Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 1 (March 2005) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority Mismatching Medical Devices and Accessories P ennsylvania facilities have submitted reports to PA-PSRS describing injuries to patients from the use of incompatible device parts. For example, one then removed without damaging the glans. The bell of the clamp assembly is placed over the glans beneath the foreskin. The bell is positioned through a hole in report involved a patient that received deep cuts from the base plate. The arm of the plate is used to pull the a dermatome device in the thigh during harvesting of bell through the hole by adjusting the nut (see Figure a skin graft. The facility determined that a cutting 2). A properly assembled, properly applied clamp re- blade from a manufacturer other than the dermatome sults in an evenly distributed force around the foreskin manufacturer was used with the dermatome device to between the bell and plate, allowing the foreskin to be obtain the graft. Another report involved excessive removed with a scalpel. If the bell and plate of the bleeding during circumcision. During the procedure, a clamp are not uniformly positioned around the hole Gomco®-type circumcision clamp broke apart. The surrounding the foreskin, bleeding from the cut fore- facility concluded that mismatched parts of different skin may occur. clamps were assembled during the sterilization proc- ess. Mismatching parts of devices or devices and associ- ated accessories can have a significant impact on These reports demonstrate the need for clinical staff patient safety. Examples of mismatching parts and/or to be aware of the compatibility of medical devices accessories include:4 and their associated accessories and devices that require assembly prior to use. • Mixing devices and parts or accessories from dif- ferent manufacturers or incompatible parts and The example involving the dermatome is not new. In accessories from the same manufacturer. 1994, ECRI published a Hazard Report and a Hazard Alerts Action Item about a similar incident involving • Attaching an accessory to the wrong connector of deep lacerations to a patient due to a dermatome a device. blade manufactured by Padgett that was inserted into • Cleaning and/or processing different disassem- a Zimmer dermatome device.1 Though the Padgett bled devices together. blade appeared to fit well into the Zimmer derma- tome, there were no identifying marks on the blade as • Using parts or accessories from sources other to the manufacturer or the correct blade orientation. than the original device manufacturer that may The specific shape of the Zimmer blade was such that not be completely compatible or that have been it could only be installed into the Zimmer dermatome modified. in the correct orientation, unlike the Padgett blade To minimize the likelihood of injuries due to mis- used in this case. The Hazard Report further stated matches, some hospitals provide education to users that, in their user manuals, both manufacturers in proper disassembly and reassembly of device parts (Zimmer and Padgett) warn against using incompati- and accessories and in identifying which accessories ble manufacturers’ blades. are for use with specific medical devices. Other ex- amples of ways to mitigate mismatches are to place In the circumcision clamp example above, the specific unassembled parts of each device in separate instru- mismatch of parts was not stated in the report submit- ted to PA-PSRS. However, an example of a mismatch of clamp parts would be the bell or base plate arm This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 2, No. from one manufacturer assembled to the base plate 1—March 2005. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI & ISMP under contract to the Authority as of another manufacturer (see Figure 1). Another sce- part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). nario of an injury occurring during circumcision is us- ing a damaged or worn clamp, which can result in Copyright 2005 by the Patient Safety Authority. This publication may be re- inadequate clamping force.2,3 printed and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. Gomco-type circumcision clamps are used to crush the foreskin distal to the glans penis. The foreskin is To see other articles or issues of the Advisory, visit our web site at www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2005 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 1 (March 2005) Mismatching Medical Devices and Accessories (Continued) ment sterilization trays or bags, to use pictures of correctly assembled devices to guide device reas- sembly, and to verify the proper operation of a de- vice after assembly or before use. Notes 1. ECRI. Use of Incompatible Dermatomes and Blades [Hazard Report]. Health Devices 1994 Apr;23(4):145. 2. ECRI. Incompatibility of Different Brands of Gomco-Type Cir- cumcision Clamps [Hazard Report]. Health Devices 1997 Feb;26 (2):76-77. 3. Food and Drug Administration. Potential for injury from circum- cision clamps [online]. 29 Aug 2000. [Cited 21 Feb 2005.] Avail- able from the Internet: http://www.fda.gov/cdrh/safety/ circumcision.html. Figure 1. Exploded View of Gomco-type Circumcision Clamp. Source: ECRI. Reprinted with permission. 4. ECRI. Hazards of Mismatched Parts and Accessories [Guidance Article]. Health Devices 1996 Jan;25(1):31. Figure 2. Correctly Assembled Gomco-type Circumcision Clamp. Source: ECRI. Reprinted with permission. Page 2 ©2005 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 1 (March 2005) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. ©2005 Pennsylvania Patient Safety Authority Page 3