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LETTERS: Nicola Baker, Claire Tweedale, and Chris J Ellis Adverse events with medical devices may go unreported BMJ 2002; 325: 905 [Full text]

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"Grandfathered" circumcision devices should be tested for safety and efficacy.

George Hill   (18 October 2002)

Angiocaths vs insytes

Judith A. Koster   (21 October 2002)

Sphygmomanometer luer slips cost lives.

Phillip J. Colquitt   (22 October 2002)

"Grandfathered" circumcision devices should be tested for safety and efficacy. 18 October 2002
George Hill, Executive Secretary Doctors Opposing Circumcision 98107 Send response to journal: Re: "Grandfathered" circumcision devices should be tested for safety and efficacy.	EDITOR--Doctors Opposing Circumcision (DOC) concurs with the view of Baker et al.1 that we are only seeing the tip of the iceberg regarding injuries from medical devices. Two of the most notorious medical devices are the Gomco clamp and the Plastibel that are used to perform circumcisions on newborns. The Gomco clamp was invented in the 1930s and the Plastibell was developed in the 1950s. When the United States Food and Drug Administration was given statutory power to regulate medical devices in the 1970s, existing devices were “grandfathered”. That is, they did not have to pass the rigourous tests required of new medical devices. They were simply assumed to be safe and efficacious. Such was the case with the Gomco clamp and the Plastibel. More than 1,100,000 newborn boys are unnecessarily circumcised in the United States alone with these devices. Every male circumcision produces a documented physical injury to the penis. Taylor et al. document that circumcision excises about 51 percent of the skin and specialized mucosa from the penis.2 The portion removed contains the most sensitive and erogenous areas of the penis. Studies released in the past year show that the injury is more than hypothetical. Actual injury to sexual functioning has been reported by several researchers.3-5 The Gomco clamp, developed at a time when medical doctors naively believed that newborn infants did not feel pain, is notorious for producing pain. It relies on crushing tissue to produce hemostasis. The crushed tissue is jampacked with nerves2 and is amongst the most sensitive tissue in the human body. Full anaesthesia is necessary for circumcision, but they commonly are performed with no anaesthesia, or at best an ineffective partial nerve block (DPNB).6 The Plastibell has a long history of complications including infection, retention of the plastic ring, and even a ruptured bladder.7-10 Six Australasian medical societies recently concurred with the Canadian Paediatric Society that there is no medical indication for newborn circumcision and that circumcision of the newborn should not be routinely performed.11-12. Neonatal Circumcision is not documented to prevent or cure any disease so the devices themselves are inefficacious.11-12 Given this, it is time for the United States Food and Drug Administration and other governmental licensing authorities to subject devices used to perform circumcisions to the same rigourous tests of safety and efficacy that it requires new devices to have. If they fail to pass, then the Food and Drug Administration should remove them from the market. George Hill Executive Secretary Doctors Opposing Circumcision Suite 42 2442 NW Market Street Seattle, Washington 98107 USA Web: http://www.doctorsopposingcircumcision.org/ Baker N, Tweedale C, Ellis CJ. Adverse events with medical devices may go unreported. BMJ 2002;325:905. Taylor JR, Lockwood AP, Taylor AJ. The prepuce: specialized mucosa of the penis and its loss to circumcision. Br J Urol 1996;77:291-295. Coursey JW, Morey AF, McAninch JW, et al. Erectile function after anterior urethroplasty. J Urol 2001;166(6):2273-6. Pang MG, Kim DS. Extraordinarily high rates of male circumcision in South Korea: history and underlying causes. BJU Int 2002;89:48-54. Fink KS, Carson CC, DeVellis RF. Adult Circumcision Outcomes Study: Effect on Erectile Function, Penile Sensitivity, Sexual Activity and Satisfaction. J Urol 2002;167(5):2113-211. Van Howe RS. Anaesthesia for Circumcision. In Male