989

Computerized optometric records and the law.

Today, most computerized optometric records contain the financial and business data for a practice. As technology advances in both optometric instrumentation and computerization, data for the optometric examination is also becoming part of the computerized recordkeeping system. This paper discusses legal aspects of computerized optometric examination records with respect to content, patient confidentiality, authentication for litigation defense, and proper handling by staff.

Confidentiality↗

PubMed1987

Informed consent in contact lens practice.

The legal doctrine of informed consent mandates that the doctor provide sufficient information so a patient can refuse or consent to an optometric procedure in a knowledgeable, intelligent manner. Informed consent is especially important in contact lens practice. The informed consent procedures presented here are simple and straightforward. They should be a natural part of optometric practice, and will better educate patients who will less likely be displeased with the course of treatment because of unrealistic expectations.

Contact Lenses↗