UGANDA HEART INSTITUTE

Our Ref: ADM/215/212/01

Your Ref: ………………………………

26th August, 2013.

The Director,
Uganda Heart Institute

Thru: The Clinical Head

Uganda Heart Institute

Dear Sir,

POOR QUALITY SURGICAL BLADES

I wish to bring to your notice the quality of surgical blades we have been using over the past two months. We receive
our surgical blades from the National Medical Stores (NMS) on a quarterly basis.

We however, have been experiencing the following challenges with the current blades.
1. The blades are blunt and can hardly cut skin.
2. Soft tissues surgery requiring high precision such as blood vessel arteriotomy can no longer be easily
performed as the blades compel one to press hard in order to cut hence causing damage to tissue.
3. Many of the blades cannot fit on their respective BP handles.

The blades were subjected to cutting paper and thereafter human tissue (Human skin). Their capacity to sustain good
cutting capability following multiple incisions was demonstrated. Find below an evaluation of the blades as well as their
fittings (handling capabilities).

More recently we received blades that are not fit for use in our unit and are probably required by units such as ?
urology i.e Blade No 12, manufacturer - DOLPHINE® , batch No. 201102.

We also wish to note that the DOLPHINE® brand of surgical blades has no manufacturer details indicated on its
package. Follow-up of quality for such a product could turn out to be difficult.

NB. We have previously complained about the quality of surgical blades by brand name GITTOES® that were supplied
with open foil packaging and hence unsterile.

1
 UGANDA HEART INSTITUTE

EVALUATION OF DIFFERENT TYPES OF BLADES

Cutting Cutting
Sample Fitting on capability - capability -
No. BLADE MAKE Manufacturer SIZE Batch No. Expiry date BP Holder holder Paper Human Skin
NIRAJ INDUSTRIES PVT LTD
177/25 Ballabgarh,
1 TECHNO CUT® FARIDABAD, INDIA 11 101511 Oct 2015 No. 3 YES OPTIMUM POOR
Huaian Tianda Medical
Instruments Co. Ltd ?
2 MEDICARE® Hong Kong 11 08286 Sept 2013 No. 3 NO POOR POOR

Not indicated
3 DOLPHINE® 12 10585 Feb 2016 No. 3 NO OPTIMUM POOR

Not indicated
4 DOLPHINE® 12 201102 Feb 2016 No. 3 NO POOR POOR
Huaiyin Tianda Medical
Instruments Co. Ltd No. 8
West Mingyuan Road ,
Huaian, Jiangsu CHINA
(NB. Logo on packet
5 GITTOES® same as for Medicare® ) 15 110805 Aug 2016 No. 3 NO OPTIMUM POOR
Boen Health Care Co. Ltd,
No.535, Shenxu Road
Suzhou, Jiagsu China
6 BOENMED® 21 121102 Nov 2017 No. 4 YES OPTIMUM POOR
Boen Health Care Co. Ltd,
No.535, Shenxu Road
Suzhou, Jiagsu China
7 BOENMED® 20 121102 Nov 2017 No. 4 YES POOR POOR
Boen Health Care Co. Ltd,
No.535, Shenxu Road
Suzhou, Jiagsu China
8 BOENMED® 24 121102 Nov 2017 No. 4 YES POOR POOR

The purpose of this letter is to request your authority to raise a complaint to NMS concerning the current poor quality
blades as well as wrongly supplied blades (No. 12) and avail us those that are appropriate and of better quality.

We also request that the National Drug Authority (NDA) performs a physio-clinical evaluation of these blades to
ascertain their quality.

Sincerely,

Dr Mwambu Tom
Consultant Surgeon/ Cardiovascular and Thoracic Surgery

c.c The In-charge UHI, Stores

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