and Female Circumcision: Medical, Legal, and Ethical Considerations in Pediatric Practice. George C. Denniston, Frederick Mansfield Hodges, Marilyn Fayre Milos, (eds.) New York: Kluwer Academic/Plenum Publishers, !999: 67-97. Malo T, Bonforte RJ. Hazards of plastic bell circumcision. Obstet Gynecol 1969; 33: 869; 1969. Jonas G. Retention of a plastibell circumcision ring: report of a case. Obstetr Gynecol 1984; 24: 835. Owen ER, Kitson JL. Plastibell circumcision. Br J Clin Pract 1990; 44: 661. Lee LD, Millar AJW. Ruptured bladder following circumcision using Plasticbell device. Br J Urol 1990; 65: 216-17. Fetus and Newborn Committee, Canadian Paediatric Society. Neonatal circumcision revisited. (CPS) Can Med Assoc J 1996; 154(6): 769-780. Beasley S, Darlow B, Craig J, et al. Position statement on circumcision . Sydney: Royal Australasian College of Physicians, 2002.
Angiocaths vs insytes 21 October 2002
Judith A. Koster, RN in urgent care local hospital, 49007 Send response to journal: Re: Angiocaths vs insytes	Hospital ER reluctant to use Insytes, eventhough they are used throughout rest of hospital. Excuse used is that angiocaths may be needed in case patient needs CT to rule out pulmonary embolus (special dye compatible only with angiocath). But that is rare, indeed. The company who makes both says Insytes cause less phlebitis, but ER reluctant to change. Any suggestions?
Sphygmomanometer luer slips cost lives. 22 October 2002
Phillip J. Colquitt, Independent Technical Advisor Send response to journal: Re: Sphygmomanometer luer slips cost lives.	Editor, Hill[1] used the term “Grandfathered” to describe medical devices that are assumed to be safe, merely because they have been around a long time, and so do avoid legislative scrutiny - this in response to Baker et al.[2], who advise that adverse events with medical devices may go unreported. The nineteenth century invented, bi-metal luer slip(BMLS) connector used to connect cuff to gauge, on the ubiquitous manual sphygmomanometer fails frequently, and probably costs lives directly by impeding the ongoing evaluation of the effectiveness of cardio-pulmonary resuscitation (CPR) procedure, and indirectly through downtime spent doing unnecessary repairs. Rouse[3] gives some sense of the situation in a 2000 article in Nursing Times as follows:- “The ferrules which join should be a friction fit. However, these ferrules quite commonly are too loose. Consequently, they come apart when the nurse blows up the cuff. As a result the nurse has to hold the ferrules and tubing together, hold the stethoscope in place, blow up the cuff and unscrew the pressure release valve with her only two hands”. But one also frequently sees nurses resorting to running for artery clamps to loosen BMLS connectors, after having found them over tightened. Under such circumstances, how can anyone have faith that effective CPR can be reliably performed if the sphygmomanometer cuff needs changing to accommodate a larger arm? Manufacturers of electronic sphygmomanometers appear to have not fallen for the trap of using the same unsafe luer slip connector, and one sees a variety of metal and polymer based connectors. The decision to perpetuate unsafe luer connectors on manual sphygmomanometers is often in the hands of non-clinicians such as biomedical engineers, most of whom have no idea about clinical emergencies. I have reported the above device problem to major manufacturers of sphygmomanometers, to the FDA[4], and to ECRI[5], so far without any response. Presumably saving lives is a sensitive issue that takes second place to job justification. Competing interests: None declared. References: [1] "Grandfathered" circumcision devices should be tested for safety and efficacy. George Hill (18 October 2002) [2] Adverse events with medical devices may go unreported Baker et al. (19 October 2002) [3] Rouse A. How reliable are sphygmomanometers? http://www.nursingtimes.net/features/fipage.asp?story=nt20000911f04&gutter=features_index_gutter> Posted on 09/12/2000. Accessed on October 15 2002. [4] US Food and Drug Administration. Available on 15 October 2002 at http://www.fda.gov/ [5] ECRI (formerly the Emergency Care Research Institute). Available on October 15 2002, at http://www.ecri.org/