Some considerations in clinical evaluation of mental health care products.
Mental health professionals in clinical settings have a responsibility to ensure that product evaluations are carried out safely and produce results useful to patients, clinicians and administrators. Little information regarding this issue has appeared in mental health literature. Increasing concern in this area has led to new Food and Drug Administration regulations which require more stringent product evaluations. A case study of a product evaluation carried out in a large mental health facility is presented. The study illustrates the questions mental health professionals should address in a product evaluation: prior product testing, consequences of product use for staff and ethical issues in carrying out the evaluation. The authors conclude that a comprehensive evaluation design will help to ensure the safety of both patients and staff and identify the overall costs to the institution of using the product.
Caley
L M
LM
Millard Fillmore Health, Education and Research Foundation, Buffalo, New York.
Pinchoff
D M
DM
D004992:Ethics, Medical; D005260:Female; D006778:Hospitals, Psychiatric; D006801:Humans; D008297:Male; D009518:New York; D010344:Patient Advocacy; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D015397:Program Evaluation; D011570:Psychiatry / Q000295:instrumentation*; D012149:Restraint, Physical / Q000295:instrumentation; D014481:United States